<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/NCT04495439</url>
  </required_header>
  <id_info>
    <org_study_id>ISSCLIN-01</org_study_id>
    <nct_id>NCT04495439</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures</brief_title>
  <official_title>Safety and Efficacy of the New ISS Sleeve Augmentation Technique in the Treatment of Osteoporotic/Osteopenic Vertebral Fractures in the Thoraco-lumbar Spine: A Pilot Study and Subsequent Comparison to the Standard PMMA-Screw Augmentation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nexilis AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nexilis AG</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone&#xD;
      interface, the ISS stabilization system has been developed. The goal of the study is to&#xD;
      investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of&#xD;
      pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic&#xD;
      thoracolumbar fracture.&#xD;
&#xD;
      The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to&#xD;
      measure clinical and radiological performance and usability of both systems.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2022</start_date>
  <completion_date type="Anticipated">June 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the bi-segmental kyphosis angle (Correction Loss)</measure>
    <time_frame>Day 3 to 6 Months</time_frame>
    <description>The evaluation will be done from a comparison of plain x-rays taken post-operatively before discharge (day 3 (± 1 day)) and 6 months post operatively both in upright position. The correction loss of the bi-segmental kyphosis angle will be compared in the ISS Sleeve screw augmentation group and the standard PMMA screw augmentation group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of x-ray exposure</measure>
    <time_frame>Surgery</time_frame>
    <description>accumulated duration; from skin incision to skin suture) of patients and medical personnel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compression rate</measure>
    <time_frame>post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively</time_frame>
    <description>Compression rate of the anterior vertebral body height measured in the lateral x-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screw loosening</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Screw loosening measured following the method of Aghayev et al. The angle between the axes of the pedicle screws and the cranial endplate are measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the functional outcome with the Oswestry Disability</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Oswestry Disability Index (ODI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the pain level</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months</time_frame>
    <description>Pain Scale as Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the clinical outcome</measure>
    <time_frame>baseline, 3 months, 6 months, 12 months</time_frame>
    <description>SF-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment success</measure>
    <time_frame>at 6 and 12 months postoperatively</time_frame>
    <description>composite endpoint including the correction loss of the bi-segmental kyphosis angle, the ODI and the occurrence of any device-related serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Osteoporotic Fracture of Vertebra</condition>
  <arm_group>
    <arm_group_label>Treatment with ISS Sleeve</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The biocompatible, resorbable ISS sleeve is used for augmentation to enhance screw anchorage. It is melted into the trabecular bone structure of the osteoporotic vertebra using ultrasound. A standard pedicle screw is inserted into the sleeve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment with PMMA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The bone cement Polymethylmethacrylat (PMMA) that is injected into the osteoporotic vertebra.PMMA augmentation of pedicle screws is done using standard cannulated and perforated pedicle screws. The cancellous bone surrounding the screw is enhanced with PMMA bone cement to increase screw anchorage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Augmentation with the ISS Study System</intervention_name>
    <description>Augmentation with the ISS Study System</description>
    <arm_group_label>Treatment with ISS Sleeve</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Augmentation with PMMA</intervention_name>
    <description>Augmentation with PMMA (standard)</description>
    <arm_group_label>Treatment with PMMA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient&#xD;
&#xD;
          1. Age ≥ 50 and ≤ 85, male and female patients&#xD;
&#xD;
          2. Subject is able to understand the risks and benefits of participating in the study and&#xD;
             is willing to provide written informed consent.&#xD;
&#xD;
          3. Psychosocially, mentally and physically able to fully comply with the protocol&#xD;
             requirements for the duration of the study including adhering to scheduled visits,&#xD;
             treatment plan, completing forms and other study procedures.&#xD;
&#xD;
             Fracture&#xD;
&#xD;
          4. Fractures between the 10th thoracic and 4th lumbar vertebra, both included&#xD;
&#xD;
          5. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment&#xD;
             of the screening qCT scan).&#xD;
&#xD;
          6. Fractures with the indication and possibility for augmented bi-segmental dorsal&#xD;
             pedicle screw and rod stabilization including kyphoplasty in the broken vertebra&#xD;
&#xD;
          7. All fractures where pedicle screws can be used&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient&#xD;
&#xD;
          1. Substance use disorders (incl. tobacco abuse &gt;20 cigarettes/day) and alcohol abuse&#xD;
             disorders within the last 2 years before randomization.&#xD;
&#xD;
          2. BMI &gt; 35&#xD;
&#xD;
          3. Permanent or progressive neurologic deficits (incl. upper motor neuron disease and&#xD;
             myelopathy)&#xD;
&#xD;
          4. Known Creutzfeldt Jacob Disease&#xD;
&#xD;
          5. Systemic infections:&#xD;
&#xD;
               -  Known infection with human immunodeficiency virus (HIV) or, hepatitis B or C&#xD;
                  requiring treatment&#xD;
&#xD;
               -  Any active infection requiring the use of parenteral anti-microbial agents or&#xD;
                  that is &gt; grade 2 Common Terminology Criteria for Adverse Events (CTCAE) Version&#xD;
                  4.03&#xD;
&#xD;
          6. Rheumatoid arthritis or known disorders of bone metabolism (excl.&#xD;
             osteopenia/osteoporosis, Vitamin D deficiency)&#xD;
&#xD;
          7. Radiation therapy of the spine in medical history&#xD;
&#xD;
          8. Contraindications to pedicle screw and rod stabilization&#xD;
&#xD;
          9. Breast feeding, pregnancy or child-bearing potential (female patients of childbearing&#xD;
             potential and male patients with a partner of child bearing potential must agree to&#xD;
             use a highly effective contraceptive method).&#xD;
&#xD;
         10. A compromised immune system or a therapy with systemic corticosteroids or&#xD;
             immunosuppressants&#xD;
&#xD;
         11. Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor)&#xD;
             &lt;2 years ago from time of randomization&#xD;
&#xD;
         12. Known allergy to any component of the investigational device&#xD;
&#xD;
         13. History of severe allergy, anaphylactic reactions and hypersensitivity reactions&#xD;
             experienced in previous surgical interventions.&#xD;
&#xD;
         14. Other concurrent severe and/or uncontrolled medical conditions (e.g. insufficiently&#xD;
             treated diabetes (HbA1c &gt; 8 %), active or uncontrolled infection) that could cause&#xD;
             unacceptable safety risks or compromise compliance with the protocol&#xD;
&#xD;
         15. Participation in other clinical investigations for drugs or devices&#xD;
&#xD;
             Fracture&#xD;
&#xD;
         16. Fracture age &gt; 3 months&#xD;
&#xD;
         17. Major surgery to the spine planned for at least 12 months following enrolment&#xD;
&#xD;
         18. Any treatment of the fracture other than that specified in the inclusion criteria&#xD;
             (e.g. index screws in the fractured vertebra, vertebroplasty, additional ventral&#xD;
             stabilization)&#xD;
&#xD;
         19. Severe spinal deformations or fusion at the target vertebral or adjacent segments&#xD;
&#xD;
         20. Previous operations at the spine in the target or adjacent vertebrae&#xD;
&#xD;
         21. Infections or inflammatory processes at vertebral bodies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Lindtner, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Trauma Surgery, Medical University of Innsbruck, Austria</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Leanna Caron</last_name>
    <phone>+41619220508</phone>
    <email>leanna.caron@nexilis.ch</email>
  </overall_contact>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bone augmentation</keyword>
  <keyword>spine</keyword>
  <keyword>pedicle screw</keyword>
  <keyword>osteoporosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Osteoporotic Fractures</mesh_term>
    <mesh_term>Spinal Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495439
org study id: ISSCLIN-01
nct id: NCT04495439
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone
      interface, the ISS stabilization system has been developed. The goal of the study is to
      investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of
      pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic
      thoracolumbar fracture.

      The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to
      measure clinical and radiological performance and usability of both systems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Change of the bi-segmental kyphosis angle (Correction Loss)
time frame: Day 3 to 6 Months
description: The evaluation will be done from a comparison of plain x-rays taken post-operatively before discharge (day 3 (± 1 day)) and 6 months post operatively both in upright position. The correction loss of the bi-segmental kyphosis angle will be compared in the ISS Sleeve screw augmentation group and the standard PMMA screw augmentation group.
measure: Time of x-ray exposure
time frame: Surgery
description: accumulated duration; from skin incision to skin suture) of patients and medical personnel.
measure: Compression rate
time frame: post-operatively before discharge (day 3 (± 1 day)) compared to 3, 6 and 12 months postoperatively
description: Compression rate of the anterior vertebral body height measured in the lateral x-ray
measure: Screw loosening
time frame: up to 12 months
description: Screw loosening measured following the method of Aghayev et al. The angle between the axes of the pedicle screws and the cranial endplate are measured
measure: Evaluation of the functional outcome with the Oswestry Disability
time frame: baseline, 3 months, 6 months, 12 months
description: Oswestry Disability Index (ODI)
measure: Evaluation of the pain level
time frame: baseline, 3 months, 6 months, 12 months
description: Pain Scale as Visual Analogue Scale (VAS)
measure: Evaluation of the clinical outcome
time frame: baseline, 3 months, 6 months, 12 months
description: SF-12
measure: Treatment success
time frame: at 6 and 12 months postoperatively
description: composite endpoint including the correction loss of the bi-segmental kyphosis angle, the ODI and the occurrence of any device-related serious adverse events
arm group label: Treatment with ISS Sleeve
arm group type: Other
description: The biocompatible, resorbable ISS sleeve is used for augmentation to enhance screw anchorage. It is melted into the trabecular bone structure of the osteoporotic vertebra using ultrasound. A standard pedicle screw is inserted into the sleeve.
arm group label: Treatment with PMMA
arm group type: Other
description: The bone cement Polymethylmethacrylat (PMMA) that is injected into the osteoporotic vertebra.PMMA augmentation of pedicle screws is done using standard cannulated and perforated pedicle screws. The cancellous bone surrounding the screw is enhanced with PMMA bone cement to increase screw anchorage.
intervention type: Device
intervention name: Augmentation with the ISS Study System
description: Augmentation with the ISS Study System
arm group label: Treatment with ISS Sleeve
intervention type: Other
intervention name: Augmentation with PMMA
description: Augmentation with PMMA (standard)
arm group label: Treatment with PMMA
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Richard Lindtner, M.D
role: Principal Investigator
affiliation: Department of Trauma Surgery, Medical University of Innsbruck, Austria
last name: Leanna Caron
phone: +41619220508
email: leanna.caron@nexilis.ch
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Osteoporotic Fractures
mesh term: Spinal Fractures
sharing ipd: No