Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Arthroscopic Rotator Cuff Repair Augmented With Bioinductive Implant for Full-Thickness Tears: A Randomized Controlled Study
Henry Ford Health System
78 participants
Aug 16, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria9
- 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
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Interventions
This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.
A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.
An ultrasound will be performed on each patient one year postoperatively.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05439850