Embody Post-Market Clinical Follow-Up Study (RAISE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tendon Injuries- Subscapularis
• Intervention / Treatment: Device: Tapestry Biointegrative Implant

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93101
      • Alta Orthopaedics
  • Florida
    • Atlantis, Florida, United States, 33462
      • HCA Florida - JFK Hospital
    • Palm Beach Gardens, Florida, United States, 33410
      • Atlantis Orthopaedics
  • Indiana
    • Carmel, Indiana, United States, 46037
      • Central Indiana Orthopedics
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • University of Louisville Physicians, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subscapularis Tendon Injuries; Tapestry Biointegrative Implant	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subscapularis repair integrity	Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subscapularis tendon tissue quality	Assessed using ultrasound to evaluate and measure thickness compared to normal (9, 10) subscapularis tendon thickness at 6-months postoperatively. Tendon tissue thickness and quality evaluation will be measured by trained personnel per the EMBODY-003 ultrasound procedure manual.	6 months postoperatively
Internal rotation strength in the belly-press (11,12) position, measured by an electronic handheld dynamometer.	Subscapularis repair integrity	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Subscapularis repair integrity	Assessed by internal rotation strength in the Bear-Hug position.	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Adverse events	Procedure and/or treatment	Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Serious adverse events	Procedure and/or treatment	Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Serious adverse events necessitating a second surgical intervention (SSI)	Procedure and/or treatment	Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient Questionnaire	Patient Satisfaction	3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Forward evaluation	Active Range of Motion (ROM)	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Abduction	Active ROM	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
External rotation	Active ROM	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Internal rotation	Active ROM	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
American Shoulder and Elbow Surgeon Evaluation (ASES)	Patient reported clinical outcome scores	Baseline/3 months/6 months/12 months/24 months postoperatively
Visual Analog Scale (VAS)	Patient reported clinical outcome scores	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Simple Shoulder Test (SST)	Patient reported clinical outcome scores	Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Embody Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID Numbers: EMBODY-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No