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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery | Device | Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data collected at a single time point per patient in the course of 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection rate | Determined by adverse events reported from patient medical charts. | Data collected at time points from patient medical charts in the course of 18 months. |
| Intraoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| Primary indication for the surgery / diagnosis | Diagnosis collected from patient medical charts. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Center for Orthognathic and Maxillofacial Surgery | New York | New York | 10022 | United States | ||
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| Label | URL |
|---|---|
| Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology. | View source |
| Lee, Z. Hye, et al. 2020. "The Latest Evolution in Virtual Surgical Planning: Cus-tomized Reconstruction Plates in Free Fibula Flap M | View source |
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Determined by adverse events reported from patient medical charts.
| 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. | 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. | Data collected at time points per patient in the course of 18 months. |
| Plate failure | Determined by adverse events reported from patient medical charts. | 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 | 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) | 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) | 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)). | 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. | 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. | Data collected at time points per patient in the course of 18 months. |
| 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 | 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. | 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 | 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). | 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. | 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. | 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 | 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 | Data collected at a single time point per patient in the course of 18 months. |
| Orthognathic cases | Usage of splints in orthognathic cases. | Data collected at a single time point per patient in the course of 18 months. |
| Year smoking was stopped | Year smoking was stopped (YYYY) | 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). | Data collected at time points per patient in the course of 18 month |
| Smoking duration | Duration of smoking (pack years) | Data collected at time points per patient in the course of 18 month |
| Years of active smoking | Total number of years active smoker (YY) | Data collected at time points per patient in the course of 18 month |
| Patient weight | Weight (kg, lb) | Data collected at a single time point per patient in the course of 18 months. |
| Patient height | Height (cm, feet, inches) | Data collected at a single time point per patient in the course of 18 months. |
| Patient age | Age (years) | Data collected at a single time point per patient in the course of 18 months. |
| Gender | Responses: Male, Female, undifferentiated, unknown | Data collected at a single time point per patient in the course of 18 months |
| New York Center for Orthognathic and Maxillofacial Surgery, Lake Success, New York |
| New York |
| New York |
| 11042 |
| United States |
| Witjes, Max J. H., Rutger H. Schepers, and Joep Kraeima. 2018. "Impact of 3D Virtual Planning on Recon-struction of Mandibular and Maxillary Surgical Defects in Head and Neck Oncology." Current Opinion in Otolaryngology and Head and Neck Surgery. | View source |
| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| D008440 | Maxillary Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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