An observational study in Zygomatic Fractures, Orbital Fractures and Maxilla Fractures, sponsored by Stryker Craniomaxillofacial. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Stryker Craniomaxillofacial · Observational
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.
Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Exclusion Criteria:
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.
Successful 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
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.
Age
Patient age (year of birth, age in years)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Primary indication for the surgery / diagnosis
Diagnosis collected from patient medical charts
Time frame: Data collected at a single time point per patient in the course of 12 months.
Surgical approach/access
Surgical approach taken for the procedure. Including: orthognathic, trauma, oncological, congenital defect, other. Usage of the device in the maxilla and maximal incisal mouth opening (post- and pre-operation). Application of post-operative Maxillo-Mandibular Fixation
Time frame: Data collected at a single time point per patient in the course of 12 months.
Anatomical area treated
Area to treated by the device: orbital region, zygomatic region, dento-alveolar region, maxilla, frontal region, other.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Other implants used
Other implants that may have been used during the surgical procedure.
Time frame: Data collected at time points per patient in the course of 12 months.
Max follow-up time
Maximum post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visits.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Orthognathic cases
Satisfactory occlusion expected to be achieved after potential additional orthodontic treatment.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Patient Radiation Exposure
Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts (number and type of radiation procedures performed). Radiation therapy performed on the anatomical area treated with the device. Any postoperative radiation therapy recorded in patient medical charts.
Time frame: Data collected at time points per patient in the course of 12 months.
Sterilization method used
Sterilization method used for the device. Qualitative responses from site.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Tightening of screws
Tools used to fix the device during the procedure. Manually, electric screw driver
Time frame: Data collected at a single time point per patient in the course of 12 months.
Implants Used
Quantity, part numbers \& descriptions of implants used from the device.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Gender
Patient gender (Male, Female, undifferentiated, unknown)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Height
Patient height (cm, feet, inches)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Weight
Patient weight (kg, lb)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Year smoking was stopped
Year smoking was stopped (YYYY)
Time frame: Data collected at time points per patient in the course of 16 months.
Smoking frequency
The frequency of exposure to smoking during periods of smoking (average number of cigarettes per day).
Time frame: Data collected at time points per patient in the course of 12 months
Smoking duration
Duration of smoking (pack years)
Time frame: Data collected at time points per patient in the course of 12 month
Years of active smoking
Total number of years active smoker (YY)
Time frame: Data collected at time points per patient in the course of 12 months
Plan to share: Undecided
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Zygomatic Fractures
Stryker Craniomaxillofacial