Orbital Fractures Registry (OFx)

AO Innovation Translation Center

Status

Active, not recruiting

Conditions

Orbital Fractures

Blow Out Fracture of Orbit

Treatments

Other: Nonsurgical

Procedure: Primary "delayed" reconstruction

Procedure: Primary "early" reconstruction

Procedure: Secondary reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT03887988

OFx Registry_RP_v.1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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