Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT05439850
Phase
PHASE4
Status
Recruiting
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Conditions

  • Rotator Cuff Tear Arthropathy
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • arthroscopic rotator cuff repair — PROCEDURE
    This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.
  • Bioinductive implant — BIOLOGICAL
    A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.
  • Ultrasound Imaging — DIAGNOSTIC_TEST
    An ultrasound will be performed on each patient one year postoperatively.

Study Details

The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.

Key Dates

Start date
Aug 16, 2022
Status verified
Feb 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2029

Study Design

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

Arms

  • Active Comparator: Control Group
    Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
  • Experimental: Study Group
    Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Primary Outcome Measure

Rotator cuff repair integrity [ Time Frame: Preoperative to 1 year postoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Johnny Kasto, MD
[email protected]
3132448078
Stephanie J Muh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Henry Ford Health· Detroit, MI

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