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NCT03887988 · ClinicalTrials.gov registry record
Orbital Fractures Registry
A clinical trial of Orbital Fractures and Blow Out Fracture of Orbit, sponsored by AO Innovation Translation Center.
- Active
- Registry status
- 300
- Enrollment target
- 14
- Study locations
NCT03887988: Active study of Orbital Fractures and Blow Out Fracture of Orbit, sponsored by AO Innovation Translation Center.
NCT03887988 is a study of Orbital Fractures and Blow Out Fracture of Orbit that is active but no longer recruiting, run by AO Innovation Translation Center. The registered enrollment target is 300 participants. The trial reports 14 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03887988, a study of Orbital Fractures and Blow Out Fracture of Orbit, is active but no longer recruiting, sponsored by AO Innovation Translation Center.
- ACTIVE NOT RECRUITING
- Registry status
- 300 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
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)
Conditions Studied
Interventions
- PROCEDURE Primary "early" reconstruction
- OTHER Nonsurgical
- PROCEDURE Primary "delayed" reconstruction
- PROCEDURE Secondary reconstruction
Study Locations (14)
Other
- Medical Center Hamburg Eppendorf - Hamburg
- Klinikum der LMU München - Munich
- Eramus MC - Rotterdam
- Mayo Hospital - Lahore
- Hamad Medical Corporation - Doha
- Emergency Clinical County Hospital of Constanta - Constanța
- Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation - Moscow
- Clinic for Maxillofacial Surgery, University of Belgrade - Belgrade
- King Edward VIII Hospital - Durban
- Uppsala University Hospital - Uppsala
- Universitaetsspital Basel - Basel
California
- UC Davis - Sacramento
Catalonia
- Hospital Vall d' Hebron - Barcelona
Madrid
- 12 de Octubre University Hospital - Madrid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2026-03 |
What the registry record for NCT03887988 still lists
NCT03887988 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Orbital Fractures appearing as the primary indexed condition, and to 4 interventions - of which Primary "early" reconstruction is the first listed.
NCT03887988 lists 14 locations in 4 states (Other, California, Catalonia).
Frequently Asked Questions
What is clinical trial NCT03887988 about?
NCT03887988 is a clinical study titled "Orbital Fractures Registry". 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.
What is the current status of trial NCT03887988?
This trial is currently active not recruiting. The enrollment target is 300 participants. The study started on 2019-11-01. Estimated completion is 2026-03.
What conditions does trial NCT03887988 study?
This clinical trial studies the following conditions: Orbital Fractures, Blow Out Fracture of Orbit.
What interventions are being tested in trial NCT03887988?
The interventions under investigation include: Primary "early" reconstruction (PROCEDURE), Nonsurgical (OTHER), Primary "delayed" reconstruction (PROCEDURE), Secondary reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT03887988?
This trial is sponsored by AO Innovation Translation Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03887988 being conducted?
This trial has 14 study locations across California, Catalonia, Madrid. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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