Clinical trials: Orbital Fractures
Orbital Fractures
Orbital Fractures Measurement: Intraoperative Versus Computed Tomography (CT) Scan
Purpose to compare the orbital fracture size measured by orbital CT scan and compare it to the actual orbital fracture size intraoperatively in patients who needed surgical intervention to correct the fracture.
- Trial name
- NCT01464541
- Testing
- operative fracture size vs CT fracture size, orbital fracture intraoperative measurement
- Where
- 2 sites in Israel
- Volunteers
- 20 people
- Sponsor
- HaEmek Medical Center, Israel
Orbital Fractures
Clinical Outcomes of Transconjunctival Vs Transcutaneous Approaches in Orbital Fracture Repair
Open reduction and internal fixation of zygomaticomaxillary complex (ZMC) fractures has a challenging impact on the selection of the suitable surgical approach to the orbital and zygomatic skeleton.
- Trial name
- Vs: versus (NCT07759440)
- Testing
- orbital fracture reduction and fixation
- Where
- Egypt
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Alexandria University
Orbital Fractures
Use of a Low Profile Titanium Mesh in Orbital Reconstruction
In craniofacial trauma, the involvement of orbital structures is noted in up to 40% of cases (Ellis 1985). Post-traumatic orbital deformities caused by incorrect reconstruction of orbital dimensions are severe complications…
- Trial name
- NCT01432964
- Testing
- Orbital revision surgery
- Where
- Switzerland
- Volunteers
- 27 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Orbital Trauma, Orbital Fractures
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Patients with orbital injuries are entered into the trial. Age: 20 - 70. After obtaining appropriate consent, they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh (established…
- Trial name
- NCT00233922
- Testing
- Osteosheet(r)
- Where
- Singapore
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National University Hospital, Singapore
Blow-Out Fractures
Reconstruction of Orbital Floor Blow-out Fractures by Titanium Mesh Versus Autogenous Iliac Graft
Blow-out fractures result from direct blunt impacts to the orbit which causes an immediate rise increase in intra-orbital pressure. Decompression via fracture of the orbital floor then occurs.
- Trial name
- NCT07340879
- Testing
- Titanium mesh, autogenous iliac graft
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Assiut University
Orbital Fractures, Orbital Cellulitis
The Use of Prophylactic Antibiotics in Isolated Blowout Fractures
The purpose of the research is to perform a quality assurance evaluation using randomized prospective analysis the rate of orbital cellulitis as a complication of nonsurgical orbital blowout fracture in patients treated versus…
- Trial name
- NCT01504568
- Testing
- Treatment
- Where
- United States
- Sponsor
- University of Arkansas
Orbital Fractures
Using the Transconjuctival Approach Alone Versus Using it Together With Lateral Canthotomy in Orbital Fractures
All cases will undergo surgery under general anesthesia. Evaluation of patients with suspected orbital fracture should involve radiologic examination, motility test, diplopia field test and exophthalmometry.
- Trial name
- NCT03813732
- Testing
- orbital fracture
- Where
- Egypt
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Cairo University
Orbital Floor (Blow-Out) Open Fracture, Enophthalmos Traumatic
3D Printed Titanium Mesh vs Guided Autogenous Graft
In this study, the hypothesis states that there is no significant difference between specified populations. In our case, the 3D printed patient-specific titanium mesh is thought to have the same effect and results in comparison…
- Trial name
- NCT05550285
- Testing
- orbital floor recontriction
- Where
- Egypt
- Volunteers
- 32 people
- Sponsor
- Mohammed Ghassan Mohammed Shaalan
Facial Injuries, Mandible Fracture
Multi-Institutional IMPACT Validation
The goal of this observational study is to validate a novel patient-reported outcome measure (PROM) for patients suffering maxillofacial trauma: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial…
- Conditions
- Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture
- Trial name
- NCT06850857
- Testing
- IMPACT-G Module, IMPACT-N Module, IMPACT-O Module
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- University of Tennessee
Blow-Out Fractures, Orbital Fractures
Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction
Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient…
- Conditions
- Blow-Out Fractures, Orbital Fractures, Orbital Floor Fracture, Orbital Trauma
- Trial name
- NCT06369129
- Testing
- Orbital floor reconstruction with Patient Specific Zirconia Implant, Orbital floor reconstruction with Patient Specific Titanium Implant
- Where
- Egypt
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cairo University
Facial Fractures, Maxillofacial Injuries
Epidemiological and Statistical Study of Facial Traumatic Fractures at Assiut University Trauma Hospital
Facial traumatic fractures represent a significant global and regional health burden that can impair essential functions such as breathing, speaking, and chewing, while carrying substantial functional and psychological…
- Conditions
- Facial Fractures, Maxillofacial Injuries, Mandibular Fractures, Maxillary Fractures
- Trial name
- NCT07827209
- Volunteers
- 50 people
- Sponsor
- Assiut University
Orbital Fractures
The Use of 3D Printing in Orbital Fractures
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…
- Trial name
- NCT03673865
- Testing
- office-based 3-dimensional printers (OB3DP), standard stock orbital plate
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Emory University
Zygomatic Fractures, Orbital Fractures
Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up
A retrospective post-market clinical follow-up to confirm the performance and safety of the Upper-Face and Mid-Face modules of the Stryker Universal CMF System in a clinical setting.
- Conditions
- Zygomatic Fractures, Orbital Fractures, Maxilla Fractures, Facial Fractures
- Trial name
- UMF (NCT07245719)
- Testing
- Upper-Face and/or Mid-Face modules (1.2 / 1.7 modules) of the Stryker Universal CMF System
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Stryker Craniomaxillofacial
Orbital Fractures
Computer Aided Evaluation of Orbital Volume
A retrospective review to assess the performance and clinical predictive value of a novel software program (Maxillo) designed to perform complex volumetric analysis with application in the field of orbital trauma.
- Trial name
- NCT00584506
- Volunteers
- 250 people
- Sponsor
- University of California, Davis
Maxillofacial Injury
Computer Modeling With Reconstruction of Maxillofacial Skeleton
Investigator initial study to evaluate the use of preoperative computer modeling and the intraoperative navigation to guide reconstruction of the maxillofacial skeleton.
- Trial name
- NCT00583856
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of California, Davis
Cranial Bone Defect, Orbital Base Fracture
Clinical Study of FRC Implant to Treat Skull Bone Defects
Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects. Functional and aesthetic outcome is assessed by patient and doctor.
- Trial name
- Cranio-2 (NCT01874613)
- Testing
- FRC implant reconstruction
- Where
- Finland
- Volunteers
- 19 people
- Sponsor
- Turku University Hospital
Fractures, Enophthalmos
Polycaprolactone / Tricalcium Phosphate (PCL/TCP) v Titanium Orbital Implant : Randomised Trial
Hypothesis: Polycaprolactone / Tricalcium Phosphate Orbital (PCL / TCP) Implant is as effective in the reconstruction of the Orbital walls as Titanium Mesh implant.
- Conditions
- Fractures, Enophthalmos, Diplopia
- Trial name
- PCL/TCP (NCT01119144)
- Testing
- Polycaprolactone / Tri-Calcium Phosphate, Titanium Mesh
- Where
- Singapore
- Volunteers
- 80 people
- Sponsor
- National University Hospital, Singapore
Orbital Floor Fracture, Medial Orbital Wall Fracture
Prospective Multicenter Trial to Compare Preformed vs Non Preformed Orbital Implants
Accuracy of posttraumatic orbital reconstruction of the medial orbital wall and/or floor is better with preoperatively preformed orbital implants than with non-preformed orbital implants.
- Trial name
- Orbita 3 (NCT01121159)
- Testing
- orbital fracture repair
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 185 people
- Sponsor
- AO Clinical Investigation and Publishing Documentation
Orbital Fractures, Blow Out Fracture of Orbit
Orbital Fractures Registry
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…
- Trial name
- OFx (NCT03887988)
- Testing
- Primary "early" reconstruction, Nonsurgical, Primary "delayed" reconstruction
- Where
- 14 sites in United States, Germany and 10 more
- Volunteers
- 300 people
- Sponsor
- AO Innovation Translation Center
Orbital Fractures, Zygomatic Fractures
Modified Anatomical Mesh In The Management Of Orbito-Zygomatico-Maxillary Complex Fractures
Orbito-Zygomaticomaxillary-complex fractures is a form of a complex orbital floor fracture, with affection of the inferior orbital rim and the orbital walls.
- Trial name
- NCT06958510
- Testing
- 3D-Modified Anatomical-Mesh., conventional orbital rim miniplates and orbital mesh configuration
- Where
- Egypt
- Volunteers
- 24 people
- Sponsor
- Alexandria University