NCT03887988

Orbital Fractures Registry

International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: AO Innovation Translation Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orbital Fractures
• Blow Out Fracture of Orbit

Interventions

Type	Name	Description
PROCEDURE	Primary "early" reconstruction	Primary surgical reconstruction of the fracture within 3 weeks after injury
OTHER	Nonsurgical	Nonsurgical treatment of fracture
PROCEDURE	Primary "delayed" reconstruction	Primary surgical reconstruction of the fracture more than 3 weeks after injury
PROCEDURE	Secondary reconstruction	Second surgical reconstruction of the fracture after a primary reconstruction.

Timeline

• Start date: 2019-11-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2019-03-25
• Last updated: 2025-12-19

Locations

14 sites across 12 countries: United States, Germany, Netherlands, Pakistan, Qatar, Romania, Russia, Serbia, South Africa, Spain, Sweden, Switzerland