Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rotator cuff repair.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tears. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Rotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.
Primary outcome measures
- Western Ontario Rotator Cuff Index (WORC) [Time frame: 12 mos post-op]
Secondary outcome measures (5)
- Western Ontario Rotator Cuff Index (WORC) [Time frame: pre-op, 3 mos, 6 mos, 24 mos post-op]
- Single Assessment Numeric Evaluation (SANE) [Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op]
- EuroQOL5D [Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op]
- Shoulder pain assessed by visual analog scale (VAS) [Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op]
- Anatomic healing [Time frame: 12mos post-op]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06215417 · REB23-0276