Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up (UPC)

Stryker

Status: Enrolling

Conditions: Facial Fracture; Orthognathic Surgical Procedures; Mandibular Fractures; Maxilla Fracture

Treatments: Device: Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT07245810

UPC_2023_10_CIP_v 1.0

Details and patient eligibility

About

A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting. 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 Facial iD UPC plating system 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 80 patients will be enrolled in the study. Additional patients may be enrolled up to 800 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful fixation or reconstruction of the midface 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 received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
2. Patients for whom data on the primary outcome variable is available.

Exclusion criteria

1. Patients with non-reducible and unstable fractures at the time of surgery
2. Patients with fractures of a severely atrophic mandible at the time of surgery
3. Patients with active local infections at the time of surgery
4. Patients with metal allergies and/or foreign body sensitivity at the time of surgery
5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
6. Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions