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Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Description

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 TearsRotator Cuff Tear Arthropathy
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Related Conditions:

Rotator Cuff TearsRotator Cuff Tear Arthropathy

Study Overview

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Study Details

Study overview

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.

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

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Condition
Rotator Cuff Tears
Intervention / Treatment

-

Contacts and Locations

Detroit

Henry Ford Health, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Indicated and scheduled for arthroscopic rotator cuff repair.
  • * Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
  • * Chronic, degenerative rotator cuff tears.
  • * Ability to read and understand English.
  • * Age ≥18 years
  • * Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
  • * Patient scheduled for open or mini-open rotator cuff repair
  • * Prior surgery of affected shoulder (except diagnostic arthroscopy)
  • * Partial-thickness rotator cuff tears
  • * Small (\<1 cm) rotator cuff tears
  • * Rotator cuff tears involving the subscapularis tendon
  • * Acute and traumatic rotator cuff tears
  • * Active infection
  • * Cancer
  • * Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Henry Ford Health System,

Stephanie J Muh, MC, PRINCIPAL_INVESTIGATOR, Henry Ford Health

Study Record Dates

2025-12-01