NCT05439850

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rotator Cuff Tears
• Rotator Cuff Tear Arthropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-16
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2022-06-30
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study