Embody Post-Market Clinical Follow-Up Study (NCT05735119) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Embody Post-Market Clinical Follow-Up Study
United States100 participantsStarted 2022-11-09
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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.
. 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.