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Bioinductive Patch for Full-Thickness Rotator Cuff Tears

NCT05439850 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears
  • Rotator Cuff Tear Arthropathy

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.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Stephanie J Muh, MC · Henry Ford Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-16
Primary Completion
2028-07-01
Completion
2029-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05439850 on ClinicalTrials.gov