Status:
NOT_YET_RECRUITING
Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial
Lead Sponsor:
University of Calgary
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
Detailed Description
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair. Subjects will be randomized intraoperatively after confirmation of inclusion criter...
Eligibility Criteria
Inclusion
- \>18 years
- \- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing
Exclusion
- tears where only a partial repair is achieved
- significant glenohumeral joint arthropathy (Hamada grade 2 and above)
- irreparable rotator cuff tears
- patients unable or unwilling to consent or comply with study questionnaires
- patients with upper limb neurological deficits affecting the ipsilateral limb
- workers compensation cases
- cases involving litigation
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06215417
Start Date
March 1 2024
End Date
December 1 2029
Last Update
January 22 2024
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