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Clinical Trials/NCT01987973
NCT01987973
Completed
Not Applicable

Arthroscopic Repair of Chronic Two-tendon Rotator Cuff Tears by Human Dermal Allograft

Ivan Wong1 site in 1 country29 target enrollmentFebruary 2015

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
March 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ivan Wong
Responsible Party
Sponsor Investigator
Principal Investigator

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.

Study Sites (1)

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