Clinical trial NCT06215417: Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial
Official title: Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Rotator Cuff Tears
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a parallel group 1:1 randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: 12 mos post-op
Secondary outcomes:
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: pre-op, 3 mos, 6 mos, 24 mos post-op
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
measure: EuroQOL5D
timeFrame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
measure: Shoulder pain assessed by visual analog scale (VAS)
timeFrame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
measure: Anatomic healing
timeFrame: 12mos post-op
Other outcomes:
Locations:
Study officials:
References: