Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05439850
Study type	Interventional
Source	Henry Ford Health System
Contact	Johnny Kasto, MD
Phone	313-244-8078
Email	jkasto1@hfhs.org
Status	Recruiting
Phase	Phase 4
Start date	August 16, 2022
Completion date	December 1, 2025

View Details

See also
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