Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-01 @ 8:18 PM
Study NCT ID:
NCT03218150
Status:
UNKNOWN
Last Update Posted:
2017-07-14
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety : minimize incidence of infection', 'timeFrame': '360 days after surgery', 'description': 'incidence of adverse events ((infection, reabsorption))'}], 'secondaryOutcomes': [{'measure': 'efficacy', 'timeFrame': '60 , 120 , 360 days after surgery', 'description': 'quality of life improvement evaluation : (( glasgow coma score))'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Decompression Injury']}, 'descriptionModule': {'briefSummary': "Prospective, comparative, observational study.\n\nThe project's aim is long term follow up of patient's having skull bone defects due to traumatic or lesion resection causes, treated , in standard clinical practice, with autologous bone graft , bone cement or titanium mesh and to compare the clinical outcome and safety among the 3 types of treatment.\n\nEligibility to each treatment will respect the standard clinical practice.\n\nPrimary outcome: minimize post operative infection\n\nSecondary outcomes: decrease operation time , clinical and psychological improvement of the patient, decrease the cost on the patient", 'detailedDescription': 'Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty is not only a cosmetic issue; also, the repair of cranial defects gives relief to psychological drawbacks and increases the social performances. Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, ongoing researches on both biologic and non biologic substitutions continue aiming to develop the ideal reconstruction material.\n\nAutologous bone grafts remain the best option for adult and pediatric patients with viable donor sites and small-to-medium defects. Large defects in the adult population can be reconstructed with titanium mesh and polymethylmethacrylate overlay with or without the use of computer-assisted design and manufacturing customization. Advances in alloplastic materials and custom manufacturing of implants will have an important influence on cranioplasty techniques in the years to come.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patient's that need cranioplasty surgery admitted in assiut university hospital", 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients that have reconstructive surgery of cranial defects due to traumatic or lesion resection causes .\n2. Age older than 10 and less than 60 years\n3. Provided written informed consent\n\nExclusion Criteria:\n\n1. Cases of cranial defects due to congenital anomalies or growing skull fractures .\n2. Severe disease with limited life expectancy of less than one year'}, 'identificationModule': {'nctId': 'NCT03218150', 'briefTitle': 'Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Cranioplasty: Autogenous Bone Graft Versus Artificial Substitutes', 'orgStudyIdInfo': {'id': 'Assiut cranioplasty'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bone cement group', 'description': 'patient underwent to cranioplasty reconstruction with customized hydroxyapatite prosthesis', 'interventionNames': ['Procedure: cranioplasty']}, {'label': 'titanium mesh group', 'description': 'patient underwent to cranioplasty reconstruction with titanium mesh', 'interventionNames': ['Procedure: cranioplasty']}, {'label': 'autologous bone group', 'description': 'patient underwent to cranioplasty reconstruction with autologous bone graft', 'interventionNames': ['Procedure: cranioplasty']}], 'interventions': [{'name': 'cranioplasty', 'type': 'PROCEDURE', 'description': '. The margins of the craniectomy defects exposed, and the bone flaps fixed in their original positions using wires or titanium plates with screws. As prophylaxis, all patients intravenously administered with pre- and postoperative antibiotics.\n\nIn cases of artificial substitutes , The polymethyemethacrylate implant fixed to the defective region with titanium plates and self-tapping screws.', 'armGroupLabels': ['autologous bone group', 'bone cement group', 'titanium mesh group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Alaeddin Mohamed Ali', 'investigatorAffiliation': 'Assiut University'}}}}