Rotator Cuff Augmentation With Human Dermal Allograft Versus Bovine Collagen Xenograft Patch: A Randomized Controlled Trial

Sponsor
University of Calgary
Study ID
NCT06215417
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Rotator cuff repair — PROCEDURE
    Arthroscopic rotator cuff repair augmented with graft.

Study Details

Randomized controlled trial comparing human dermal allograft with bovine collagen xenograft in rotator cuff repair.

Key Dates

First listed
Jan 22, 2024
Start date
Mar 31, 2024
Status verified
Jan 2024
Primary completion
Sep 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HDA
    Human dermal allograft (LifeNet Health Arthroflex graft)
  • Active Comparator: Regeneten
    Bovine collagen patch xenograft (Smith \& Nephew Regeneten)

Primary Outcome Measure

Western Ontario Rotator Cuff Index (WORC) [ Time Frame: 12 mos post-op ]

Central Contacts

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