MANDIBLE, Mandible; Deformity, Mandible Fracture, Mandibular Fractures, Orthognathic Surgical Procedures
Conditions
Keywords
Mandibular Reconstruction, Reconstruction Plate, Orthognathic Surgery, Mandibular Reconstruction* / Methods
Brief summary
A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction. 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 Customized Plates for Mandibular Reconstruction (CMRP) in the clinical setting. his study will include patients who have previously undergone a surgical procedure involving the Study Device, with surgical outcomes evaluated retrospectively. The Customized Mandible Recon Plate Kit is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction. Up to 3 investigational sites in US will be participating. Based on a non-inferiority study power calculation 80 subjects will be enrolled in the study. The primary outcome parameter evaluating successful reconstruction of the mandible without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
Interventions
Primary or secondary reconstruction of the mandible using customized Mandible Reconstruction Plate (referred to as CMRP)
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 Facial iD CMRP 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 | Data collected at a single time point per patient in the course of 16 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 |
|---|---|---|
| Rate of satisfactory occlusion achieved with orthodontic treatment. | Data collected at a single time point per patient in the course of 16 months. | Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment. |
| Infection rate | Data collected at time points from patient medical charts in the course of 16 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 16 months. | Determined by adverse events reported from patient medical charts. |
| Postoperative complications | Data collected at time points per patient in the course of 16 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 16 months. | Determined by adverse events reported from patient medical charts. |
| Rate of plate or screw failure | Data collected at time points point per patient in the course of 16 months. | Determined by rate of adverse events reported from patient medical charts involving plate or screw fracture. |
| Operating room (OR) time | Data collected at a single time point per patient in the course of 16 months. | Time patients are operated (dd:hh) |
| Time to return to solid food/normal diet | Data collected at a single time point per patient in the course of 16 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 16 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 16 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)). |
| End user questionnaire | Data collected during the course of 16 months. | Questionnaire only for medically trained professionals on site staff using the device. Questions relate to subjective rating of ease of use by the surgeon if compared to stock plates (evaluated per treating surgeon, not per patient). Questionnaire is qualitative response regarding the ease of use of the device. |
| Misfit of implant | Data collected at time points per patient in the course of 16 months. | Fit of implant Time for adaptations |
| Facial Appearance, Quality of Life, and Satisfaction Questionnaire (if available) | Data collected at time points per patient in the course of 16 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 16 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. |
| Visual Analogue Scale (VAS) Pain | Data collected at time points per patient in the course of 16 months. | The visual analogue scale (VAS) is a psychometric response scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. |
| Ischemia time | Data collected at a single time point per patient in the course of 16 months. | Ischemia time (dd:hh) |
| Frequency of Maxilla-mandibular fixation | Data collected at time points per patient in the course of 16 months. | Number of maxillo-mandibular fixation procedures (number per patient). |
Countries
United States
Outcome results
None listed