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
Status	Clinical Trial	Phase
Recruiting	`NCT04974242` - Physiotherapy for Patients Awaiting Rotator Cuff Repair	N/A
Recruiting	`NCT06055478` - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair	N/A
Completed	`NCT04552925` - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears	N/A
Not yet recruiting	`NCT06032416` - DenCT Shoulder Bone Quality Evaluation	N/A
Not yet recruiting	`NCT04047745` - Post-operative Exparel Study Following Rotator Cuff Repair	N/A
Completed	`NCT01029574` - Platelet Rich Plasma on Rotator Cuff Repair	Phase 3
Not yet recruiting	`NCT05817578` - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting	`NCT05670080` - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?	N/A
Suspended	`NCT04421417` - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing	N/A
Recruiting	`NCT06156423` - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery	N/A
Completed	`NCT06145815` - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting	`NCT05009498` - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery	N/A
Terminated	`NCT04855968` - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption	N/A
Not yet recruiting	`NCT04538001` - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear	N/A
Completed	`NCT04594408` - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery	Phase 4
Completed	`NCT04710966` - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears	N/A
Recruiting	`NCT06192459` - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear	N/A
Recruiting	`NCT05925881` - Lower Trapezius Transfer vs Bridging Reconstruction	N/A
Recruiting	`NCT05988541` - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.	N/A
Not yet recruiting	`NCT04587037` - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear	N/A