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

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Summary

Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06215417
Study type Interventional
Source University of Calgary
Contact Kristie More, MSc
Phone 14032208954
Email kristie.more@ucalgary.ca
Status Not yet recruiting
Phase Phase 4
Start date March 2024
Completion date December 2029
View Details
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