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A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a 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 the Stryker Universal System when used in a 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 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments 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 |
|---|---|---|---|---|
| Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System | Device | The Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful stabilization and/or fixation of bony segments 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 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | Determined by intraoperative adverse events reported from patient medical charts. | Data collected at a single time point per patient in the course of 12 months. |
| Postoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Patient age (year of birth, age in years) | 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 |
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 |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine Oral and Maxillofacial Surgery 525 East 68th Street, F-2132 | New York | New York | 10065 | United States |
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Determined by post operative adverse events reported from patient medical charts.
| Data collected at time points per patient in the course of 12 months. |
| Any known adverse events potentially related to the primary outcome objective and/or device | Determined by adverse events reported from patient medical charts. | Data collected at time points per patient in the course of 12 months. |
| Implant failure | Determined by adverse events reported from patient medical charts. | Data collected at time points point per patient in the course of 12 months. |
| Operating room (OR) time | Time patients are operated (dd:hh) | Data collected at a single time point per patient in the course of 12 months. |
| Hospitalization time | Time the patient was hospitalized post procedure (ICU and normal ward; dd:hh) | Data collected at a single time point per patient in the course of 12 months. |
| Post-operative bone consolidation | Clinical observation of post-op bone consolidation (medical charts) Timing of post-op observation of bone consolidation (yymmdd) Availability of post op imaging to determine bone consolidation Timing of post-op imaging (number of scans, yymmdd) | Data collected at time points point per patient in the course of 12 months. |
| Data collected at a single time point per patient in the course of 12 months. |
| Surgical approach/access | Surgical approach taken for the procedure. Including: orthognathic, trauma, oncological, congenital defect, other. Usage of the device in the maxilla and maximal incisal mouth opening (post- and pre-operation). Application of post-operative Maxillo-Mandibular Fixation | Data collected at a single time point per patient in the course of 12 months. |
| Anatomical area treated | Area to treated by the device: orbital region, zygomatic region, dento-alveolar region, maxilla, frontal region, other. | Data collected at a single time point per patient in the course of 12 months. |
| Other implants used | Other implants that may have been used during the surgical procedure. | Data collected at time points per patient in the course of 12 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. | Data collected at a single time point per patient in the course of 12 months. |
| Orthognathic cases | Satisfactory occlusion expected to be achieved after potential additional orthodontic treatment. | Data collected at a single time point per patient in the course of 12 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 12 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 12 months. |
| Tightening of screws | Tools used to fix the device during the procedure. Manually, electric screw driver | Data collected at a single time point per patient in the course of 12 months. |
| Implants Used | Quantity, part numbers & descriptions of implants used from the device. | Data collected at a single time point per patient in the course of 12 months. |
| Gender | Patient gender (Male, Female, undifferentiated, unknown) | Data collected at a single time point per patient in the course of 12 months. |
| Height | Patient height (cm, feet, inches) | Data collected at a single time point per patient in the course of 12 months. |
| Weight | Patient weight (kg, lb) | Data collected at a single time point per patient in the course of 12 months. |
| Year smoking was stopped | Year smoking was stopped (YYYY) | Data collected at time points per patient in the course of 16 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 12 months |
| Smoking duration | Duration of smoking (pack years) | Data collected at time points per patient in the course of 12 month |
| Years of active smoking | Total number of years active smoker (YY) | Data collected at time points per patient in the course of 12 months |
| ID | Term |
|---|---|
| D015051 | Zygomatic Fractures |
| D009917 | Orbital Fractures |
| D008440 | Maxillary Fractures |
| ID | Term |
|---|---|
| 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 |
| D007572 | Jaw Fractures |
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