Clinical Trials Logo

Clinical Trial Summary

The study is a prospective randomized longitudinal clinical study to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants (the latter being the traditional approach and current standard of care).


Clinical Trial Description

Orbital fracture, which accounts for 10-25% of facial fractures, is one of the most difficult facial fractures to treat. The complex bone anatomy and the proximity of adjacent vital structures make reconstruction of these fractures challenging. Inadequate orbital fracture reconstruction leads to cosmetic and functional complications. Cosmetic complications include enophthalmos, which is defined as posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (bone) relative to its contents (the eyeball and orbital fat). Functional complications include diplopia, defined as a type of vision disorder in which two images are seen of a single object. This is a prospective randomized clinical study with longitudinal follow-up. The study duration is 2 years, and it will be conducted at Grady Memorial Hospital (GMH). The study targets low-income, urban adults suffering blunt facial trauma who are diagnosed with unilateral orbital fracture. The purpose of this study is to compare pre-adapted patient-specific orbital implants utilizing an office-based 3-D printer versus standard non-adapted orbital implants. Main aims of the study are to 1) preoperatively generate a patient-specific model to pre-adapt the titanium mesh for use in unilateral orbital fractures; 2) accurately restore the orbital volume to pre-injury levels; 3) prevent postoperative complications including enophthalmos and diplopia; and 4) decrease the operative time, therefore decreasing overall cost and increasing value. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03673865
Study type Interventional
Source Emory University
Contact
Status Terminated
Phase N/A
Start date October 11, 2019
Completion date June 10, 2021

See also
  Status Clinical Trial Phase
Completed NCT03057405 - Intra-operative (IO) Navigation and IO-CBCT for 3D Orbital Reconstruction
Completed NCT00584506 - Computer Aided Evaluation of Orbital Volume N/A
Recruiting NCT03887988 - Orbital Fractures Registry
Not yet recruiting NCT04271137 - Correction of Enophthalmos and Orbital Volume Using Pre-bent Mesh Versus 3d Printed Onlay in Orbital Fracture Cases N/A
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