Summary

for people ages 18 years and up (full criteria)
at UC Davis
study started
estimated completion

Description

Summary

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.

Official Title

International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome

Details

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.

Keywords

Orbital Fractures Blow Out Fracture of Orbit Fracture fixation Orbital implant Midface fracture Diplopia Fractures, Bone Primary "early" reconstruction Nonsurgical Primary "delayed" reconstruction Secondary reconstruction Orbital Fracture

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UC Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AO Clinical Investigation and Documentation
ID
NCT03887988
Study Type
Observational [Patient Registry]
Last Updated