Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial
- Conditions
- Rotator Cuff Tears
- Interventions
- Procedure: Rotator cuff repair
- Registration Number
- NCT06215417
- Lead Sponsor
- University of Calgary
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 102
>18 years
- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regeneten Rotator cuff repair Bovine collagen patch xenograft (Smith \& Nephew Regeneten) HDA Rotator cuff repair Human dermal allograft (LifeNet Health Arthroflex graft)
- Primary Outcome Measures
Name Time Method Western Ontario Rotator Cuff Index (WORC) 12 mos post-op rotator cuff quality of life outcome questionnaire
- Secondary Outcome Measures
Name Time Method Western Ontario Rotator Cuff Index (WORC) pre-op, 3 mos, 6 mos, 24 mos post-op rotator cuff quality of life outcome questionnaire
Shoulder pain assessed by visual analog scale (VAS) pre-op, 3mos, 6mos, 12mos, 24mos post-op assessment of shoulder pain
Anatomic healing 12mos post-op anatomic healing as assessed via MRI
Single Assessment Numeric Evaluation (SANE) pre-op, 3mos, 6mos, 12mos, 24mos post-op numeric score indicating shoulder assessment
EuroQOL5D pre-op, 3mos, 6mos, 12mos, 24mos post-op general health assessment score