S02 T90.2
Conditions
Interventions
Group 1: Patients with fractures or deformities in the midface and orbita are surgically treated with the marPOR implant and followed up.
Sponsors
Karl Leibinger Medizintechnik GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient is 18 years and older • Patient is undergoing surgery using the marPOR polyethylene implants • Informed consent obtained, i.e. o Ability to understand the content of the patient information/Informed Consent Form o Patient is willing and able to attend all follow-up visits and is willing to adhere to the rehabilitation protocol o Signed and dated written informed consent
Exclusion criteria
Exclusion criteria: • Any not medically managed severe systemic disease • Recent history of substance abuse (i.e. excessive use of or addiction to recreational drugs, alcohol) that would preclude reliable assessment • Pregnancy or women planning to conceive within the study period • Prisoner (as follow-up cannot be guaranteed) • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study • Skeletal immaturity • Intraoperative decision to use implants other than the device under investigation • Status of immunosuppression • Previous radiotherapy in the respective operative field
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of surgical outcome in terms of postoperative facial symmetry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Aesthetics based on expert opinion and patient reports (ANA score), ocular motor function, eyelid deviations, sensory disturbances, and the rate of complications such as infections, fibrotization, or implant deformities within the first 12 months after surgery. | — |
Countries
Germany
Contacts
Public ContactMarco Kesting
Universitätsklinikum ErlangenMund-, Kiefer- und Gesichtschirurgische Klinik
Outcome results
None listed