Orbital Fractures Registry

Orbital Fractures Clinical Trial

— OFx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03887988
• Other study ID #: OFx Registry_RP_v.1.0
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: AO Innovation Translation Center
• Contact: Joffrey Baczkowski
• Phone: +41 79 171 84 55
• Email: joffrey.baczkowski[@]aofoundation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blow Out Fracture of Orbit
• Fractures, Bone
• Orbital Fractures

Intervention

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

Other:
• Nonsurgical
Nonsurgical treatment of fracture

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	Medical Center Hamburg Eppendorf	Hamburg
Germany	Klinikum der LMU München	Munich
Netherlands	Eramus MC	Rotterdam
Pakistan	Mayo Hospital	Lahore
Qatar	Hamad Medical Corporation	Doha
Romania	Emergency Clinical County Hospital of Constanta	Constanta
Russian Federation	Federal State Budgetary Institution "National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation	Moscow
Serbia	Clinic for Maxillofacial Surgery, University of Belgrade	Belgrade
South Africa	King Edward VIII Hospital	Durban
Spain	Hospital Vall d' Hebron	Barcelona	Catalonia
Spain	12 de Octubre University Hospital	Madrid
Sweden	Uppsala University Hospital	Uppsala
Switzerland	Universitaetsspital Basel	Basel
United States	UC Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  Pakistan,  Qatar,  Romania,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Visual acuity	Measured using a visual test chart in healthy and injured sides with and without vision aids.	6, 12, 24 weeks post-treatment
Secondary	Extra-ocular mobility	Follow-my finger test	6, 12, 24 weeks post-treatment
Secondary	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