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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular reconstruction | Device | Primary or secondary reconstruction of the mandible using customized Mandible Reconstruction Plate (referred to as CMRP) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful reconstruction of the mandible without the need for unplanned revision surgery | 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 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 a single time point per patient in the course of 16 months. |
| Infection rate |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up time | 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 16 months. |
| Flap used |
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 |
|---|---|---|---|---|---|---|
| Head & Neck Surgery Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30115476 | Background | van Baar GJC, Forouzanfar T, Liberton NPTJ, Winters HAH, Leusink FKJ. 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. | |
| 34900674 | Background | Mollmann HL, Apeltrath L, Karnatz N, Wilkat M, Riedel E, Singh DD, Rana M. Comparison of the Accuracy and Clinical Parameters of Patient-Specific and Conventionally Bended Plates for Mandibular Reconstruction. Front Oncol. 2021 Nov 26;11:719028. doi: 10.3389/fonc.2021.719028. eCollection 2021. |
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| ID | Term |
|---|---|
| D008337 | Mandibular Fractures |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D007572 | Jaw Fractures |
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D063175 | Mandibular Reconstruction |
| ID | Term |
|---|---|
| D056948 | Orthognathic Surgical Procedures |
| D019647 | Oral Surgical Procedures |
| D003813 | Dentistry |
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Determined by adverse events reported from patient medical charts. |
| Data collected at time points from patient medical charts in the course of 16 months. |
| Intraoperative complications | Determined by adverse events reported from patient medical charts. | Data collected at a single time point per patient in the course of 16 months. |
| Postoperative complications | Determined by adverse events reported from patient medical charts. | Data collected at time points per patient in the course of 16 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 16 months. |
| Rate of plate or screw failure | Determined by rate of adverse events reported from patient medical charts involving plate or screw fracture. | Data collected at time points point per patient in the course of 16 months. |
| Operating room (OR) time | Time patients are operated (dd:hh) | Data collected at a single time point per patient in the course of 16 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 16 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 16 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 16 months. |
| End user questionnaire | 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. | Data collected during the course of 16 months. |
| Misfit of implant | Fit of implant Time for adaptations | Data collected at time points per patient in the course of 16 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 16 months. |
| 12-Item Short Form Health Survey (SF-12) | 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. | Data collected at time points per patient in the course of 16 months. |
| Visual Analogue Scale (VAS) Pain | 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. | Data collected at time points per patient in the course of 16 months. |
| Ischemia time | Ischemia time (dd:hh) | Data collected at a single time point per patient in the course of 16 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 16 months. |
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 16 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 16 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 16 months. |
| Sterilization method used | Sterilization method used for the device. | Data collected at a single time point per patient in the course of 16 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 18 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 16 months. |
| Patient age | Age (years) | Data collected at a single time point per patient in the course of 16 months. |
| Gender | Responses: Male, Female, undifferentiated, unknown | Data collected at a single time point per patient in the course of 16 months |
| Primary indication for the surgery / diagnosis | Diagnosis collected from patient medical charts. | Data collected at a single time point per patient in the course of 16 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. |
| 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 16 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 16 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 16 months. |
| Patient height | Height (cm, feet, inches) | Data collected at a single time point per patient in the course of 16 months. |
| Patient weight | Weight (kg, lb) | Data collected at a single time point per patient in the course of 16 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 16 month |
| Smoking duration | Duration of smoking (pack years) | Data collected at time points per patient in the course of 16 month |
| Years of active smoking | Total number of years active smoker (YY) | Data collected at time points per patient in the course of 16 month |
| 29470184 | Background | Witjes MJH, Schepers RH, Kraeima J. Impact of 3D virtual planning on reconstruction of mandibular and maxillary surgical defects in head and neck oncology. Curr Opin Otolaryngol Head Neck Surg. 2018 Apr;26(2):108-114. doi: 10.1097/MOO.0000000000000437. |
| 32590512 | Background | Lee ZH, Alfonso AR, Ramly EP, Kantar RS, Yu JW, Daar D, Hirsch DL, Jacobson A, Levine JP. The Latest Evolution in Virtual Surgical Planning: Customized Reconstruction Plates in Free Fibula Flap Mandibular Reconstruction. Plast Reconstr Surg. 2020 Oct;146(4):872-879. doi: 10.1097/PRS.0000000000007161. |
| 29362116 | Background | Kakarala K, Shnayder Y, Tsue TT, Girod DA. Mandibular reconstruction. Oral Oncol. 2018 Feb;77:111-117. doi: 10.1016/j.oraloncology.2017.12.020. Epub 2018 Jan 4. |
| D020196 |
| Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |