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Clinical Trials in Spain / NCT03887988
Active, not recruiting Observational

Orbital Fractures Registry

NCT03887988 · tracked via the Priya Life Science Spain tracker
Sponsor
AO Innovation Translation Center
Phase
Observational
Started
2019-11-01
Last updated
2026-05-26

Condition(s) studied

Orbital FracturesBlow Out Fracture of Orbit

Investigational drug(s) / intervention(s)

Primary "early" reconstructionNonsurgicalPrimary "delayed" reconstructionSecondary reconstruction

Primary "early" reconstruction: Primary surgical reconstruction of the fracture within 3 weeks after injury

Nonsurgical: Nonsurgical treatment of fracture

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

Secondary reconstruction: Second surgical reconstruction of the fracture after a primary reconstruction.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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)

Trial sites (14)

FacilityCityRegionStatus
UC Davis Sacramento California
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 Constanța 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 Russia
Clinic for Maxillofacial Surgery, University of Belgrade Belgrade Serbia
King Edward VIII Hospital Durban South Africa
Hospital Vall d' Hebron Barcelona Catalonia
12 de Octubre University Hospital Madrid Madrid
Uppsala University Hospital Uppsala Sweden
Universitaetsspital Basel Basel Switzerland

More AO Innovation Translation Center trials in Spain

Periprosthetic Fracture Registry (PPFx) Recruiting
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis Recruiting
Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry Recruiting
Registry of Pediatric Orthopedic Trauma and Health Outcomes in Skeletally Immature Children Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03887988 on ClinicalTrials.gov ↗ ← All trials in Spain