Tendon Injuries- SubscapularisRAISENCT05735119
Embody Post-Market Clinical Follow-Up Study
An observational study of Tendon Injuries- Subscapularis, run by Zimmer Biomet at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tendon Injuries- Subscapularis
- What is being tested?
- Tapestry Biointegrative Implant
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Nov 2022to Jun 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing shoulder arthroplasty, who meet the study eligibility criteria.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
HCA Florida - JFK Hospital
Atlantis, Florida, 33462
Central Indiana Orthopedics
Carmel, Indiana, 46037
University of Louisville Physicians, Inc.
Louisville, Kentucky, 40215
Atlantis Orthopaedics
Palm Beach Gardens, Florida, 33410
Alta Orthopaedics
Santa Barbara, California, 93101
About this study
Official title: 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.
Read the 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
- Being tested
- Tapestry Biointegrative Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapestry Biointegrative ImplantDevice
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 group | Role | What they receive |
|---|---|---|
| Subscapularis Tendon Injuries | Tapestry Biointegrative Implant Receives: Device: Tapestry Biointegrative Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subscapularis repair integrity
Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.
Measured: 6 months postoperatively
Secondary outcomes (14)
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.
Measured: 6 months postoperatively
Internal rotation strength in the belly-press (11,12) position, measured by an electronic handheld dynamometer.
Subscapularis repair integrity
Measured: 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.
Measured: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Adverse events
Procedure and/or treatment
Measured: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Serious adverse events
Procedure and/or treatment
Measured: 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
Measured: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Patient Questionnaire
Patient Satisfaction
Measured: 3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Forward evaluation
Active Range of Motion (ROM)
Measured: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Abduction
Active ROM
Measured: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
External rotation
Active ROM
Measured: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Internal rotation
Active ROM
Measured: 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
Measured: Baseline/3 months/6 months/12 months/24 months postoperatively
Visual Analog Scale (VAS)
Patient reported clinical outcome scores
Measured: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Simple Shoulder Test (SST)
Patient reported clinical outcome scores
Measured: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start9 Nov 2022
- Primary completionNov 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon Injuries- SubscapularisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735119
- Sponsor's protocol ID
- EMBODY-003
- Acronym
- RAISE
- Status last verified
- May 2026
- First submitted
- 6 Feb 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Post-Market Clinical Follow-Up Study: Subscapularis Repair Augmented With Tapestry Biointegrative Implant After Shoulder Arthroplasty Evaluation (RAISE)
- ClinicalTrials.gov ID
- NCT05735119
- Acronym / sponsor ID
- RAISE / EMBODY-003
- Conditions
- Tendon Injuries- Subscapularis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subscapularis Tendon Injuries | – | Device: Tapestry Biointegrative ImplantTapestry Biointegrative Implant |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing shoulder arthroplasty, who meet the study eligibility criteria.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapestry Biointegrative ImplantCollagen-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. | Device | Subscapularis Tendon Injuries |
Primary outcome
Subscapularis repair integrity
Time frame: 6 months postoperatively
Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.
14 secondary outcomes
Subscapularis tendon tissue quality
Time frame: 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
Time frame: 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
Serious adverse events
Time frame: 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
Patient Questionnaire
Time frame: 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
Abduction
Time frame: 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
Internal rotation
Time frame: 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
Visual Analog Scale (VAS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Tendon Injuries- Subscapularis
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Subscap Reverse Shoulder Arthroplasty
Shoulder Injuries, Rotator Cuff Injuries
Not yet recruitingObservational study
Arthroscopic Subscapularis Augmentation
Shoulder Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendon Injuries- Subscapularis, run by Zimmer Biomet at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subscapularis repair integrity (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.