<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/NCT01706978</url>
  </required_header>
  <id_info>
    <org_study_id>2009042-01H</org_study_id>
    <nct_id>NCT01706978</nct_id>
  </id_info>
  <brief_title>A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair</brief_title>
  <official_title>A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair: Soft Tissue or Bone Trephination, a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ottawa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff&#xD;
      repair; soft tissue and bone trephination. &quot;Trephination&quot; is a procedure that involves making&#xD;
      small perforations either in the torn tendon near its edge, or in the bone that the tendon is&#xD;
      repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the&#xD;
      shoulder. Trephination is a new technique that is used in addition to the standard method of&#xD;
      repairing the rotator cuff tendon.&#xD;
&#xD;
      This study will help to determine whether this technique improves the speed of healing, the&#xD;
      strength and the re-tear rate of the repair. You are being asked to take part in this study&#xD;
      because you have a tear of the rotator cuff that requires surgical treatment. A total of 90&#xD;
      participants will participate in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario Rotator Cuff Index</measure>
    <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
    <description>The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores</measure>
    <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
    <description>The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Constant Score</measure>
    <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
    <description>The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing Rates</measure>
    <time_frame>From surgery to up until 24-Months Post-Operative</time_frame>
    <description>Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">176</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>Soft Tissue Trephination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bone Trephination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone Trephination</intervention_name>
    <arm_group_label>Bone Trephination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Soft Tissue Trephination</intervention_name>
    <arm_group_label>Soft Tissue Trephination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have failed standard non-surgical management of their rotator cuff tear,&#xD;
             and who would benefit from a surgical repair of the cuff.&#xD;
&#xD;
          -  Failed medical management will be defined as persistent pain and disability despite&#xD;
             adequate standard non-operative management for 6 months.&#xD;
&#xD;
        Medical management will be defined as:&#xD;
&#xD;
          -  The use of drugs including analgesics and non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Physiotherapy consisting of stretching, strengthening and local modalities&#xD;
             (ultrasound, cryotherapy, etc)&#xD;
&#xD;
          -  Activity modification&#xD;
&#xD;
          -  Imaging, and intra-operative findings confirming a full thickness tear of the rotator&#xD;
             cuff.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration&#xD;
             in the muscles grade III (50%) or greater; superior subluxation of the humeral head;&#xD;
             retraction of the cuff to the level of the glenoid rim.&#xD;
&#xD;
          2. Partial thickness cuff tears.&#xD;
&#xD;
          3. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis&#xD;
&#xD;
          4. Previous surgery on affected shoulder e.g. Previous rotator cuff repair.&#xD;
&#xD;
          5. Patients with active worker's compensation claims&#xD;
&#xD;
          6. Active joint or systemic infection&#xD;
&#xD;
          7. Significant muscle paralysis&#xD;
&#xD;
          8. Rotator cuff tear arthropathy&#xD;
&#xD;
          9. Charcot's arthropathy&#xD;
&#xD;
         10. Significant medical comorbidity that could alter the effectiveness of the surgical&#xD;
             intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)&#xD;
&#xD;
         11. Major medical illness (life expectancy less then 1 year or unacceptably high operative&#xD;
             risk)&#xD;
&#xD;
         12. Unable to speak or read English/French&#xD;
&#xD;
         13. Psychiatric illness that precludes informed consent&#xD;
&#xD;
         14. Unwilling to be followed for 1 year&#xD;
&#xD;
         15. Advanced physiologic age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Lapner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guy Trudel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Ottawa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Campbell TM, Lapner P, Dilworth FJ, Sheikh MA, Laneuville O, Uhthoff H, Trudel G. Tendon contains more stem cells than bone at the rotator cuff repair site. J Shoulder Elbow Surg. 2019 Sep;28(9):1779-1787. doi: 10.1016/j.jse.2019.02.008. Epub 2019 Apr 26.</citation>
    <PMID>31036422</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>March 25, 2020</results_first_submitted>
  <results_first_submitted_qc>April 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2020</results_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rotator cuff tear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 8, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT01706978/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A number of participants who consented to be part of this study were withdrawn or excluded, prior to randomization due to study procedures not being able to be arranged pre-operatively for various reasons. A large number of participants were crossed over into another parallel study being run at The Ottawa Hospital.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Soft Tissue Trephination</title>
          <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
        </group>
        <group group_id="P2">
          <title>Bone Trephination</title>
          <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Soft Tissue Trephination</title>
          <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
        </group>
        <group group_id="B2">
          <title>Bone Trephination</title>
          <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</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="47"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.5" lower_limit="40" upper_limit="73"/>
                    <measurement group_id="B2" value="58.8" lower_limit="42" upper_limit="75"/>
                    <measurement group_id="B3" value="59.2" lower_limit="40" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hand Dominance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="41"/>
                    <count group_id="B3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Non-Dominant Arm Affected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dominant Arm Affected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Western Ontario Rotator Cuff Index</title>
        <description>The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.</description>
        <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Soft Tissue Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
          </group>
          <group group_id="O2">
            <title>Bone Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario Rotator Cuff Index</title>
          <description>The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.</description>
          <units>score 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="38"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82" spread="25"/>
                    <measurement group_id="O2" value="80" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores</title>
        <description>The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.</description>
        <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Soft Tissue Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
          </group>
          <group group_id="O2">
            <title>Bone Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</description>
          </group>
        </group_list>
        <measure>
          <title>American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores</title>
          <description>The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.</description>
          <units>score 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="38"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="22"/>
                    <measurement group_id="O2" value="84" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Constant Score</title>
        <description>The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).</description>
        <time_frame>From baseline to up until 24-Months Post-Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Soft Tissue Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
          </group>
          <group group_id="O2">
            <title>Bone Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</description>
          </group>
        </group_list>
        <measure>
          <title>The Constant Score</title>
          <description>The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).</description>
          <units>score 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="38"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81" spread="16"/>
                    <measurement group_id="O2" value="83" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strength</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="6.4"/>
                    <measurement group_id="O2" value="15.8" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healing Rates</title>
        <description>Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.</description>
        <time_frame>From surgery to up until 24-Months Post-Operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Soft Tissue Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
          </group>
          <group group_id="O2">
            <title>Bone Trephination</title>
            <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</description>
          </group>
        </group_list>
        <measure>
          <title>Healing Rates</title>
          <description>Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of Participants Healed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Participants Partially-Healed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Participants Non-Healed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from the time the participant was enrolled up until 2-years post-operative for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Soft Tissue Trephination</title>
          <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Soft Tissue Trephination</description>
        </group>
        <group group_id="E2">
          <title>Bone Trephination</title>
          <description>Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the &quot;bone trephination&quot; or &quot;soft tissue trephination&quot; groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.&#xD;
Bone Trephination</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </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="2" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Radiating Pain into Hand</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Revision Surgery</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="41"/>
              </event>
              <event>
                <sub_title>Olecranon Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="41"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>The sample size achieved would have detected a clinically significant difference based on power analysis but remains susceptible to type II error. The lack of a prospective control group also restricts the interpretation of the study finding.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Peter Lapner</name_or_title>
      <organization>The Ottawa Hospital Research Institute</organization>
      <phone>613-737-8899 ext 78377</phone>
      <email>plapner@toh.ca</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/NCT01706978
org study id: 2009042-01H
nct id: NCT01706978
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff
      repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making
      small perforations either in the torn tendon near its edge, or in the bone that the tendon is
      repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the
      shoulder. Trephination is a new technique that is used in addition to the standard method of
      repairing the rotator cuff tendon.

      This study will help to determine whether this technique improves the speed of healing, the
      strength and the re-tear rate of the repair. You are being asked to take part in this study
      because you have a tear of the rotator cuff that requires surgical treatment. A total of 90
      participants will participate in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Western Ontario Rotator Cuff Index
time frame: From baseline to up until 24-Months Post-Operative
description: The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WORC is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. These scores are combined and translated into a percentage out of 100. A higher total score indicates a better outcome.
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) Scores
time frame: From baseline to up until 24-Months Post-Operative
description: The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
measure: The Constant Score
time frame: From baseline to up until 24-Months Post-Operative
description: The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
measure: Healing Rates
time frame: From surgery to up until 24-Months Post-Operative
description: Imaging parameters will be examined using ultrasound and magnetic resonance imaging (MRI). These images will be analyzed to determine healing status of the tissues post-operatively. Imaging will determine whether the tissue is healed, partially torn, or fully torn after surgery. Higher incidence of tearing will be compared between groups. A higher incidence of tearing indicates worse outcomes.
arm group label: Soft Tissue Trephination
arm group type: Experimental
description: Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.
arm group label: Bone Trephination
arm group type: Active Comparator
description: Ten days prior to the standard rotator cuff repair, a trephination procedure will be carried out. The trephination procedure will take approximately 30 minutes to complete and will be carried out under local anesthesia. A needle will be placed through the skin over the shoulder and either into the bone or into the edge of the cuff tendon, depending on whether you are allocated to the "bone trephination" or "soft tissue trephination" groups. The needle will be used to make 6 small holes in either bone or the tendon in the shoulder in the area where the cuff is to be repaired.
intervention type: Procedure
intervention name: Bone Trephination
arm group label: Bone Trephination
intervention type: Procedure
intervention name: Soft Tissue Trephination
arm group label: Soft Tissue Trephination
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Peter Lapner, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
last name: Guy Trudel, MD
role: Principal Investigator
affiliation: University of Ottawa
facility: 
country: Canada
citation: Campbell TM, Lapner P, Dilworth FJ, Sheikh MA, Laneuville O, Uhthoff H, Trudel G. Tendon contains more stem cells than bone at the rotator cuff repair site. J Shoulder Elbow Surg. 2019 Sep;28(9):1779-1787. doi: 10.1016/j.jse.2019.02.008. Epub 2019 Apr 26.
PMID: 31036422
responsible party type: Sponsor
mesh term: Rotator Cuff Injuries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The sample size achieved would have detected a clinically significant difference based on power analysis but remains susceptible to type II error. The lack of a prospective control group also restricts the interpretation of the study finding.
point of contact: 