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NCT05439850 | RECRUITING | Rotator Cuff Tears

Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Sponsor:

Henry Ford Health System

Information provided by (Responsible Party):

Stephanie Muh, MD

Brief 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.

Condition or disease

Rotator Cuff Tears

Rotator Cuff Tear Arthropathy

Intervention/treatment

arthroscopic rotator cuff repair

Bioinductive implant

Ultrasound Imaging

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 78 participants
Masking : SINGLE
Masking Description : The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
Primary Purpose : TREATMENT
Official Title : Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Actual Study Start Date : 2022-08-16
Estimated Primary Completion Date : 2024-12-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
Exclusion Criteria
  • * 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
Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Location Details

NCT05439850

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How to Participate

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Locations

RECRUITING

United States, Michigan

Henry Ford Health

Detroit, Michigan, United States, 48202