Overview
Approximately 300 patients presenting orbital blow-out fracture will be enrolled prospectively in this registry. All patients, surgically and nonsurgically treated as per standard (routine) of care will be followed-up (FU) within the registry for a period of 6 months.
Description
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.
Eligibility
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
