<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/NCT02228226</url>
  </required_header>
  <id_info>
    <org_study_id>JJKK-MIT-002</org_study_id>
    <nct_id>NCT02228226</nct_id>
  </id_info>
  <brief_title>Follow-up Study After Bankart Repair Using MG-1</brief_title>
  <official_title>Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson K.K. Medical Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johnson &amp; Johnson K.K. Medical Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1&#xD;
      for dislocation of shoulder to evaluate anchor bone hole condition and ossification.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Hole Condition</measure>
    <time_frame>over 24 months after surgery</time_frame>
    <description>To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.&#xD;
Definitions of the score are described as below.&#xD;
Type 1: Opened or enlarged&#xD;
Type 2: Slightly closed (&lt;50%)&#xD;
Type 3: Almost closed (&gt;=50%)&#xD;
Type 4: Completely closed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ossification</measure>
    <time_frame>over 24 months after surgery</time_frame>
    <description>To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.&#xD;
Definitions of the score are described as below.&#xD;
Type 1: Little or no ossification&#xD;
Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim&#xD;
Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone&#xD;
Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Function Evaluation</measure>
    <time_frame>over 24 months after surgery</time_frame>
    <description>To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery&#xD;
JSS-SIS Score (subscales are summed, higher values represent a better outcome):&#xD;
Pain (0 to 20)&#xD;
Function (0 to 20)&#xD;
Range of Motion (0 to 20)&#xD;
Evaluation of X-ray findings (0 to 10)&#xD;
Stability (0 to 30)&#xD;
Rowe Score (subscales are summed, higher values represent a better outcome):&#xD;
Stability (0 to 50)&#xD;
Motion (0 to 20)&#xD;
Function (0 to 30)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Shoulder Dislocation</condition>
  <arm_group>
    <arm_group_label>MG-1treated group</arm_group_label>
    <description>MG-1treated group: Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using&#xD;
        MG-1&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic&#xD;
             Hospital and who don't withdraw the consent&#xD;
&#xD;
          -  Patient who understand the contents of the study and from whom a written consent can&#xD;
             be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with dementia&#xD;
&#xD;
          -  Patient who cannot undergo CT examination&#xD;
&#xD;
          -  Patient who underwent further surgery to ipsilateral shoulder joint after the clinical&#xD;
             trial&#xD;
&#xD;
          -  Patient who is pregnant or lactating&#xD;
&#xD;
          -  Patient judged to be inappropriate for the study by the (sub)investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hiroyuki Sugaya, MD, Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Funabashi Orthopaedic Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Funabashi Orthopaedic Hospital</name>
      <address>
        <city>Funabashi</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>April 15, 2015</last_update_submitted>
  <last_update_submitted_qc>April 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arthroscopic Bankart repair</keyword>
  <keyword>Bone hole</keyword>
  <keyword>Ossification</keyword>
  <keyword>Suture anchor</keyword>
  <keyword>Shoulder dislocation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Dislocations</mesh_term>
    <mesh_term>Shoulder Dislocation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02228226
org study id: JJKK-MIT-002
nct id: NCT02228226
lead sponsor: 
has dmc: No
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1
      for dislocation of shoulder to evaluate anchor bone hole condition and ossification.
observational model: Case-Only
time perspective: Prospective
measure: Bone Hole Condition
time frame: over 24 months after surgery
description: To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.
Definitions of the score are described as below.
Type 1: Opened or enlarged
Type 2: Slightly closed (<50%)
Type 3: Almost closed (>=50%)
Type 4: Completely closed
measure: Ossification
time frame: over 24 months after surgery
description: To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.
Definitions of the score are described as below.
Type 1: Little or no ossification
Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim
Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone
Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone
measure: Clinical Function Evaluation
time frame: over 24 months after surgery
description: To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery
JSS-SIS Score (subscales are summed, higher values represent a better outcome):
Pain (0 to 20)
Function (0 to 20)
Range of Motion (0 to 20)
Evaluation of X-ray findings (0 to 10)
Stability (0 to 30)
Rowe Score (subscales are summed, higher values represent a better outcome):
Stability (0 to 50)
Motion (0 to 20)
Function (0 to 30)
arm group label: MG-1treated group
description: MG-1treated group: Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Hiroyuki Sugaya, MD, Ph. D
role: Principal Investigator
affiliation: Funabashi Orthopaedic Hospital
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Joint Dislocations
mesh term: Shoulder Dislocation