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Embody Post-Market Clinical Follow-Up Study
Sponsor: Zimmer Biomet
Summary
A multi-center, prospective post-market clinical follow-up study: subscapularis repair augmented with Tapestry Biointegrative Implant after shoulder arthroplasty. The primary objective of this study is to evaluate the long-term integrity of the subscapularis tendon repair after shoulder arthroplasty augmented with Tapestry Biointegrative Implant, assessed by ultrasound 6 months postoperatively. Secondary objectives are to assess shoulder function (internal rotation strength), safety, and patient reported outcomes. Patients will be evaluated preoperatively, at the time of surgery, 3, 6, 12 and 24 months after surgery.
Official title: A Multi-Center, Prospective Post-Market Clinical Follow-Up Study: Subscapularis Repair Augmented With Tapestry Biointegrative Implant After Shoulder Arthroplasty Evaluation (RAISE)
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2022-11-09
Completion Date
2028-03
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Tapestry Biointegrative Implant
Collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant.
Locations (5)
Alta Orthopaedics
Santa Barbara, California, United States
HCA Florida - JFK Hospital
Atlantis, Florida, United States
Atlantis Orthopaedics
Palm Beach Gardens, Florida, United States
Central Indiana Orthopedics
Carmel, Indiana, United States
University of Louisville Physicians, Inc.
Louisville, Kentucky, United States