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Orbital Fractures Registry

NCT03887988 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Orbital Fractures
  • Blow Out Fracture of Orbit

Interventions

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.

Sponsors & Collaborators

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Eppo B. Wolvius, Prof. · Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States
  • Germany
  • Netherlands
  • Pakistan
  • Qatar
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Sweden
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887988 on ClinicalTrials.gov