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.
Study Type
OBSERVATIONAL
Enrollment
80
Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery
New York Center for Orthognathic and Maxillofacial Surgery
New York, New York, United States
RECRUITINGNew York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York
New York, New York, United States
RECRUITINGSuccessful 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
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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.