Clinical trial NCT03887988: Orbital Fractures Registry
Official title: International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Orbital Fractures
Blow Out Fracture of Orbit
Keywords: Fracture fixation
Orbital implant
Midface fracture
Diplopia
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients older than 18 years old with displaced fracture of the inferior and/or medial orbital wall (blow-out fractures) that require treatment (either surgically or non-surgically)

Brief 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: Diplopia
timeFrame: 24 weeks post-treatment
Secondary outcomes:
measure: Globe position
timeFrame: 6, 12, 24 weeks post-treatment
measure: Visual acuity
timeFrame: 6, 12, 24 weeks post-treatment
measure: Extra-ocular mobility
timeFrame: 6, 12, 24 weeks post-treatment
measure: Patient-reported outcomes
timeFrame: pre-treatment, 6, 12, 24 weeks post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Hamburg
country: Germany
facility: Medical Center Hamburg Eppendorf
city: Munich
country: Germany
facility: Klinikum der LMU München
city: Rotterdam
country: Netherlands
facility: Eramus MC
city: Lahore
country: Pakistan
facility: Mayo Hospital
city: Doha
country: Qatar
facility: Hamad Medical Corporation
city: Constanta
country: Romania
facility: Emergency Clinical County Hospital of Constanta
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
city: Belgrade
country: Serbia
facility: Clinic for Maxillofacial Surgery, University of Belgrade
city: Durban
country: South Africa
facility: King Edward VIII Hospital
city: Barcelona
country: Spain
facility: Hospital Vall d' Hebron
state: Catalonia
city: Madrid
country: Spain
facility: 12 de Octubre University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Basel
country: Switzerland
facility: Universitaetsspital Basel
Study officials:
affiliation: Department of Oral &amp; Maxillofacial Surgery, Erasmus MC, Rotterdam
name: Eppo B. Wolvius, Prof.
role: PRINCIPAL_INVESTIGATOR
References: