Cranioplasty Using Titanium Mesh Vs Bone Cement

Osman Hassan Osman Zafraan

Status and phase: Not yet enrolling; Phase 2

Conditions: Cranioplasty; Decompressive Craniectomy and Cranioplasty; Bone Defects

Treatments: Procedure: Cranioplasty with bone cement; Procedure: Cranioplasty with Titanium mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06662903

Cranioplasty

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Titanium mesh

Active Comparator group

Description:

this group is operated using titanium mesh

Treatment:

Procedure: Cranioplasty with Titanium mesh

Bone cement

Active Comparator group

Description:

this group is operated using bone cement

Treatment:

Procedure: Cranioplasty with bone cement