Orbital Fractures Registry (OFx)

May 21, 2026 updated by: AO Innovation Translation Center

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Medical Center Hamburg Eppendorf
      • Munich, Germany, 80337
        • Klinikum der LMU München
  • Netherlands
      • Rotterdam, Netherlands
        • Eramus MC
  • Pakistan
      • Lahore, Pakistan
        • Mayo Hospital
  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
  • Romania
      • Constanța, Romania
        • Emergency Clinical County Hospital of Constanta
  • Russia
      • Moscow, Russia
        • Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation
  • Serbia
      • Belgrade, Serbia
        • Clinic for Maxillofacial Surgery, University of Belgrade
  • South Africa
      • Durban, South Africa
        • King Edward VIII Hospital
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital Vall d' Hebron
    • Madrid
      • Madrid, Madrid, Spain
        • 12 de Octubre University Hospital
  • Sweden
      • Uppsala, Sweden
        • Uppsala University Hospital
  • Switzerland
      • Basel, Switzerland
        • Universitaetsspital Basel
  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients older than 18 years old with displaced fracture of the inferior and/or medial orbital wall (blow-out fractures) that require treatment (either surgically or non-surgically)

Description

Inclusion Criteria:

  • Age 18 years or older at the time of the injury

  • 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:

  • Bilateral orbital fracture
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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:
  • Surgical
  • Operative
Other: Nonsurgical
Nonsurgical treatment of fracture
Other Names:
  • Conservative
Procedure: Primary "delayed" reconstruction
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Other Names:
  • Surgical
  • Operative
Procedure: Secondary reconstruction
Second surgical reconstruction of the fracture after a primary reconstruction.
Other Names:
  • Secondary surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diplopia
Time Frame: 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

  1. mild (diplopia appears more than 30 degrees from the primary position)
  2. moderate (diplopia appears between 10 and 30 degrees from the primary position)
  3. severe (diplopia appears within 10 degrees from the primary position)
24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Globe position
Time Frame: 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
6, 12, 24 weeks post-treatment
Visual acuity
Time Frame: 6, 12, 24 weeks post-treatment
Measured using a visual test chart in healthy and injured sides with and without vision aids.
6, 12, 24 weeks post-treatment
Extra-ocular mobility
Time Frame: 6, 12, 24 weeks post-treatment
Follow-my finger test
6, 12, 24 weeks post-treatment
Patient-reported outcomes
Time Frame: pre-treatment, 6, 12, 24 weeks post-treatment
AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry
pre-treatment, 6, 12, 24 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Innovation Translation Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFx Registry_RP_v.1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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