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Orbital Fractures Registry (OFx)

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ClinicalTrials.gov Identifier: NCT03887988
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief 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.

Condition or disease Intervention/treatment
Orbital Fractures Blow Out Fracture of Orbit Procedure: Primary "early" reconstruction Other: Nonsurgical Procedure: Primary "delayed" reconstruction Procedure: Secondary reconstruction

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: International, Multicenter, Prospective Registry to Collect Data on Orbital Fractures (OFx), Their Primary and Secondary Treatment and Outcome
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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:
  • Operative
  • Surgical

Other: Nonsurgical
Nonsurgical treatment of fracture
Other Name: Conservative

Procedure: Primary "delayed" reconstruction
Primary surgical reconstruction of the fracture more than 3 weeks after injury
Other Names:
  • Operative
  • Surgical

Procedure: Secondary reconstruction
Second surgical reconstruction of the fracture after a primary reconstruction.
Other Name: Secondary surgery




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Extra-ocular mobility [ Time Frame: 6, 12, 24 weeks post-treatment ]
    Follow-my finger test

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887988


Contacts
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Contact: Victor Diaz, PhD +41 81 414 25 07 victor.diaz@aofoundation.org
Contact: Brigitte Gallo, PhD +41 44 200 24 06 brigitte.gallo@aofoundation.org

Locations
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United States, California
UC Davis Recruiting
Sacramento, California, United States, 95817
Contact: Bradley Strong, MD    916-734-5573    ebstrong@ucdavis.edu   
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
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Principal Investigator: Eppo B. Wolvius, Prof. Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam

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Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT03887988     History of Changes
Other Study ID Numbers: OFx Registry_RP_v.1.0
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AO Clinical Investigation and Documentation:
Fracture fixation
Orbital implant
Midface fracture
Diplopia
Additional relevant MeSH terms:
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Orbital Fractures
Fractures, Bone
Wounds and Injuries
Maxillofacial Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Skull Fractures