<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01681004</url>
  </required_header>
  <id_info>
    <org_study_id>300103</org_study_id>
    <nct_id>NCT01681004</nct_id>
  </id_info>
  <brief_title>Investigation of Sacroiliac Fusion Treatment (INSITE)</brief_title>
  <acronym>INSITE</acronym>
  <official_title>INSITE Investigation of Sacroiliac Fusion Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SI-BONE, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SI-BONE, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis&#xD;
      (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of&#xD;
      the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo&#xD;
      specific, targeted non-surgical treatment of the SI joint.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intended analysis was to examine differences in responses at 6 months. It was&#xD;
      acknowledged that subjects with chronic pain in the NSM arm group might not experience any&#xD;
      benefit as there was little evidence at the time that NSM was helpful. The protocol included&#xD;
      optional crossover to other treatments, including surgical treatment. The protocol&#xD;
      anticipated a high crossover rate and therefore did not include any comparative analyses&#xD;
      after month 6.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel group randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject Success</measure>
    <time_frame>6 months</time_frame>
    <description>Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in SI Joint Pain VAS Score at 1 Month</measure>
    <time_frame>1 month</time_frame>
    <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Si Joint Pain VAS Score at 3 Months</measure>
    <time_frame>3 Months</time_frame>
    <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in SI Joint Pain VAS Score at 6 Months</measure>
    <time_frame>6 Months</time_frame>
    <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in SI Joint Pain VAS Score at 12 Months</measure>
    <time_frame>12 Months</time_frame>
    <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in SI Joint Pain VAS Score at 24 Months</measure>
    <time_frame>24 Months</time_frame>
    <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Back Dysfunction</measure>
    <time_frame>1 month</time_frame>
    <description>Improvement in ODI score of greater than or equal to 15 points, at month 1.&#xD;
Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Back Dysfunction</measure>
    <time_frame>3 Months</time_frame>
    <description>Improvement in ODI score of greater than or equal to 15 points, at month 3.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Back Dysfunction</measure>
    <time_frame>6 Months</time_frame>
    <description>Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Back Dysfunction</measure>
    <time_frame>12 Months</time_frame>
    <description>Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Back Dysfunction</measure>
    <time_frame>24 Months</time_frame>
    <description>Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</measure>
    <time_frame>6 months</time_frame>
    <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</measure>
    <time_frame>12 Months</time_frame>
    <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</measure>
    <time_frame>24 months</time_frame>
    <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</measure>
    <time_frame>6 months</time_frame>
    <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</measure>
    <time_frame>12 Months</time_frame>
    <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</measure>
    <time_frame>24 months</time_frame>
    <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory Status</measure>
    <time_frame>24 months (surgical group), 6 months (non-surgical group)</time_frame>
    <description>Time to full ambulation among those without full ambulation at baseline.&#xD;
60 days was the median of time to full ambulation for the iFuse implant System arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>1 month</time_frame>
    <description>Proportion of non-working (due to back pain or other reasons) subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>3 Months</time_frame>
    <description>Non-working subjects (due to back pain or other reasons) who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>6 Months</time_frame>
    <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>12 Months</time_frame>
    <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>18 Months</time_frame>
    <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work Status</measure>
    <time_frame>24 Months</time_frame>
    <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Procedure, discharge, 1, 3, 6, 12, 18 and 24 months</time_frame>
    <description>Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">159</enrollment>
  <condition>Degenerative Sacroiliitis</condition>
  <condition>Sacroiliac Joint Disruption</condition>
  <arm_group>
    <arm_group_label>iFuse Implant System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgical placement of iFuse implants in the affected SI joint</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Surgical Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medications, SI joint injection, physical therapy and RF ablation of SI joint</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iFuse Implant System</intervention_name>
    <description>Placement of iFuse implant system via surgery</description>
    <arm_group_label>iFuse Implant System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-surgical management</intervention_name>
    <description>Medications for pain, physical therapy, SI joint injection and RF ablation</description>
    <arm_group_label>Non-Surgical Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 21-70 at time of screening&#xD;
&#xD;
          2. Patient has lower back pain for &gt;6 months inadequately responsive to conservative care&#xD;
&#xD;
          3. Diagnosis of sacroiliac joint disruption or degenerative sacroiliitis based on ALL of&#xD;
             the following:&#xD;
&#xD;
               1. Patient has pain at or close to the posterior superior iliac spine (PSIS) with&#xD;
                  possible radiation into buttocks, posterior thigh or groin and can point with a&#xD;
                  single finger to the location of pain (Fortin Finger Test), and&#xD;
&#xD;
               2. Patient has at least 3 of 5 physical examination maneuvers specific for the SI&#xD;
                  joint (see Table 3), and&#xD;
&#xD;
               3. Patient has improvement in lower back pain numeric rating scale (NRS) of at least&#xD;
                  50% after injection of local anesthetic into affected SI joint(s) (see Section&#xD;
                  3.6.4), and&#xD;
&#xD;
               4. One or more of the following:&#xD;
&#xD;
             i. SI joint disruption:&#xD;
&#xD;
               -  Asymmetric SI joint widening on X-ray or CT scan, or&#xD;
&#xD;
               -  Leakage of contrast on diagnostic arthrography&#xD;
&#xD;
             ii. Degenerative sacroiliitis:&#xD;
&#xD;
               -  Radiographic evidence of SI joint degeneration, including sclerosis, osteophytes,&#xD;
                  subchondral cysts, or vacuum phenomenon on CT or plain film, or&#xD;
&#xD;
               -  Due to prior lumbosacral spine fusion&#xD;
&#xD;
          4. Baseline Oswestry Disability Index (ODI) score of at least 30%&#xD;
&#xD;
          5. Baseline SI joint pain score of at least 50 on 0-100 mm visual analog scale*&#xD;
&#xD;
          6. Patient has signed study-specific informed consent form&#xD;
&#xD;
          7. Patient has the necessary mental capacity to participate and is physically able to&#xD;
             comply with study protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe back pain due to other causes, such as lumbar disc degeneration, lumbar disc&#xD;
             herniation, lumbar spondylolisthesis, lumbar spinal stenosis, lumbar facet&#xD;
             degeneration, and lumbar vertebral body fracture**&#xD;
&#xD;
          2. Other known sacroiliac pathology such as:&#xD;
&#xD;
               1. Sacral dysplasia&#xD;
&#xD;
               2. Inflammatory sacroiliitis (e.g., ankylosing spondylitis or other HLA-associated&#xD;
                  spondyloarthropathy)&#xD;
&#xD;
               3. Tumor&#xD;
&#xD;
               4. Infection&#xD;
&#xD;
               5. Acute fracture&#xD;
&#xD;
               6. Crystal arthropathy&#xD;
&#xD;
          3. History of recent (&lt;1 year) major trauma to pelvis&#xD;
&#xD;
          4. Previously diagnosed osteoporosis (defined as prior T-score &lt;-2.5 or history of&#xD;
             osteoporotic fracture). Patients meeting the osteoporosis screening criteria&#xD;
             identified by the National Osteoporosis Foundation should be screened for osteoporosis&#xD;
             with DEXA.**** See Section 3.6.4.&#xD;
&#xD;
          5. Osteomalacia or other metabolic bone disease&#xD;
&#xD;
          6. Chronic rheumatologic condition (e.g., rheumatoid arthritis)&#xD;
&#xD;
          7. Any condition or anatomy that makes treatment with the iFuse Implant System infeasible&#xD;
&#xD;
          8. Chondropathy&#xD;
&#xD;
          9. Known allergy to titanium or titanium alloys&#xD;
&#xD;
         10. Use of medications known to have detrimental effects on bone quality and soft-tissue&#xD;
             healing&#xD;
&#xD;
         11. Prominent neurologic condition that would interfere with physical therapy&#xD;
&#xD;
         12. Current local or systemic infection that raises the risk of surgery&#xD;
&#xD;
         13. Patient currently receiving or seeking worker's compensation, disability remuneration,&#xD;
             and/or involved in injury litigation.&#xD;
&#xD;
         14. Currently pregnant or planning pregnancy in the next 2 years&#xD;
&#xD;
         15. Patient is a prisoner or a ward of the state.&#xD;
&#xD;
         16. Known or suspected drug or alcohol abuse***&#xD;
&#xD;
         17. Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality&#xD;
             disorders) that could interfere with study participation&#xD;
&#xD;
         18. Patient is participating in an investigational study or has been involved in an&#xD;
             investigational study within 3 months prior to evaluation for participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel J Cher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SI-BONE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BASIC Spine</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver Health Sciences</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Clinic of Daytona Beach</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain and Spine Center, LLC</name>
      <address>
        <city>Panama City</city>
        <state>Florida</state>
        <zip>32405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Resurgen's Orthopaedics</name>
      <address>
        <city>McDonough</city>
        <state>Georgia</state>
        <zip>30253</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurosurgery Consultants/ Riverside Hospital</name>
      <address>
        <city>Kankakee</city>
        <state>Illinois</state>
        <zip>60901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic Center of Southern Illinois</name>
      <address>
        <city>Mount Vernon</city>
        <state>Illinois</state>
        <zip>62864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Neurosurgery Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluegrass Orthopaedics &amp; Hand Care Research</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spine institute of Louisiana</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCA Midwest</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroSpine Institute, LLC</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Orthopedic Specialty Hospital</name>
      <address>
        <city>Franklin</city>
        <state>Wisconsin</state>
        <zip>53132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Bay Care Medical Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN; INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016 Aug 23;10:28. doi: 10.14444/3028. eCollection 2016.</citation>
    <PMID>27652199</PMID>
  </results_reference>
  <results_reference>
    <citation>Polly D, Cher D, Whang PG, Frank C, Sembrano J; INSITE Study Group. Does Level of Response to SI Joint Block Predict Response to SI Joint Fusion? Int J Spine Surg. 2016 Jan 21;10:4. doi: 10.14444/3004. eCollection 2016.</citation>
    <PMID>26913224</PMID>
  </results_reference>
  <results_reference>
    <citation>Cher DJ, Frasco MA, Arnold RJ, Polly DW. Cost-effectiveness of minimally invasive sacroiliac joint fusion. Clinicoecon Outcomes Res. 2015 Dec 18;8:1-14. doi: 10.2147/CEOR.S94266. eCollection 2016. Erratum In: Clinicoecon Outcomes Res. 2016;8:305.</citation>
    <PMID>26719717</PMID>
  </results_reference>
  <results_reference>
    <citation>Polly DW, Cher DJ, Wine KD, Whang PG, Frank CJ, Harvey CF, Lockstadt H, Glaser JA, Limoni RP, Sembrano JN; INSITE Study Group. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015 Nov;77(5):674-90; discussion 690-1. doi: 10.1227/NEU.0000000000000988.</citation>
    <PMID>26291338</PMID>
  </results_reference>
  <results_reference>
    <citation>Whang P, Cher D, Polly D, Frank C, Lockstadt H, Glaser J, Limoni R, Sembrano J. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015 Mar 5;9:6. doi: 10.14444/2006. eCollection 2015.</citation>
    <PMID>25785242</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <results_first_submitted>June 22, 2017</results_first_submitted>
  <results_first_submitted_qc>August 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 25, 2017</results_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>si joint</keyword>
  <keyword>si joint pain</keyword>
  <keyword>si joint injury</keyword>
  <keyword>si joint treatment</keyword>
  <keyword>si joint injections</keyword>
  <keyword>si joint inflammation</keyword>
  <keyword>si joint problems</keyword>
  <keyword>si joint symptoms</keyword>
  <keyword>hypermobile si joint</keyword>
  <keyword>si joint arthritis</keyword>
  <keyword>si joint pain treatment</keyword>
  <keyword>inflamed si joint</keyword>
  <keyword>si joint sclerosis</keyword>
  <keyword>locked si joint</keyword>
  <keyword>si joint injuries</keyword>
  <keyword>si joint disease</keyword>
  <keyword>si joint infection</keyword>
  <keyword>sacroiliac joint pelvic pain</keyword>
  <keyword>sacroiliac joint arthritis treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacroiliitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>INSITE</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>http://yoda.yale.edu/</doc_url>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Of the 442 patients who were screened for participation at 19 sites, 159 (37.8%) were enrolled. Eleven subjects withdrew before treatment (1 before randomization and 10 after randomization but before any treatment was performed), yielding a total of 148 subjects who were enrolled, randomized and treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>iFuse Implant System</title>
          <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
        </group>
        <group group_id="P2">
          <title>Non-Surgical Management</title>
          <description>Medications, SI joint injection, physical therapy and RF ablation of SI joint&#xD;
Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Primary Endpoint: 6 Months</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Crossover to Surgical Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="39">Crossover to surgical treatment allowed per study protocol after the 6-month visit was complete.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Study Completion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Site Termination</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Of the 442 patients who were screened for participation at 19 sites, 159 (37.8%) were enrolled. Eleven subjects withdrew before treatment (1 before randomization and 10 after randomization but before any treatment was performed), yielding a total of 148 subjects who were enrolled, randomized and treated (102 to iFuse Implant System &amp; 46 to NSM).</population>
      <group_list>
        <group group_id="B1">
          <title>iFuse Implant System</title>
          <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
        </group>
        <group group_id="B2">
          <title>Non-Surgical Management</title>
          <description>Medications, SI joint injection, physical therapy and RF ablation of SI joint&#xD;
Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="148"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ethnicity: Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index, mean (range)</title>
          <units>kg / m2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.4" lower_limit="16.7" upper_limit="49.5"/>
                    <measurement group_id="B2" value="30.6" lower_limit="19.4" upper_limit="48.9"/>
                    <measurement group_id="B3" value="30.43" lower_limit="16.7" upper_limit="49.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status (n, %)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Current Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ambulatory without assistance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Work status (n, %)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Working full time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Working part time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not working, student</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not working, retired</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not working due to back pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not working other reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Lumbar fusion (n, %)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Underlying diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Degenerative sacroiliitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sacroiliac joint disruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of pain, mean (range)</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.0" lower_limit="0.5" upper_limit="40.7"/>
                    <measurement group_id="B2" value="5.0" lower_limit="0.5" upper_limit="38.9"/>
                    <measurement group_id="B3" value="6.0" lower_limit="0.5" upper_limit="40.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain Syndrome</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Pain began peripartum</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain radiates down leg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Groin pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain worse with sitting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain worse with rising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain worse with walking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain worse with climbing stairs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain worse with descending stairs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior treatments</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Physical therapy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Steroid SIJ injection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RF ablation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Taking opiods</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with lumbar stenosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with hip diagnosis (n, %)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with sacral trauma (n, %)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>VAS SIJ pain score, mean</title>
          <description>The Visual Analog Scale (VAS) is a 100 mm line on which the subjects mark their pain rating. 0= no pain and 100= worst pain imaginable.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.3" spread="11.9"/>
                    <measurement group_id="B2" value="82.2" spread="9.9"/>
                    <measurement group_id="B3" value="82.3" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ODI score, mean</title>
          <description>Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. If all sections are answered, the total possible score is 50/50 = 100% which is the worst disability possible on the scale. (0/50 = no disability at all.) If any section is skipped by the study participant, the total possible score for that section is removed from the denominator. Example - section 8 skipped, total possible score is 45/45 = 100%.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.2" spread="12.8"/>
                    <measurement group_id="B2" value="56.0" spread="14.0"/>
                    <measurement group_id="B3" value="56.8" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SF-36, mean</title>
          <description>The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains.&#xD;
The PCS is the Physical Component Summary score. 0% would represent the lowest or worst possible level of functioning while 100% would represent the highest / best possible level of functioning.&#xD;
The MCS is the Mental Component Summary score. 0% would represent the lowest or worst possible level of functioning while 100% would represent the highest / best possible level of functioning.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Physical component summary (PCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.2" spread="6.2"/>
                    <measurement group_id="B2" value="30.8" spread="6.2"/>
                    <measurement group_id="B3" value="30.4" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental component summary (MCS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.0" spread="11.5"/>
                    <measurement group_id="B2" value="43.3" spread="12.1"/>
                    <measurement group_id="B3" value="43.1" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EQ-5D</title>
          <description>EQ-5D is a five-question broad quality of life measure that is combined into a single index using population norm data called time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health. (Scores &lt;0 are also possible, representing states worse than death.) EQ-5D also includes a 0-100 mm health thermometer, where 0 means death and 100 means perfect health.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Time trade-off (TTO) score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.44" spread="0.18"/>
                    <measurement group_id="B2" value="0.47" spread="0.19"/>
                    <measurement group_id="B3" value="0.45" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health Thermometer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.2" spread="23.8"/>
                    <measurement group_id="B2" value="57.8" spread="22.9"/>
                    <measurement group_id="B3" value="54.6" spread="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subject Success</title>
        <description>Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.</description>
        <time_frame>6 months</time_frame>
        <population>A modified intent-to-treat approach was used.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM with reporting to 6 months only.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Success</title>
          <description>Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.</description>
          <population>A modified intent-to-treat approach was used.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in SI Joint Pain VAS Score at 1 Month</title>
        <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>1 month</time_frame>
        <population>2 iFuse and 1 NSM subjects did not complete the pain score.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in SI Joint Pain VAS Score at 1 Month</title>
          <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>2 iFuse and 1 NSM subjects did not complete the pain score.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Si Joint Pain VAS Score at 3 Months</title>
        <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>3 Months</time_frame>
        <population>2 iFuse and 3 NSM subjects did not complete the 3-month pain score.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Si Joint Pain VAS Score at 3 Months</title>
          <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>2 iFuse and 3 NSM subjects did not complete the 3-month pain score.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in SI Joint Pain VAS Score at 6 Months</title>
        <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>6 Months</time_frame>
        <population>1 iFuse and 3 NSM subjects did not complete the 6-month pain score.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in SI Joint Pain VAS Score at 6 Months</title>
          <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative &amp; NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>1 iFuse and 3 NSM subjects did not complete the 6-month pain score.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in SI Joint Pain VAS Score at 12 Months</title>
        <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
        <time_frame>12 Months</time_frame>
        <population>2 iFuse subjects did not complete the 12-month pain score. Analysis of 12-month scores in the NSM group is not valid because of the high crossover rate.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in SI Joint Pain VAS Score at 12 Months</title>
          <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
          <population>2 iFuse subjects did not complete the 12-month pain score. Analysis of 12-month scores in the NSM group is not valid because of the high crossover rate.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in SI Joint Pain VAS Score at 24 Months</title>
        <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
        <time_frame>24 Months</time_frame>
        <population>12 iFuse subjects did not complete the 24-month pain score. Analysis of 24-month scores in the NSM group is not valid because of the high crossover rate.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in SI Joint Pain VAS Score at 24 Months</title>
          <description>Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
          <population>12 iFuse subjects did not complete the 24-month pain score. Analysis of 24-month scores in the NSM group is not valid because of the high crossover rate.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Back Dysfunction</title>
        <description>Improvement in ODI score of greater than or equal to 15 points, at month 1.&#xD;
Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>1 month</time_frame>
        <population>2 iFuse and 1 NSM subjects did not complete ODI at 1 month</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Back Dysfunction</title>
          <description>Improvement in ODI score of greater than or equal to 15 points, at month 1.&#xD;
Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>2 iFuse and 1 NSM subjects did not complete ODI at 1 month</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Back Dysfunction</title>
        <description>Improvement in ODI score of greater than or equal to 15 points, at month 3.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>3 Months</time_frame>
        <population>2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Back Dysfunction</title>
          <description>Improvement in ODI score of greater than or equal to 15 points, at month 3.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Back Dysfunction</title>
        <description>Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>6 Months</time_frame>
        <population>1 iFuse and 2 NSM subjects did not complete ODI at month 6.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Back Dysfunction</title>
          <description>Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>1 iFuse and 2 NSM subjects did not complete ODI at month 6.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Back Dysfunction</title>
        <description>Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
        <time_frame>12 Months</time_frame>
        <population>2 iFuse subjects did not complete ODI at month 12. ODI analysis is not valid in NSM group at 12 months because of high crossover.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Back Dysfunction</title>
          <description>Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
          <population>2 iFuse subjects did not complete ODI at month 12. ODI analysis is not valid in NSM group at 12 months because of high crossover.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Back Dysfunction</title>
        <description>Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
        <time_frame>24 Months</time_frame>
        <population>The Count of participants = number of subjects that had a threshold change in ODI score of greater than or equal to 15 points. Overall number of participants = number of subjects analyzed. Of the 102, a total of 13 iFuse Implant subjects exited the study and 1 did not complete the ODI survey. By 6 months, 39 NSM subjects crossed over to surgical.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Back Dysfunction</title>
          <description>Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.</description>
          <population>The Count of participants = number of subjects that had a threshold change in ODI score of greater than or equal to 15 points. Overall number of participants = number of subjects analyzed. Of the 102, a total of 13 iFuse Implant subjects exited the study and 1 did not complete the ODI survey. By 6 months, 39 NSM subjects crossed over to surgical.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</title>
        <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>6 months</time_frame>
        <population>2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</title>
          <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="10.5"/>
                    <measurement group_id="O2" value="1.3" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</title>
        <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>12 Months</time_frame>
        <population>A total of 2 iFuse subjects had exited the study before making it to their 12 month visit. This outcome is not evaluated in the NSM group at month 12 because high crossover to surgical treatment prevents valid analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</title>
          <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>A total of 2 iFuse subjects had exited the study before making it to their 12 month visit. This outcome is not evaluated in the NSM group at month 12 because high crossover to surgical treatment prevents valid analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" spread="9.9"/>
                    <measurement group_id="O2" value="NA" spread="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</title>
        <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>24 months</time_frame>
        <population>Change in QOL score at 24 months. 89 participants had QOL information at 24 months. Analysis of the NSM cohort is not done because high crossover to surgery prevents valid analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits</title>
          <description>Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that &quot;normal&quot; scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Change in QOL score at 24 months. 89 participants had QOL information at 24 months. Analysis of the NSM cohort is not done because high crossover to surgery prevents valid analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="10.7"/>
                    <measurement group_id="O2" value="NA" spread="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</title>
        <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>6 months</time_frame>
        <population>Results show improvement in score from baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</title>
          <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Results show improvement in score from baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.22"/>
                    <measurement group_id="O2" value="0.06" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</title>
        <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>12 Months</time_frame>
        <population>2 iFuse subjects did not complete the survey at month 12. Due to high crossover rate to surgery, analysis in the NSM group is not valid.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</title>
          <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>2 iFuse subjects did not complete the survey at month 12. Due to high crossover rate to surgery, analysis in the NSM group is not valid.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.22"/>
                    <measurement group_id="O2" value="NA" spread="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</title>
        <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>24 months</time_frame>
        <population>13 iFuse subjects did not complete the 24-month assessment. Analysis was not done for the NSM group at 24 months due to the high crossover rate.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits</title>
          <description>Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>13 iFuse subjects did not complete the 24-month assessment. Analysis was not done for the NSM group at 24 months due to the high crossover rate.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.24"/>
                    <measurement group_id="O2" value="NA" spread="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ambulatory Status</title>
        <description>Time to full ambulation among those without full ambulation at baseline.&#xD;
60 days was the median of time to full ambulation for the iFuse implant System arm.</description>
        <time_frame>24 months (surgical group), 6 months (non-surgical group)</time_frame>
        <population>Number of days to full ambulation among those without full ambulation at baseline. At baseline only 13 in the surgical arm were not Ambulatory without assistance and for the NSM group, it was only 5 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months..&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Ambulatory Status</title>
          <description>Time to full ambulation among those without full ambulation at baseline.&#xD;
60 days was the median of time to full ambulation for the iFuse implant System arm.</description>
          <population>Number of days to full ambulation among those without full ambulation at baseline. At baseline only 13 in the surgical arm were not Ambulatory without assistance and for the NSM group, it was only 5 at baseline.</population>
          <units>Days, median</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="46" upper_limit="NA">Upper confidence limit not defined due to small sample size.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">By month 6, only 40% of non-ambulatory NSM subjects regained full ambulation status</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Status</title>
        <description>Proportion of non-working (due to back pain or other reasons) subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>1 month</time_frame>
        <population>Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Status</title>
          <description>Proportion of non-working (due to back pain or other reasons) subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Status</title>
        <description>Non-working subjects (due to back pain or other reasons) who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>3 Months</time_frame>
        <population>Patients not working at baseline due to back or other pain</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Status</title>
          <description>Non-working subjects (due to back pain or other reasons) who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Patients not working at baseline due to back or other pain</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Status</title>
        <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>6 Months</time_frame>
        <population>Patients not working at baseline due to back or other pain</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Status</title>
          <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Patients not working at baseline due to back or other pain</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Status</title>
        <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>12 Months</time_frame>
        <population>Patients not working at baseline due to back or other pain</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Status</title>
          <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Patients not working at baseline due to back or other pain</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Status</title>
        <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>18 Months</time_frame>
        <population>Patients not working at baseline due to back or other pain</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Status</title>
          <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Patients not working at baseline due to back or other pain</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Work Status</title>
        <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
        <time_frame>24 Months</time_frame>
        <population>Patients not working at baseline due to back or other pain</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM followed to 6 months.&#xD;
Subjects were allowed to cross over to other treatments (including surgical treatments) after the month 6 visit was complete.</description>
          </group>
        </group_list>
        <measure>
          <title>Work Status</title>
          <description>Non-working subjects who return to work&#xD;
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.</description>
          <population>Patients not working at baseline due to back or other pain</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="NA">The intended analysis was to examine differences in responses at 6 months. The protocol anticipated a high crossover rate and therefore did not include any comparative analyses after month 6.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.</description>
        <time_frame>Procedure, discharge, 1, 3, 6, 12, 18 and 24 months</time_frame>
        <population>All treated study subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>iFuse Implant System</title>
            <description>Surgical placement of iFuse implants in the affected SI joint&#xD;
iFuse Implant System: Placement of iFuse implant system via surgery</description>
          </group>
          <group group_id="O2">
            <title>Non-Surgical Management</title>
            <description>This arm includes all subjects randomized to NSM. Many of these subjects crossed over to treatment after 6 months of NSM.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.</description>
          <population>All treated study subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month, 3 months, 6 months, 12 months, 18 months, 24 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>iFuse Implant System</title>
          <description>Surgical placement of iFuse implants in the affected SI joint iFuse Implant System: Placement of iFuse implant system via surgery</description>
        </group>
        <group group_id="E2">
          <title>Non-Surgical Management</title>
          <description>This arm includes all subjects randomized to NSM followed to 6 months&#xD;
Non-surgical management: Medications for pain, physical therapy, SI joint injection and RF ablation.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Myocardial infarction - fatal</sub_title>
                <description>Myocardial infarction - fatal</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Small bowel obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Bowel obstruct, leading to surgery</sub_title>
                <description>Bowel obstruct, leading to surgery</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wound hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Revision - SIJ pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Revision - neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Neuropathy - Resolved with revision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation / respira failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis of the knee</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Meniscal tear</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Contralateral SIJ pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Degenerative disease - spine</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Disc herniation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Rotator cuff tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Ipsilateral - SIJ pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Osteoarthritis of the hip</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Avascular necrosis of left hip</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hip revision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Restrolisthesis T12-L1</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Fracture - tibia / fibula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Knee pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Labral tear &amp; ilium fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Snapping scapula syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>S1 neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Kidney disfunction due to nsaid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>COPD</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="102"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="102"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Degenerative disease - spine</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="102"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>SIJ pain - ipsilateral</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="102"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Shoulder pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="102"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>SIJ pain - contralateral</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="102"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Trochanteric bursitis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="102"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Leg pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Hip pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Open-label (non-blinded) study. Most (&gt;90%) NSM subjects with continued pain crossed over after the 6-month visit. Analysis across groups after 6 months is therefore biased, since surgery by definition is not a component of non-surgical treatment.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Daniel Cher, Vice President of Clinical Affairs</name_or_title>
      <organization>SI-BONE, Inc.</organization>
      <phone>408-207-0700</phone>
      <email>dcher@si-bone.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01681004
org study id: 300103
nct id: NCT01681004
lead sponsor: 
has dmc: No
The purpose of this study is to compare outcomes when patients with degenerative sacroiliitis
      (arthritis of the SI joint) and or sacroiliac disruption (abnormal separation or tearing of
      the sacroiliac joint)undergo either SI joint fusion with the iFuse Implant System or undergo
      specific, targeted non-surgical treatment of the SI joint.
The intended analysis was to examine differences in responses at 6 months. It was
      acknowledged that subjects with chronic pain in the NSM arm group might not experience any
      benefit as there was little evidence at the time that NSM was helpful. The protocol included
      optional crossover to other treatments, including surgical treatment. The protocol
      anticipated a high crossover rate and therefore did not include any comparative analyses
      after month 6.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel group randomized controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Subject Success
time frame: 6 months
description: Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.
measure: Improvement in SI Joint Pain VAS Score at 1 Month
time frame: 1 month
description: Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Si Joint Pain VAS Score at 3 Months
time frame: 3 Months
description: Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in SI Joint Pain VAS Score at 6 Months
time frame: 6 Months
description: Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in SI Joint Pain VAS Score at 12 Months
time frame: 12 Months
description: Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
measure: Improvement in SI Joint Pain VAS Score at 24 Months
time frame: 24 Months
description: Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
measure: Improvement in Back Dysfunction
time frame: 1 month
description: Improvement in ODI score of greater than or equal to 15 points, at month 1.
Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Back Dysfunction
time frame: 3 Months
description: Improvement in ODI score of greater than or equal to 15 points, at month 3.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Back Dysfunction
time frame: 6 Months
description: Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Back Dysfunction
time frame: 12 Months
description: Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
measure: Improvement in Back Dysfunction
time frame: 24 Months
description: Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.
measure: Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
time frame: 6 months
description: Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
time frame: 12 Months
description: Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits
time frame: 24 months
description: Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that "normal" scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
time frame: 6 months
description: Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
time frame: 12 Months
description: Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits
time frame: 24 months
description: Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Ambulatory Status
time frame: 24 months (surgical group), 6 months (non-surgical group)
description: Time to full ambulation among those without full ambulation at baseline.
60 days was the median of time to full ambulation for the iFuse implant System arm.
measure: Work Status
time frame: 1 month
description: Proportion of non-working (due to back pain or other reasons) subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Work Status
time frame: 3 Months
description: Non-working subjects (due to back pain or other reasons) who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Work Status
time frame: 6 Months
description: Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Work Status
time frame: 12 Months
description: Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Work Status
time frame: 18 Months
description: Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Work Status
time frame: 24 Months
description: Non-working subjects who return to work
Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: Procedure, discharge, 1, 3, 6, 12, 18 and 24 months
description: Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.
arm group label: iFuse Implant System
arm group type: Experimental
description: Surgical placement of iFuse implants in the affected SI joint
arm group label: Non-Surgical Management
arm group type: Active Comparator
description: Medications, SI joint injection, physical therapy and RF ablation of SI joint
intervention type: Device
intervention name: iFuse Implant System
description: Placement of iFuse implant system via surgery
arm group label: iFuse Implant System
intervention type: Other
intervention name: Non-surgical management
description: Medications for pain, physical therapy, SI joint injection and RF ablation
arm group label: Non-Surgical Management
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Daniel J Cher, MD
role: Principal Investigator
affiliation: SI-BONE
facility: 
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country: United States
citation: Polly DW, Swofford J, Whang PG, Frank CJ, Glaser JA, Limoni RP, Cher DJ, Wine KD, Sembrano JN; INSITE Study Group. Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction. Int J Spine Surg. 2016 Aug 23;10:28. doi: 10.14444/3028. eCollection 2016.
PMID: 27652199
citation: Polly D, Cher D, Whang PG, Frank C, Sembrano J; INSITE Study Group. Does Level of Response to SI Joint Block Predict Response to SI Joint Fusion? Int J Spine Surg. 2016 Jan 21;10:4. doi: 10.14444/3004. eCollection 2016.
PMID: 26913224
citation: Cher DJ, Frasco MA, Arnold RJ, Polly DW. Cost-effectiveness of minimally invasive sacroiliac joint fusion. Clinicoecon Outcomes Res. 2015 Dec 18;8:1-14. doi: 10.2147/CEOR.S94266. eCollection 2016. Erratum In: Clinicoecon Outcomes Res. 2016;8:305.
PMID: 26719717
citation: Polly DW, Cher DJ, Wine KD, Whang PG, Frank CJ, Harvey CF, Lockstadt H, Glaser JA, Limoni RP, Sembrano JN; INSITE Study Group. Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes. Neurosurgery. 2015 Nov;77(5):674-90; discussion 690-1. doi: 10.1227/NEU.0000000000000988.
PMID: 26291338
citation: Whang P, Cher D, Polly D, Frank C, Lockstadt H, Glaser J, Limoni R, Sembrano J. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial. Int J Spine Surg. 2015 Mar 5;9:6. doi: 10.14444/2006. eCollection 2015.
PMID: 25785242
responsible party type: Sponsor
mesh term: Sacroiliitis
sharing ipd: Undecided
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Open-label (non-blinded) study. Most (>90%) NSM subjects with continued pain crossed over after the 6-month visit. Analysis across groups after 6 months is therefore biased, since surgery by definition is not a component of non-surgical treatment.
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