<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/NCT02208453</url>
  </required_header>
  <id_info>
    <org_study_id>IS-CL-05</org_study_id>
    <secondary_id>72746</secondary_id>
    <nct_id>NCT02208453</nct_id>
  </id_info>
  <brief_title>InSpace™ System Implantation in a Procedure Under Local Anesthesia</brief_title>
  <official_title>A Single Arm, Open-label, Prospective, Study to Assess the Feasibility, Efficacy and Safety of InSpace™ Device Implantation in a Procedure Under Local Anesthesia for a Treatment of Subjects With Massive, Irreparable Rotator Cuff Tear</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>
      The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device&#xD;
      implantation in a surgical procedure under local anesthesia using arthroscopic and/or&#xD;
      fluoroscopic visualization of the affected shoulder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety&#xD;
      of InSpace™ device implantation in a procedure under local anesthesia for a treatment of&#xD;
      subjects with massive, irreparable rotator cuff tear.&#xD;
&#xD;
      Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion&#xD;
      criteria, will be enrolled for the study treatment.&#xD;
&#xD;
      Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or&#xD;
      arthroscopic visualization of InSpace™ implantation.&#xD;
&#xD;
      Subjects will then be followed for safety and efficacy for a 24 months following the&#xD;
      implantation.&#xD;
&#xD;
      The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device&#xD;
      implantation in a surgical procedure under local anesthesia using arthroscopic and/or&#xD;
      fluoroscopic visualization of the affected shoulder.&#xD;
&#xD;
      The efficacy will be assess by using Constant and ASES outcome score The Constant and the&#xD;
      ASES will be completed by the investigator at each study visit .The patient will complete the&#xD;
      patient self-evaluation part of the ASES at each study visit.&#xD;
&#xD;
      The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout&#xD;
      the entire study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">June 2018</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>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in total shoulder outcome scores (Constant and ASES)</measure>
    <time_frame>6 months post implanatation</time_frame>
    <description>Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Total Shoulder scores</measure>
    <time_frame>up to 24 months post implantation</time_frame>
    <description>Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety Assessment</measure>
    <time_frame>24 months post implantation</time_frame>
    <description>The Safety assessment will include all device related AEs/SAEs throughout the entire study period.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>InSpace implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>InSpace device implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InSpace Implantation</intervention_name>
    <description>InSpace device Implantation</description>
    <arm_group_label>InSpace implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 50 or older.&#xD;
&#xD;
          2. Positive diagnostic MRI of the affected shoulder indicating full thickness massive&#xD;
             irreparable RCT of at least 5cm in diameter (according to Cofield classification)&#xD;
             including fatty infiltration grade III or IV (according to classification of&#xD;
             Goutallier).&#xD;
&#xD;
          3. Persistent pain and failure of non-operative treatment of the affected shoulder for at&#xD;
             least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy to the balloon material&#xD;
&#xD;
          2. Evidence of significant osteoarthritis or cartilage damage in the shoulder&#xD;
&#xD;
          3. Evidence of gleno-humeral instability&#xD;
&#xD;
          4. Evidence of major joint trauma, infection, or necrosis in the shoulder&#xD;
&#xD;
          5. Major medical condition or known drug or alcohol abuses that could affect quality of&#xD;
             life and influence the results of the study.&#xD;
&#xD;
          6. Concurrent participation in any other invasive clinical study one month prior to&#xD;
             enrollment to the study and during the entire study period.&#xD;
&#xD;
          7. Subjects with worker's compensation claims or other litigation claims related to the&#xD;
             shoulder being treated in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enrico Gervasi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Orthopedic Department, Latisana Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Latisana</name>
      <address>
        <city>Latisana</city>
        <state>Udine</state>
        <zip>33503</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/27900707</url>
    <description>Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears.</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 29, 2013</study_first_submitted>
  <study_first_submitted_qc>August 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Massive Rotator Cuff Tear</keyword>
  <keyword>Local anesthesia</keyword>
  <keyword>Sub-acromial spacer</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/NCT02208453
org study id: IS-CL-05
secondary id: 72746
nct id: NCT02208453
lead sponsor: 
has dmc: No
The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device
      implantation in a surgical procedure under local anesthesia using arthroscopic and/or
      fluoroscopic visualization of the affected shoulder.
A single arm, open-label, prospective, study to assess the feasibility, efficacy and safety
      of InSpace™ device implantation in a procedure under local anesthesia for a treatment of
      subjects with massive, irreparable rotator cuff tear.

      Subjects with radiological confirmed massive RCT who are eligible per inclusion/exclusion
      criteria, will be enrolled for the study treatment.

      Subjects will undergo surgical intervention under local anesthesia , fluoroscopic and/ or
      arthroscopic visualization of InSpace™ implantation.

      Subjects will then be followed for safety and efficacy for a 24 months following the
      implantation.

      The study objective is to assess the feasibility, efficacy and safety of the InSpace™ Device
      implantation in a surgical procedure under local anesthesia using arthroscopic and/or
      fluoroscopic visualization of the affected shoulder.

      The efficacy will be assess by using Constant and ASES outcome score The Constant and the
      ASES will be completed by the investigator at each study visit .The patient will complete the
      patient self-evaluation part of the ASES at each study visit.

      The Safety assessment will be conducted by collecting all device related AEs/SAEs throughout
      the entire study period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Change in total shoulder outcome scores (Constant and ASES)
time frame: 6 months post implanatation
description: Change in total shoulder outcome scores (Constant and ASES)at 6 month post implantattion
measure: Change in Total Shoulder scores
time frame: up to 24 months post implantation
description: Change in Total Shoulder scores and improvement compare to baseline at each time point (6W, 3m, 12m and 24m).
measure: Safety Assessment
time frame: 24 months post implantation
description: The Safety assessment will include all device related AEs/SAEs throughout the entire study period.
arm group label: InSpace implantation
arm group type: Experimental
description: InSpace device implantation
intervention type: Device
intervention name: InSpace Implantation
description: InSpace device Implantation
arm group label: InSpace implantation
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Enrico Gervasi, MD
role: Principal Investigator
affiliation: Orthopedic Department, Latisana Hospital
facility: 
country: Italy
url: http://www.ncbi.nlm.nih.gov/pubmed/27900707
description: Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears.
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries