<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/NCT02256891</url>
  </required_header>
  <id_info>
    <org_study_id>04100-11-C</org_study_id>
    <nct_id>NCT02256891</nct_id>
  </id_info>
  <brief_title>Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique</brief_title>
  <acronym>RCRPRFM</acronym>
  <official_title>Arthroscopic Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique: A Randomized Blinded Outcomes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Musculoskeletal Transplant Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of&#xD;
      patients treated with arthroscopic rotator cuff repair using one of two techniques. One&#xD;
      technique used is the standard double row repairs utilizing medial and laterally based anchor&#xD;
      fixation and the other technique is the standard double row repairs utilizing medial and&#xD;
      laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is&#xD;
      hypothesized that patients undergoing the surgery with the PRFM will report a higher quality&#xD;
      of life than the patients that do not receive this treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Return to Function</measure>
    <time_frame>Baseline</time_frame>
    <description>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Return to Function</measure>
    <time_frame>6 months</time_frame>
    <description>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Return to Function</measure>
    <time_frame>24 months</time_frame>
    <description>Western Ontario Rotator Cuff Index</description>
  </primary_outcome>
  <other_outcome>
    <measure>Spraspinatus Strength Measurements</measure>
    <time_frame>Baseline</time_frame>
    <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
  </other_outcome>
  <other_outcome>
    <measure>MRI</measure>
    <time_frame>6 months</time_frame>
    <description>MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.&#xD;
Higher grades are worse radiographic outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Supraspinatus Strength Measurements</measure>
    <time_frame>6 months</time_frame>
    <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Supraspinatus Strength Measurements</measure>
    <time_frame>24 months</time_frame>
    <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Infraspinatus Strength Measurements</measure>
    <time_frame>Baseline</time_frame>
    <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Infraspinatus Strength Measurements</measure>
    <time_frame>6 months</time_frame>
    <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
  </other_outcome>
  <other_outcome>
    <measure>Infraspinatus Strength Measurements</measure>
    <time_frame>24 months</time_frame>
    <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Double Row</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double Row</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Double Row with PRFM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double Row with PRFM</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PRFM</intervention_name>
    <arm_group_label>Double Row with PRFM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Double Row</intervention_name>
    <arm_group_label>Double Row</arm_group_label>
    <arm_group_label>Double Row with PRFM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of a rotator cuff tear as determined by clinical examination and diagnostic&#xD;
             imaging (MRI)&#xD;
&#xD;
          -  Patient undergoes arthroscopic rotator cuff repair&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pre-operative exclusion criteria&#xD;
&#xD;
          -  Patient has had a previous arthroscopic rotator cut repair&#xD;
&#xD;
          -  A previous diagnosis of Rheumatoid Arthritis&#xD;
&#xD;
          -  Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation,&#xD;
             inflammatory or degenerative glenohumeral arthropathy, frozen shoulder, or previous&#xD;
             surgery of the affected shoulder,&#xD;
&#xD;
          -  Evidence of significant rotator cuff arthropathy with superior humeral translation and&#xD;
             acromial erosion diagnosed by x-ray or other investigations,&#xD;
&#xD;
          -  Medical device that would exclude the patient from having a MRI, including a&#xD;
             pacemaker, cardiac defibrillator, aneurysm clips, carotid artery clamp,&#xD;
             neurostimulator, insulin or infusion pump, implanted drug infusion device, bone&#xD;
             growth/fusion stimulator, or ear implant.&#xD;
&#xD;
          -  Major medical illness (life expectancy less then 2 years or unacceptably high&#xD;
             operative risk),&#xD;
&#xD;
          -  Inability to speak or read English&#xD;
&#xD;
          -  Psychiatric illness that precludes informed consent.&#xD;
&#xD;
          -  Pregnant patients.&#xD;
&#xD;
          -  Age 17 or younger&#xD;
&#xD;
          -  Unwillingness to be followed for 2 years.&#xD;
&#xD;
          -  Bilateral Rotator cuff tear confirmed by clinical exam and MRI&#xD;
&#xD;
          -  Patients enrolled in the study who demonstrate retear on clinical exam and MRI, then&#xD;
             elect for a repeat surgery.&#xD;
&#xD;
        Intra-operative exclusion criteria (Note: This information will be collected during the&#xD;
        chart audit and patients will be excluded from the study at that time.)&#xD;
&#xD;
          -  Irreparable cuff tears or tears extending into the subscapularis or teres minor&#xD;
&#xD;
          -  Isolated teres minor or subscapularis tears.&#xD;
&#xD;
          -  Inelastic and immobile tendon which cannot be advanced to articular margin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>TRIA Orthopaedic Center</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <results_first_submitted>January 24, 2017</results_first_submitted>
  <results_first_submitted_qc>July 11, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2017</results_first_posted>
  <last_update_submitted>July 11, 2017</last_update_submitted>
  <last_update_submitted_qc>July 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rotator cuff tear</keyword>
  <keyword>Rotator cuff injury</keyword>
  <keyword>Shoulder pain</keyword>
  <keyword>Shoulder injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Double Row</title>
          <description>Double Row&#xD;
Double Row</description>
        </group>
        <group group_id="P2">
          <title>Double Row With PRFM</title>
          <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen Fail</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Equipment Malfunction</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Double Row Only</title>
          <description>Double Row</description>
        </group>
        <group group_id="B2">
          <title>Double Row With PRFM</title>
          <description>PRFM</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="97"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.00" lower_limit="34" upper_limit="73"/>
                    <measurement group_id="B2" value="58.64" lower_limit="42" upper_limit="75"/>
                    <measurement group_id="B3" value="56.15" lower_limit="34" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Return to Function</title>
        <description>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>PRFM</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Function</title>
          <description>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1257.45" spread="396.07"/>
                    <measurement group_id="O2" value="1106.31" spread="393.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Return to Function</title>
        <description>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Function</title>
          <description>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371.38" spread="312.18"/>
                    <measurement group_id="O2" value="297.13" spread="221.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Return to Function</title>
        <description>Western Ontario Rotator Cuff Index</description>
        <time_frame>24 months</time_frame>
        <population>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Return to Function</title>
          <description>Western Ontario Rotator Cuff Index</description>
          <population>The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174.8" spread="254.41"/>
                    <measurement group_id="O2" value="103.11" spread="144.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Spraspinatus Strength Measurements</title>
        <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
        <time_frame>Baseline</time_frame>
        <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Spraspinatus Strength Measurements</title>
          <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
          <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
          <units>percentage of uninvolved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.4" spread="34.2"/>
                    <measurement group_id="O2" value="51.8" spread="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>MRI</title>
        <description>MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.&#xD;
Higher grades are worse radiographic outcomes.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>MRI</title>
          <description>MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.&#xD;
Higher grades are worse radiographic outcomes.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.21" spread="1.07"/>
                    <measurement group_id="O2" value="2.74" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Supraspinatus Strength Measurements</title>
        <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
        <time_frame>6 months</time_frame>
        <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Supraspinatus Strength Measurements</title>
          <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
          <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
          <units>percentage of uninvolved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0" spread="29.0"/>
                    <measurement group_id="O2" value="81.0" spread="26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Supraspinatus Strength Measurements</title>
        <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
        <time_frame>24 months</time_frame>
        <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Supraspinatus Strength Measurements</title>
          <description>Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
          <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
          <units>percentage of uninvolved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.0" spread="53.0"/>
                    <measurement group_id="O2" value="96.0" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Infraspinatus Strength Measurements</title>
        <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
        <time_frame>Baseline</time_frame>
        <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Infraspinatus Strength Measurements</title>
          <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
          <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
          <units>percentage of uninvolved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" spread="67.4"/>
                    <measurement group_id="O2" value="73.7" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Infraspinatus Strength Measurements</title>
        <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
        <time_frame>6 months</time_frame>
        <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Infraspinatus Strength Measurements</title>
          <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
          <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
          <units>percentage of uninvolved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" spread="33.0"/>
                    <measurement group_id="O2" value="96.0" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Infraspinatus Strength Measurements</title>
        <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
        <time_frame>24 months</time_frame>
        <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
        <group_list>
          <group group_id="O1">
            <title>Double Row</title>
            <description>Double Row&#xD;
Double Row</description>
          </group>
          <group group_id="O2">
            <title>Double Row With PRFM</title>
            <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
          </group>
        </group_list>
        <measure>
          <title>Infraspinatus Strength Measurements</title>
          <description>Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.</description>
          <population>There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.</population>
          <units>percentage of uninvolved</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102.0" spread="23.0"/>
                    <measurement group_id="O2" value="104.0" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 month</time_frame>
      <desc>24 month visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Double Row</title>
          <description>Double Row&#xD;
Double Row</description>
        </group>
        <group group_id="E2">
          <title>Double Row With PRFM</title>
          <description>Double Row with PRFM&#xD;
PRFM&#xD;
Double Row</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>ENT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Optomological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Oncological</sub_title>
                <description>Cancer</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary/Respiratory</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>A disadvantage is the majority of the tears are small or medium sized. These have a higher intrinsic healing and as such may not require platelet augmentation to afford a successful outcome.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Michael Walsh</name_or_title>
      <organization>Health Partners</organization>
      <phone>(952) 831-8742</phone>
      <email>michael.walsh@tria.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02256891
org study id: 04100-11-C
nct id: NCT02256891
lead sponsor: 
collaborator: 
has dmc: Yes
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of
      patients treated with arthroscopic rotator cuff repair using one of two techniques. One
      technique used is the standard double row repairs utilizing medial and laterally based anchor
      fixation and the other technique is the standard double row repairs utilizing medial and
      laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is
      hypothesized that patients undergoing the surgery with the PRFM will report a higher quality
      of life than the patients that do not receive this treatment.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Return to Function
time frame: Baseline
description: The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.
measure: Return to Function
time frame: 6 months
description: The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.
measure: Return to Function
time frame: 24 months
description: Western Ontario Rotator Cuff Index
measure: Spraspinatus Strength Measurements
time frame: Baseline
description: Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.
measure: MRI
time frame: 6 months
description: MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.
Higher grades are worse radiographic outcomes.
measure: Supraspinatus Strength Measurements
time frame: 6 months
description: Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.
measure: Supraspinatus Strength Measurements
time frame: 24 months
description: Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.
measure: Infraspinatus Strength Measurements
time frame: Baseline
description: Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.
measure: Infraspinatus Strength Measurements
time frame: 6 months
description: Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.
measure: Infraspinatus Strength Measurements
time frame: 24 months
description: Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.
arm group label: Double Row
arm group type: Experimental
description: Double Row
arm group label: Double Row with PRFM
arm group type: Experimental
description: Double Row with PRFM
intervention type: Device
intervention name: PRFM
arm group label: Double Row with PRFM
intervention type: Procedure
intervention name: Double Row
arm group label: Double Row
arm group label: Double Row with PRFM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A disadvantage is the majority of the tears are small or medium sized. These have a higher intrinsic healing and as such may not require platelet augmentation to afford a successful outcome.
point of contact: 