Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06662903

Cranioplasty Using Titanium Mesh vs Bone Cement

A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
46 (estimated)
Sponsor
Osman Hassan Osman Zafraan · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECranioplasty with Titanium meshCranioplasty using titanium mesh
PROCEDURECranioplasty with bone cementCranioplasty using bone cement

Timeline

Start date
2024-10-01
Primary completion
2026-03-01
Completion
2026-05-01
First posted
2024-10-29
Last updated
2024-10-29

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06662903. Inclusion in this directory is not an endorsement.