Allograft Reconstruction of Massive Rotator Cuff Tears vs Partial Repair Alone

Ivan Wong

Status: Completed

Conditions: Disorder of Rotator Cuff; Rotator Cuff Injury; Skin Graft (Allograft) (Autograft) Failure; Full Thickness Rotator Cuff Tear; Rotator Cuff Syndrome

Treatments: Procedure: Partial Rotator Cuff Repair with Allograft Augmentation; Procedure: Partial Rotator Cuff Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01987973

2014-182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Non surgical candidate, unable to consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Partial Repair / Debridement

Active Comparator group

Description:

Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair". This is the control group.

Treatment:

Procedure: Partial Rotator Cuff Repair

Allograft Reconstruction

Experimental group

Description:

Subjects in this arm of the study will receive the intervention "Partial Rotator Cuff Repair with Allograft Augmentation"

Treatment:

Procedure: Partial Rotator Cuff Repair with Allograft Augmentation