Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears
ConditionRotator Cuff Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSmith & Nephew, Inc.
About this trial
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
Eligibility criteria
Qualifiers
The subject must provide written informed consent.
Subject is > eighteen (18) years of age (no upper limit).
Subject has an isolated high-grade (>50% or >6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus.
Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear.
Disqualifiers
Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system.
Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation.
Subjects with Samilson-Prieto osteoarthritis grade 2 and greater.
Subjects with current or prior infection of the ipsilateral shoulder.
Trial design
Treatments tested in this trial
- Isolated Bioinductive Repair
- Completion and Repair
Treatment groups
234 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov