Status:
RECRUITING
Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Lead Sponsor:
Henry Ford Health System
Conditions:
Rotator Cuff Tears
Rotator Cuff Tear Arthropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 rep...
Detailed Description
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients...
Eligibility Criteria
Inclusion
- Indicated and scheduled for arthroscopic rotator cuff repair.
- Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
- Chronic, degenerative rotator cuff tears.
- Ability to read and understand English.
- Age ≥18 years
- Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
Exclusion
- Patient scheduled for open or mini-open rotator cuff repair
- Prior surgery of affected shoulder (except diagnostic arthroscopy)
- Partial-thickness rotator cuff tears
- Small (\<1 cm) rotator cuff tears
- Rotator cuff tears involving the subscapularis tendon
- Acute and traumatic rotator cuff tears
- Active infection
- Cancer
- Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT05439850
Start Date
August 16 2022
End Date
December 1 2027
Last Update
February 17 2025
Active Locations (1)
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1
Henry Ford Health
Detroit, Michigan, United States, 48202