Ireland
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Active, not recruiting Observational

Embody Post-Market Clinical Follow-Up Study

NCT05735119 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2022-11-09
Last updated
2026-05-22

Condition(s) studied

Tendon Injuries- Subscapularis

Investigational drug(s) / intervention(s)

Tapestry Biointegrative Implant

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.

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Adult, 21 years and older. 2. 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). 3. Patients healthy enough to undergo primary anatomic or reverse shoulder arthroplasty, in the opinion of the investigator; 4. Patients receiving shoulder arthroplasty with anticipated subscapularis tenotomy (ST) or subscapularis peel (SP). 5. 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. 6. Ability and willingness to comply with prescribed post-operative rehabilitation program. 7. Ability and willingness to comply with follow-up visit schedule. 8. 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. 9. Ability to read, understand, and complete subject-reported outcomes in English. Exclusion Criteria: 1. Shoulder arthroplasty requiring a lesser tuberosity osteotomy or revision arthroplasty. 2. Prior index shoulder surgery requiring treatment to the subscapularis. 3. Intraoperative identification of irreparable subscapularis tear (rTSA) 4. Diabetic patients with hemoglobin A1c (HbA1c) level \>8% prior to surgery. 5. Patients with inflammatory arthritis or patients that are immunocompromised, or patients that have a glenoid deficiency. 6. Patients with a known history of hypersensitivity to bovine-derived materials. 7. Hypersensitivity to poly(D,L-lactide) materials. 8. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study. 9. Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder. 10. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study. 11. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.

Primary outcome measure(s)

  • Subscapularis repair integrity — 6 months postoperatively
    Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.

Trial sites (5)

FacilityCityRegionStatus
Alta Orthopaedics Santa Barbara California
HCA Florida - JFK Hospital Atlantis Florida
Atlantis Orthopaedics Palm Beach Gardens Florida
Central Indiana Orthopedics Carmel Indiana
University of Louisville Physicians, Inc. Louisville Kentucky

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05735119 on ClinicalTrials.gov ↗ ← All trials in the USA