Orbital Fractures Registry

Last updated: March 24, 2025
Sponsor: AO Innovation Translation Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Primary "early" reconstruction

Secondary reconstruction

Primary "delayed" reconstruction

Clinical Study ID

NCT03887988
OFx Registry_RP_v.1.0
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 theinjury, OR

  • Who will undergo secondary reconstruction

Exclusion

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 theprevious month(s) that could influence the results of the present study

Study Design

Total Participants: 300
Treatment Group(s): 4
Primary Treatment: Primary "early" reconstruction
Phase:
Study Start date:
November 01, 2019
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Medical Center Hamburg Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • Klinikum der LMU München

    Munich, 80337
    Germany

    Site Not Available

  • Eramus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Mayo Hospital

    Lahore,
    Pakistan

    Site Not Available

  • Hamad Medical Corporation

    Doha,
    Qatar

    Site Not Available

  • Emergency Clinical County Hospital of Constanta

    Constanta,
    Romania

    Site Not Available

  • Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

    Moscow,
    Russian Federation

    Site Not Available

  • Clinic for Maxillofacial Surgery, University of Belgrade

    Belgrade,
    Serbia

    Site Not Available

  • King Edward VIII Hospital

    Durban,
    South Africa

    Site Not Available

  • Hospital Vall d' Hebron

    Barcelona, Catalonia
    Spain

    Site Not Available

  • 12 de Octubre University Hospital

    Madrid,
    Spain

    Site Not Available

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Site Not Available

  • Universitaetsspital Basel

    Basel,
    Switzerland

    Site Not Available

  • UC Davis

    Sacramento, California 95817
    United States

    Site Not Available

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