Orbital Fractures Registry (NCT03887988) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Orbital Fractures Registry
United States, Germany, Netherlands300 participantsStarted 2019-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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