<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/NCT03230279</url>
  </required_header>
  <id_info>
    <org_study_id>X-99</org_study_id>
    <nct_id>NCT03230279</nct_id>
  </id_info>
  <brief_title>Sacroiliac Joint Fusion Comparison Study</brief_title>
  <official_title>Randomized Controlled Trial Of Minimally Invasive Sacroiliac Joint Fusion Compared To Radiofrequency Ablation For Sacroiliac Joint Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Globus Medical Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ochsner Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or&#xD;
      radiofrequency ablation. The radio frequency ablation is performed using either conventional&#xD;
      or &quot;cooled&quot; techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally&#xD;
      invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to&#xD;
      increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at&#xD;
      comparing treatment success at 6-month follow-up time-point after minimally invasive&#xD;
      sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction This document is a protocol for a human research study. This study is to be&#xD;
      conducted according to US and international standards of Good Clinical Practice (FDA Title 21&#xD;
      part 312 and International Conference on Harmonization guidelines), applicable government&#xD;
      regulations and Institutional research policies and procedures.&#xD;
&#xD;
      Background&#xD;
&#xD;
      Sacroiliac joint (SIJ) dysfunction is a common pain condition involving the buttock and may&#xD;
      irradiate in the low back, groin and/or lower extremity. About one in five patients with low&#xD;
      back pain is estimated to have SI joint pain. The economic burden of SIJ pain is high in the&#xD;
      United States and there is a need for more cost effective treatment options. There is a lack&#xD;
      of relevant high quality studies that compared nonsurgical and surgical treatment for SI&#xD;
      joint dysfunction.&#xD;
&#xD;
      Sacroiliac joint (SIJ) dysfunction has been estimated to be the origin of lower back pain in&#xD;
      13 to 30% of patients. SIJ pain is usually referred to the buttock, low back, groin and/or&#xD;
      lower extremity. SIJ osteoarthritis, trauma, SIJ degeneration following lumbar fusion and&#xD;
      postpartum SIJ dysfunction are common causes of SIJ pain found in a clinical setting. Other&#xD;
      less common causes for SIJ pain include inflammatory sacroiliitis, infective sacroiliitis,&#xD;
      insufficiency stress fractures and neoplasia.&#xD;
&#xD;
      Diagnostic evidences for SIJ dysfunction&#xD;
&#xD;
      The presenting symptoms of SIJ dysfunction can be similar to those of other spinal conditions&#xD;
      such as disc herniation or degenerative spinal stenosis. Unlike radiculopathy, there is often&#xD;
      an absence of specific radiological finding with SIJ dysfunction. A gold standard for SI&#xD;
      joint pain diagnosis does not exist, but dual comparative local anesthetic joint blocks with&#xD;
      at least 70% pain relief are considered a validated diagnostic test for SI joint pain.&#xD;
      Reproducibility of SIJ pain with at least 3 SIJ-selective stressing tests, including the&#xD;
      thigh trust, compression, Patrick's, distraction and Gaenslen's test, is also considered&#xD;
      having good diagnostic validity.&#xD;
&#xD;
      Investigational Agents and Preclinical Data&#xD;
&#xD;
      Nonsurgical treatment efficacy for SIJ dysfunction&#xD;
&#xD;
      Sacroiliac dysfunction is thought to be secondary to a loss of SIJ stability caused by either&#xD;
      deficient form closure (joint anatomy) or force closure (compressive forces exerted by&#xD;
      neuromuscular and ligamentous structures around the joint. Physical therapy can improve SI&#xD;
      joint pain by increasing force closure. Pelvic stabilization, strengthening and self-bracing&#xD;
      exercises have been showed to improve force closure and may provide SIJ pain relief.&#xD;
&#xD;
      When SIJ pain fails to improve with physical therapy, several pain management interventions&#xD;
      can be offered to patients. Up to now, the level of evidence for SIJ intraarticular or&#xD;
      periarticular steroid injections is mainly limited to short-term outcome (3 months) and the&#xD;
      effectiveness results are conflicting between different studies.&#xD;
&#xD;
      Compared to conventional radio frequency ablation, the effectiveness of cooled radiofrequency&#xD;
      ablation is supported by superior level of evidence. Two randomized controlled trials&#xD;
      comparing cooled radio frequency ablation vs placebo demonstrated a success rate varying&#xD;
      between 38 to 57% at 6 months for cooled radiofrequency ablation. Observational studies also&#xD;
      demonstrated success rate varying from 40% to 71% at 6 months for both conventional and&#xD;
      cooled radio frequency ablation. The effectiveness of conventional and cooled radio frequency&#xD;
      ablation at 9 and 12 months are more limited and some studies did report loss of&#xD;
      effectiveness at 12 months. Based on the available data, there is no evidence supporting&#xD;
      clinical superiority between traditional and cool radio frequency ablation. A retrospective&#xD;
      study on 88 patients revealed comparable effectiveness between conventional and cool radio&#xD;
      frequency ablation with &gt; 50% pain reduction in the majority of patients after 3 and 6&#xD;
      months.&#xD;
&#xD;
      Surgical treatment evidence for SIJ dysfunction&#xD;
&#xD;
      Minimally invasive SIJ fusion is a surgical treatment aimed at stabilizing the SIJ to reduce&#xD;
      pain, disability and improve quality of life. In a recent randomized controlled trial called&#xD;
      Investigation of Sacroiliac Fusion Treatment (INSITE), minimally invasive SIJ fusion, using&#xD;
      triangular titanium implants (iFuse Implant System, SI-BONE®, San Jose, CA), has been shown&#xD;
      superior to non-surgical treatments in managing SIJ dysfunction at 6 months (81.4% vs 26.1%&#xD;
      success rate) and the results in the surgical group were sustained at one year and two years&#xD;
      of follow-up. In this trial, success rate was defined as a decreased in SIJ pain Visual&#xD;
      Analogue Score of at least 20 mm compared to baseline, an absence of device-related serious&#xD;
      adverse events, an absence of neurological worsening and no surgical reintervention. There&#xD;
      were 101 subjects in the SIJ fusion group who completed the 6 months follow-up.&#xD;
&#xD;
      Clinical Data to Date The INSITE study is the first and only published Level 1 randomized&#xD;
      controlled trial to have compared SIJ fusion with nonsurgical treatment. Although this study&#xD;
      demonstrated prolonged improvement in pain, disability and quality of life with SIJ fusion,&#xD;
      superiority of SIJ fusion compared to nonsurgical treatment at 6 months cannot be&#xD;
      generalized. This superiority trial may not have been truly clinically relevant because there&#xD;
      was no specific treatment protocol used in the nonsurgical group for each subject.&#xD;
      Nonsurgical management consisted of physical therapy in 98%, at least one steroid injection&#xD;
      in 74%, 2 steroid injections in 4% and radiofrequency ablation of the sacral nerve root&#xD;
      lateral branches in 46% of the 46 subjects assigned to nonsurgical treatment. The different&#xD;
      proportions of treatment offered in the nonsurgical group may in fact differ from other pain&#xD;
      management clinical practices and the generalizability of the results is questionable.&#xD;
&#xD;
      Compared to all nonsurgical treatment available for SIJ pain, the effectiveness of&#xD;
      radiofrequency ablation is supported by literature of higher level of evidence. Prolonged&#xD;
      therapeutic effect up to 6 months after the procedure has been demonstrated for&#xD;
      radiofrequency ablation. In the INSITE study, only 21 subjects received radio frequency&#xD;
      ablation, a group size that corresponds to only 21% of the number of subjects studied for SIJ&#xD;
      fusion. This may explain why the nonsurgical group only had 26.1% success rate in this trial.&#xD;
      The quality of evidence for the INSITE study may also be contested as the study sponsor,&#xD;
      SI-BONE®, participated in the manuscript redaction and performed the statistical analysis.&#xD;
&#xD;
      The costs of nonsurgical treatments for SIJ pain are substantial in the United Sates medicare&#xD;
      population and there is a need to assess the best cost effective therapy for SI joint pain.&#xD;
      SIJ fusion and RFN are two SIJ pain treatment modalities that have been studied with a higher&#xD;
      level of evidence compared to other modalities, showing significant effectiveness lasting&#xD;
      more than 6 months after each procedure. However the effectiveness and costs associated with&#xD;
      these two different treatments have never been compared in a clinically relevant randomized&#xD;
      trial.&#xD;
&#xD;
      Dose Rationale and Risk/Benefits&#xD;
&#xD;
      RISKS&#xD;
&#xD;
      General / Unforeseeable&#xD;
&#xD;
      The risks of receiving a SIJ fusion include but are not limited to:&#xD;
&#xD;
        -  post-operative incisional pain or worsened pain due to muscle spams&#xD;
&#xD;
        -  hematoma and/or surgical site infection (less likely)&#xD;
&#xD;
        -  nerve damage that can cause paralysis, loss of sensation or pain (unlikely&#xD;
&#xD;
        -  possible second intervention for revision or withdrawal of implants (unlikely)&#xD;
&#xD;
      The risks of receiving SIJ radiofrequency ablation include but are not limited to:&#xD;
&#xD;
        -  Pain or discomfort around the area treated&#xD;
&#xD;
        -  numbness of skin covering the area treated, worsened pain due to muscle spasm,&#xD;
&#xD;
        -  permanent nerve pain (less likely)&#xD;
&#xD;
        -  allergies or reactions to medications, infection and/or hematoma (less likely) 3rd&#xD;
           degree burn (rare)&#xD;
&#xD;
        -  Nerve damage due to trauma (rare)&#xD;
&#xD;
      Other risks that are not specifically related to SIJ fusion or SIJ radiofrequency ablation&#xD;
      but may occur during any procedure include:&#xD;
&#xD;
        -  cardiovascular and /or cerebrovascular events&#xD;
&#xD;
        -  cardiac arrhythmia&#xD;
&#xD;
        -  deep vein thrombosis&#xD;
&#xD;
        -  pulmonary emboli&#xD;
&#xD;
        -  pneumonia&#xD;
&#xD;
        -  urinary tract infection&#xD;
&#xD;
        -  skin abrasions&#xD;
&#xD;
        -  coma or death&#xD;
&#xD;
      Radiation Risks&#xD;
&#xD;
      Fluoroscopy is an imaging technique that uses X-rays during the SIJ fusion or SIJ&#xD;
      radiofrequency ablation. This form or ionizing radiation poses a potential for increasing the&#xD;
      patient's risk of radiation-induced cancer. Radiations doses and exposure during the study&#xD;
      are the same that would be used if the subjects were receiving the treatment outside of this&#xD;
      study. Therefore, this study does not involve any additional radiation risk for the subjects.&#xD;
&#xD;
      Study Objectives&#xD;
&#xD;
      Primary objective: Determine clinical superiority between minimally invasive SIJ fusion and&#xD;
      radiofrequency ablation in chronic SIJ dysfunction patients&#xD;
&#xD;
      Secondary Objectives: Compare cost-effectiveness between treatment groups&#xD;
&#xD;
      Study Design&#xD;
&#xD;
      General Design&#xD;
&#xD;
        -  Randomized controlled trial where randomization is done by a random number generator.&#xD;
           Even numbers will be directed to the SI joint procedure group and odd numbers will be&#xD;
           directed to the radiofrequency ablation procedure.&#xD;
&#xD;
        -  The enrolment uses a 1:1 ratio of SIJ fusion to radio frequency ablation&#xD;
&#xD;
        -  The subjects and investigators are not blinded to treatment allocation&#xD;
&#xD;
      Subjects will have a detailed medical history and will complete these questionnaires&#xD;
&#xD;
        -  SIJ pain rating using the Visual Analogue Scale (VAS)&#xD;
&#xD;
        -  Oswestry Disability Index (ODI)&#xD;
&#xD;
        -  Short Form-36 (SF-36)&#xD;
&#xD;
      All subjects will be evaluated at randomization and at follow-up visits scheduled at 1, 3, 6,&#xD;
      9, and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Was not financed, Sponsor withdrawn&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Study Population: Chronic SIJ dysfunction patients presenting at selected Ochsner Health System healthcare centers&#xD;
Recruiting mode: Participation will be offered by the principal investigator or the sub-investigators during an outpatient visit in the neurosurgery or pain management clinic.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment success</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Comparison in the proportion of subjects having a success between groups at 6-month follow-up time-point. Treatment success is defined as a ≥ 50% decrease in VAS pain score; a 10-point increase in SF-36BP (amelioration); a 15-point decrease in ODI (amelioration); absence of device-related serious adverse events; absence of focal neurological deficit or neuropathic pain related to lumbosacral nerve roots injury and absence of surgical reintervention for SIJ pain (revision, removal of hardware, additional fixation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness between SIJ fusion and radio frequency ablation</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Cost-effectiveness comparison between groups. Cost-effectiveness is measured using the SF-6D utility score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean changes from baseline in visual analog score for pain</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Comparison of mean changes from baseline between groups in VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiofrequency ablation subgroups analysis</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Subgroups analysis will be carried on between conventional and cooled radio frequency ablation to attempt to determine if any effect is attributable to one form of RFN or the other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean changes from baseline in Oswestry Disability Index score</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Comparison of mean changes from baseline between groups in ODI score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean changes from baseline in SF-36 physical component summary score</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Comparison of mean changes from baseline between groups in SF-36 physical component summary score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean changes from baseline in SF-36 mental component summary score</measure>
    <time_frame>6 months after the intervention</time_frame>
    <description>Comparison of mean changes from baseline between groups in SF-36 mental component summary score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Sacroiliac Joint Somatic Dysfunction</condition>
  <condition>Sacroiliac; Spondylitis</condition>
  <arm_group>
    <arm_group_label>Sacroiliac joint fusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subject will receive a sacroiliac joint fusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sacroiliac radio frequency ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subject will receive a sacroiliac joint radiofrequency ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sacroiliac joint fusion</intervention_name>
    <description>Minimally invasive SIJ fusion will be performed under general anesthesia with fluoroscopy. Using SI-LOK®, Sacroiliac Joint Fixation System, Globus Medical Inc. (Audubon, PA), this procedure involve placement of 2 to 3 implants across the SIJ to achieve stabilization and arthrodesis.</description>
    <arm_group_label>Sacroiliac joint fusion</arm_group_label>
    <other_name>Minimally invasive sacroiliac joint arthrodesis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sacroiliac joint radiofrequency ablation</intervention_name>
    <description>Sacroiliac joint radio frequency ablation will be performed using either conventional or cooled radiofrequency ablation techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. The choice between conventional or cooled RFN will be determined by the provider expertise.</description>
    <arm_group_label>Sacroiliac radio frequency ablation</arm_group_label>
    <other_name>Sacroiliac joint neurotomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Once the informed consent has been obtained, the following screening procedures/tests will&#xD;
        be performed:&#xD;
&#xD;
          -  Local anesthetic sacroiliac joint block and steroid injection performed by a qualified&#xD;
             Ochsner pain management provider in less than 3 months following the consent date&#xD;
&#xD;
          -  The subject will rate his pain level using the VAS at 2, 4, 6, 8 and 10 hours after&#xD;
             the sacroiliac joint block and steroid injection&#xD;
&#xD;
          -  Patient will be excluded from the study if they do not meet this criteria: VAS defined&#xD;
             as at least 75% pain relief that is sustained for at least 2 hours in a 10 hours&#xD;
             period after the block&#xD;
&#xD;
          -  Sacroiliac joint injection will be done without any analgesics but anti anxiety&#xD;
             medication can be used on case by case based&#xD;
&#xD;
          -  The subject will attend a follow-up visit at 6 weeks after the SIJ block and steroid&#xD;
             injection. During this visit if the subject's VAS has recurred to at least 50mm the&#xD;
             patient will be randomized in either sacroiliac joint fusion or radiofrequency&#xD;
             ablation.&#xD;
&#xD;
          -  Subjects with VAS smaller than 50mm will be seen at 12 weeks of follow-up. During this&#xD;
             visit if the subject's VAS has recurred to at least 50mm the patient will be&#xD;
             randomized in either sacroiliac joint fusion or radiofrequency ablation. Subjects with&#xD;
             smaller that 50mm VAS will be excluded from randomization at this time point.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Participation will be offered by treating physicians during an outpatient visit in the&#xD;
        neurosurgery or pain management clinic. Subjects need to meet all inclusion criteria in&#xD;
        order to participate in the study.&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Subject is willing and able to give informed consent for participation in the study&#xD;
&#xD;
          -  Unilateral or bilateral SIJ pain for more than 50 days&#xD;
&#xD;
          -  Persistent SIJ pain despite a trial of physical therapy for SI joint pain&#xD;
&#xD;
          -  Agreement to avoid conception during trial&#xD;
&#xD;
          -  Average VAS of at least 50 mm&#xD;
&#xD;
          -  Minimal ODI score of at least 40%&#xD;
&#xD;
          -  Etiology of SIJ dysfunction: osteoarthritis, past surgical history of lumbar or&#xD;
             lumbosacral fusion, traumatic injury, post-partum.&#xD;
&#xD;
          -  The SIJ pain can not be explained by a lumbar spine pathology seen on MRI: (disc&#xD;
             herniation, lateral recess stenosis, moderate or severe spinal stenosis, synovial&#xD;
             cyst, mass)&#xD;
&#xD;
          -  Successful SIJ injection based on criteria discussed in recruitment section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All participants meeting any of the exclusion criteria at baseline will be excluded from&#xD;
        study participation.&#xD;
&#xD;
          -  Neurological deficit&#xD;
&#xD;
          -  History of cancer&#xD;
&#xD;
          -  Active spinal or systemic infection&#xD;
&#xD;
          -  Past medical history or active psychiatric condition&#xD;
&#xD;
          -  Prohibited drug use&#xD;
&#xD;
          -  Subject with pacemaker&#xD;
&#xD;
          -  Pregnancy or Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel R Denis, MD-MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ochsner Health System</affiliation>
  </overall_official>
  <reference>
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    <PMID>8875721</PMID>
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  <reference>
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  <reference>
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  </reference>
  <reference>
    <citation>Cheng J, Pope JE, Dalton JE, Cheng O, Bensitel A. Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. Clin J Pain. 2013 Feb;29(2):132-7. doi: 10.1097/AJP.0b013e3182490a17.</citation>
    <PMID>22688606</PMID>
  </reference>
  <reference>
    <citation>Duhon BS, Cher DJ, Wine KD, Kovalsky DA, Lockstadt H; SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Global Spine J. 2016 May;6(3):257-69. doi: 10.1055/s-0035-1562912. Epub 2015 Aug 11.</citation>
    <PMID>27099817</PMID>
  </reference>
  <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>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Ackerman SJ, Polly DW Jr, Knight T, Schneider K, Holt T, Cummings J. Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States Medicare population: potential economic implications of a new minimally-invasive technology. Clinicoecon Outcomes Res. 2013 Nov 20;5:575-87. doi: 10.2147/CEOR.S52967. eCollection 2013.</citation>
    <PMID>24348055</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ochsner Health System</investigator_affiliation>
    <investigator_full_name>Daniel Denis</investigator_full_name>
    <investigator_title>Neurosurgeon staff at Ochsner Medical Center and Clinical Assistant Professor, Dept. Neurosurgery, Tulane University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Sacroiliac pain</keyword>
  <keyword>Low back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03230279
org study id: X-99
nct id: NCT03230279
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients diagnosed with chronic SIJ pain that can be treated by sacroiliac joint fusion or
      radiofrequency ablation. The radio frequency ablation is performed using either conventional
      or "cooled" techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. Minimally
      invasive sacroiliac joint consists of implanting 2 to 3 metallic implants inside the SIJ to
      increase the stability and eventually fuse the SIJ. This randomized controlled trial aims at
      comparing treatment success at 6-month follow-up time-point after minimally invasive
      sacroiliac joint fusion and radiofrequency ablation for chronic SIJ dysfunction.
Introduction This document is a protocol for a human research study. This study is to be
      conducted according to US and international standards of Good Clinical Practice (FDA Title 21
      part 312 and International Conference on Harmonization guidelines), applicable government
      regulations and Institutional research policies and procedures.

      Background

      Sacroiliac joint (SIJ) dysfunction is a common pain condition involving the buttock and may
      irradiate in the low back, groin and/or lower extremity. About one in five patients with low
      back pain is estimated to have SI joint pain. The economic burden of SIJ pain is high in the
      United States and there is a need for more cost effective treatment options. There is a lack
      of relevant high quality studies that compared nonsurgical and surgical treatment for SI
      joint dysfunction.

      Sacroiliac joint (SIJ) dysfunction has been estimated to be the origin of lower back pain in
      13 to 30% of patients. SIJ pain is usually referred to the buttock, low back, groin and/or
      lower extremity. SIJ osteoarthritis, trauma, SIJ degeneration following lumbar fusion and
      postpartum SIJ dysfunction are common causes of SIJ pain found in a clinical setting. Other
      less common causes for SIJ pain include inflammatory sacroiliitis, infective sacroiliitis,
      insufficiency stress fractures and neoplasia.

      Diagnostic evidences for SIJ dysfunction

      The presenting symptoms of SIJ dysfunction can be similar to those of other spinal conditions
      such as disc herniation or degenerative spinal stenosis. Unlike radiculopathy, there is often
      an absence of specific radiological finding with SIJ dysfunction. A gold standard for SI
      joint pain diagnosis does not exist, but dual comparative local anesthetic joint blocks with
      at least 70% pain relief are considered a validated diagnostic test for SI joint pain.
      Reproducibility of SIJ pain with at least 3 SIJ-selective stressing tests, including the
      thigh trust, compression, Patrick's, distraction and Gaenslen's test, is also considered
      having good diagnostic validity.

      Investigational Agents and Preclinical Data

      Nonsurgical treatment efficacy for SIJ dysfunction

      Sacroiliac dysfunction is thought to be secondary to a loss of SIJ stability caused by either
      deficient form closure (joint anatomy) or force closure (compressive forces exerted by
      neuromuscular and ligamentous structures around the joint. Physical therapy can improve SI
      joint pain by increasing force closure. Pelvic stabilization, strengthening and self-bracing
      exercises have been showed to improve force closure and may provide SIJ pain relief.

      When SIJ pain fails to improve with physical therapy, several pain management interventions
      can be offered to patients. Up to now, the level of evidence for SIJ intraarticular or
      periarticular steroid injections is mainly limited to short-term outcome (3 months) and the
      effectiveness results are conflicting between different studies.

      Compared to conventional radio frequency ablation, the effectiveness of cooled radiofrequency
      ablation is supported by superior level of evidence. Two randomized controlled trials
      comparing cooled radio frequency ablation vs placebo demonstrated a success rate varying
      between 38 to 57% at 6 months for cooled radiofrequency ablation. Observational studies also
      demonstrated success rate varying from 40% to 71% at 6 months for both conventional and
      cooled radio frequency ablation. The effectiveness of conventional and cooled radio frequency
      ablation at 9 and 12 months are more limited and some studies did report loss of
      effectiveness at 12 months. Based on the available data, there is no evidence supporting
      clinical superiority between traditional and cool radio frequency ablation. A retrospective
      study on 88 patients revealed comparable effectiveness between conventional and cool radio
      frequency ablation with > 50% pain reduction in the majority of patients after 3 and 6
      months.

      Surgical treatment evidence for SIJ dysfunction

      Minimally invasive SIJ fusion is a surgical treatment aimed at stabilizing the SIJ to reduce
      pain, disability and improve quality of life. In a recent randomized controlled trial called
      Investigation of Sacroiliac Fusion Treatment (INSITE), minimally invasive SIJ fusion, using
      triangular titanium implants (iFuse Implant System, SI-BONE®, San Jose, CA), has been shown
      superior to non-surgical treatments in managing SIJ dysfunction at 6 months (81.4% vs 26.1%
      success rate) and the results in the surgical group were sustained at one year and two years
      of follow-up. In this trial, success rate was defined as a decreased in SIJ pain Visual
      Analogue Score of at least 20 mm compared to baseline, an absence of device-related serious
      adverse events, an absence of neurological worsening and no surgical reintervention. There
      were 101 subjects in the SIJ fusion group who completed the 6 months follow-up.

      Clinical Data to Date The INSITE study is the first and only published Level 1 randomized
      controlled trial to have compared SIJ fusion with nonsurgical treatment. Although this study
      demonstrated prolonged improvement in pain, disability and quality of life with SIJ fusion,
      superiority of SIJ fusion compared to nonsurgical treatment at 6 months cannot be
      generalized. This superiority trial may not have been truly clinically relevant because there
      was no specific treatment protocol used in the nonsurgical group for each subject.
      Nonsurgical management consisted of physical therapy in 98%, at least one steroid injection
      in 74%, 2 steroid injections in 4% and radiofrequency ablation of the sacral nerve root
      lateral branches in 46% of the 46 subjects assigned to nonsurgical treatment. The different
      proportions of treatment offered in the nonsurgical group may in fact differ from other pain
      management clinical practices and the generalizability of the results is questionable.

      Compared to all nonsurgical treatment available for SIJ pain, the effectiveness of
      radiofrequency ablation is supported by literature of higher level of evidence. Prolonged
      therapeutic effect up to 6 months after the procedure has been demonstrated for
      radiofrequency ablation. In the INSITE study, only 21 subjects received radio frequency
      ablation, a group size that corresponds to only 21% of the number of subjects studied for SIJ
      fusion. This may explain why the nonsurgical group only had 26.1% success rate in this trial.
      The quality of evidence for the INSITE study may also be contested as the study sponsor,
      SI-BONE®, participated in the manuscript redaction and performed the statistical analysis.

      The costs of nonsurgical treatments for SIJ pain are substantial in the United Sates medicare
      population and there is a need to assess the best cost effective therapy for SI joint pain.
      SIJ fusion and RFN are two SIJ pain treatment modalities that have been studied with a higher
      level of evidence compared to other modalities, showing significant effectiveness lasting
      more than 6 months after each procedure. However the effectiveness and costs associated with
      these two different treatments have never been compared in a clinically relevant randomized
      trial.

      Dose Rationale and Risk/Benefits

      RISKS

      General / Unforeseeable

      The risks of receiving a SIJ fusion include but are not limited to:

        -  post-operative incisional pain or worsened pain due to muscle spams

        -  hematoma and/or surgical site infection (less likely)

        -  nerve damage that can cause paralysis, loss of sensation or pain (unlikely

        -  possible second intervention for revision or withdrawal of implants (unlikely)

      The risks of receiving SIJ radiofrequency ablation include but are not limited to:

        -  Pain or discomfort around the area treated

        -  numbness of skin covering the area treated, worsened pain due to muscle spasm,

        -  permanent nerve pain (less likely)

        -  allergies or reactions to medications, infection and/or hematoma (less likely) 3rd
           degree burn (rare)

        -  Nerve damage due to trauma (rare)

      Other risks that are not specifically related to SIJ fusion or SIJ radiofrequency ablation
      but may occur during any procedure include:

        -  cardiovascular and /or cerebrovascular events

        -  cardiac arrhythmia

        -  deep vein thrombosis

        -  pulmonary emboli

        -  pneumonia

        -  urinary tract infection

        -  skin abrasions

        -  coma or death

      Radiation Risks

      Fluoroscopy is an imaging technique that uses X-rays during the SIJ fusion or SIJ
      radiofrequency ablation. This form or ionizing radiation poses a potential for increasing the
      patient's risk of radiation-induced cancer. Radiations doses and exposure during the study
      are the same that would be used if the subjects were receiving the treatment outside of this
      study. Therefore, this study does not involve any additional radiation risk for the subjects.

      Study Objectives

      Primary objective: Determine clinical superiority between minimally invasive SIJ fusion and
      radiofrequency ablation in chronic SIJ dysfunction patients

      Secondary Objectives: Compare cost-effectiveness between treatment groups

      Study Design

      General Design

        -  Randomized controlled trial where randomization is done by a random number generator.
           Even numbers will be directed to the SI joint procedure group and odd numbers will be
           directed to the radiofrequency ablation procedure.

        -  The enrolment uses a 1:1 ratio of SIJ fusion to radio frequency ablation

        -  The subjects and investigators are not blinded to treatment allocation

      Subjects will have a detailed medical history and will complete these questionnaires

        -  SIJ pain rating using the Visual Analogue Scale (VAS)

        -  Oswestry Disability Index (ODI)

        -  Short Form-36 (SF-36)

      All subjects will be evaluated at randomization and at follow-up visits scheduled at 1, 3, 6,
      9, and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study Population: Chronic SIJ dysfunction patients presenting at selected Ochsner Health System healthcare centers
Recruiting mode: Participation will be offered by the principal investigator or the sub-investigators during an outpatient visit in the neurosurgery or pain management clinic.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Treatment success
time frame: 6 months after the intervention
description: Comparison in the proportion of subjects having a success between groups at 6-month follow-up time-point. Treatment success is defined as a ≥ 50% decrease in VAS pain score; a 10-point increase in SF-36BP (amelioration); a 15-point decrease in ODI (amelioration); absence of device-related serious adverse events; absence of focal neurological deficit or neuropathic pain related to lumbosacral nerve roots injury and absence of surgical reintervention for SIJ pain (revision, removal of hardware, additional fixation)
measure: Cost-effectiveness between SIJ fusion and radio frequency ablation
time frame: 6 months after the intervention
description: Cost-effectiveness comparison between groups. Cost-effectiveness is measured using the SF-6D utility score
measure: Mean changes from baseline in visual analog score for pain
time frame: 6 months after the intervention
description: Comparison of mean changes from baseline between groups in VAS
measure: Radiofrequency ablation subgroups analysis
time frame: 6 months after the intervention
description: Subgroups analysis will be carried on between conventional and cooled radio frequency ablation to attempt to determine if any effect is attributable to one form of RFN or the other
measure: Mean changes from baseline in Oswestry Disability Index score
time frame: 6 months after the intervention
description: Comparison of mean changes from baseline between groups in ODI score
measure: Mean changes from baseline in SF-36 physical component summary score
time frame: 6 months after the intervention
description: Comparison of mean changes from baseline between groups in SF-36 physical component summary score
measure: Mean changes from baseline in SF-36 mental component summary score
time frame: 6 months after the intervention
description: Comparison of mean changes from baseline between groups in SF-36 mental component summary score
arm group label: Sacroiliac joint fusion
arm group type: Active Comparator
description: The subject will receive a sacroiliac joint fusion
arm group label: Sacroiliac radio frequency ablation
arm group type: Active Comparator
description: The subject will receive a sacroiliac joint radiofrequency ablation
intervention type: Procedure
intervention name: Sacroiliac joint fusion
description: Minimally invasive SIJ fusion will be performed under general anesthesia with fluoroscopy. Using SI-LOK®, Sacroiliac Joint Fixation System, Globus Medical Inc. (Audubon, PA), this procedure involve placement of 2 to 3 implants across the SIJ to achieve stabilization and arthrodesis.
arm group label: Sacroiliac joint fusion
other name: Minimally invasive sacroiliac joint arthrodesis
intervention type: Procedure
intervention name: Sacroiliac joint radiofrequency ablation
description: Sacroiliac joint radio frequency ablation will be performed using either conventional or cooled radiofrequency ablation techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. The choice between conventional or cooled RFN will be determined by the provider expertise.
arm group label: Sacroiliac radio frequency ablation
other name: Sacroiliac joint neurotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Daniel R Denis, MD-MSc
role: Principal Investigator
affiliation: Ochsner Health System
citation: Maigne JY, Aivaliklis A, Pfefer F. Results of sacroiliac joint double block and value of sacroiliac pain provocation tests in 54 patients with low back pain. Spine (Phila Pa 1976). 1996 Aug 15;21(16):1889-92. doi: 10.1097/00007632-199608150-00012.
PMID: 8875721
citation: Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine (Phila Pa 1976). 1995 Jan 1;20(1):31-7. doi: 10.1097/00007632-199501000-00007.
PMID: 7709277
citation: Sembrano JN, Polly DW Jr. How often is low back pain not coming from the back? Spine (Phila Pa 1976). 2009 Jan 1;34(1):E27-32. doi: 10.1097/BRS.0b013e31818b8882.
PMID: 19127145
citation: Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.
PMID: 18996232
citation: Capobianco R, Cher D; SIFI Study Group. Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial. Springerplus. 2015 Oct 5;4:570. doi: 10.1186/s40064-015-1359-y. eCollection 2015.
PMID: 26543705
citation: Longo UG, Loppini M, Berton A, Laverde L, Maffulli N, Denaro V. Degenerative changes of the sacroiliac joint after spinal fusion: an evidence-based systematic review. Br Med Bull. 2014 Dec;112(1):47-56. doi: 10.1093/bmb/ldu030. Epub 2014 Oct 29.
PMID: 25355839
citation: Unoki E, Abe E, Murai H, Kobayashi T, Abe T. Fusion of Multiple Segments Can Increase the Incidence of Sacroiliac Joint Pain After Lumbar or Lumbosacral Fusion. Spine (Phila Pa 1976). 2016 Jun;41(12):999-1005. doi: 10.1097/BRS.0000000000001409.
PMID: 26689576
citation: Kok HK, Mumtaz A, O'Brien C, Kane D, Torreggiani WC, Delaney H. Imaging the Patient With Sacroiliac Pain. Can Assoc Radiol J. 2016 Feb;67(1):41-51. doi: 10.1016/j.carj.2015.08.001. Epub 2015 Nov 26.
PMID: 26632100
citation: Irwin RW, Watson T, Minick RP, Ambrosius WT. Age, body mass index, and gender differences in sacroiliac joint pathology. Am J Phys Med Rehabil. 2007 Jan;86(1):37-44. doi: 10.1097/phm.0b013e31802b8554.
PMID: 17304687
citation: Simopoulos TT, Manchikanti L, Gupta S, Aydin SM, Kim CH, Solanki D, Nampiaparampil DE, Singh V, Staats PS, Hirsch JA. Systematic Review of the Diagnostic Accuracy and Therapeutic Effectiveness of Sacroiliac Joint Interventions. Pain Physician. 2015 Sep-Oct;18(5):E713-56.
PMID: 26431129
citation: Szadek KM, van der Wurff P, van Tulder MW, Zuurmond WW, Perez RS. Diagnostic validity of criteria for sacroiliac joint pain: a systematic review. J Pain. 2009 Apr;10(4):354-68. doi: 10.1016/j.jpain.2008.09.014. Epub 2008 Dec 19.
PMID: 19101212
citation: Hungerford B, Gilleard W, Hodges P. Evidence of altered lumbopelvic muscle recruitment in the presence of sacroiliac joint pain. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1593-600.
PMID: 12865851
citation: O'Sullivan PB, Beales DJ, Beetham JA, Cripps J, Graf F, Lin IB, Tucker B, Avery A. Altered motor control strategies in subjects with sacroiliac joint pain during the active straight-leg-raise test. Spine (Phila Pa 1976). 2002 Jan 1;27(1):E1-8. doi: 10.1097/00007632-200201010-00015.
PMID: 11805650
citation: Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.
PMID: 18648237
citation: Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2.
PMID: 22299761
citation: Cheng J, Pope JE, Dalton JE, Cheng O, Bensitel A. Comparative outcomes of cooled versus traditional radiofrequency ablation of the lateral branches for sacroiliac joint pain. Clin J Pain. 2013 Feb;29(2):132-7. doi: 10.1097/AJP.0b013e3182490a17.
PMID: 22688606
citation: Duhon BS, Cher DJ, Wine KD, Kovalsky DA, Lockstadt H; SIFI Study Group. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study. Global Spine J. 2016 May;6(3):257-69. doi: 10.1055/s-0035-1562912. Epub 2015 Aug 11.
PMID: 27099817
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
citation: Ackerman SJ, Polly DW Jr, Knight T, Schneider K, Holt T, Cummings J. Comparison of the costs of nonoperative care to minimally invasive surgery for sacroiliac joint disruption and degenerative sacroiliitis in a United States Medicare population: potential economic implications of a new minimally-invasive technology. Clinicoecon Outcomes Res. 2013 Nov 20;5:575-87. doi: 10.2147/CEOR.S52967. eCollection 2013.
PMID: 24348055
responsible party type: Principal Investigator
investigator affiliation: Ochsner Health System
investigator full name: Daniel Denis
investigator title: Neurosurgeon staff at Ochsner Medical Center and Clinical Assistant Professor, Dept. Neurosurgery, Tulane University School of Medicine
mesh term: Spondylitis
sharing ipd: No