Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215417
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-10
Brief Title:
Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch A Randomized Controlled Trial
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Clinical and Cost Effectiveness of Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HDA v Regen
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None