Bioinductive Patch for Full-Thickness Rotator Cuff Tears

NCT05439850 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 15702
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

Rotator Cuff Tear; Bioinductive; Arthroscopic Rotator Cuff Repair; Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (1)

• Rotator cuff repair integrity

  absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.

  Preoperative to 1 year postoperative

Secondary Outcomes (7)

• PROMs scores for upper extremity function

  Preoperative to 2 years postoperative

• PROMs scores for depression

  Preoperative to 2 years postoperative

• PROMs scores for upper extremity pain interference

  Preoperative to 2 years postoperative

• Shoulder Range of Motion

  Preoperative to 2 years postoperative

• Shoulder Strength

  Preoperative to 2 years postoperative

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Procedure: arthroscopic rotator cuff repair; Diagnostic Test: Ultrasound Imaging

Study Group

EXPERIMENTAL

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Procedure: arthroscopic rotator cuff repair; Biological: Bioinductive implant; Diagnostic Test: Ultrasound Imaging

Interventions

arthroscopic rotator cuff repair PROCEDURE

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

Control Group; Study Group

Bioinductive implant BIOLOGICAL

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

Also known as: Bioinductive patch

Study Group

Ultrasound Imaging DIAGNOSTIC_TEST

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

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stephanie J Muh, MC

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnny Kasto, MD

CONTACT

313-244-8078; jkasto1@hfhs.org

Stephanie J Muh, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Service Chief, Principal Investigator

Model Details: Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for rotator cuff tears: debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in postoperative ultrasound imaging studies.

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 30, 2022
• Study Start: August 16, 2022
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)