Recruiting

Bioinductive Patch

Sponsor:

Henry Ford Health System

Code:

NCT05439850

Conditions

Rotator Cuff Tears

Rotator Cuff Tear Arthropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

arthroscopic rotator cuff repair

Bioinductive implant

Ultrasound Imaging

Study Details

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 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.

Conditions

Rotator Cuff Tears

Rotator Cuff Tear Arthropathy

Study ID

NCT05439850

Start date

Aug 16, 2022

Status verified date

Feb, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 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, psoriatic arthritis, systemic lupus erythematosus

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

arthroscopic rotator cuff repair

This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

Bioinductive implant

A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.

Ultrasound Imaging

An ultrasound will be performed on each patient one year postoperatively.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Johnny Kasto, MD

313-244-8078jkasto1@hfhs.org

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Johnny Kasto, MD

3132448078jkasto1@hfhs.org

Principal Investigator:

Stephanie J Muh, MD

More Information

Sponsor

Henry Ford Health System

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Rotator Cuff Tear
  • Bioinductive
  • Arthroscopic Rotator Cuff Repair
  • Rotator Cuff Tear Arthropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-02-27.