Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up to Confirm Safety, Performance and Effectiveness of The Universal CMF System
Stryker Craniomaxillofacial
120 participants
Mar 28, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria5
- 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.
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Interventions
The Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07245719