Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

Not Applicable

Completed

• Conditions: Rotator Cuff Injury; Rotator Cuff Syndrome; Disorder of Rotator Cuff; Full Thickness Rotator Cuff Tear; Skin Graft (Allograft) (Autograft) Failure
• Interventions: Procedure: Partial Rotator Cuff Repair with Allograft Augmentation; Procedure: Partial Rotator Cuff Repair

• Registration Number: NCT01987973
• Lead Sponsor: Ivan Wong

Brief Summary

The investigators hypothesize that the use of an allograft adjuvant to partial repair will lead to improved shoulder outcome measure scores compared to partial repair alone in massive rotator cuff tears.

Detailed Description

A total of 30 patients will be enrolled in the study. Subjects will be randomized into two arms, either (1) Partial Repair/Debridement or (2) Allograft Reconstruction.

The patients will complete a structured clinical examination conducted by a sports medicine fellowship trained orthopaedic consultant, Pre-operatively and Post-operatively at 6 weeks, 3, 6, 12, 24 months. The examination will consist of range of motion testing by goniometer as well as strength testing by hand dynamometer. The patient will also complete the Western Ontario Rotator Cuff Index (WORC) questionnaire.

The main benefit of this procedure is that patients who have currently irreparable massive, chronic rotator cuff tears may acquire a means for their cuff to be repaired. This may aid in improving function of the shoulder, restoring ability to complete activities of daily living, while decreasing pain and sleep disturbances. This would allow the participant to become more functional after rehabilitation. It is our belief that this study could provide new information in helping to understand this relationship, which would in turn lead to future study in this area of orthopaedic surgery.

Study Timeline

• Study First Submitted: 2013-11-09
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2015-02
• Primary Completion: 2019-12
• Study Completion: 2021-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Large/Massive rotator cuff tear >3cm proven on MRI

Exclusion Criteria

• Non surgical candidate, unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allograft Reconstruction	Partial Rotator Cuff Repair with Allograft Augmentation	Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"
Partial Repair / Debridement	Partial Rotator Cuff Repair	Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group.

Primary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff (WORC) Index	24 months	A patient questionnaire evaluating shoulder pain, function.

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada