OFx: Orbital Fractures Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Orbital Fracture Patients with dislocated fracture of the inferior and/or medial orbital wall |
Procedure: Primary "early" reconstruction
Primary surgical reconstruction of the fracture within 3 weeks after injury
Other Names:
Other: Nonsurgical
Nonsurgical treatment of fracture
Other Names:
Procedure: Primary "delayed" reconstruction
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Other Names:
Procedure: Secondary reconstruction
Second surgical reconstruction of the fracture after a primary reconstruction.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Diplopia [24 weeks post-treatment]
The degree of diplopia is quantified by measuring the field of single binocular vision, ranging from 0 to 3. 0: no diplopia mild (diplopia appears more than 30 degrees from the primary position) moderate (diplopia appears between 10 and 30 degrees from the primary position) severe (diplopia appears within 10 degrees from the primary position)
Secondary Outcome Measures
- Globe position [6, 12, 24 weeks post-treatment]
Exo/enophthalmos (in mm) using Naugle or Hertel exophthalmometer Hyper/hypophthalmos: vertical globe displacement is measured as the pupilar height difference (in mm) from the healthy side to the injured side
- Visual acuity [6, 12, 24 weeks post-treatment]
Measured using a visual test chart in healthy and injured sides with and without vision aids.
- Extra-ocular mobility [6, 12, 24 weeks post-treatment]
Follow-my finger test
- Patient-reported outcomes [pre-treatment, 6, 12, 24 weeks post-treatment]
AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 years or older at the time of the injury
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Patients with a dislocated fracture of the inferior and/or medial orbital wall, either
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Diagnosed at the study site via CT or CBCT within 2 weeks of the date of the injury, OR
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Who will undergo secondary reconstruction
Exclusion Criteria:
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Bilateral orbital fracture
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Concomitant displaced fracture(s) of the orbital roof or any other area of the orbit
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Concomitant ruptured globe
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Displaced fracture of the malar bone
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Displaced midface fracture
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Displaced nasoorbitoethmoidal (NOE) fracture or complex zygoma fractures
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Presence at the time of enrollment of any disease with influence on eye motility (eg, strabismus, myasthenia gravis, Graves' ophthalmopathy)
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Previous radiotherapy in the orbital region
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Participation in any other medical device or medicinal product study within the previous month(s) that could influence the results of the present study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UC Davis | Sacramento | California | United States | 95817 |
| 2 | Medical Center Hamburg Eppendorf | Hamburg | Germany | ||
| 3 | Klinikum der LMU München | Munich | Germany | 80337 | |
| 4 | Eramus MC | Rotterdam | Netherlands | ||
| 5 | Mayo Hospital | Lahore | Pakistan | ||
| 6 | Hamad Medical Corporation | Doha | Qatar | ||
| 7 | Emergency Clinical County Hospital of Constanta | Constanta | Romania | ||
| 8 | Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation | Moscow | Russian Federation | ||
| 9 | Clinic for Maxillofacial Surgery, University of Belgrade | Belgrade | Serbia | ||
| 10 | King Edward VIII Hospital | Durban | South Africa | ||
| 11 | Hospital Vall d' Hebron | Barcelona | Catalonia | Spain | |
| 12 | 12 de Octubre University Hospital | Madrid | Spain | ||
| 13 | Uppsala University Hospital | Uppsala | Sweden | ||
| 14 | Universitaetsspital Basel | Basel | Switzerland |
Sponsors and Collaborators
- AO Clinical Investigation and Publishing Documentation
Investigators
- Principal Investigator: Eppo B. Wolvius, Prof., Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OFx Registry_RP_v.1.0