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

Not Applicable

• Conditions: Rotator Cuff Tears

• Registration Number: NCT04587037
• Lead Sponsor: Beijing Jishuitan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Last Update Submitted: 2020-10-07
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2022-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) score	2 year postoperatively	A patient-reported outcome measurement
Retear rate	1 year postoperatively	Measured in MRI
Acromiohumeral distance (AHD)	1 year postoperatively	measured in X-ray