<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/NCT02210910</url>
  </required_header>
  <id_info>
    <org_study_id>IS-CL-02-01</org_study_id>
    <nct_id>NCT02210910</nct_id>
  </id_info>
  <brief_title>InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.</brief_title>
  <official_title>A Randomized, Two-arm, Prospective Study to Assess the Efficacy and Safety of InSpace™ Device Implanted Over a Rotator Cuff Repair in Comparison With Rotator Cuff Repair Only</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoSpace Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OrthoSpace Ltd.</source>
  <brief_summary>
    <textblock>
      This is a post-marketing study to further assess the safety and effectiveness of the InSpace™&#xD;
      in the study population in comparison to surgical RCT repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick&#xD;
      DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily&#xD;
      living (ADL) and improvement of range of motion (ROM).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in the Shoulder Score</measure>
    <time_frame>baseline and 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Best Repair of torn Rotator Cuff</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>InSpace™ system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair, and placement of the InSpace™ system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InSpace™ system over repair</intervention_name>
    <arm_group_label>InSpace™ system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Best Repair of torn Rotator Cuff</intervention_name>
    <arm_group_label>Best Repair of torn Rotator Cuff</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Age 40 or older.&#xD;
&#xD;
          -  Positive diagnostic MRI of the affected shoulder indicating full thickness large to&#xD;
             massive RCT of at least 3cm in diameter (according to Cofield classification2)&#xD;
             involving one or more tendons. (MRI can be done up to 6 months prior to&#xD;
             randomization.)&#xD;
&#xD;
          -  Persistent pain and functional disability of the affected shoulder for at least 3&#xD;
             months.&#xD;
&#xD;
        Main Exclusion Criteria :&#xD;
&#xD;
          -  Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).&#xD;
&#xD;
          -  Evidence of significant osteoarthritis or cartilage damage in the shoulder&#xD;
&#xD;
          -  Evidence of gleno-humeral instability&#xD;
&#xD;
          -  Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy&#xD;
&#xD;
          -  Evidence of major joint trauma, infection, or necrosis in the shoulder&#xD;
&#xD;
          -  Partial-thickness tears of the rotator cuff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Assuta Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>60710</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Massive Rotator Cuff Tear, Sub-acromial spacer, Best repair of rotator cuff</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT02210910
org study id: IS-CL-02-01
nct id: NCT02210910
lead sponsor: 
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™
      in the study population in comparison to surgical RCT repair.
The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick
      DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily
      living (ADL) and improvement of range of motion (ROM).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The change in the Shoulder Score
time frame: baseline and 6 months
arm group label: Best Repair of torn Rotator Cuff
arm group type: Sham Comparator
description: Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair.
arm group label: InSpace™ system
arm group type: Active Comparator
description: Subjects will undergo surgical intervention (usually arthroscopy) to perform debridement, acromioplasty if deemed necessary, long head of biceps tenotomy, and at least partial repair, and placement of the InSpace™ system.
intervention type: Device
intervention name: InSpace™ system over repair
arm group label: InSpace™ system
intervention type: Procedure
intervention name: Best Repair of torn Rotator Cuff
arm group label: Best Repair of torn Rotator Cuff
criteria: 
gender: All
minimum age: 40 Years
maximum age: 95 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries