RecruitingPhase 4NCT05439850

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

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


Sponsor

Henry Ford Health System

Enrollment

78 participants

Start Date

Aug 16, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a bioinductive collagen patch placed over large rotator cuff tears during arthroscopic surgery. The patch is designed to stimulate the growth of new tendon tissue, potentially improving healing and reducing re-tear rates for medium to massive rotator cuff tears in the shoulder. You may be eligible if: - You are 18 or older and scheduled for arthroscopic rotator cuff repair - You have a full-thickness medium (1-3cm), large (3-5cm), or massive (over 5cm) rotator cuff tear confirmed by MRI or ultrasound - The tear is chronic and degenerative (not due to a sudden injury) - You have tried at least 6 weeks of physical therapy or structured home therapy without full recovery - You can read and understand English You may NOT be eligible if: - You are having open or mini-open surgery (not arthroscopic) - You had prior shoulder surgery (other than diagnostic arthroscopy) - Your tear is only partial-thickness, very small (under 1 cm), or involves the subscapularis tendon - The tear was caused by an acute trauma - You have an active infection, cancer, or autoimmune disease such as rheumatoid arthritis or lupus Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREarthroscopic rotator cuff repair

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

BIOLOGICALBioinductive implant

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

DIAGNOSTIC_TESTUltrasound Imaging

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


Locations(1)

Henry Ford Health

Detroit, Michigan, United States

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NCT05439850


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