A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. The study is performed to confirm the product's performance and safety by systematically collecting clinical data on its use.
This is a retrospective non-interventional post-market follow up aiming at confirming safety and performance of the Stryker Universal System when used in a 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 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
Study Type
OBSERVATIONAL
Enrollment
120
The Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries.
Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132
New York, New York, United States
RECRUITINGSuccessful stabilization and/or fixation of bony segments without the need for unplanned revision surgery
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.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Intraoperative complications
Determined by intraoperative adverse events reported from patient medical charts.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Postoperative complications
Determined by post operative adverse events reported from patient medical charts.
Time frame: Data collected at time points per patient in the course of 12 months.
Any known adverse events potentially related to the primary outcome objective and/or device
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points per patient in the course of 12 months.
Implant failure
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points point per patient in the course of 12 months.
Operating room (OR) time
Time patients are operated (dd:hh)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Hospitalization time
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Time the patient was hospitalized post procedure (ICU and normal ward; dd:hh)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Post-operative bone consolidation
Clinical observation of post-op bone consolidation (medical charts) Timing of post-op observation of bone consolidation (yymmdd) Availability of post op imaging to determine bone consolidation Timing of post-op imaging (number of scans, yymmdd)
Time frame: Data collected at time points point per patient in the course of 12 months.