An observational study in Mandible Fracture and Mandibular Reconstruction, sponsored by Stryker Craniomaxillofacial. Completed at 2 sites in 2 countries. 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 Surgeon iD Plates (SMRP) medical device. 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 Surgeon iD Mandible Recon Plate 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 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for included patients.
Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Exclusion Criteria:
Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).
Also known as: Mandibular Fracture Fixation
Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature.
Rate of unplanned revision surgery determined by reviewing adverse events in patient medical charts after surgery. Used to document whether an unplanned revision surgery was required or not for each patient.
Time frame: Data collected at a single time point per patient in the course of 12 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 12 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 12 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 12 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 12 months.
Rate of Plate failure
Determined by adverse events reported from patient medical charts.
Time frame: Data collected at time points per patient in the course of 12 months.
Operating room (OR) time
Time patients are operated (hh:mm)
Time frame: Data collected at a single time point per patient in the course of 12 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 12 months.
Rate of satisfactory occlusion achieved with orthodontic treatment.
Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment.
Time frame: Data collected at time points per patient in the course of 12 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 12 months.
Short-form-12-health-survey-questionnaire (if available)
Short-form-12-health-survey-Questionnaire (Scale of 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health).
Time frame: Data collected at time points per patient in the course of 12 months.
Ischemia time
Ischemia time (dd:hh)
Time frame: Data collected at a single time point per patient in the course of 12 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 12 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 12 months.
Patient age
Age (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.
Follow-up time
Post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visit.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Surgical approach
Surgical approach taken for the procedure. Including: transoral; transbuccal; submandibular; preauricular; other
Time frame: Data collected at a single time point per patient in the course of 16 months.
Rate of osteotomy
Cases where osteotomy (e.g. BSSO) was performed. Instrumentation used to perform the osteotomy.
Time frame: Data collected at time points per patient in the course of 12 months.
Frequency of Maxilla-mandibular fixation
Number of maxillo-mandibular fixation procedures (number per patient).
Time frame: Data collected at time points per patient in the course of 12 months.
Relevant Medical conditions
Descriptive data of any underlying medical conditions and medications recorded in patient medical charts that may be related to the device or primary outcome (qualitative measure).
Time frame: Data collected at time points per patient in the course of 12 months.
Primary/secondary reconstruction performed
Type of reconstruction procedure performed (e.g. immediately or after an initial surgery).
Time frame: Data collected at time points point per patient in the course of 12 months
Localization of the defect
Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; other
Time frame: Data collected at time points point per patient in the course of 12 months.
Flap used
Type of flap used: vascularized fibula flap, vascularized scapula flap, vascularized iliac crest flap, avascularized fibula flap, avascularized scapula flap, avascularized iliac crest flap, others
Time frame: Data collected at a single time point per patient in the course of 12 months.
Radiation
Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts. 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.
Dental reconstruction in a single stage surgery
Data for dental reconstruction collected from 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.
Time frame: Data collected at a single time point per patient in the course of 12 months.
Fixation system used
System used to fix the device during the procedure. Stryker Universal Mandible System; other Types and number of screws
Time frame: Data collected at a single time point per patient in the course of 12 months.
Plate types
2.0 or 2.8 plates used, hemi or full reconstruction plate used
Time frame: Data collected at a single time point per patient in the course of 12 months.
Gender
Responses: Male, Female, undifferentiated, unknown
Time frame: Data collected at a single time point per patient in the course of 12 months
Patient height
Height (cm, feet, inches)
Time frame: Data collected at a single time point per patient in the course of 12 months.
Patient weight
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 12 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 month
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 month
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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Stryker Craniomaxillofacial