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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Titanium mesh | Active Comparator | this group is operated using titanium mesh |
|
| Bone cement | Active Comparator | this group is operated using bone cement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranioplasty with Titanium mesh | Procedure | Cranioplasty using titanium mesh |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion, an average 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | follow up rate of post operative infection | through study completion, an average 1 years |
| Reoperation | rate of reoperation after using each material a post-operative follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osman Hassan Zafraan, Resident doctor | Contact | +201220993578 | docosmanhassan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuit University Hospital | Asyut | Asyut Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Mousa M, Eissa S, Raslan M, Abu ElNaga B, Balaha A. Evaluation of three different methods of cranioplasty; a comparative prospective randomized study. Pan Arab Journal of Neurosurgery. 2021;16 | ||
| 28607825 | Result | Andrabi SM, Sarmast AH, Kirmani AR, Bhat AR. Cranioplasty: Indications, procedures, and outcome - An institutional experience. Surg Neurol Int. 2017 May 26;8:91. doi: 10.4103/sni.sni_45_17. eCollection 2017. | |
| 37366436 |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001843 | Bone Cements |
| ID | Term |
|---|---|
| D012117 | Resins, Synthetic |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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Titanium mesh VS Bone cement in Cranioplasty
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| Cranioplasty with bone cement |
| Procedure |
Cranioplasty using bone cement |
|
| through study completion, an average 1 years |
| CSF leak | post-operative complication of CSF leak due to changes in Dynamics of CSF flow | through study completion, an average 1 years |
| complications | post-operative as hematoma formation , neurologic defict and fits. | through study completion, an average 1 years |
| Result |
| Capitelli-McMahon H, Kahlar N, Rahman S. Titanium Versus Autologous Bone-Based Cranioplasty: A Systematic Review and Meta-Analysis. Cureus. 2023 May 26;15(5):e39516. doi: 10.7759/cureus.39516. eCollection 2023 May. |
| 21897681 | Result | Aydin S, Kucukyuruk B, Abuzayed B, Aydin S, Sanus GZ. Cranioplasty: Review of materials and techniques. J Neurosci Rural Pract. 2011 Jul;2(2):162-7. doi: 10.4103/0976-3147.83584. |
| 32387405 | Result | Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001697 |
| Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |