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

May 20, 2026 updated by: Zimmer Biomet

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Subscapularis repair integrity
Time Frame: 6 months postoperatively
Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.
6 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subscapularis tendon tissue quality
Time Frame: 6 months postoperatively
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.
Time Frame: 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
Subscapularis repair integrity
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
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
Time Frame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Procedure and/or treatment
Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Serious adverse events
Time Frame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
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)
Time Frame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Procedure and/or treatment
Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient Questionnaire
Time Frame: 3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient Satisfaction
3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Forward evaluation
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Active Range of Motion (ROM)
Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Abduction
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Active ROM
Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
External rotation
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Active ROM
Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Internal rotation
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Active ROM
Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
American Shoulder and Elbow Surgeon Evaluation (ASES)
Time Frame: Baseline/3 months/6 months/12 months/24 months postoperatively
Patient reported clinical outcome scores
Baseline/3 months/6 months/12 months/24 months postoperatively
Visual Analog Scale (VAS)
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient reported clinical outcome scores
Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Simple Shoulder Test (SST)
Time Frame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient reported clinical outcome scores
Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Embody Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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