Embody Post-Market Clinical Follow-Up Study

NCT05735119 | Active Not Recruiting FDA Device

• 1 other identifier: EMBODY-003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Tendon Injuries- Subscapularis

Outcome Measures

Primary Outcomes (1)

• Subscapularis repair integrity

  Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.

  6 months postoperatively

Secondary Outcomes (14)

• Subscapularis tendon tissue quality

  6 months postoperatively

• Internal rotation strength in the belly-press (11,12) position, measured by an electronic handheld dynamometer.

  Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively

• Subscapularis repair integrity

  Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively

• Adverse events

  Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively

• Serious adverse events

  Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively

Study Arms (1)

Subscapularis Tendon Injuries

Tapestry Biointegrative Implant

Device: Tapestry Biointegrative Implant

Interventions

Tapestry Biointegrative Implant DEVICE

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.

Subscapularis Tendon Injuries

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing shoulder arthroplasty, who meet the study eligibility criteria.

You may qualify if:

• Adult, 21 years and older.
• Patient requires shoulder arthroplasty (anatomic or reverse) with subscapularis repair due to osteoarthritis, rotator cuff injury, rheumatoid arthritis and/or other inflammatory disorder, osteonecrosis, and/or post-traumatic injury (e.g., humerus fractures).
• Patients healthy enough to undergo primary anatomic or reverse shoulder arthroplasty, in the opinion of the investigator;
• Patients receiving shoulder arthroplasty with anticipated subscapularis tenotomy (ST) or subscapularis peel (SP).
• Intact rotator cuff including subscapularis tendon for anatomic shoulder arthroplasty or a repairable subscapularis tendon for reverse shoulder arthroplasty, as determined by preoperative examination or imaging, if indicated or available preoperatively. Imaging is not required for this assessment.
• Ability and willingness to comply with prescribed post-operative rehabilitation program.
• Ability and willingness to comply with follow-up visit schedule.
• Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
• Ability to read, understand, and complete subject-reported outcomes in English.

You may not qualify if:

• Shoulder arthroplasty requiring a lesser tuberosity osteotomy or revision arthroplasty.
• Prior index shoulder surgery requiring treatment to the subscapularis.
• Intraoperative identification of irreparable subscapularis tear (rTSA)
• Diabetic patients with hemoglobin A1c (HbA1c) level \>8% prior to surgery.
• Patients with inflammatory arthritis or patients that are immunocompromised, or patients that have a glenoid deficiency.
• Patients with a known history of hypersensitivity to bovine-derived materials.
• Hypersensitivity to poly(D,L-lactide) materials.
• Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study.
• Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder.
• Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study.
• History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Alta Orthopaedics

Santa Barbara, California, 93101, United States

Location

HCA Florida - JFK Hospital

Atlantis, Florida, 33462, United States

Location

Atlantis Orthopaedics

Palm Beach Gardens, Florida, 33410, United States

Location

Central Indiana Orthopedics

Carmel, Indiana, 46037, United States

Location

University of Louisville Physicians, Inc.

Louisville, Kentucky, 40215, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 21, 2023
• Study Start: November 9, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (5)