CompletedNot Applicable

Reconstruction of Orbital Floor Blow-out Fractures by Titanium Mesh Versus Autogenous Iliac Graft

Egypt80 participantsStarted 2020-05-02

Plain-language summary

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. Motor vehicle accidents are the main cause of orbital trauma. Also, industrial accidents, sports-related facial trauma, and assaults are important causes. Clinical manifestations include ecchymosis, limitation of eye movements resulting in diplopia, enophthalmos. Very rarely, severe pain and nausea immediately after the injury are reported. Radiologic evaluation including computed tomography (CT), plane radiology and magnetic resonance imaging (MRI) are the mainstay diagnostic modalities used for evaluation of cases with orbital trauma. Treatment of the orbital blow-out fractures is aimed at restoring floor continuity, thus providing adequate support for orbital contents preventing their herniation and incarceration, thereby possible subsequent fibrosis of soft tissues most importantly extraocular muscles. Various alloplastic or autogenous grafts are used for reconstruction of orbital blow-out fractures.

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical Enophthalmos, diplopia, and/or limited ocular motility in one or more directions. Radiological: \- CT scan (axial, coronal \& 3 dimensional): Fracture of the orbital floor with herniation of the orbital contents (extra-ocular muscles, or orbital fat) Exclusion Criteria: * patients with bilateral orbital fractures or severe facial fractures. * Patients with bad general condition or uncontrolled diabetes mellitus.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess visual acuity, extra-ocular motility, pupillary reaction. Also, the degree of enophthalmos

Timeframe: 1 year

Trial details

NCT IDNCT07340879

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-30

View on ClinicalTrials.gov More Blow-Out Fractures trials