Facial Fracture, Mandibular Fractures, Maxilla Fracture, Orthognathic Surgical Procedures
Conditions
Keywords
Orthognathic Surgery, Mandibular Reconstruction, Mandibular Fractures, Mandibular Reconstruction* / Methods
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOrthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
Osteotomy, Mandible and Maxillofacial reconstruction, Orthognathic surgery
Sponsors
Stryker Craniomaxillofacial
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients who received a Stryker UPC plate for osteotomy, stabilization and rigid fixation of maxillofacial fractures or reconstruction as per routine clinical practice 2. Patients for whom data on the primary outcome variable is available.
Exclusion criteria
1. Patients with non-reducible and unstable fractures at the time of surgery 2. Patients with fractures of a severely atrophic mandible at the time of surgery 3. Patients with active local infections at the time of surgery 4. Patients with metal allergies and/or foreign body sensitivity at the time of surgery 5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery 6. Potentially non-compliant patients who are unwilling or incapable of following postoperative care instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful fixation or reconstruction of the midface without the need for unplanned revision surgery. | Data collected at a single time point per patient in the course of 18 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection rate | Data collected at time points from patient medical charts in the course of 18 months. | Determined by adverse events reported from patient medical charts. |
| Intraoperative complications | Data collected at a single time point per patient in the course of 18 months. | Determined by adverse events reported from patient medical charts. |
| Postoperative complications | Data collected at time points per patient in the course of 18 months. | Determined by adverse events reported from patient medical charts. |
| Any known adverse events | Data collected at time points per patient in the course of 18 months. | Determined by adverse events reported from patient medical charts. |
| Plate failure | Data collected at time points point per patient in the course of 18 months. | Determined by adverse events reported from patient medical charts. |
| Satisfactory occlusion achieved after additional orthodontic treatment | Data collected at a single time point per patient in the course of 18 months. | Data reported in patient medical charts |
| Time to return to solid food/normal diet | Data collected at a single time point per patient in the course of 18 months. | Time for patient to return to solid food/normal diet post operation (dd) |
| Hospitalization time; ICU and normal ward | Data collected at a single time point per patient in the course of 18 months. | Time the patient was hospitalized post procedure (dd:hh) |
| EuroQol-5 Domain Questionnaire (if available) | Data collected at time points per patient in the course of 18 months. | 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)). |
| Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available) | Data collected at time points per patient in the course of 18 months. | 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. |
| 12-Item Short Form Health Survey (SF-12) | Data collected at time points per patient in the course of 18 months. | 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. |
Countries
United States
Outcome results
None listed