Orbital Fractures Registry

Approximately 300 patients presenting with a displaced orbital fracture (OFx) in the floor and/or medial wall (blow-out fracture) will be enrolled prospectively in this registry. All patients, surgically and nonsurgical treated will be followed-up (FU) within the registry. FU period for all patients will include assessments post-treatment at 6 weeks, 3 months and 6 months as corresponding with the local standard (routine) visit schedule at each participating clinic.

Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (ie, complications). Computer Tomography (CT) scans or Cone Beam-CT (CBCT) scans taken as per standard of care will be collected within the registry.

Inclusion criteria

• Age 18 years or older at the time of the injury
• Patients with a dislocated fracture of the inferior and/or medial orbital wall, either

• Diagnosed at the study site via CT or CBCT within 2 weeks of the date of the injury, OR
• Who will undergo secondary reconstruction

Exclusion criteria

• Bilateral orbital fracture
• Concomitant displaced fracture(s) of the orbital roof or any other area of the orbit
• Concomitant ruptured globe
• Displaced fracture of the malar bone
• Displaced midface fracture
• Displaced nasoorbitoethmoidal (NOE) fracture or complex zygoma fractures
• Presence at the time of enrollment of any disease with influence on eye motility (eg, strabismus, myasthenia gravis, Graves' ophthalmopathy)
• Previous radiotherapy in the orbital region
• Participation in any other medical device or medicinal product study within the previous month(s) that could influence the results of the present study