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NCT05735119 · ClinicalTrials.gov registry record
Embody Post-Market Clinical Follow-Up Study
A clinical trial, sponsored by Zimmer Biomet.
- Active
- Registry status
- 100
- Enrollment target
NCT05735119: Active study, sponsored by Zimmer Biomet.
NCT05735119 is a clinical trial that is active but no longer recruiting, run by Zimmer Biomet. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05735119 is active but no longer recruiting, sponsored by Zimmer Biomet.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Assessed by ultrasound evaluation per the EMBODY-003 ultrasound procedure manual.
Interventions
- DEVICE Tapestry Biointegrative Implant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-11-09 |
| Est. Completion | 2028-06 |
What the registry record for NCT05735119 still lists
NCT05735119 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Tapestry Biointegrative Implant is the first listed.
NCT05735119 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05735119 about?
NCT05735119 is a clinical study titled "Embody Post-Market Clinical Follow-Up Study". 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...
What is the current status of trial NCT05735119?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2022-11-09. Estimated completion is 2028-06.
What interventions are being tested in trial NCT05735119?
The interventions under investigation include: Tapestry Biointegrative Implant (DEVICE).
Who is sponsoring clinical trial NCT05735119?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
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