Facial Fractures, Maxilla Fractures, Orbital Fractures, Zygomatic Fractures
Conditions
Brief summary
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting. 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 the Stryker Universal System when used in a 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 120 patients will be enrolled in the study. Additional patients may be enrolled up to 150 subjects depending on site enrolment rate and patient availability. Up to 2 investigational sites within the United States will participate in this study. The primary outcome parameter evaluating successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery will be evaluated at all available follow-up timepoints of the included patients.
Interventions
DEVICEUpper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
The Universal CMF System is a plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Depending on the selected module, the design of the devices is more suitable for specific indications within the broad indication of CMF fractures and CMF reconstructive surgeries.
Sponsors
Stryker Craniomaxillofacial
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Skeletally mature patients at the time of surgery. 2. Patients who underwent a craniomaxillofacial procedure using implants of the Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System as per routine clinical practice. 3. Patients for whom data on the primary outcome variable is available. 4. Patients with data available from follow-up visits.
Exclusion criteria
1. Patients with active infections at the time of surgery. 2. Patients with known metal allergies and/or foreign body sensitivity at the time of surgery. 3. Subjects with non-reducible and unstable fractures (except reconstruction plates) at the time of surgery that were treated with the subject devices. 4. Patients who underwent secondary reconstructions with non-secondary reconstruction plates 5. Patients with limited blood supply or insufficient quality or quantity of bone at the time of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful stabilization and/or fixation of bony segments without the need for unplanned revision surgery | Data collected at a single time point per patient in the course of 12 months. | Assessed by reviewing adverse events in patient medical charts at time point after surgery. Used to document whether an unplanned revision surgery was required or not for patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative complications | Data collected at a single time point per patient in the course of 12 months. | Determined by intraoperative adverse events reported from patient medical charts. |
| Postoperative complications | Data collected at time points per patient in the course of 12 months. | Determined by post operative adverse events reported from patient medical charts. |
| Any known adverse events potentially related to the primary outcome objective and/or device | Data collected at time points per patient in the course of 12 months. | Determined by adverse events reported from patient medical charts. |
| Implant failure | Data collected at time points point per patient in the course of 12 months. | Determined by adverse events reported from patient medical charts. |
| Operating room (OR) time | Data collected at a single time point per patient in the course of 12 months. | Time patients are operated (dd:hh) |
| Hospitalization time | Data collected at a single time point per patient in the course of 12 months. | Time the patient was hospitalized post procedure (ICU and normal ward; dd:hh) |
| Post-operative bone consolidation | Data collected at time points point per patient in the course of 12 months. | Clinical observation of post-op bone consolidation (medical charts) Timing of post-op observation of bone consolidation (yymmdd) Availability of post op imaging to determine bone consolidation Timing of post-op imaging (number of scans, yymmdd) |
Countries
United States
Outcome results
None listed