Cranioplasty Using Titanium Mesh Vs Bone Cement

October 25, 2024 updated by: Osman Hassan Osman Zafraan

A Comparative Study Between Cranioplasty Using Titanium Mesh Vs Bone Cement

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assuit University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Titanium mesh
this group is operated using titanium mesh
Procedure: Cranioplasty with Titanium mesh
Cranioplasty using titanium mesh
Active Comparator: Bone cement
this group is operated using bone cement
Procedure: Cranioplasty with bone cement
Cranioplasty using bone cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction using patient ssatisfaction grade
Time Frame: 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
through study completion, an average 1 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osman Hassan Osman Zafraan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cranioplasty

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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