NCT06215417

Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial

Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 criteria. Subjects will be followed-up at 3 weeks, 3 months, 6 months, 12 months and 24 months post-operatively. Primary outcome is Western Ontario Rotator Cuff Index (WORC) at 12 months. Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Single Numeric Evaluation (SANE) score, EuroQoL (5 domains) score (a quality of life score), and Visual Analogue Scale, healing rate as determined by Magnetic Resonance Imaging (MRI) scan at 12 months post surgery. To determine the cost utility, data will be collected on the cumulative cost for the total episode of care up to 12 months post surgery inclusive of surgical costs, implant costs, outpatient costs, and medication costs. Quality-Adjusted Life Years (QALYs) gained will be calculated using the mean total cost and the quality of life score (EQ-5D) improvement from pre-operative to 12 months post surgery.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
PROCEDURE	Rotator cuff repair	Arthroscopic rotator cuff repair augmented with graft.

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-09-01
• Completion: 2029-12-01
• First posted: 2024-01-22
• Last updated: 2024-01-22