A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear
Primary Purpose
Rotator Cuff Tears
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fascia lata allograft
human dermal allograft
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, Fascia lata allograft, human dermal allograft
Eligibility Criteria
Inclusion Criteria:
- Patients with irreparable rotator cuff tears
- Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
- At least two years follow-up
Exclusion Criteria:
- reparable rotator cuff tears
- underwent partial repair or reverse total shoulder arthroplasty
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Fascia lata group
Dermal allograft group
Arm Description
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
NCT04587037
First Posted
October 7, 2020
Last Updated
October 7, 2020
Sponsor
Beijing Jishuitan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04587037
Brief Title
A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear
Official Title
A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear
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
Biomechanical and clinical success of the superior capsule reconstruction (SCR) using fascia lata (FL) grafts has been reported in treating irreparable rotator cuff tear. Human dermal (HD) allograft has been used successfully for SCRs; however, the clinical comparative study between FL and HD have not been reported.
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, Fascia lata allograft, human dermal allograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fascia lata group
Arm Type
Experimental
Arm Title
Dermal allograft group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
fascia lata allograft
Intervention Description
underwent superior capsule reconstruction using fascia lata allograft
Intervention Type
Procedure
Intervention Name(s)
human dermal allograft
Intervention Description
underwent superior capsule reconstruction using human dermal allograft
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 capsule reconstruction using fascia lata allograft with human dermal allograft
At least two years follow-up
Exclusion Criteria:
reparable rotator cuff tears
underwent partial repair or 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
Learn more about this trial
A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear
We'll reach out to this number within 24 hrs