Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2019-11-01
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Orbital Fracture
Patients with dislocated fracture of the inferior and/or medial orbital wall
Primary "early" reconstruction
Primary surgical reconstruction of the fracture within 3 weeks after injury
Nonsurgical
Nonsurgical treatment of fracture
Primary "delayed" reconstruction
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Secondary reconstruction
Second surgical reconstruction of the fracture after a primary reconstruction.
Interventions
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Primary "early" reconstruction
Primary surgical reconstruction of the fracture within 3 weeks after injury
Nonsurgical
Nonsurgical treatment of fracture
Primary "delayed" reconstruction
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Secondary reconstruction
Second surgical reconstruction of the fracture after a primary reconstruction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AO Innovation Translation Center
OTHER
Responsible Party
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Principal Investigators
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Eppo B. Wolvius, Prof.
Role: PRINCIPAL_INVESTIGATOR
Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam
Locations
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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
Countries
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References
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Strabbing EM; OFx Registry Study Group; Wolvius EB. Surgical versus non-surgical management of orbital fractures: study protocol for evidence generation of a prospective multicentre observational cohort registry. BMJ Open. 2025 Jul 30;15(7):e100508. doi: 10.1136/bmjopen-2025-100508.
Other Identifiers
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OFx Registry_RP_v.1.0
Identifier Type: -
Identifier Source: org_study_id