Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Syndrome
- Sponsor
- Ivan Wong
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Western Ontario Rotator Cuff (WORC) Index
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ivan Wong
Orthopedic Surgeon
Nova Scotia Health Authority
Eligibility Criteria
Inclusion Criteria
- •Large/Massive rotator cuff tear \>3cm proven on MRI
Exclusion Criteria
- •Non surgical candidate, unable to consent
Outcomes
Primary Outcomes
Western Ontario Rotator Cuff (WORC) Index
Time Frame: 24 months
A patient questionnaire evaluating shoulder pain, function.