Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears
Primary Purpose
Rotator Cuff Tears
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
superior capsular reconstuction
partial rotator cuff repair
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction
Eligibility Criteria
Inclusion Criteria:
- patients with Irreparable Rotator Cuff Tears
- underwent superior capsular reconstruction or partial repair
- at least two years follow-up
Exclusion Criteria:
- reparable Rotator Cuff Tears
- underwent reverse total shoulder arthroplasty
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SCR group
Partial group
Arm Description
underwent superior capsular reconstruction
underwent partial rotator cuff repair
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Surgeons (ASES) score
A patient-reported outcome measurement
Acromiohumeral distance (AHD)
measured in x-ray
retear rate
measured in MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT04584476
First Posted
October 7, 2020
Last Updated
October 7, 2020
Sponsor
Beijing Jishuitan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04584476
Brief Title
Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears
Official Title
Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears: A Prospective Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Jishuitan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Rotator cuff tear is one of the common injuries that cause shoulder pain in the elderly. After the rotator cuff tendon is injured, repairing the torn rotator cuff tendon through arthroscopic surgery is an effective treatment that is currently widely used. In the rotator cuff injury, irreparable rotator cuff injury is a difficult point in treatment, especially for patients with a long injury time, the obvious shrinkage of the injured tendon, muscle atrophy and steatosis may occur, all of which lead to the poor quality of the rotator cuff tendon needed to be repaired , Poor healing ability, seriously affecting the shoulder joint function and daily life of these patients. For this part of patients, arthroscopic partial repair of torn rotator cuffs is one of the commonly used methods. In addition, in recent years, superior capsular reconstruction has been gradually applied to the clinic and has achieved good clinical effects, but there are no controlled studies to compare Clinical effect of partial repair and superior capsular reconstruction on irreparable rotator cuff injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Irreparable Rotator Cuff Tears, Superior Capsular Reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCR group
Arm Type
Experimental
Arm Description
underwent superior capsular reconstruction
Arm Title
Partial group
Arm Type
Other
Arm Description
underwent partial rotator cuff repair
Intervention Type
Procedure
Intervention Name(s)
superior capsular reconstuction
Intervention Description
these patients underwent arthroscopic superior capsular reconstuction
Intervention Type
Procedure
Intervention Name(s)
partial rotator cuff repair
Intervention Description
these patients underwent arthroscopic partial rotator cuff repair
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) score
Description
A patient-reported outcome measurement
Time Frame
2 year postoperatively
Title
Acromiohumeral distance (AHD)
Description
measured in x-ray
Time Frame
1 year postoperatively
Title
retear rate
Description
measured in MRI
Time Frame
1 year postoperatively
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with Irreparable Rotator Cuff Tears
underwent superior capsular reconstruction or partial repair
at least two years follow-up
Exclusion Criteria:
reparable Rotator Cuff Tears
underwent reverse total shoulder arthroplasty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhijun Zhang, M.D.
Phone
+86 15201277648
Email
zzj5285029@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunyan Jiang
Organizational Affiliation
Sports Medicine Service, Beijing Jishuitan hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears
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