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Orbital Fractures Registry

Study acronym: OFx
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Mar 2026 to Dec 2026v17
  2. Primary and study completion dates: Jun 2025 to Mar 2026v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 14 of 14 sites
    v15
  4. Lead sponsor: AO Clinical Investigation and Publishing Documentation to AO Innovation Translation Center
    • Site details revised at 2 of 14 sites
    v14
  5. Primary completion date: Sep 2024 to Jun 2025
    • Study completion date: Dec 2024 to Jun 2025
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Sep 2023 to Sep 2024v12
  2. Primary completion date: Jun 2022 to Sep 2023
    • Study completion date: Dec 2022 to Dec 2024
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Study sites: 13 to 14v9
  5. Re-verified, no change to tracked fieldsv8
  6. Site details revised at 1 of 13 sitesv7
  7. Study sites: 12 to 13v6
  8. Re-verified, no change to tracked fieldsv5
  9. Study sites: 1 to 12v4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2019 to Nov 1, 2019
    v3
  11. Start date: Jun 2019 to Nov 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03887988
Lead Sponsor AO Innovation Translation Center
Conditions
(from sponsor)		 Orbital Fractures, Blow Out Fracture of Orbit
Related terms Diplopia, Orbital Fractures
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov