Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Henry Ford Health System
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.
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 measu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 cu…
Interventions
- Procedurearthroscopic rotator cuff repair
This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.
- BiologicalBioinductive implant
A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.
- Diagnostic TestUltrasound Imaging
An ultrasound will be performed on each patient one year postoperatively.
Location
- Henry Ford HealthDetroit, Michigan