Rotator Cuff Tears
Conditions
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.
Interventions
PROCEDURERotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and research assistants collecting data will be unaware of the treatment assigned until the completion of the study.
Intervention model description
This study is designed as a parallel group 1:1 randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | 12 mos post-op | rotator cuff quality of life outcome questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff Index (WORC) | pre-op, 3 mos, 6 mos, 24 mos post-op | rotator cuff quality of life outcome questionnaire |
| 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 |
| 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 |
Contacts
Primary ContactKristie More, MSc
Outcome results
None listed