Cranioplasty Using Titanium Mesh Vs Bone Cement

Phase 2

Not yet recruiting

• Conditions: Bone Defects; Decompressive Craniectomy and Cranioplasty; Cranioplasty

• Registration Number: NCT06662903
• Lead Sponsor: Osman Hassan Osman Zafraan

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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-03
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient satisfaction using patient ssatisfaction grade	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 Outcome Measures

Name	Time	Method
Infection	through study completion, an average 1 years	follow up rate of post operative infection
Reoperation	through study completion, an average 1 years	rate of reoperation after using each material a post-operative follow up
CSF leak	through study completion, an average 1 years	post-operative complication of CSF leak due to changes in Dynamics of CSF flow
complications	through study completion, an average 1 years	post-operative as hematoma formation , neurologic defict and fits.

Trial Locations

Locations (1)

Assuit University Hospital; 🇪🇬 Asyut, Egypt