Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular Reconstruction | Device | Mandibular Reconstruction or mandibular fracture fixation using a Surgeon iD Mandible Reconstruction Plate (referred to as Surgeon iD Plates). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful reconstruction of the mandible without the need for unplanned revision surgery compared to benchmark devices in scientific literature. | 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. | Data collected at a single time point per patient in the course of 12 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 12 months. |
| Intraoperative complications |
| Measure | Description | Time Frame |
|---|---|---|
| Patient age | Age (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:
Not provided
Not provided
Not provided
Not provided
Eligible patients will be identified as having had a surgical procedure involving the Subject Device.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Otolaryngology Head and Neck Surgery | San Francisco | California | 94143 | United States | ||
| Heinrich-Braun-Klinikum gGmbH |
Not provided
| Label | URL |
|---|---|
| Kakarala, Kiran, Yelizaveta Shnayder, Terance T. Tsue, and Douglas A. Girod. 2018. "Mandibular Recon-struction." Oral Oncology. | View source |
| Lee,Z. et. al.2020. "The Latest Evolution in Virtual Surgical Planning: Customized Reconstruction Plates in Free Fibula Flap Mandibular Reconstruction." Plastic and Reconstructive Surgery. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
Not provided
Not provided
| ID | Term |
|---|---|
| D063175 | Mandibular Reconstruction |
| ID | Term |
|---|---|
| D056948 | Orthognathic Surgical Procedures |
| D019647 | Oral Surgical Procedures |
| D003813 | Dentistry |
Not provided
Not provided
Not provided
Not provided
Not provided
Determined by adverse events reported from patient medical charts.
| Data collected at a single time point per patient in the course of 12 months. |
| Postoperative complications | Determined by adverse events reported from patient medical charts. | Data collected at time points per patient in the course of 12 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 12 months. |
| Rate of Plate failure | Determined by adverse events reported from patient medical charts. | Data collected at time points per patient in the course of 12 months. |
| Operating room (OR) time | Time patients are operated (hh:mm) | Data collected at a single time point per patient in the course of 12 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 12 months. |
| Rate of satisfactory occlusion achieved with orthodontic treatment. | Assessed by review of individual patient medical records that document the rate of satisfactory occlusion achieved with orthodontic treatment. | Data collected at time points per patient in the course of 12 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 12 months. |
| Short-form-12-health-survey-questionnaire (if available) | 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). | Data collected at time points per patient in the course of 12 months. |
| Ischemia time | Ischemia time (dd:hh) | Data collected at a single time point per patient in the course of 12 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 12 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 12 months. |
| Data collected at a single time point per patient in the course of 12 months. |
| Follow-up time | Post operative follow up time for patients within standard of care. Reported in patient medical charts during hospital follow up visit. | Data collected at a single time point per patient in the course of 12 months. |
| Surgical approach | Surgical approach taken for the procedure. Including: transoral; transbuccal; submandibular; preauricular; other | Data collected at a single time point per patient in the course of 16 months. |
| Rate of osteotomy | Cases where osteotomy (e.g. BSSO) was performed. Instrumentation used to perform the osteotomy. | Data collected at time points per patient in the course of 12 months. |
| Frequency of Maxilla-mandibular fixation | Number of maxillo-mandibular fixation procedures (number per patient). | Data collected at time points per patient in the course of 12 months. |
| Relevant Medical conditions | Descriptive data of any underlying medical conditions and medications recorded in patient medical charts that may be related to the device or primary outcome (qualitative measure). | Data collected at time points per patient in the course of 12 months. |
| Primary/secondary reconstruction performed | Type of reconstruction procedure performed (e.g. immediately or after an initial surgery). | Data collected at time points point per patient in the course of 12 months |
| Localization of the defect | Area to treated by the device: mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; other | Data collected at time points point per patient in the course of 12 months. |
| Flap used | Type of flap used: vascularized fibula flap, vascularized scapula flap, vascularized iliac crest flap, avascularized fibula flap, avascularized scapula flap, avascularized iliac crest flap, others | Data collected at a single time point per patient in the course of 12 months. |
| Radiation | Exposure of patient to radiation therapy within 12 months around the surgery date recorded in patient medical charts. 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. |
| Dental reconstruction in a single stage surgery | Data for dental reconstruction collected from 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. | Data collected at a single time point per patient in the course of 12 months. |
| Fixation system used | System used to fix the device during the procedure. Stryker Universal Mandible System; other Types and number of screws | Data collected at a single time point per patient in the course of 12 months. |
| Plate types | 2.0 or 2.8 plates used, hemi or full reconstruction plate used | Data collected at a single time point per patient in the course of 12 months. |
| Gender | Responses: Male, Female, undifferentiated, unknown | Data collected at a single time point per patient in the course of 12 months |
| Patient height | Height (cm, feet, inches) | Data collected at a single time point per patient in the course of 12 months. |
| Patient weight | 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 12 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 month |
| 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 month |
| Zwickau |
| 08060 |
| Germany |
| 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 |
| Zeller AN, et al. Correction to: Patient-Specific Mandibular Reconstruction Plates Increase Accuracy and Long-Term Stability in Immediate Alloplastic Reconstruction of Segmental Mandibular Defects. J Maxillofac Oral Surg. 2022 Dec;21(4):1096. | View source |
| Möllmann HL, et al. Comparison of the Accuracy and Clinical Parameters of Patient-Specific and Conventionally Bended Plates for Mandibular Reconstruction. Front Oncol. 2021 Nov 26;11:719028. | View source |
| van Baar, et al, Accuracy of computer-assisted surgery in mandibular reconstruction: A systematic review. Oral Oncol. 2018 Sep;84:52-60. doi: 10.1016/j.oraloncology.2018.07.004. Epub 2018 Jul 20. PMID: 30115476. | View source |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |