A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. 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 Customized Plates for Mandibular Reconstruction (CMRP) in the clinical setting. his study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. Up to 3 investigational sites in US will be participating. Based on a non-inferiority study power calculation 80 subjects will be enrolled in the study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
Study Type
OBSERVATIONAL
Enrollment
80
Primary or secondary reconstruction of the mandible using customized Mandible Reconstruction Plate (referred to as CMRP)
Head & Neck Surgery Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGRate of successful reconstruction of the mandible without the need for unplanned revision surgery
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 16 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 a single time point per patient in the course of 16 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 16 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 16 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 16 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 16 months.
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Rate of plate or screw failure
Determined by rate of adverse events reported from patient medical charts involving plate or screw fracture.
Time frame: Data collected at time points point per patient in the course of 16 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 16 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 16 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 16 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 16 months.
End user questionnaire
Questionnaire only for medically trained professionals on site staff using the device. Questions relate to subjective rating of ease of use by the surgeon if compared to stock plates (evaluated per treating surgeon, not per patient). Questionnaire is qualitative response regarding the ease of use of the device.
Time frame: Data collected during the course of 16 months.
Misfit of implant
Fit of implant Time for adaptations
Time frame: Data collected at time points per patient in the course of 16 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 16 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 16 months.
Visual Analogue Scale (VAS) Pain
The visual analogue scale (VAS) is a psychometric response scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Time frame: Data collected at time points per patient in the course of 16 months.
Ischemia time
Ischemia time (dd:hh)
Time frame: Data collected at a single time point per patient in the course of 16 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 16 months.