Orbital Fractures Registry

N/AActive Not RecruitingNCT03887988

AO Innovation Translation Center300 enrolled

Overview

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.

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

300

Conditions

Orbital Fractures Blow Out Fracture of Orbit

Interventions

Primary "early" reconstructionPROCEDURE

Primary surgical reconstruction of the fracture within 3 weeks after injury

NonsurgicalOTHER

Nonsurgical treatment of fracture

Primary "delayed" reconstructionPROCEDURE

Primary surgical reconstruction of the fracture more than 3 weeks after injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

UC Davis

Sacramento, California, United States

Medical Center Hamburg Eppendorf

Hamburg, Germany

Klinikum der LMU München

Munich, Germany

Outcomes

Primary Outcomes

Diplopia

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)

Time frame: 24 weeks post-treatment

Secondary Outcomes

Globe position

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

Time frame: 6, 12, 24 weeks post-treatment

Visual acuity

Measured using a visual test chart in healthy and injured sides with and without vision aids.

Time frame: 6, 12, 24 weeks post-treatment

Extra-ocular mobility

Follow-my finger test

Time frame: 6, 12, 24 weeks post-treatment

Patient-reported outcomes

AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry

Time frame: pre-treatment, 6, 12, 24 weeks post-treatment

Data from ClinicalTrials.gov

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