Primary or secondary mandibular reconstruction and fixation of mandibular fractures.
Conditions
Interventions
Group 1: This is a retrospective data collection of patients who underwent primary or secondary mandibular reconstruction or mandibular fracture fixation using Stryker Surgeon iD implant as per routin
Sponsors
Stryker European Operations Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who underwent primary or secondary mandibular reconstruction or mandibular fracture fixation using a Stryker Surgeon iD implants as per routine clinical practice. 2. Patients for whom data on the primary outcome variabel is available.
Exclusion criteria
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 at the time of surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients experiencing successful reconstruction of the mandible without the need for unplanned revision (e.g. due to unplanned device removal, malunion/non-union, instability, patient dissatisfaction or other reasons potentially directly related to the initial procedure). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infection rate 2. Intraoperative complications 3. Postoperative complications 4. Any known adverse events 5. Plate failure 6. OR time 7. Ischemia time 8. Time to return to solid food/normal diet 9. Is a satisfactory occlusion been expected to be achieved after potential additional orthodontic treatment? (yes/no) 10. Hospitalization time 11. Subjective rating of ease of use by the surgeon if compared to stock plates (to be evaluated per treating surgeon, not per patient) 12. Any patient-reported outcomes, if collected as part of standard of care (e.g., SF-12, EQ-5D) Control parameters to be collected: 1. Patient age and gender 2. Patient height and weight 3. Primary indication for the surgery / diagnosis 4. Max follow-up time 5. Surgical approach (transoral; transbuccal; submandibular; preauricular; other, please specify) 6. Patient put in maxilla-mandibular fixation post-operatively? (yes/no) - If yes, for how long after surgery? (days) 7. Underlying medical conditions 8. Primary/secondary reconstruction performed 9. Localization of the defect (mandibular ramus; mandibular body; mandibular condyle; parasymphysis; paramedian; other, please specify) 10. Flap used? (yes/no) - If yes, flap type used (vascularized fibula flap, vascularized scapula flap, vescularized iliac crest flap, avascularized fibula flap, avascularized scapula flap, avascularized iliac crest flap, others specified) 11. Smoking habits 12. Radiation history 13. Dental reconstruction in a single stage surgery 14. Postoperative radiation therapy 15. Sterilization method used 16. Fixation system used (Stryker Universal Mandible System; others, please specify) 17. 2.0 or 2.8 plate used 18. Hemi or full reconstruction plate used | — |
Countries
Germany, United States
Contacts
Public ContactIlka Meinert
Stryker European Operations Limited
Outcome results
None listed