Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up to Confirm Safety and Performance
Stryker Craniomaxillofacial
80 participants
Nov 18, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice
- Patients for whom data on the primary outcome variable is available.
Exclusion Criteria6
- Patients with non-reducible and unstable fractures at the time of surgery
- Patients with fractures of a severely atrophic mandible at the time of surgery
- Patients with active local infections at the time of surgery
- Patients with metal allergies and/or foreign body sensitivity at the time of surgery
- Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery
- Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions
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Interventions
Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07245810