NCT07245758

Facial iD Customized Mandible Reconstruction Plates

Stryker Customized Plates for Mandibular Reconstruction: A Retrospective Post Market Follow Up to Confirm Safety and Performance of Facial iD Customized Mandible Reconstruction Plates

• 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 the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. 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 Customized Plates for Mandibular Reconstruction (CMRP) in the clinical setting. his study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. Up to 3 investigational sites in US will be participating. Based on a non-inferiority study power calculation 80 subjects will be enrolled in the study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.

Conditions

• Mandibular Fractures
• Mandible Fracture
• Mandible; Deformity
• MANDIBLE
• Orthognathic Surgical Procedures

Interventions

Type	Name	Description
DEVICE	Mandibular reconstruction	Primary or secondary reconstruction of the mandible using customized Mandible Reconstruction Plate (referred to as CMRP)

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study