<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/NCT02976285</url>
  </required_header>
  <id_info>
    <org_study_id>PitchPatch54</org_study_id>
    <nct_id>NCT02976285</nct_id>
  </id_info>
  <brief_title>Polyester Patch in Massive Rotator Cuff Repair Improves Healing</brief_title>
  <official_title>Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Etzel Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Etzel Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to assess the impact and potential advantage of a novel&#xD;
      synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and&#xD;
      radiological approaches. The investigators hypothesized that implanting this patch will&#xD;
      improve individual shoulder function, while reducing re-tear rates compared to the current&#xD;
      literature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate this, patches were implanted into 54 shoulders and prospectively followed up&#xD;
      clinically and radiologically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Function assessed with the Constant-Murley-Score</measure>
    <time_frame>25 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Function assessed with the Subjective Shoulder Value</measure>
    <time_frame>25 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tendon integrity evaluated radiologically</measure>
    <time_frame>1-35 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">54</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arthroscopic rotator cuff repair with a polyester patch</intervention_name>
    <description>Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the&#xD;
        time of surgery was 65 years (range 41 - 75).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria were age greater 18 years and a RC tear involving at least two&#xD;
             tendons, presenting a massive RC-tear as described by Gerber et al.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded patients older than 75, fatty infiltration grade 4 according to&#xD;
             Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>arthroscopic rotator cuff repair</keyword>
  <keyword>patch augmentation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</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/NCT02976285
org study id: PitchPatch54
nct id: NCT02976285
lead sponsor: 
has dmc: Yes
The purpose of this study was to assess the impact and potential advantage of a novel
      synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and
      radiological approaches. The investigators hypothesized that implanting this patch will
      improve individual shoulder function, while reducing re-tear rates compared to the current
      literature.
To evaluate this, patches were implanted into 54 shoulders and prospectively followed up
      clinically and radiologically.
observational model: Cohort
time perspective: Prospective
measure: Function assessed with the Constant-Murley-Score
time frame: 25 months
measure: Function assessed with the Subjective Shoulder Value
time frame: 25 months
measure: Tendon integrity evaluated radiologically
time frame: 1-35 months
intervention type: Procedure
intervention name: arthroscopic rotator cuff repair with a polyester patch
description: Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
sharing ipd: No