Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06662903

Cranioplasty Using Titanium Mesh vs Bone Cement

The aim of this study is:

To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.

To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assuit University Hospital

Asyut, Asyut Governorate, Egypt

About this study

Cranioplasty is a common neurosurgical procedure performed to repair skull vault defects.

The skull vault defects may result mostly after traumatic injuries as depressed skull fractures, Tumor removal (infiltrating skull bones), decompressive craniectomies, congenital anomalies or inflammatory lesions.

At present, there is no gold standard material for cranioplasty with the use of autologous bone as well as other synthetic materials as bone cement and titanium mesh.

Bone cement is malleable, lightweight, strong, and heat resistant, but it may cause burn injury during the process of its preparation and is used for relatively small defects.

Titanium mesh good mechanical strength, a low infection rate, and an acceptable cost but may cause metal allergy, tissue erosion, implant exposure, and deformity upon application of external force.

Cranioplasty not only provides Brain protection and cosmetic aspects but also, decrease incidence of epilepsy, relief to psychological drawbacks and increases social performance, restoring the dynamics of CSF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Patients requiring cranioplasty for a skull defect due to Decompressive Craniectomy, trauma, tumor resection, or congenital issues.
  • All ages .
  • Both sex.
  • Informed consent obtained from all participants.
  • Patient fit for surgery.
  • Exclusion Criteria:
  • Patients with active infection at the surgical site
  • Patient Unfit for surgery.
  • Patient refuse consent

Treatment and study plan

Cranioplasty with Titanium mesh

Procedure

Cranioplasty using titanium mesh

Cranioplasty with bone cement

Procedure

Cranioplasty using bone cement

Primary outcomes

  1. Patient satisfaction using patient ssatisfaction grade

    Time frame: through study completion, an average 1 years

    Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied

Secondary outcomes

  1. Infection

    Time frame: through study completion, an average 1 years

    follow up rate of post operative infection

  2. Reoperation

    Time frame: through study completion, an average 1 years

    rate of reoperation after using each material a post-operative follow up

  3. CSF leak

    Time frame: through study completion, an average 1 years

    post-operative complication of CSF leak due to changes in Dynamics of CSF flow

  4. complications

    Time frame: through study completion, an average 1 years

    post-operative as hematoma formation , neurologic defict and fits.

Study contacts

Contact information is provided by the study sponsor or research team.

Osman Hassan Zafraan, Resident doctor

CONTACT

[email protected]

+201220993578

Sponsors and collaborators

Lead sponsor

Osman Hassan Osman Zafraan

Other

Registry information

Official study title

A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.