Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stryker Craniomaxillofacial
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
