Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT06662903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cranioplasty Using Titanium Mesh Vs Bone Cement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001843', 'term': 'Bone Cements'}], 'ancestors': [{'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Titanium mesh VS Bone cement in Cranioplasty'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction using patient ssatisfaction grade', 'timeFrame': 'through study completion, an average 1 years', 'description': 'Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied'}], 'secondaryOutcomes': [{'measure': 'Infection', 'timeFrame': 'through study completion, an average 1 years', 'description': 'follow up rate of post operative infection'}, {'measure': 'Reoperation', 'timeFrame': 'through study completion, an average 1 years', 'description': 'rate of reoperation after using each material a post-operative follow up'}, {'measure': 'CSF leak', 'timeFrame': 'through study completion, an average 1 years', 'description': 'post-operative complication of CSF leak due to changes in Dynamics of CSF flow'}, {'measure': 'complications', 'timeFrame': 'through study completion, an average 1 years', 'description': 'post-operative as hematoma formation , neurologic defict and fits.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cranioplasty', 'Titanium mesh', 'Bone cement', 'Traumatic brain injury'], 'conditions': ['Bone Defects', 'Decompressive Craniectomy and Cranioplasty', 'Cranioplasty']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '28607825', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '37366436', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21897681', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32387405', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is:\n\nTo compare the surgical outcomes between titanium mesh and bone cement in cranioplasty.\n\nTo assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery', 'detailedDescription': 'Cranioplasty is a common neurosurgical procedure performed to repair skull vault defects.\n\nThe 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.\n\nAt 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.\n\nBone 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.\n\nTitanium 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.\n\nCranioplasty 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n * Patients requiring cranioplasty for a skull defect due to Decompressive Craniectomy, trauma, tumor resection, or congenital issues.\n * All ages .\n * Both sex.\n * Informed consent obtained from all participants.\n * Patient fit for surgery.\n* Exclusion Criteria:\n\n * Patients with active infection at the surgical site\n * Patient Unfit for surgery.\n * Patient refuse consent'}, 'identificationModule': {'nctId': 'NCT06662903', 'briefTitle': 'Cranioplasty Using Titanium Mesh Vs Bone Cement', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'A Comparative Study Between Cranioplasty Using Titanium Mesh Vs Bone Cement', 'orgStudyIdInfo': {'id': 'Cranioplasty'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Titanium mesh', 'description': 'this group is operated using titanium mesh', 'interventionNames': ['Procedure: Cranioplasty with Titanium mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bone cement', 'description': 'this group is operated using bone cement', 'interventionNames': ['Procedure: Cranioplasty with bone cement']}], 'interventions': [{'name': 'Cranioplasty with Titanium mesh', 'type': 'PROCEDURE', 'description': 'Cranioplasty using titanium mesh', 'armGroupLabels': ['Titanium mesh']}, {'name': 'Cranioplasty with bone cement', 'type': 'PROCEDURE', 'description': 'Cranioplasty using bone cement', 'armGroupLabels': ['Bone cement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Assuit University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Osman Hassan Zafraan, Resident doctor', 'role': 'CONTACT', 'email': 'docosmanhassan@gmail.com', 'phone': '+201220993578'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osman Hassan Osman Zafraan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Osman Hassan Osman Zafraan', 'investigatorAffiliation': 'Assiut University'}}}}