Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial
NCT ID: NCT06215417
Last Updated: 2024-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
102 participants
INTERVENTIONAL
2024-03-31
2029-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HDA
Human dermal allograft (LifeNet Health Arthroflex graft)
Rotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.
Regeneten
Bovine collagen patch xenograft (Smith \& Nephew Regeneten)
Rotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.
Interventions
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Rotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.
Eligibility Criteria
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Inclusion Criteria
\- fully reparable full thickness rotator cuff tear whereby the treating surgeon feels a graft augment is needed to enhance healing
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Calgary
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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REB23-0276
Identifier Type: -
Identifier Source: org_study_id
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