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Not yet recruiting NCT06662903

Cranioplasty Using Titanium Mesh vs Bone Cement

Phase II Interventional Bone Defects Decompressive Craniectomy and Cranioplasty Cranioplasty

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cranioplasty with Titanium mesh, Cranioplasty with bone cement.
Who it may be relevant to
Registry conditions: Bone Defects, Decompressive Craniectomy and Cranioplasty, Cranioplasty. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement

Overview

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

Detailed description

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.

Interventions

  • Procedure Cranioplasty with Titanium mesh
    Cranioplasty using titanium mesh
  • Procedure Cranioplasty with bone cement
    Cranioplasty using bone cement

Primary outcome measures

  • Patient satisfaction using patient ssatisfaction grade [Time frame: through study completion, an average 1 years]
Secondary outcome measures (4)
  • Infection [Time frame: through study completion, an average 1 years]
  • Reoperation [Time frame: through study completion, an average 1 years]
  • CSF leak [Time frame: through study completion, an average 1 years]
  • complications [Time frame: through study completion, an average 1 years]

Eligibility criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assuit University Hospital — Asyut

Publications

  • Mousa M, Eissa S, Raslan M, Abu ElNaga B, Balaha A. Evaluation of three different methods of cranioplasty; a comparative prospective randomized study. Pan Arab Journal of Neurosurgery. 2021;16
  • Andrabi SM, Sarmast AH, Kirmani AR, Bhat AR. Cranioplasty: Indications, procedures, and outcome - An institutional experience. Surg Neurol Int. 2017 May 26;8:91. doi: 10.4103/sni.sni_45_17. eCollection 2017. PMID 28607825
  • Capitelli-McMahon H, Kahlar N, Rahman S. Titanium Versus Autologous Bone-Based Cranioplasty: A Systematic Review and Meta-Analysis. Cureus. 2023 May 26;15(5):e39516. doi: 10.7759/cureus.39516. eCollection 2023 May. PMID 37366436
  • Aydin S, Kucukyuruk B, Abuzayed B, Aydin S, Sanus GZ. Cranioplasty: Review of materials and techniques. J Neurosci Rural Pract. 2011 Jul;2(2):162-7. doi: 10.4103/0976-3147.83584. PMID 21897681
  • Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6. PMID 32387405

Identifiers

NCT: NCT06662903 · Cranioplasty

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗