Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery: Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Successful fixation or reconstruction of the midface without the need for unplanned revision surgery. — Data collected at a single time point per patient in the course of 18 months. Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients.
Trial sites (2)
Facility
City
Region
Status
New York Center for Orthognathic and Maxillofacial Surgery
New York
New York
New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York
New York
New York
More Stryker Craniomaxillofacial trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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