Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Recruiting now · Phase 4

Conditions studied: Rotator Cuff Tears, Rotator Cuff Tear Arthropathy

In brief

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 facts

Study ID

NCT05439850

Run by

Henry Ford Health System

People needed

78

Starts

2022-08-16

Expected to finish

2029-07-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Henry Ford Health — Detroit, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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