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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Henry Ford Health
RECRUITING
Detroit
Contact Information
Primary
Johnny Kasto, MD
jkasto1@hfhs.org
313-244-8078
Backup
Stephanie J Muh, MD
Time Frame
Start Date: 2022-08-16
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 78
Treatments
Active_comparator: Control Group
Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.
Experimental: Study Group
Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.
Sponsors
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov