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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2019/06/14
    • Registered Date : 2019/07/12
    • Last Updated Date : 2019/07/11
Background Information
1.Background  
CRIS Registration Number KCT0004138 
Unique Protocol ID H-1903-041-1016 
Public/Brief Title The muscle advancement versus superior capsular reconstruction in treatment of irreparable rotator cuff tears 
Scientific Title The muscle advancement versus superior capsular reconstruction in treatment of irreparable rotator cuff tears  
Acronym SCR 
MFDS Regulated Study Yes
IND/IDE Protocol Yes
Registered at Other Registry No
Healthcare Benefit
Approval Status
Submitted pending
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number H-1903-041-1016 
Approval Date 2019-06-10 
Institutional Review Board  
- Name Institutional review board  
- Address 103, Daehak-ro, Jongno-gu, Seoul 
- Telephone 02-2072-0694 
Data Monitoring Committee    
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Saehoon Kim 
- Title Pf. 
- Telephone +82-2-2072-3930 
- Affiliation Seoul National University Hospital 
- Address SNUH, 101 Daehakro, Jongrogu, Seoul 
Contact Person for Public Queries
- Name Jangwoo Kim 
- Title Dr. 
- Telephone +82-2-2072-2368 
- Affiliation Seoul National University Bundang Hospital 
- Address SNUH, 101 Daehakro, Jongrogu, Seoul 
Contact Person for Updating Information
- Name Jangwoo Kim 
- Title Dr. 
- Telephone +82-2-2072-2368 
- Affiliation Seoul National University Bundang Hospital 
- Address SNUH, 101 Daehakro, Jongrogu, Seoul 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2019-07-09 , Actual
Target Number of Participant 70
Primary Completion Date 2020-12-31 , Anticipated
Study Completion Date 2020-12-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Seoul National University Hospital 
- Recruitment Status Recruiting  
- Date of First Enrollment 2019-07-09 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Seoul National University Hospital 
- Organization Type Medical Institute  
- Project ID H-1903-041-1016 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Seoul National University Hospital 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary In 70 patients with rotator cuff tear that underwent arthroscopic rotator cuff repair, the patients were divided into two groups: randomly assigned to experimental group and control group. Superior capsular reconstruction was performed for the experimental group, followed by muscle advancement for the control group. Clinical indicators including joint range of motion, pain, and degree of anatomical restoration of the rotator cuff are monitored for comparison.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Single 
Blinded Subject Subject 
Allocation RCT 
Intervention Type /Procedure/Surgery  
Intervention Description Superior capsular reconstruction: An arthroscopic procedure during rotator cuff repair surgery, using an autogenous or allograft tendon in the irreparable rotator cuff tear
Muscle advancement: Transfer of a part of the latissimus dorsi to cover the attachment of the rotator cuff in the irreparable rotator cuff tear  
Number of Arms
Arm 1 Arm Label Superior capsular reconstruction group 
Target Number of Participant 35 
Arm Type Experimental 
Arm Description Superior capsular reconstruction: An arthroscopic procedure during rotator cuff repair surgery, using an autogenous or allograft tendon in the irreparable rotator cuff tear 
Arm 2 Arm Label Muscle advancement group 
Target Number of Participant 35 
Arm Type Experimental 
Arm Description Muscle advancement : Mobilization of the chronic inward contracted supraspinatus and infraspinatus by detachment from its origin 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the musculo-skeletal system and connective tissue
Irreparable rotator cuff injuries  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age No Limit ~ No Limit
Description Patients with irreparable full-thickness rotator cuff tear who underwent arthroscopic rotator cuff repair under general anesthesia.  
Exclusion Criteria 1. Patients who had previously undergone surgery on the ipsilateral shoulder
2. Patients with tear of rotator cuff that can not be reconstructed
3. Patients with cuff tear arthropathy, moderate osteoarthritis or rheumatoid arthritis
4. Patients who underwent additional procedures such as acromioplasty, SLAP reconstruction
5. Patients with infectious disease, immune disease, systemic bone disease
6. Neuromuscular disorder
7. Patients with significantly reduced compliance with post-operative rehabilitation therapy, such as Parkinson's disease and dementia
8. Patients who do not want to participate in this study  
Healthy Volunteers No
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome Pain VAS 
- Timepoint 5weeks, 3months, 6months, 1yr after surgery 
Primary Outcome(s) 2 
- Outcome ASES score 
- Timepoint 5weeks, 3months, 6months, 1yr after surgery 
Primary Outcome(s) 3 
- Outcome Constant score 
- Timepoint 5weeks, 3months, 6months, 1yr after surgery 
Primary Outcome(s) 4 
- Outcome Simple shoulder test 
- Timepoint 5weeks, 3months, 6months, 1yr after surgery 
Secondary Outcome(s) 1 
- Outcome SONO 
- Timepoint 5weeks, 3months, 6months, 1yr after surgery 
Secondary Outcome(s) 2 
- Outcome MRI 
- Timepoint 5weeks, 3months, 6months, 1yr after surgery 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No