NCT07245810

Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up

Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up to Confirm Safety and Performance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Stryker Craniomaxillofacial · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the 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 Stryker's Facial iD UPC plating system when used in the 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 80 patients will be enrolled in the study. Additional patients may be enrolled up to 800 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful fixation or reconstruction of the midface without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.

Conditions

• Mandibular Fractures
• Facial Fracture
• Maxilla Fracture
• Orthognathic Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery	Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery

Timeline

• Start date: 2024-11-18
• Primary completion: 2025-11-15
• Completion: 2026-01-15
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study