RECRUITING

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-16
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05439850

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Indicated and scheduled for arthroscopic rotator cuff repair.
  2. * 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.
  3. * Chronic, degenerative rotator cuff tears.
  4. * Ability to read and understand English.
  5. * Age ≥18 years
  6. * Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy
  1. * Patient scheduled for open or mini-open rotator cuff repair
  2. * Prior surgery of affected shoulder (except diagnostic arthroscopy)
  3. * Partial-thickness rotator cuff tears
  4. * Small (\<1 cm) rotator cuff tears
  5. * Rotator cuff tears involving the subscapularis tendon
  6. * Acute and traumatic rotator cuff tears
  7. * Active infection
  8. * Cancer
  9. * Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

Contacts and Locations

Study Contact

Johnny Kasto, MD
CONTACT
313-244-8078
jkasto1@hfhs.org
Stephanie J Muh, MD
CONTACT

Principal Investigator

Stephanie J Muh, MC
PRINCIPAL_INVESTIGATOR
Henry Ford Health

Study Locations (Sites)

Henry Ford Health
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

  • Stephanie J Muh, MC, PRINCIPAL_INVESTIGATOR, Henry Ford Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-16
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-08-16
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Rotator Cuff Tear
  • Bioinductive
  • Arthroscopic Rotator Cuff Repair
  • Rotator Cuff Tear Arthropathy

Additional Relevant MeSH Terms

  • Rotator Cuff Tears
  • Rotator Cuff Tear Arthropathy