<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/NCT03797144</url>
  </required_header>
  <id_info>
    <org_study_id>MDT17040SD1703</org_study_id>
    <nct_id>NCT03797144</nct_id>
  </id_info>
  <brief_title>Fenestrated Screw Study</brief_title>
  <acronym>FNS</acronym>
  <official_title>A Prospective, Multicenter Evaluation of the CD HORIZON® Fenestrated Screw Spinal System With Fenestrated Screw Cement When Used in the Treatment of Spinal Conditions in Subjects With Compromised Bone Quality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Spinal and Biologics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Spinal and Biologics</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this post-market study is to demonstrate that Oswestry disability&#xD;
      index (ODI) score improved significantly at 12 months post-operatively as compared to&#xD;
      baseline for each indication (degenerative spinal disease and deformity) in subjects with&#xD;
      compromised bone quality, who will receive a surgical procedure requiring posterior&#xD;
      stabilization and/or immobilization of one or more spinal segments using CD HORIZON®&#xD;
      Fenestrated Screw Spinal System with Fenestrated Screw Cement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Delay in enrollment as compared to plan (impacted by COVID-19 pandemic) and availability of&#xD;
    data from other data sources to support the products in scope.&#xD;
  </why_stopped>
  <start_date type="Actual">April 18, 2019</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.&#xD;
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in ODI From Baseline at 3 Months Visit</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.&#xD;
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline</measure>
    <time_frame>Baseline, 3, 12 months</time_frame>
    <description>Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline</measure>
    <time_frame>Baseline, 3, 12 months</time_frame>
    <description>The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting &quot;no health problems,&quot; &quot;slight health problems,&quot; &quot;moderate health problems,&quot; &quot;severe health problems,&quot; and &quot;extreme health problems.&quot; The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).&#xD;
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Neurological Success at 12-month Visit</measure>
    <time_frame>Baseline to 12 months.</time_frame>
    <description>Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).&#xD;
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Intraoperative Cement Extravasation/Leakage. Patients</measure>
    <time_frame>Surgery to 12 months.</time_frame>
    <description>The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Intraoperative Cement Extravasation/Leakage. Screws</measure>
    <time_frame>Surgery to 12 months.</time_frame>
    <description>The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device and/or Procedure Related Adverse Events Through 12 Months.</measure>
    <time_frame>Surgery to 12 months.</time_frame>
    <description>The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.&#xD;
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment&#xD;
21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery</measure>
    <time_frame>Surgery to 12 months.</time_frame>
    <description>When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.&#xD;
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.&#xD;
One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.</measure>
    <time_frame>Surgery to 12 months.</time_frame>
    <description>The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.&#xD;
The following were considered as signs of instrumentation instability:&#xD;
Screw pullout&#xD;
Screw loosening&#xD;
Screw toggle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.</measure>
    <time_frame>Surgery to 12 months.</time_frame>
    <description>The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.&#xD;
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (&lt;4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as &quot;No fusion success&quot;. For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:&#xD;
Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).&#xD;
Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:&#xD;
Coronal alignment : Distance between C7 plumb line and the central sacral vertical line&#xD;
Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:&#xD;
- Coronal Curve Type&#xD;
Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:&#xD;
Curve type L: patients with a lumbar or thoracolumbar major curve &gt;30˚ (apical level of T10 or lower)&#xD;
Curve type T: patients with a thoracic major curve of &gt;30˚ (apical level of T9 or higher)&#xD;
Curve type D: patients with a double major curve, with each curve &gt;30˚.&#xD;
Curve type N: patients with no coronal curve &gt;30˚.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Degenerative Spinal Disease</condition>
  <condition>Deformity of Spine</condition>
  <arm_group>
    <arm_group_label>Fenestrated Screw System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement</intervention_name>
    <description>The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.</description>
    <arm_group_label>Fenestrated Screw System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A subject must meet the following inclusion criteria to participate in this trial:&#xD;
&#xD;
          1. One or more of the following diagnostic indications:&#xD;
&#xD;
               -  Degenerative Spinal Disease (e.g. degenerative disc disease, spondylolisthesis&#xD;
                  and/or spinal stenosis)&#xD;
&#xD;
               -  Deformity (e.g. degenerative deformity)&#xD;
&#xD;
          2. Degenerative Spinal Disease patients only: Patient has been unresponsive to&#xD;
             non-operative treatment for at least three months or has progressive symptoms or signs&#xD;
             of nerve root/spinal cord compression while undergoing continued non-operative&#xD;
             management.&#xD;
&#xD;
          3. Compromised bone quality defined as a hip DXA scan T-score less than or equal to -1.0&#xD;
             or spine quantitative CT (qCT) actual volumetric bone mineral density threshold of ≤&#xD;
             120 mg/cm3.&#xD;
&#xD;
          4. Requires a procedure with an instrumented, posterior thoracic and/or lumbar spinal&#xD;
             stabilization and/or immobilization.&#xD;
&#xD;
          5. Is scheduled to receive a construct using CD Horizon® Spinal System components with at&#xD;
             least one Fenestrated Screw cemented with Fenestrated Screw Cement.&#xD;
&#xD;
          6. At least 22 years old or greater at the time of informed consent.&#xD;
&#xD;
          7. Is able to understand and willing to sign the Patient Informed Consent Form.&#xD;
&#xD;
          8. Is willing and able to undergo the study procedure and perform the follow up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A subject will be excluded from participating in this trial for any of the following&#xD;
        reasons:&#xD;
&#xD;
          1. Has undergone stabilization and/or fusion procedure at the index or adjacent levels.&#xD;
&#xD;
          2. Will undergo vertebroplasty or kyphoplasty procedure during surgery.&#xD;
&#xD;
          3. Has been diagnosed with cauda equina syndrome.&#xD;
&#xD;
          4. Has been previously diagnosed with clinically significant peripheral neuropathy.&#xD;
&#xD;
          5. Has any degree of permanent neurologic deficit due to the presenting spinal disease&#xD;
             (e.g. drop foot or gait deficit).&#xD;
&#xD;
          6. Has obesity defined by BMI greater than or equal to 35kg/m2.&#xD;
&#xD;
          7. Has documented allergy to the materials that will be used in the surgical or any&#xD;
             imaging procedure (e.g. titanium alloys, cobalt-chromium-molybdenum alloys and PMMA&#xD;
             Fenestrated Screw Cement, contrast medium)&#xD;
&#xD;
          8. Has overt or active bacterial infection, local or systemic, and/or potential for&#xD;
             bacteremia.&#xD;
&#xD;
          9. Has a non-correctable spontaneous or therapeutic coagulation disorder or history of&#xD;
             coagulation disorder associated with bleeding.&#xD;
&#xD;
         10. Has evolutive cardiac disease (e.g. symptomatic congestive heart failure, unstable&#xD;
             angina pectoris, cardiac arrhythmia) nonreactive to medical treatment.&#xD;
&#xD;
         11. Has any disease (e.g., neuromuscular disease, etc.) that would preclude the potential&#xD;
             benefit and/or accurate clinical evaluation of the safety of the spinal implant&#xD;
             surgery.&#xD;
&#xD;
         12. Is pregnant or planning to become pregnant during the study duration.&#xD;
&#xD;
         13. Is illiterate or considered vulnerable as per the Investigator's assessment (e.g.,&#xD;
             participants incapable of judgment, or participants under tutelage).&#xD;
&#xD;
         14. Concurrent participation in another clinical study that may add additional safety&#xD;
             risks and/or confound study results*.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UZ Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tyks Surgical Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20700</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Pitié Salpétrière</name>
      <address>
        <city>Paris Cedex 13</city>
        <zip>75651</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Athens Medical Center</name>
      <address>
        <city>Marousi</city>
        <state>Athens</state>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mediterraneo Hospital</name>
      <address>
        <city>Athens</city>
        <zip>16675</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Clinico Humanitas di Milano</name>
      <address>
        <city>Rozzano</city>
        <zip>20086</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Finland</country>
    <country>France</country>
    <country>Greece</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <results_first_submitted>April 26, 2021</results_first_submitted>
  <results_first_submitted_qc>July 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2021</results_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03797144/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03797144/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study aimed at evaluating overall 100 subjects with around 50 subjects (no less than 48 subjects) in each indication subgroup at approximately 10 study sites in Europe. Due to the premature closure of the study, the number of enrolled subjects was 27 (16 belonging to the degenerative spinal disease group and 11 to the deformity group) in 6 sites in Europe.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Degenerative Spinal Disease</title>
          <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
        </group>
        <group group_id="P2">
          <title>Deformity</title>
          <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrollment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Surgery</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3 Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Early termination cut-off date</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12 Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Early termination cut-off date</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>24 Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Early termination cut-off date</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>
      <group_list>
        <group group_id="B1">
          <title>Degenerative Spinal Disease</title>
          <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
        </group>
        <group group_id="B2">
          <title>Deformity</title>
          <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</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="11"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.5" spread="10"/>
                    <measurement group_id="B2" value="70.9" spread="6.6"/>
                    <measurement group_id="B3" value="70.7" spread="8.3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.8" spread="13.3"/>
                    <measurement group_id="B2" value="66.6" spread="10.8"/>
                    <measurement group_id="B3" value="63.5" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="159.3" spread="7.3"/>
                    <measurement group_id="B2" value="158.6" spread="8.2"/>
                    <measurement group_id="B3" value="159.0" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Max Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.9" spread="4.1"/>
                    <measurement group_id="B2" value="26.4" spread="3.6"/>
                    <measurement group_id="B3" value="25.1" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of conservative treatment</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.6" spread="49.0"/>
                    <measurement group_id="B2" value="20.9" spread="22.7"/>
                    <measurement group_id="B3" value="21.3" spread="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Back Pain Resulting in Planned Surgery</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" spread="13.6"/>
                    <measurement group_id="B2" value="17.5" spread="17.9"/>
                    <measurement group_id="B3" value="15.4" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Leg Pain Resulting in Planned Surgery</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.0" spread="11.4"/>
                    <measurement group_id="B2" value="9.2" spread="6.1"/>
                    <measurement group_id="B3" value="10.1" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Other Generalized Pain Resulting in Planned Surgery</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.0" spread="0.0"/>
                    <measurement group_id="B2" value="12.0" spread="37.9"/>
                    <measurement group_id="B3" value="5.7" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patients with previous surgeries</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Bone Density Assessment</title>
          <description>DXA scan of the Hip. A T-score within 1 SD (+1 or -1) of the young adult mean indicates normal bone density.&#xD;
A T-score of 1 to 2.5 SD below the young adult mean (-1 to -2.5 SD) indicates low bone mass.&#xD;
A T-score of 2.5 SD or more below the young adult mean (more than -2.5 SD) indicates the presence of osteoporosis.</description>
          <population>For 3 subjects the Bone Density Assessment was missing, and compromised bone quality was confirmed during surgery.</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="-1.9" spread="0.8"/>
                    <measurement group_id="B2" value="-1.9" spread="0.8"/>
                    <measurement group_id="B3" value="-1.9" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline</title>
        <description>Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.&#xD;
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.</description>
        <time_frame>Baseline to 12 months</time_frame>
        <population>Due to the premature termination of the study, the number of subjects who completed the 12 month follow-up visit was very low (N=2/21, 9.5%).</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline</title>
          <description>Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.&#xD;
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.</description>
          <population>Due to the premature termination of the study, the number of subjects who completed the 12 month follow-up visit was very low (N=2/21, 9.5%).</population>
          <units>score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.0"/>
                    <measurement group_id="O2" value="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in ODI From Baseline at 3 Months Visit</title>
        <description>Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.&#xD;
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.</description>
        <time_frame>Baseline, 3 months</time_frame>
        <population>The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in ODI From Baseline at 3 Months Visit</title>
          <description>Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.&#xD;
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.</description>
          <population>The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point.</population>
          <units>score 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="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.7" spread="20.0"/>
                    <measurement group_id="O2" value="39.6" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="24.9"/>
                    <measurement group_id="O2" value="23.0" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.5" spread="28.9"/>
                    <measurement group_id="O2" value="16.6" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_ODI ≤ 0, and the alternative hypothesis was Ha: μ_ODI &gt; 0 where μ_ODI is the mean improvement of ODI score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.06</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of ODI from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_ODI ≤ 0, and the alternative hypothesis was Ha: μ_ODI &gt; 0 where μ_ODI is the mean improvement of ODI score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.012</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline</title>
        <description>Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</description>
        <time_frame>Baseline, 3, 12 months</time_frame>
        <population>The results are summarized for 21 subjects who were assessed at Baseline,19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline</title>
          <description>Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.&#xD;
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</description>
          <population>The results are summarized for 21 subjects who were assessed at Baseline,19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</population>
          <units>score 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="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Back Pain_Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.9"/>
                    <measurement group_id="O2" value="6.8" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back Pain_3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="2.8"/>
                    <measurement group_id="O2" value="1.7" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back Pain_Change from Baseline at 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.6"/>
                    <measurement group_id="O2" value="5.1" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back Pain_12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.0"/>
                    <measurement group_id="O2" value="3.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Back Pain_Change from Baseline at 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.0"/>
                    <measurement group_id="O2" value="0.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Pain_Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="2.2"/>
                    <measurement group_id="O2" value="7.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Pain_3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.3"/>
                    <measurement group_id="O2" value="1.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Pain_Change from Baseline at 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="2.7"/>
                    <measurement group_id="O2" value="5.8" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Pain_12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.0"/>
                    <measurement group_id="O2" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leg Pain_Change form Baseline at 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="0.0"/>
                    <measurement group_id="O2" value="1.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS &gt; 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <p_value_desc>Back Pain</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS &gt; 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Back Pain</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS &gt; 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Leg Pain</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of VAS from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_VAS ≤ 0, and the alternative hypothesis was Ha: μ_VAS &gt; 0 where μ_VAS is the mean improvement of VAS score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Leg Pain</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline</title>
        <description>The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting &quot;no health problems,&quot; &quot;slight health problems,&quot; &quot;moderate health problems,&quot; &quot;severe health problems,&quot; and &quot;extreme health problems.&quot; The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).&#xD;
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</description>
        <time_frame>Baseline, 3, 12 months</time_frame>
        <population>The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported. The reported EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline</title>
          <description>The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting &quot;no health problems,&quot; &quot;slight health problems,&quot; &quot;moderate health problems,&quot; &quot;severe health problems,&quot; and &quot;extreme health problems.&quot; The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).&#xD;
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported.</description>
          <population>The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow-up visit and 2 subjects who completed the 12 months follow-up visit.&#xD;
The 24 months follow-up visit did not have data collected and are not reported. The reported EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.</population>
          <units>score 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="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Index score_Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.25"/>
                    <measurement group_id="O2" value="0.39" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index score_3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.37"/>
                    <measurement group_id="O2" value="0.68" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index score_Change from Baseline at 3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.36"/>
                    <measurement group_id="O2" value="0.28" spread="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index score_12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.910" spread="0.0"/>
                    <measurement group_id="O2" value="0.910" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Index score_Change from Baseline at 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.423" spread="0.0"/>
                    <measurement group_id="O2" value="0.423" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health State score_Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.8" spread="20.3"/>
                    <measurement group_id="O2" value="57.5" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health State score_3 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.8" spread="21.7"/>
                    <measurement group_id="O2" value="82.2" spread="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health State score_Change from Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="35.8"/>
                    <measurement group_id="O2" value="24.7" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health State score_12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" spread="0.0"/>
                    <measurement group_id="O2" value="70.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health State score_Change from Baseline at 12 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" spread="0.0"/>
                    <measurement group_id="O2" value="20.0" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L &gt; 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.174</p_value>
            <p_value_desc>Health State Score</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L &gt; 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.002</p_value>
            <p_value_desc>Health State Score</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L &gt; 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.003</p_value>
            <p_value_desc>Index score</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To verify that the improvement of EQ-5D 5L from Baseline to 3 Month was significantly greater than 0 for each indication subgroup the following statistical analyses were planned.&#xD;
The null hypothesis was H0: μ_EQ-5D 5L ≤ 0, and the alternative hypothesis was Ha: μ_EQ-5D 5L &gt; 0 where μ_EQ-5D 5L is the mean improvement of EQ-5D 5L score at 3 months from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>A paired t-test for normally distributed data was performed to test whether the mean improvement from baseline was significantly greater than 0.&#xD;
The normality of the data distribution was assessed with the Shapiro-Wilk test.</non_inferiority_desc>
            <p_value>0.012</p_value>
            <p_value_desc>Index score</p_value_desc>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Neurological Success at 12-month Visit</title>
        <description>Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).&#xD;
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).</description>
        <time_frame>Baseline to 12 months.</time_frame>
        <population>21 subjects were assessed at Baseline,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Due to the premature termination of the study, the number of subjects who completed the 12 months follow-up visit was very low (N=2/21, 9.5%).</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Neurological Success at 12-month Visit</title>
          <description>Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).&#xD;
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).</description>
          <population>21 subjects were assessed at Baseline,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Due to the premature termination of the study, the number of subjects who completed the 12 months follow-up visit was very low (N=2/21, 9.5%).</population>
          <units>score on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Motor Functions_Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Motor Functions_12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory Functions_Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory Functions_12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflexes_Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflexes_12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Straight Leg Raise_Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Straight Leg Raise_12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Intraoperative Cement Extravasation/Leakage. Patients</title>
        <description>The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.</description>
        <time_frame>Surgery to 12 months.</time_frame>
        <population>21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Intraoperative Cement Extravasation/Leakage. Patients</title>
          <description>The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.</description>
          <population>21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with cement extravasation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with symptomatic extravasation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Intraoperative Cement Extravasation/Leakage. Screws</title>
        <description>The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.</description>
        <time_frame>Surgery to 12 months.</time_frame>
        <population>21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Intraoperative Cement Extravasation/Leakage. Screws</title>
          <description>The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.</description>
          <population>21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 months follow-up visit.</population>
          <units>Screws</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Cemented Fenestrated Screws</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fenestrated Screws with cement extravasation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fenestrated screws with symptomatic cement extravasation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device and/or Procedure Related Adverse Events Through 12 Months.</title>
        <description>The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.&#xD;
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment&#xD;
21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.</description>
        <time_frame>Surgery to 12 months.</time_frame>
        <population>21 subjects were assessed at surgery,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Adverse events up to 12 month follow-up visits are reported in the Outcome Measure Data Table.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Device and/or Procedure Related Adverse Events Through 12 Months.</title>
          <description>The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.&#xD;
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment&#xD;
21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.</description>
          <population>21 subjects were assessed at surgery,19 subjects completed the 3 months follow-up visit and 2 subjects completed the 12 months follow-up visit. Adverse events up to 12 month follow-up visits are reported in the Outcome Measure Data Table.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Event (AE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Event (SAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Device Effect (SADE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unexpected Serious Adverse Device Effect (USADE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Access System</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Cage/Interbody</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Anterior Plate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Bone Grafts and Substitutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Rods</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Fenestrated Screw Cement_Investigator assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Fenestrated Screw Cement_Sponsor assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to Fenestrated Screw(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to other components of the Fixation (stabilization) System</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to an underlying condition or disease_Investigator assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs Related to an underlying condition or disease_Sponsor assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Related SAEs_Investigator assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Related SAEs_Sponsor assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery</title>
        <description>When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.&#xD;
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.&#xD;
One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.</description>
        <time_frame>Surgery to 12 months.</time_frame>
        <population>21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery</title>
          <description>When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.&#xD;
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.&#xD;
One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.</description>
          <population>21 subjects were assessed at surgery,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.</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="11"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.</title>
        <description>The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.&#xD;
The following were considered as signs of instrumentation instability:&#xD;
Screw pullout&#xD;
Screw loosening&#xD;
Screw toggle</description>
        <time_frame>Surgery to 12 months.</time_frame>
        <population>2 subjects completed the 12 month follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.</title>
          <description>The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.&#xD;
The following were considered as signs of instrumentation instability:&#xD;
Screw pullout&#xD;
Screw loosening&#xD;
Screw toggle</description>
          <population>2 subjects completed the 12 month follow-up visit.</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="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Stable Construct</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unstable Construct</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.</title>
        <description>The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.&#xD;
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (&lt;4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as &quot;No fusion success&quot;. For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.</description>
        <time_frame>Surgery to 12 months.</time_frame>
        <population>2 subjects who completed the 12 month follow-up visit were analyzed for fusion assessment with radiographic images.</population>
        <group_list>
          <group group_id="O1">
            <title>Degenerative Spinal Disease</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
          </group>
          <group group_id="O2">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.</title>
          <description>The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.&#xD;
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (&lt;4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as &quot;No fusion success&quot;. For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.</description>
          <population>2 subjects who completed the 12 month follow-up visit were analyzed for fusion assessment with radiographic images.</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="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Fusion success</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No fusion success</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unable to determine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.</title>
        <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:&#xD;
Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).&#xD;
Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)</description>
        <time_frame>Baseline to 12 months</time_frame>
        <population>1 subject who completed the 12 month follow-up visit was analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.</title>
          <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:&#xD;
Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).&#xD;
Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)</description>
          <population>1 subject who completed the 12 month follow-up visit was analyzed.</population>
          <units>Degrees</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Thoracic Kyphosis (TK) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Thoracic Kyphosis (TK) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Thoracolumbar kyphosis (TLK) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Thoracolumbar kyphosis (TLK) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Lumbar lordosis (LL) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Lumbar Lordosis (LL) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Pelvic Incidence (PI) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Pelvic Incidence (PI) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Pelvic Tilt (PT) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Pelvic Tilt (PT) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Sacral Slope (SS) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Sacral Slope (SS) (degrees)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.</title>
        <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:&#xD;
Coronal alignment : Distance between C7 plumb line and the central sacral vertical line&#xD;
Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)</description>
        <time_frame>Baseline to 12 months</time_frame>
        <population>1 subject who completed the 12 month follow-up visit was analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.</title>
          <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:&#xD;
Coronal alignment : Distance between C7 plumb line and the central sacral vertical line&#xD;
Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)</description>
          <population>1 subject who completed the 12 month follow-up visit was analyzed.</population>
          <units>mm</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Coronal alignment (mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Coronal alignment (mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Sagittal vertical axis (SVA) (mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months Sagittal vertical axis (SVA) (mm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months</title>
        <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:&#xD;
- Coronal Curve Type&#xD;
Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:&#xD;
Curve type L: patients with a lumbar or thoracolumbar major curve &gt;30˚ (apical level of T10 or lower)&#xD;
Curve type T: patients with a thoracic major curve of &gt;30˚ (apical level of T9 or higher)&#xD;
Curve type D: patients with a double major curve, with each curve &gt;30˚.&#xD;
Curve type N: patients with no coronal curve &gt;30˚.</description>
        <time_frame>Baseline to 12 months</time_frame>
        <population>1 subject who completed the 12 month follow-up visit was analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Deformity</title>
            <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</description>
          </group>
        </group_list>
        <measure>
          <title>For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months</title>
          <description>Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.&#xD;
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.&#xD;
The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:&#xD;
- Coronal Curve Type&#xD;
Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:&#xD;
Curve type L: patients with a lumbar or thoracolumbar major curve &gt;30˚ (apical level of T10 or lower)&#xD;
Curve type T: patients with a thoracic major curve of &gt;30˚ (apical level of T9 or higher)&#xD;
Curve type D: patients with a double major curve, with each curve &gt;30˚.&#xD;
Curve type N: patients with no coronal curve &gt;30˚.</description>
          <population>1 subject who completed the 12 month follow-up visit was analyzed.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline curve type L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months curve type L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline curve type T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months curve type T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline curve type D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months curve type D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline curve type N</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-months curve type N</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Degenerative Spinal Disease</title>
          <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for Degenerative Spinal Disease indication, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies (e.g. degenerative disc disease, spondylolisthesis and/or spinal stenosis).</description>
        </group>
        <group group_id="E2">
          <title>Deformity</title>
          <description>Subjects with compromised bone quality requiring stabilization and/or immobilization of the thoracic and/or lumbar spine for deformity indication (e.g. degenerative deformity).</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="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>INGUINAL HERNIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>INCISION WOUND DEHISCENCE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>SPINAL FRACTURE AT LEVEL T12</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>FORAMINAL STENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>SPINAL CSF LEAK</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>PULMONARY EDEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>PROXIMAL JUNCTIONAL KYPHOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HEMATOMA AT INDEX LEVEL CAUSING FEVER ABOVE 37.8°C</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Research Specialist</name_or_title>
      <organization>Medtronic</organization>
      <phone>+39 3450225929</phone>
      <email>francesca.molineris@medtronic.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/NCT03797144
org study id: MDT17040SD1703
nct id: NCT03797144
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The primary objective of this post-market study is to demonstrate that Oswestry disability
      index (ODI) score improved significantly at 12 months post-operatively as compared to
      baseline for each indication (degenerative spinal disease and deformity) in subjects with
      compromised bone quality, who will receive a surgical procedure requiring posterior
      stabilization and/or immobilization of one or more spinal segments using CD HORIZON®
      Fenestrated Screw Spinal System with Fenestrated Screw Cement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline
time frame: Baseline to 12 months
description: Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections.
Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.
The results are summarized for 21 subjects who were assessed at Baseline and 2 subjects who completed the 12 month follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline point minus the value of the 12 months time point.
measure: Change in ODI From Baseline at 3 Months Visit
time frame: Baseline, 3 months
description: Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. [23]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders.
ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100.
The results are summarized for 21 subjects who were assessed at Baseline and 19 subjects who completed the 3 months follow-up visit. The 24 months follow-up visit did not have data collected and are not reported. The reported ODI was calculated from two timepoints as the value of the baseline time point minus the value of the 3 months time point.
measure: Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline
time frame: Baseline, 3, 12 months
description: Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible.
The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the value of the 12 months time point.
The 24 months follow-up visit did not have data collected and are not reported.
measure: Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline
time frame: Baseline, 3, 12 months
description: The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on a 0 to 100 scale (0 = maximal health-related problems, 100 = minimal health-related problems).
EQ-5D 5L was calculated from two timepoints as the value of the baseline point minus the value of the 3 months follow-up visit and the value of the baseline point minus the value of the 12 months follow-up visit.
The 24 months follow-up visit did not have data collected and are not reported.
measure: Rate of Neurological Success at 12-month Visit
time frame: Baseline to 12 months.
description: Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Against Full Resistance (full strength) and straight leg raise (1 = Positive. Patient experiences radiating leg pain below the knee on elevating the leg between 15° and 70° with the knee extended, 2 = Negative. No pain experienced).
Overall neurological success will be defined as maintenance or improvement in all sections for time period evaluated (each element must remain the same or improve).
measure: Rate of Intraoperative Cement Extravasation/Leakage. Patients
time frame: Surgery to 12 months.
description: The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
measure: Rate of Intraoperative Cement Extravasation/Leakage. Screws
time frame: Surgery to 12 months.
description: The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.
measure: Device and/or Procedure Related Adverse Events Through 12 Months.
time frame: Surgery to 12 months.
description: The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship.
For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment
21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-up visit and 2 subjects completed the 12 month follow-up visit.
measure: Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery
time frame: Surgery to 12 months.
description: When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery.
Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other.
One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.
measure: Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit.
time frame: Surgery to 12 months.
description: The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months.
The following were considered as signs of instrumentation instability:
Screw pullout
Screw loosening
Screw toggle
measure: Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended.
time frame: Surgery to 12 months.
description: The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays.
The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion success". For multi-level subjects, fusion success was assessed for each level and overall fusion status was defined as achieving fusion at all treated levels. If one level's fusion status could not be determined, then the subject level was considered unable to determine.
measure: For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit.
time frame: Baseline to 12 months
description: Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:
Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL).
Sagittal spinopelvic parameters: Pelvic Incidence (PI): Pelvic Tilt (PT) and Sacral Slope (SS)
measure: For Deformity Subjects Only: Change in Coronal Alignment and Sagittal Vertical Axis From Baseline at the 12-month Visit.
time frame: Baseline to 12 months
description: Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.
The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray:
Coronal alignment : Distance between C7 plumb line and the central sacral vertical line
Sagittal alignment - Global parameter: Sagittal vertical axis (SVA)
measure: For Deformity Subjects Only: Number of Participants With Coronal Curve Type (T, L, D or N) at Baseline and 12 Months
time frame: Baseline to 12 months
description: Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery.
Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment.
The following spinopelvic alignment parameter was assessed in the deformity patients on standing frontal full spine X-ray:
- Coronal Curve Type
Coronal curve type is determined on the basis of maximal coronal angle measured according to standard Cobb technique and is classified as:
Curve type L: patients with a lumbar or thoracolumbar major curve >30˚ (apical level of T10 or lower)
Curve type T: patients with a thoracic major curve of >30˚ (apical level of T9 or higher)
Curve type D: patients with a double major curve, with each curve >30˚.
Curve type N: patients with no coronal curve >30˚.
arm group label: Fenestrated Screw System
arm group type: Experimental
intervention type: Device
intervention name: CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
description: The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.
arm group label: Fenestrated Screw System
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Finland
country: France
country: Greece
country: Italy
responsible party type: Sponsor
mesh term: Spinal Diseases
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 