Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tears; Rotator Cuff Tear Arthropathy
• Intervention / Treatment: Procedure: arthroscopic rotator cuff repair; Diagnostic test: Ultrasound Imaging; Biological: Bioinductive implant

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Johnny Kasto, MD; Phone Number: 313-244-8078; Email: jkasto1@hfhs.org
• Study Contact Backup: Name: Stephanie J Muh, MD

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Johnny Kasto, MD; Phone Number: 3132448078; Email: jkasto1@hfhs.org
      • Principal Investigator: Stephanie J Muh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.	Procedure: arthroscopic rotator cuff repair; This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.; Diagnostic test: Ultrasound Imaging; An ultrasound will be performed on each patient one year postoperatively.
Experimental: Study Group; Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.	Procedure: arthroscopic rotator cuff repair; This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.; Diagnostic test: Ultrasound Imaging; An ultrasound will be performed on each patient one year postoperatively.; Biological: Bioinductive implant; A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.; Other Names: Bioinductive patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Both intra- and postoperative complications will be collected.	Intraoperative to 2 years postoperative
PROMs scores for upper extremity function	Patient-Reported Outcome Measures (PROMs) scores for upper extremity function. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 0 - 100-point scale, with a score of 50 representing the mean of the population at large, 0 representing the minimum, and 100 representing the maximum function.	Preoperative to 2 years postoperative
PROMs scores for depression	Patient-Reported Outcome Measures (PROMs) scores for depression. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher increased depression (worse).	Preoperative to 2 years postoperative
PROMs scores for upper extremity pain interference	Patient-Reported Outcome Measures (PROMs) scores for upper extremity pain and how it interferes with the patients daily life. A T-score is given with a standard deviation based on the patients answers to the computerized adaptive test. The metrics have been designed to conform to a 10 - 90-point scale, with a score of 50 representing the mean of the population at large, 10 representing the minimum, and 90 representing the maximum function. A higher T-score represents higher pain interference (worse).	Preoperative to 2 years postoperative
Shoulder Range of Motion	Standard range of motion values collected by the surgeon during preoperative and followup visits	Preoperative to 2 years postoperative
Shoulder Strength	Standard shoulder strength values collected by the surgeon during preoperative and followup visits. Medical Research Council Manual Muscle Testing scale will be used to measure the patient's strength on a 0 to 5 scale with 0 being the minimum and 5 being the maximum. Higher scores are better/normal.	Preoperative to 2 years postoperative
Reoperation	Whether or not patients required another operation.	2 years postoperative

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Stephanie J Muh, MC, Henry Ford Health

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 18, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Rotator Cuff Tear; Bioinductive; Arthroscopic Rotator Cuff Repair; Rotator Cuff Tear Arthropathy
• Additional Relevant MeSH Terms: Shoulder Injuries; Crystal Arthropathies; Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Rupture; Tendon Injuries; Chondrocalcinosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 15702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No