Orbital Fractures Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Orbital Fractures, Blow Out Fracture of Orbit

Intervention / Treatment
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* Procedure: Primary early reconstruction
* Other: Nonsurgical
* Procedure: Primary delayed reconstruction
* Procedure: Secondary reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orbital Fracture<br>Patients with dislocated fracture of the inferior and/or medial orbital wall | Procedure: Primary early reconstruction<br>* Primary surgical reconstruction of the fracture within 3 weeks after injury<br>* Other names: Surgical;Other: Nonsurgical<br>* Nonsurgical treatment of fracture<br>* Other names: Conservative;Procedure: Primary delayed reconstruction<br>* Primary surgical reconstruction of the fracture more than 3 weeks after injury<br>* Other names: Surgical;Procedure: Secondary reconstruction<br>* Second surgical reconstruction of the fracture after a primary reconstruction.<br>* Other names: Secondary surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diplopia | The degree of diplopia is quantified by measuring the field of single binocular vision, ranging from 0 to 3. 0: no diplopia mild (diplopia appears more than 30 degrees from the primary position) moderate (diplopia appears between 10 and 30 degrees from the primary position) 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 | 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 | 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 | Follow-my finger test | 6, 12, 24 weeks post-treatment | 
| Patient-reported outcomes | AOCMF Injury symptom battery Self-reported diplopia Self-perception of visual acuity, strabismus and symmetry | pre-treatment, 6, 12, 24 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture fixation, Orbital implant, Midface fracture, Diplopia