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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orbital Fracture | Patients with dislocated fracture of the inferior and/or medial orbital wall |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary "early" reconstruction | Procedure | Primary surgical reconstruction of the fracture within 3 weeks after injury |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diplopia | The degree of diplopia is quantified by measuring the field of single binocular vision, ranging from 0 to 3. 0: no diplopia
| 24 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visual acuity |
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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
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Eppo B. Wolvius, Prof. | Department of Oral & Maxillofacial Surgery, Erasmus MC, Rotterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Sacramento | California | 95817 | United States | ||
| Medical Center Hamburg Eppendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40738644 | Derived | 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. |
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| Nonsurgical | Other | Nonsurgical treatment of fracture |
|
|
| Primary "delayed" reconstruction | Procedure | Primary surgical reconstruction of the fracture more than 3 weeks after injury |
|
|
| Secondary reconstruction | Procedure | Second surgical reconstruction of the fracture after a primary reconstruction. |
|
|
Measured using a visual test chart in healthy and injured sides with and without vision aids. |
| 6, 12, 24 weeks post-treatment |
| Extra-ocular mobility | Follow-my finger test | 6, 12, 24 weeks post-treatment |
| 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 |
| Hamburg |
| Germany |
| Klinikum der LMU München | Munich | 80337 | 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 | Spain |
| 12 de Octubre University Hospital | Madrid | Madrid | Spain |
| Uppsala University Hospital | Uppsala | Sweden |
| Universitaetsspital Basel | Basel | Switzerland |
| ID | Term |
|---|---|
| D009917 | Orbital Fractures |
| D004172 | Diplopia |
| ID | Term |
|---|---|
| D008446 | Maxillofacial Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D012887 | Skull Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D057747 | Periodontal Debridement |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013812 | Therapeutics |
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