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NCT04587037 Clinical Trial

A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear

Rotator Cuff Tears Clinical Trial

Official title:
A Clinical Study Comparing Superior Capsule Reconstruction Using Fascia Lata Allograft With Human Dermal Allograft for Irreparable Rotator Cuff Tear

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04587037
Other study ID # CJiang-SCR Compare
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2020
Est. completion date October 2023

Study information
Verified date October 2020
Source Beijing Jishuitan Hospital
Contact Zhijun Zhang, M.D.
Phone +86 15201277648
Email zzj5285029@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date October 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• fascia lata allograft
underwent superior capsule reconstruction using fascia lata allograft
• human dermal allograft
underwent superior capsule reconstruction using human dermal allograft

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing Jishuitan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary American Shoulder and Elbow Surgeons (ASES) score A patient-reported outcome measurement 2 year postoperatively
Primary Acromiohumeral distance (AHD) measured in X-ray 1 year postoperatively
Primary Retear rate Measured in MRI 1 year postoperatively
See also
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Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04584476 - Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears N/A
Active, not recruiting NCT01586351 - Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection N/A