Facial iD Customized Mandible Reconstruction Plates

Stryker

Status: Enrolling

Conditions: MANDIBLE; Orthognathic Surgical Procedures; Mandible; Deformity; Mandibular Fractures; Mandible Fracture

Treatments: Device: Mandibular reconstruction

Study type: Observational

Funder types: Industry

Identifiers

NCT07245758

CMRP_2023_01_CIP_v 1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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