Mandible Fracture, Mandibular Reconstruction
Conditions
Brief summary
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. 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 Surgeon iD Mandible Recon Plate 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 27 patients will be enrolled in the study. Additional patients may be enrolled up to 80 subjects depending on site enrolment rate and patient availability. Up to 3 investigational sites within the United States and one in the EU will participate in this study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be assessed at all available follow-up timepoints for included patients.
Interventions
Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates).
Sponsors
Stryker Craniomaxillofacial
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients who underwent primary or secondary mandibular reconstruction using a Stryker Surgeon iD Plate implant as per routine clinical practice. 2. Patients for whom data on the primary outcome variable is available.
Exclusion criteria
1. Patients with active local infections at the time of surgery. 2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery. 3. Potentially non-compliant patients who were unwilling or incapable of following post-operative care instructions. 4. Patients with inadequate bone quantity or quality necessary for plate fixation or stabilization at the time of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature. | Data collected at a single time point per patient in the course of 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection rate | Data collected at time points from patient medical charts in the course of 12 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 12 months. | Determined by adverse events reported from patient medical charts. |
| Postoperative complications | Data collected at time points per patient in the course of 12 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 12 months. | Determined by adverse events reported from patient medical charts. |
| Rate of Plate failure | Data collected at time points per patient in the course of 12 months. | Determined by adverse events reported from patient medical charts. |
| Operating room (OR) time | Data collected at a single time point per patient in the course of 12 months. | Time patients are operated (hh:mm) |
| Time to return to solid food/normal diet | Data collected at a single time point per patient in the course of 12 months. | Time for patient to return to solid food/normal diet post operation (dd) |
| Rate of satisfactory occlusion achieved with orthodontic treatment. | Data collected at time points per patient in the course of 12 months. | Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment. |
| Hospitalization time: ICU and normal ward | Data collected at a single time point per patient in the course of 12 months. | Time the patient was hospitalized post procedure (dd:hh) |
| Short-form-12-health-survey-questionnaire (if available) | Data collected at time points per patient in the course of 12 months. | Short-form-12-health-survey-Questionnaire (Scale of 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health). |
| Ischemia time | Data collected at a single time point per patient in the course of 12 months. | Ischemia time (dd:hh) |
| EuroQol-5 Domain Questionnaire (if available) | Data collected at time points per patient in the course of 12 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 12 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. |
Countries
Germany, United States
Outcome results
None listed