Embody Registry Study

Study Overview
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Brief Summary
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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, and 12 months after surgery.

Detailed Description
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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, and 12 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 12 month timepoint.

Official Title
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A Multi-Center, Prospective Patient Registry: Subscapularis Repair Augmented With TAPESTRY® Biointegrative Implant After Shoulder Arthroplasty Evaluation (RAISE)

Conditions
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Tendon Injuries- Subscapularis

Intervention / Treatment
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* Device: Tapestry Biointegrative Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Shoulder arthroplasty requiring a lesser tuberosity osteotomy or revision arthroplasty. Prior index shoulder surgery requiring treatment to the subscapularis. Intraoperative identification of rotator cuff tear requiring repair. 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subscapularis Tendon Injuries<br>Tapestry Biointegrative Implant | Device: Tapestry Biointegrative Implant<br>* 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.<br>|

What is the study measuring?
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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 | 
| Subscapularis repair integrity | Assessed by internal rotation strength in the Bear-Hug position. | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| Adverse events | Procedure and/or treatment | Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| Serious adverse events | Procedure and/or treatment | Surgery visit/3 months postoperatively/6 months postoperatively/12 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 | 
| Patient Questionnaire | Patient Satisfaction | 3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| Forward evaluation | Active Range of Motion (ROM) | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| Abduction | Active ROM | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| External rotation | Active ROM | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| Internal rotation | Active ROM | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| American Shoulder and Elbow Surgeon Evaluation (ASES) | Patient reported clinical outcome scores | Baseline/3 months/6 months/12 months | 
| Visual Analog Scale (VAS) | Patient reported clinical outcome scores | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively | 
| Simple Shoulder Test (SST) | Patient reported clinical outcome scores | Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively |