RecruitingNCT07245758

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


Sponsor

Stryker Craniomaxillofacial

Enrollment

80 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria2

  • Patients who underwent primary or secondary mandibular reconstruction using a Stryker Facial iD CMRP implant as per routine clinical practice.
  • Patients for whom data on the primary outcome variable is available.

Exclusion Criteria4

  • Patients with active local infections at the time of surgery
  • Patients with known metal allergies and/or foreign body sensitivity at the time of surgery
  • Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions
  • Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMandibular reconstruction

Primary or secondary reconstruction of the mandible using customized Mandible Reconstruction Plate (referred to as CMRP)


Locations(1)

Head & Neck Surgery Medical University of South Carolina

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07245758


Related Trials