Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stryker Craniomaxillofacial
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
