<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/NCT03792594</url>
  </required_header>
  <id_info>
    <org_study_id>RD106055</org_study_id>
    <nct_id>NCT03792594</nct_id>
  </id_info>
  <brief_title>Autologous Bone Marrow Concentration for Rotator Cuff Tear</brief_title>
  <official_title>The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pei-Yuan Lee, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aeon Biotechnology Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Show Chwan Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effect of bone marrow concentration on healing of rotator&#xD;
      cuff tear by comparing clinical and imaging outcomes between patients receiving arthroscopic&#xD;
      repair with intraoperative bone marrow concentration and those receiving arthroscopic repair&#xD;
      only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rotator cuff tear is a common cause of pain and disability among adults. Most tears are&#xD;
      largely caused by the normal wear and tear that goes along with aging. Although nonsurgical&#xD;
      treatment relieves pain and improves function in the shoulder, surgical repair for a torn&#xD;
      rotator cuff is indicated if symptoms persisted or deteriorated after 3 months nonsurgical&#xD;
      treatments, Recently, arthroscopic repair has become the mainstream of surgical repair for&#xD;
      rotator cuff tear. However, the healing of a repaired tendon is not always predictable.&#xD;
      Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple&#xD;
      mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a&#xD;
      source of multiple growth factors to establish an environment conducive to soft and hard&#xD;
      tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem&#xD;
      cells, some studies have shown that autologous bone marrow concentration can improve the&#xD;
      healing of tendon grafts in a bone tunnel. Therefore, the goal of this study was to evaluate&#xD;
      the effect of bone marrow concentration on healing of rotator cuff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 12, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>3-month postoperative shoulder function evaluated by Constant Shoulder Score</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative shoulder function evaluated by Constant Shoulder Score</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative shoulder function evaluated by Constant Shoulder Score</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-month postoperative degree of healing evaluated by plain radiograph</measure>
    <time_frame>3-month postoperative</time_frame>
    <description>Degree of healing evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of healing evaluated by plain radiograph</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Degree of healing evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of healing evaluated by plain radiograph</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Degree of healing evaluated by plain radiograph</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-month postoperative degree of healing evaluated by MRI</measure>
    <time_frame>6-month postoperative</time_frame>
    <description>Degree of healing evaluated by MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-month postoperative degree of healing evaluated by MRI</measure>
    <time_frame>12-month postoperative</time_frame>
    <description>Degree of healing evaluated by MRI</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <condition>Bone Marrow</condition>
  <arm_group>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
    <description>The patients receive arthroscopic repair with bone marrow concentration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical control group</arm_group_label>
    <description>The patients receive arthroscopic repair only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>arthroscopic repair with bone marrow concentration</intervention_name>
    <description>arthroscopic repair with bone marrow concentration</description>
    <arm_group_label>Bone marrow concentration group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>arthroscopic repair</intervention_name>
    <description>arthroscopic repair only</description>
    <arm_group_label>Historical control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive eligible patients who underwent arthroscopic repair combined with autologous&#xD;
        bone marrow stem cells treatment for rotator cuff tear&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With diagnosis of rotator cuff tear&#xD;
&#xD;
          -  Age between 40 and 70 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With prior history of shoulder surgery&#xD;
&#xD;
          -  With current or prior history of trauma or infection at shoulder&#xD;
&#xD;
          -  With current diagnosis of coagulopathy&#xD;
&#xD;
          -  With current or prior history of cancer&#xD;
&#xD;
          -  With current or prior history of hematological disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients who will not cooperate with one-year followup&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pei-Yuan Lee, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chien-Sheng Lo, MD</last_name>
    <phone>+886-975611289</phone>
    <email>johnlcs@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pei-Yuan Lee, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua City</city>
        <state>Changhua</state>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chien-Sheng Lo, MD</last_name>
      <phone>+886-975611289</phone>
      <email>johnlcs@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>April 11, 2020</last_update_submitted>
  <last_update_submitted_qc>April 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Pei-Yuan Lee, MD</investigator_full_name>
    <investigator_title>Superintendent</investigator_title>
  </responsible_party>
  <keyword>Bone Marrow</keyword>
  <keyword>Mesenchymal Stromal Cells</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03792594
org study id: RD106055
nct id: NCT03792594
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of bone marrow concentration on healing of rotator
      cuff tear by comparing clinical and imaging outcomes between patients receiving arthroscopic
      repair with intraoperative bone marrow concentration and those receiving arthroscopic repair
      only.
Rotator cuff tear is a common cause of pain and disability among adults. Most tears are
      largely caused by the normal wear and tear that goes along with aging. Although nonsurgical
      treatment relieves pain and improves function in the shoulder, surgical repair for a torn
      rotator cuff is indicated if symptoms persisted or deteriorated after 3 months nonsurgical
      treatments, Recently, arthroscopic repair has become the mainstream of surgical repair for
      rotator cuff tear. However, the healing of a repaired tendon is not always predictable.
      Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple
      mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a
      source of multiple growth factors to establish an environment conducive to soft and hard
      tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem
      cells, some studies have shown that autologous bone marrow concentration can improve the
      healing of tendon grafts in a bone tunnel. Therefore, the goal of this study was to evaluate
      the effect of bone marrow concentration on healing of rotator cuff.
observational model: Case-Control
time perspective: Prospective
measure: 3-month postoperative shoulder function evaluated by Constant Shoulder Score
time frame: 3-month postoperative
description: Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
measure: 6-month postoperative shoulder function evaluated by Constant Shoulder Score
time frame: 6-month postoperative
description: Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
measure: 12-month postoperative shoulder function evaluated by Constant Shoulder Score
time frame: 12-month postoperative
description: Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
measure: 3-month postoperative degree of healing evaluated by plain radiograph
time frame: 3-month postoperative
description: Degree of healing evaluated by plain radiograph
measure: 6-month postoperative degree of healing evaluated by plain radiograph
time frame: 6-month postoperative
description: Degree of healing evaluated by plain radiograph
measure: 12-month postoperative degree of healing evaluated by plain radiograph
time frame: 12-month postoperative
description: Degree of healing evaluated by plain radiograph
measure: 6-month postoperative degree of healing evaluated by MRI
time frame: 6-month postoperative
description: Degree of healing evaluated by MRI
measure: 12-month postoperative degree of healing evaluated by MRI
time frame: 12-month postoperative
description: Degree of healing evaluated by MRI
arm group label: Bone marrow concentration group
description: The patients receive arthroscopic repair with bone marrow concentration.
arm group label: Historical control group
description: The patients receive arthroscopic repair only
intervention type: Other
intervention name: arthroscopic repair with bone marrow concentration
description: arthroscopic repair with bone marrow concentration
arm group label: Bone marrow concentration group
intervention type: Other
intervention name: arthroscopic repair
description: arthroscopic repair only
arm group label: Historical control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pei-Yuan Lee, MD
role: Study Chair
affiliation: Show Chwan Memorial Hospital
last name: Chien-Sheng Lo, MD
phone: +886-975611289
email: johnlcs@gmail.com
last name: Pei-Yuan Lee, MD
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Show Chwan Memorial Hospital
investigator full name: Pei-Yuan Lee, MD
investigator title: Superintendent
mesh term: Rotator Cuff Injuries
sharing ipd: No