Bioinductive Patch for Full-Thickness Rotator Cuff Tears
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- arthroscopic rotator cuff repair
- Bioinductive implant
- Ultrasound Imaging
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov