Orbital Floor Fracture Clinical Trial
Official title:
Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
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.
Status | Not yet recruiting |
Enrollment | 38 |
Est. completion date | September 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nahla Mahmoud Awad |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diplopia resolution using Forced duction test positive/negative | subjective patient assessment | 6 months | |
Secondary | Fracture reduction Digital radiography (Cone beam CT) | 6 months | ||
Secondary | Enophthalmus correction. Digital radiography (Cone beam CT) | mm | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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