Cranioplasty Using Titanium Mesh vs Bone Cement
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOsman Hassan Osman Zafraan
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with active infection at the surgical site
Patient Unfit for surgery.
Patient refuse consent
Trial design
Design model
Parallel
Treatments tested in this trial
Cranioplasty with Titanium mesh
Procedure/SurgeryCranioplasty using titanium mesh
Cranioplasty with bone cement
Procedure/SurgeryCranioplasty using bone cement
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Titanium meshActive comparator 1 intervention
Group B: Bone cementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient satisfaction using patient ssatisfaction grade
Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied
Time frame
through study completion, an average 1 yearsSecondary outcomes
1
Infection
follow up rate of post operative infection
Time frame
through study completion, an average 1 years2
Reoperation
rate of reoperation after using each material a post-operative follow up
Time frame
through study completion, an average 1 years3
CSF leak
post-operative complication of CSF leak due to changes in Dynamics of CSF flow
Time frame
through study completion, an average 1 years4
complications
post-operative as hematoma formation , neurologic defict and fits.
Time frame
through study completion, an average 1 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Osman Hassan Osman Zafraan
Lead sponsor
Assiut University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: