NCT07221916

Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (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 Surgeon iD Plates (SMRP) medical device. 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 Surgeon iD Mandible Recon Plate 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 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for included patients.

Conditions

• Mandible Fracture
• Mandibular Reconstruction

Interventions

Type	Name	Description
DEVICE	Mandibular Reconstruction	Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-10-28
• Last updated: 2025-10-28

Locations

2 sites across 2 countries: United States, Germany