<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/NCT02211183</url>
  </required_header>
  <id_info>
    <org_study_id>IS-CL-02-SP</org_study_id>
    <nct_id>NCT02211183</nct_id>
  </id_info>
  <brief_title>InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear</brief_title>
  <official_title>A Randomized, Two-arm, Prospective, Subject Blind Study to Assess the Safety and Efficacy of InSpace™ Device in Comparison to Full Thickness Massive Rotator Cuff Repair in Subjects Scheduled for a Repair Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OrthoSpace Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OrthoSpace Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a post-marketing study to further assess the safety and effectiveness of the InSpace™&#xD;
      device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff&#xD;
      Tear .&#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>Terminated</overall_status>
  <why_stopped>
    Very Low recruitment rate&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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 Shoulder Score from baseline</measure>
    <time_frame>baseline and 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</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 or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.</description>
  </arm_group>
  <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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InSpace™ system</intervention_name>
    <arm_group_label>InSpace™ system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Age 40 or older.&#xD;
&#xD;
          -  Positive diagnostic imaging of the affected shoulder indicating full thickness Massive&#xD;
             RCT (according to Cofield classification) or long involving more than one tendon.&#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>
  <overall_official>
    <last_name>Emilio Calvo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2016</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>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Massive Rotator Cuff Tear</keyword>
  <keyword>Sub-acromial spacer</keyword>
  <keyword>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/NCT02211183
org study id: IS-CL-02-SP
nct id: NCT02211183
lead sponsor: 
has dmc: No
This is a post-marketing study to further assess the safety and effectiveness of the InSpace™
      device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff
      Tear .
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 Shoulder Score from baseline
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 or mini invasive) of debridement, acromioplasty if deemed necessary with or without long head of biceps tenotomy, and placement of the InSpace™ system.
intervention type: Procedure
intervention name: Best Repair of torn Rotator Cuff
arm group label: Best Repair of torn Rotator Cuff
intervention type: Device
intervention name: InSpace™ system
arm group label: InSpace™ system
criteria: 
gender: All
minimum age: 40 Years
maximum age: 95 Years
healthy volunteers: No
last name: Emilio Calvo, MD
role: Principal Investigator
affiliation: Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries