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

Stryker

Status: Enrolling

Conditions: Mandibular Reconstruction; Mandible Fracture

Treatments: Device: Mandibular Reconstruction

Study type: Observational

Funder types: Industry

Identifiers

NCT07221916

Surgeon iD Plates _2023_01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate 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