Orbital Fractures Registry

Running, not enrolling

Conditions studied: Orbital Fractures, Blow Out Fracture of Orbit

In brief

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.

Key facts

Study ID

NCT03887988

Run by

AO Innovation Translation Center

People needed

300

Starts

2019-11-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• UC Davis — Sacramento, California, United States
• Medical Center Hamburg Eppendorf — Hamburg, Germany
• Klinikum der LMU München — Munich, Germany
• Eramus MC — Rotterdam, Netherlands
• Mayo Hospital — Lahore, Pakistan
• Hamad Medical Corporation — Doha, Qatar
• Emergency Clinical County Hospital of Constanta — Constanța, Romania
• Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation — Moscow, Russia
• Clinic for Maxillofacial Surgery, University of Belgrade — Belgrade, Serbia
• King Edward VIII Hospital — Durban, South Africa
• Hospital Vall d' Hebron — Barcelona, Catalonia, Spain
• 12 de Octubre University Hospital — Madrid, Madrid, Spain
• Uppsala University Hospital — Uppsala, Sweden
• Universitaetsspital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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