NCT07245719

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Stryker Craniomaxillofacial · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of the Stryker Universal System when used in a clinical setting. This study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. Based on a non-inferiority study power calculation a minimum of 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.

Conditions

• Zygomatic Fractures
• Orbital Fractures
• Maxilla Fractures
• Facial Fractures

Interventions

Type	Name	Description
DEVICE	Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System	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.

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study