Medial Orbital Wall Fracture, Orbital Floor Fracture
Conditions
Brief summary
Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.
Interventions
PROCEDUREorbital fracture repair
All patients will receive orbital fracture repair with one of the 4 specified implants
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years 2. Fracture (not older than 14 days) of the medial orbital wall and/or the orbital floor 3. Scheduled for reconstruction surgery with one of the following implants: * MatrixMIDFACE Preformed Orbital Plate * Custom-made orbital implant * Orbital Floor Mesh Plate * SynPOR Titanium Reinforced Fan Sheet 4. At least partial sight in both eyes before the accident 5. Willingness and ability to participate in the study follow-up according to the protocol 6. Ability to understand and read local language at elementary level 7. Signed informed consent
Exclusion criteria
1. Bilateral orbital fracture 2. Fractures of the orbital roof 3. Comminuted zygoma fracture 4. More than one piece fracture of the intraorbital bone lateral to the inferior orbital fissure 5. Previous dislocated orbital fractures on either side 6. Vision or diplopia not assessable 7. Injury of the globe 8. Neurological diseases with influence on eye motility or sight 9. Legal incompetence 10. Active malignancy 11. Life-threatening condition 12. Alcohol and drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| shape and volume assessing software | up to 3 days after surgery | A post-op CT or CBCT scan will be analyzed with specially developed software that can compare shape and volume of the reconstruced orbit to the uninjured orbit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| shape and volume assessing software | up to 3 days after surgery | 6 specific points and regions in the orbit will be compared between the reconstructed and the non-affected orbit |
| Clinical tests to assess vision | up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery | Globe position, visual acuity, bulbus motility and diplopia will be assessed with clinical tests |
| Rate of complications | up to 3 days after surgery, 1 week after surgery, 4 weeks after surgery, 12 weeks after surgery | Complications will be documented at every follow-up |
Countries
Germany, Singapore, Spain, United States
Outcome results
None listed