Clinical trial NCT06662903: Cranioplasty Using Titanium Mesh Vs Bone Cement
Official title: A Comparative Study Between Cranioplasty Using Titanium Mesh Vs Bone Cement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Bone Defects
Decompressive Craniectomy and Cranioplasty
Cranioplasty
Keywords: Cranioplasty
Titanium mesh
Bone cement
Traumatic brain injury
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Titanium mesh VS Bone cement in Cranioplasty
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Patient satisfaction using patient ssatisfaction grade
timeFrame: through study completion, an average 1 years
Secondary outcomes:
measure: Infection
timeFrame: through study completion, an average 1 years
measure: Reoperation
timeFrame: through study completion, an average 1 years
measure: CSF leak
timeFrame: through study completion, an average 1 years
measure: complications
timeFrame: through study completion, an average 1 years
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Assuit University Hospital
Study officials:
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.