Clinical trial NCT05735119: Embody Post-Market Clinical Follow-Up 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)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tendon Injuries- Subscapularis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing shoulder arthroplasty, who meet the study eligibility criteria.

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Subscapularis repair integrity
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Subscapularis tendon tissue quality
timeFrame: 6 months postoperatively
measure: Internal rotation strength in the belly-press (11,12) position, measured by an electronic handheld dynamometer.
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Subscapularis repair integrity
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Adverse events
timeFrame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Serious adverse events
timeFrame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Serious adverse events necessitating a second surgical intervention (SSI)
timeFrame: Surgery visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Patient Questionnaire
timeFrame: 3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Forward evaluation
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Abduction
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: External rotation
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Internal rotation
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: American Shoulder and Elbow Surgeon Evaluation (ASES)
timeFrame: Baseline/3 months/6 months/12 months/24 months postoperatively
measure: Visual Analog Scale (VAS)
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
measure: Simple Shoulder Test (SST)
timeFrame: Screening visit/3 months postoperatively/6 months postoperatively/12 months postoperatively/24 months postoperatively
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Alta Orthopaedics
state: California
city: Atlantis
country: United States
facility: HCA Florida - JFK Hospital
state: Florida
city: Carmel
country: United States
facility: Central Indiana Orthopedics
state: Indiana
city: Louisville
country: United States
facility: University of Louisville Physicians, Inc.
state: Kentucky
Study officials:
References: