Evaluation of Safety and Efficacy of a Resorbable Collagen Implant in Treatment of High Grade PArtial ThiCkness Tears; A Prospective, Multicenter, Randomized, Control Trial (IMPACT Study)
Smith & Nephew, Inc.
Summary
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.
Description
The primary objective of this study is to evaluate the functional recovery of patients with high grade (\>50%) partial thickness tears at 3 months when treated with either Isolated Bioinductive Repair (IBR) or Completion and Repair (CAR).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Subject willing and able to make all required study visits. * Subject able to follow instructions and deemed capable of completing all study questionnaires. Exclusion Criteria: * Subjects…
Interventions
- DeviceIsolated Bioinductive Repair
Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
- ProcedureCompletion and Repair
Standard surgical repair using the 'Completion and Repair' technique.
Locations (20)
- Harbin ClinicRome, Georgia
- OrthoIllinois LTDRockford, Illinois
- Sinai Hospital BaltimoreBaltimore, Maryland
- Cleveland Clinic - Sports HealthGarfield Heights, Ohio
- University of PittsburghPittsburgh, Pennsylvania
- Texas Orthopedic SpecialistsBedford, Texas