Pre-adapted 3D-printed, patient-specific mesh for unilateral orbital fractures with or without navigation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares three approaches to reconstructing unilateral orbital fractures: pre-adapting an in-stock titanium mesh on a patient-specific 3D-printed model generated from the patient’s CT data, conventional intraoperative free-hand mesh bending, and mesh placement guided by an intraoperative navigation system. Outcomes are assessed radiologically and clinically, including ocular motility, diplopia, enophthalmos, and infraorbital nerve sensation, at baseline and postoperative visits up to six months. The study uses CT-based measurements of orbital bone alignment and clinical tests to evaluate accuracy of mesh positioning and functional recovery. Eligible participants are adults 18–55 with recent unilateral orbital fractures, excluding bilateral fractures, delayed presentation, and other severe ocular or systemic conditions. Lead sponsorship is Ain Shams University with site involvement at its Cairo hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Fracture orbital wall:
* Timing: Recent (\<3 weeks from trauma) Age: 18-55 years Sex: Both

Clinical Findings:

± Globe malposition, Enophthalmos ≥ 2 mm or Diplopia CT Findings

* Fracture Pattern: unilateral fractures medial wall or floor of the orbit.
* Defect Size critical sized defects proved by CT

  * Herniation of soft tissue, and/or muscle entrapment.
  * associated non-comminuted zygomatic fracture.

Exclusion Criteria:

* Timing Delayed (\> 3 weeks from trauma)
* Pattern : Bilateral orbital fractures
* Associated with Comminuted zygomatic fracture or pan-facial fracture Ocular Manifestations
* Patients with ruptured globe or associated soft tissue injury Associated conditions
* Other life-threatening condition
* Presence of systemic diseases affecting the globe position (e.g Hyperthyroidism, Horner's syndrome)
* Presence of craniofacial anomalies and Facial asymmetries.
* History of other old facial fractures Patients refusing surgery or implant.

Where it's running

• Ain shams university hospitals, department of plastic, burn and maxillofacial surgery
  Cairo, Abbasia, Egypt Recruiting
• Ain shams university hospitals
  Cairo, Cairo Governorate, Egypt Completed

Study contacts

• Study coordinator: Reem Mohamed Mahmoud, MBBCh, MSc
• Email: reem.saas@gmail.com
• Phone: +201064483493, +201223418832

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.