A Phase 4 interventional study of Rotator cuff repair in Rotator Cuff Tears, sponsored by University of Calgary. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by University of Calgary · Phase 4, Interventional, and Treatment
Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
>18 years
Exclusion Criteria:
Human dermal allograft (LifeNet Health Arthroflex graft)
Procedure: Rotator cuff repair
Bovine collagen patch xenograft (Smith \& Nephew Regeneten)
Procedure: Rotator cuff repair
Arthroscopic rotator cuff repair augmented with graft.
Western Ontario Rotator Cuff Index (WORC)
rotator cuff quality of life outcome questionnaire
Time frame: 12 mos post-op
Western Ontario Rotator Cuff Index (WORC)
rotator cuff quality of life outcome questionnaire
Time frame: pre-op, 3 mos, 6 mos, 24 mos post-op
Single Assessment Numeric Evaluation (SANE)
numeric score indicating shoulder assessment
Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
EuroQOL5D
general health assessment score
Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
Shoulder pain assessed by visual analog scale (VAS)
assessment of shoulder pain
Time frame: pre-op, 3mos, 6mos, 12mos, 24mos post-op
Anatomic healing
anatomic healing as assessed via MRI
Time frame: 12mos post-op
No study locations are listed for this record.
Plan to share: No — No sharing of IPD.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Calgary