Orbital Floor Fracture
Conditions
Keywords
endoscopic, trans-antral, subciliary
Brief summary
Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.
Detailed description
(N.M) Operator, data entry & corresponding author; Assistant lecturer , surgery department . (I.E) Main supervisor, data monitoring & auditing; Professor, surgery department. (R.H) Co-supervisor, data entry & auditing; Lecturer, surgery department . (AM) Assistant lecturer, surgery department .Faculty of Oral & Dental Medicine Cairo University outcome assessors and data collection. (YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo University , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents. intervention: Preoperative preparation: Preoperative cone beam CT. A clearance from the ophthalmology department after examination of papillary reflexes, motility restriction and measurement of the visual acuity. Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation profile Informed consent signed by the patient. (NM and RH) will perform all procedures under general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus) surgical approach. control group: Traditional trans-orbital surgical approaches. follow up clinically and radio-graphically for 6 months.
Interventions
new surgical approach to repair the orbital floor fractures through the maxillary sinus
through the lower eyelid below the eyelashes ,then down to bone the herniated orbital content will be reduced through this incision traditional surgical approach to repair orbital floor fractures
Sponsors
Study design
Eligibility
Inclusion criteria
1. Patients with unilateral/bilateral orbital blow out fractures. 2. Positive forced-duction test. ( to ensure the muscular entrapment).
Exclusion criteria
1. Medical condition affecting bone healing. 2. Medically compromised conditions, not proper candidate for general anesthesia. 3. Tumor case encroaching on the orbital floor. 4. Pathological orbital blow out fractures. 5. Allergy/ metal hypersensitivity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diplopia resolution using Forced duction test positive/negative | 6 months | subjective patient assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fracture reduction Digital radiography (Cone beam CT) | 6 months | — |
| Enophthalmus correction. Digital radiography (Cone beam CT) | 6 months | mm |