Assuit University Hospital
Asyut, Asyut Governorate, Egypt
NCT Number: NCT06662903
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
Trial opening soon.
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Interventional
Phase 2
Asyut, Asyut Governorate, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Cranioplasty using titanium mesh
Cranioplasty using bone cement
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
Time frame: through study completion, an average 1 years
follow up rate of post operative infection
Time frame: through study completion, an average 1 years
rate of reoperation after using each material a post-operative follow up
Time frame: through study completion, an average 1 years
post-operative complication of CSF leak due to changes in Dynamics of CSF flow
Time frame: through study completion, an average 1 years
post-operative as hematoma formation , neurologic defict and fits.
Contact information is provided by the study sponsor or research team.
Osman Hassan Osman Zafraan
Other
A Comparative Study Between Cranioplasty Using Titanium Mesh vs Bone Cement
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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