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

University of Calgary

Status and phase: Not yet enrolling; Phase 4

Conditions: Rotator Cuff Tears

Treatments: Procedure: Rotator cuff repair

Study type: Interventional

Funder types: Other

Identifiers

NCT06215417

REB23-0276

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

>18 years

• fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

HDA

Experimental group

Description:

Human dermal allograft (LifeNet Health Arthroflex graft)

Treatment:

Procedure: Rotator cuff repair

Regeneten

Active Comparator group

Description:

Bovine collagen patch xenograft (Smith \& Nephew Regeneten)

Treatment:

Procedure: Rotator cuff repair