Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT05735119

Embody Post-Market Clinical Follow-Up Study

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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

Interventions

DEVICE

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