Orbital Fractures
Conditions
Keywords
orbital wall reconstruction, prebent titanium mesh, patient specific implant, PEEK
Brief summary
under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.
Detailed description
under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.
Interventions
DEVICEreconstruction of orbital walls
under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
patient select randomly from closed label
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia
Exclusion criteria
* systemic disease interfere with bone healing enophthamous less than 2 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| restoring the accurate position of eye | one month- six months | using exophthalmometer to measure enophthalmous |
| motility of eye | one month | using 9 gaze test to evaluate motility of eye |
| volume of orbit | one to six months | using CT scan to measure orbital volume pre and postoperative |
Countries
Egypt
Outcome results
None listed