Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
Completed
Conditions studied: Zygomatic Fractures, Orbital Fractures, Maxilla Fractures, Facial Fractures
In brief
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
Key facts
- Study ID
- NCT07245719
- Run by
- Stryker Craniomaxillofacial
- People needed
- 150
- Starts
- 2025-03-28
- Expected to finish
- 2026-03-27
- Last updated by the study team
- 2026-04-22
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Skeletally mature patients at the time of surgery.
- Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice.
- Patients for whom data on the primary outcome variable is available.
- Patients with data available from follow-up visits.
You may not qualify if…
- Patients with active infections at the time of surgery.
- Patients with known metal allergies and/or foreign body sensitivity at the time of surgery.
- Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices.
- Patients who underwent secondary reconstructions with non-secondary reconstruction plates
- Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.
Where it is running
- Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132 — New York, New York, United States
Full record on ClinicalTrials.gov
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