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NCT07421245 · ClinicalTrials.gov registry record
OsseoFit Stemless Shoulder System (Anatomic)
A clinical trial, sponsored by Zimmer Biomet.
- Not yet
- Registry status
- 136
- Enrollment target
NCT07421245: Clinical Trial study, sponsored by Zimmer Biomet.
NCT07421245 is a clinical trial that has not yet begun recruiting, run by Zimmer Biomet. The registered enrollment target is 136 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07421245 has not yet begun recruiting, sponsored by Zimmer Biomet.
- NOT YET RECRUITING
- Registry status
- 136 participants
- Enrollment target
Study Summary
The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.
Primary Outcome
The primary endpoint is the American Shoulder and Elbow Surgeons (ASES) Shoulder Score. Improvement from baseline to 2 years will be evaluated using the overall mean change, with effectiveness demonstrated if the mean improvement exceeds the MCID of 10.8 points. The primary endpoint analysis will use the ITT population with all available data and no imputation. Hypotheses: H0: μCFB ≤ 10.8; H1: μCFB \> 10.8, where μCFB is the mean ASES change (2 years minus baseline). The MCID of 10.8 was establi
Interventions
- DEVICE OsseoFit Stemless Inlay
- DEVICE OsseoFit Stemless Onlay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2026-07 |
| Est. Completion | 2036-01 |
What is known before NCT07421245 opens enrollment
NCT07421245 is an observational study that tracks outcomes without assigning an intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which OsseoFit Stemless Inlay is the first listed.
NCT07421245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07421245 about?
NCT07421245 is a clinical study titled "OsseoFit Stemless Shoulder System (Anatomic)". The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complicati...
What is the current status of trial NCT07421245?
This trial is currently not yet recruiting. The enrollment target is 136 participants. The study started on 2026-07. Estimated completion is 2036-01.
What interventions are being tested in trial NCT07421245?
The interventions under investigation include: OsseoFit Stemless Inlay (DEVICE), OsseoFit Stemless Onlay (DEVICE).
Who is sponsoring clinical trial NCT07421245?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
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