Orbital Fractures Registry

NCT03887988 | Active Not Recruiting

• 1 other identifier: OFx Registry_RP_v.1.0
• Study Type: observational
• Target: 300
• Locations: 11 countries
• Sites: 13

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.

Conditions

Blow Out Fracture of Orbit; Orbital Fractures

Keywords

Fracture fixation; Orbital implant; Midface fracture; Diplopia

Outcome Measures

Primary Outcomes (1)

• Diplopia

  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)

  24 weeks post-treatment

Secondary Outcomes (4)

• Globe position

  6, 12, 24 weeks post-treatment

• Visual acuity

  6, 12, 24 weeks post-treatment

• Extra-ocular mobility

  6, 12, 24 weeks post-treatment

• Patient-reported outcomes

  pre-treatment, 6, 12, 24 weeks post-treatment

Study Arms (1)

Orbital Fracture

Patients with dislocated fracture of the inferior and/or medial orbital wall

Procedure: Primary "early" reconstruction; Other: Nonsurgical; Procedure: Primary "delayed" reconstruction; Procedure: Secondary reconstruction

Interventions

Secondary reconstruction PROCEDURE

Second surgical reconstruction of the fracture after a primary reconstruction.

Also known as: Secondary surgery

Orbital Fracture

Primary "early" reconstruction PROCEDURE

Primary surgical reconstruction of the fracture within 3 weeks after injury

Also known as: Operative, Surgical

Orbital Fracture

Nonsurgical OTHER

Nonsurgical treatment of fracture

Also known as: Conservative

Orbital Fracture

Primary "delayed" reconstruction PROCEDURE

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

Also known as: Operative, Surgical

Orbital Fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients older than 18 years old with displaced fracture of the inferior and/or medial orbital wall (blow-out fractures) that require treatment (either surgically or non-surgically)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (14)

UC Davis

Sacramento, California, 95817, United States

Location

Medical Center Hamburg Eppendorf

Hamburg, Germany

Location

Klinikum der LMU München

Munich, 80337, Germany

Location

Eramus MC

Rotterdam, Netherlands

Location

Mayo Hospital

Lahore, Pakistan

Location

Hamad Medical Corporation

Doha, Qatar

Location

Emergency Clinical County Hospital of Constanta

Constanța, Romania

Location

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

Location

Clinic for Maxillofacial Surgery, University of Belgrade

Belgrade, Serbia

Location

King Edward VIII Hospital

Durban, South Africa

Location

Hospital Vall d' Hebron

Barcelona, Catalonia, Spain

Location

12 de Octubre University Hospital

Madrid, Madrid, Spain

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Universitaetsspital Basel

Basel, Switzerland

Location

Related Publications (1)

• Strabbing EM; OFx Registry Study Group; Wolvius EB. Surgical versus non-surgical management of orbital fractures: study protocol for evidence generation of a prospective multicentre observational cohort registry. BMJ Open. 2025 Jul 30;15(7):e100508. doi: 10.1136/bmjopen-2025-100508.

  PMID: 40738644 DERIVED

MeSH Terms

Conditions

Orbital Fractures; Diplopia

Interventions

Surgical Procedures, Operative; Periodontal Debridement; Conservative Treatment

Condition Hierarchy (Ancestors)

Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Therapeutics

Study Officials

• Eppo B. Wolvius, Prof.

  Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 25, 2019
• Study Start: November 1, 2019
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

ZA (1); RU (1); QA (1); SE (1); ES (2); RO (1); US (1); CH (1); NL (1); DE (2); PA (1)