Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Last updated: February 13, 2025
Sponsor: Henry Ford Health System
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Bioinductive implant

arthroscopic rotator cuff repair

Ultrasound Imaging

Clinical Study ID

NCT05439850
15702
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Indicated and scheduled for arthroscopic rotator cuff repair.

  • Full-thickness medium (1-3 cm), large (3-5 cm), and massive (>5 cm) rotator cufftears involving the supraspinatus and/or infraspinatus tendons demonstrated onmagnetic 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

Exclusion Criteria:

  • 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, psoriaticarthritis, systemic lupus erythematosus

Study Design

Total Participants: 78
Treatment Group(s): 3
Primary Treatment: Bioinductive implant
Phase: 4
Study Start date:
August 16, 2022
Estimated Completion Date:
December 01, 2027

Study 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 will have failed non-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Connect with a study center

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.