Large Orbital Floor Fracture
Conditions
Keywords
orbital reconstruction, Interlocking PEEK, Patient specific implant
Brief summary
Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically
Detailed description
Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months & radiographically for orbital volume immediately and 6 months postoperatively
Interventions
PROCEDURElarge orbital floor fracture
Twenty two patients with large orbital floor fracture will be reconstructed with interlocking polyetheretherketone patient-specific implant
Sponsors
Tanta University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with large orbital blow out fracture either isolated or combined with other fracture * Patients willing for surgical operation and follow up * Patients with no contraindications for surgical intervention
Exclusion criteria
* Patients who are not fit for G.A * Uncooperative patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglobus | 2 weeks | It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not |
| Enophthalmos | 2 weeks | It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm) |
| Orbital volume | 2 weeks | C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured |
| Ocular motility | 2 weeks | It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement |
| Diplopia | 2 weeks | It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglobus | 6 months | It is the downward displacement of the eyeball of affected eye. It is measured by drawing imaginary line horizontally across the patient's inter-pupillary axis and determine if the pupil of the affected eye is lower or not |
| Enophthalmos | 6 months | It is defined as the posterior displacement of the eyeball within the orbit. It was measured by the aid of exophthalmometer. Assessment is consisting of four grades as follow: grade 0:no enophthalmos grade 1:mild enophthalmos(less than 1 mm) grade 2:moderate enophthalmos(from 1 to 2 mm) grade 3:severe enophthalmos(over 2 mm) |
| Orbital volume | 6 months | C.T. images of the patient are imported in DICOM format into the automatic orbital analysis software and the orbital volume of both orbital cavities are measured |
| Ocular motility | 6 months | It is done by asking the patient to follow a moving target into the diagnostic positions of gaze, observing the extent of movement of each eye. The amount of limitation of movement is classified as: grade 1:slight limitation grade 2:moderate limitation grade 3:marked limitation grade 4:no movement |
| Diplopia | 6 months | It is defined as perception of two images of the same object in visual space. It is assessed if it is present in primary position of gaze or in secondary position of gaze |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMaram N Breshah, Lecturer
Tanta University, Egypt
PRINCIPAL_INVESTIGATORRafic R Beder, Prof
Tanta University, Egypt
Outcome results
None listed