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RECRUITING
NCT05439850
PHASE4

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Sponsor: Henry Ford Health System

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2022-08-16

Completion Date

2029-07-01

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

PROCEDURE

arthroscopic rotator cuff repair

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

BIOLOGICAL

Bioinductive implant

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

DIAGNOSTIC_TEST

Ultrasound Imaging

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

Locations (1)

Henry Ford Health

Detroit, Michigan, United States