Status:
UNKNOWN
Massive Rotator Cuff Tear Reconstruction
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Rotator Cuff Tear Arthropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To compare bridging reconstruction to superior capsular reconstruction using human dermal allograft augmentation for repair of massive rotator cuff tears.
Detailed Description
A total of 60 patients will be enrolled in the study. In the pre-operative period, there will be no additional time requirements for the patient, except for the informed consent process for the study....
Eligibility Criteria
Inclusion
- Magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\>3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
Exclusion
- Presence of subscapular tear
- Presence of glenohumeral osteoarthritis
- WORC score \> 70%
- Uncontrolled diabetes
- Pregnancy
- Presence of local or systemic infection
- Paralysis of the shoulder
- Poor nutritional state
- Contracture of the shoulder
- Presence of cuff tear arthropathy
- MRI proven nonvascular surgical sites
- Cancer
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03425500
Start Date
May 1 2018
End Date
August 1 2025
Last Update
August 29 2023
Active Locations (1)
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1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 2E1