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Orbital Fractures Registry — OFx  

Orbital Fractures Clinical Trial

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

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03887988
Study type Observational [Patient Registry]
Source AO Innovation Translation Center
Contact Joffrey Baczkowski
Phone +41 79 171 84 55
Email joffrey.baczkowski@aofoundation.org
Status Recruiting
Phase
Start date November 1, 2019
Completion date June 2025
View Details
See also
  Status Clinical Trial Phase
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Completed NCT02736461 - Factors Associated With Postoperative Strabismus After Floor Fracture Repair N/A
Completed NCT00233922 - Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant Phase 2
Withdrawn NCT01504568 - The Use of Prophylactic Antibiotics in Isolated Blowout Fractures N/A
Not yet recruiting NCT03813732 - Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures N/A
Recruiting NCT01464541 - Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan N/A
Completed NCT01432964 - Use of a Low Profile Titanium Mesh in Orbital Reconstruction N/A
Enrolling by invitation NCT06294535 - The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant N/A
Recruiting NCT04704414 - Exophthalmometry With 3D Face Scanners N/A
Completed NCT05439512 - Orbital Floor Fracture Repair by Titanium Mesh Via Transantral Approach. N/A
Recruiting NCT06369129 - Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction N/A