Orbital Fractures Registry

Active, not recruiting

• Conditions: Orbital Fractures; Blow Out Fracture of Orbit
• Interventions: Procedure: Primary "early" reconstruction; Other: Nonsurgical; Procedure: Primary "delayed" reconstruction; Procedure: Secondary reconstruction

• Registration Number: NCT03887988
• Lead Sponsor: AO Clinical Investigation and Publishing 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.

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 Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Study Start: 2019-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Orbital Fracture	Nonsurgical	Patients with dislocated fracture of the inferior and/or medial orbital wall
Orbital Fracture	Primary "delayed" reconstruction	Patients with dislocated fracture of the inferior and/or medial orbital wall
Orbital Fracture	Primary "early" reconstruction	Patients with dislocated fracture of the inferior and/or medial orbital wall
Orbital Fracture	Secondary reconstruction	Patients with dislocated fracture of the inferior and/or medial orbital wall

Primary Outcome Measures

Name	Time	Method
Diplopia	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

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

Trial Locations

Locations (14)

UC Davis; 🇺🇸 Sacramento, California, United States

Medical Center Hamburg Eppendorf; 🇩🇪 Hamburg, Germany

Klinikum der LMU München; 🇩🇪 Munich, Germany

Eramus MC; 🇳🇱 Rotterdam, Netherlands

Mayo Hospital; 🇵🇰 Lahore, Pakistan

Hamad Medical Corporation; 🇶🇦 Doha, Qatar

Emergency Clinical County Hospital of Constanta; 🇷🇴 Constanta, Romania

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

Clinic for Maxillofacial Surgery, University of Belgrade; 🇷🇸 Belgrade, Serbia

King Edward VIII Hospital; 🇿🇦 Durban, South Africa

Hospital Vall d' Hebron; 🇪🇸 Barcelona, Catalonia, Spain

12 de Octubre University Hospital; 🇪🇸 Madrid, Spain

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Universitaetsspital Basel; 🇨🇭 Basel, Switzerland