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

Beijing Jishuitan Hospital

Status: Unknown

Conditions: Rotator Cuff Tears

Treatments: Procedure: human dermal allograft; Procedure: fascia lata allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT04587037

CJiang-SCR Compare

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Fascia lata group

Experimental group

Treatment:

Procedure: fascia lata allograft

Dermal allograft group

Experimental group

Treatment:

Procedure: human dermal allograft