An observational study in Mandibular Fractures, Facial Fracture and Maxilla Fracture, sponsored by Stryker Craniomaxillofacial. Active, not recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Stryker Craniomaxillofacial · Observational
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.
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.
Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Exclusion Criteria:
Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery
Successful fixation or reconstruction of the midface 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 18 months.
Infection rate
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points from patient medical charts in the course of 18 months.
Intraoperative complications
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at a single time point per patient in the course of 18 months.
Postoperative complications
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points per patient in the course of 18 months.
Any known adverse events
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points per patient in the course of 18 months.
Plate failure
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points point per patient in the course of 18 months.
Satisfactory occlusion achieved after additional orthodontic treatment
Data reported in patient medical charts
Time frame: Data collected at a single time point per patient in the course of 18 months.
Time to return to solid food/normal diet
Time for patient to return to solid food/normal diet post operation (dd)
Time frame: Data collected at a single time point per patient in the course of 18 months.
Hospitalization time; ICU and normal ward
Time the patient was hospitalized post procedure (dd:hh)
Time frame: Data collected at a single time point per patient in the course of 18 months.
EuroQol-5 Domain Questionnaire (if available)
A descriptive system and a visual analogue scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with three to five levels of severity. The VAS provides a subjective rating of overall health on a scale from 0 to 100 (higher is better)).
Time frame: Data collected at time points per patient in the course of 18 months.
Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available)
40 independently functioning scales and checklists. Multiple independent scales, each with a 0-100 score, where higher scores indicate better outcomes. Scores are calculated by summing responses on a 4-point Likert scale (e.g., strongly disagree to strongly agree), which are then converted to the 0-100 range. Each scale measures a specific aspect of facial appearance, quality of life, or adverse effects and cannot be summed into a single total score.
Time frame: Data collected at time points per patient in the course of 18 months.
12-Item Short Form Health Survey (SF-12)
12 items grouped and scored to produce two separate summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). The scale is transformed to a 0-100 range with higher scores indicating better health.
Time frame: Data collected at time points per patient in the course of 18 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 18 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 18 months.
Surgical approach
Surgical approach taken for the procedure. Including: transoral; intraoral; maxillary vestibular approach; transbuccal; submandibular; preauricular; other
Time frame: Data collected at a single time point per patient in the course of 18 months.
Medical conditions
Underlying medical conditions and medication that may be related to the device or primary outcome.
Time frame: Data collected at time points point per patient in the course of 18 months.
Localization of the defect
Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; Le Fort I; Le Fort II; Le Fort III; others
Time frame: Data collected at a single time point per patient in the course of 18 months.
Post operative maxillo-mandibular fixation
For patients that receive maxillo-mandibular fixation post operation the length of time after surgery the fixation procedure took place (days).
Time frame: Data collected at a single time point per patient in the course of 18 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 18 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 18 months.
Fixation system used
System used to fix the device during the procedure. Stryker Universal CMF screws; others
Time frame: Data collected at a single time point per patient in the course of 18 months.
Tightening of screws
Tools used to fix the device during the procedure. Response options include : Manual and electric screw driver
Time frame: Data collected at a single time point per patient in the course of 18 months.
Orthognathic cases
Usage of splints in orthognathic cases.
Time frame: Data collected at a single time point per patient in the course of 18 months.
Year smoking was stopped
Year smoking was stopped (YYYY)
Time frame: Data collected at time points per patient in the course of 18 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 18 month
Smoking duration
Duration of smoking (pack years)
Time frame: Data collected at time points per patient in the course of 18 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 18 month
Patient weight
Weight (kg, lb)
Time frame: Data collected at a single time point per patient in the course of 18 months.
Patient height
Height (cm, feet, inches)
Time frame: Data collected at a single time point per patient in the course of 18 months.
Patient age
Age (years)
Time frame: Data collected at a single time point per patient in the course of 18 months.
Gender
Responses: Male, Female, undifferentiated, unknown
Time frame: Data collected at a single time point per patient in the course of 18 months
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Stryker Craniomaxillofacial