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.
Study Type
OBSERVATIONAL
Enrollment
70
Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).
UCSF Otolaryngology Head and Neck Surgery
San Francisco, California, United States
Heinrich-Braun-Klinikum gGmbH
Zwickau, Germany
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
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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.