NCT05735119

Embody Post-Market Clinical Follow-Up Study

A Multi-Center, Prospective Post-Market Clinical Follow-Up Study: Subscapularis Repair Augmented With Tapestry Biointegrative Implant After Shoulder Arthroplasty Evaluation (RAISE)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed investigation is a multi-center, prospective patient registry: 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. A total of 100 patients will be enrolled. Enrolled subjects will include adults undergoing shoulder arthroplasty, who meet the study eligibility criteria. The Tapestry Biointegrative Implant was FDA 510(k) cleared (K201572) on October 22, 2020, for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The primary analysis of subscapularis tendon repair integrity assessed by ultrasound will occur when all study subjects reach 6 months post-surgery. The goal of the analysis is to show that the tendon failure rate for subscapularis repair with Tapestry is lower than the failure rate for subscapularis repair without Tapestry a receiving surgery with the Tapestry and the literature-defined failure rate for tendon healing. Secondary endpoints will be analyzed when the last subject reaches the 24 month timepoint.

Conditions

• Tendon Injuries- Subscapularis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-09
• Primary completion: 2026-09-01
• Completion: 2028-03-01
• First posted: 2023-02-21
• Last updated: 2026-02-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study