Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT00923793
Status:
TERMINATED
Last Update Posted:
2015-05-21
First Post:
2009-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'whyStopped': 'Recruitment was stopped, due to slow recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2009-06-17', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.', 'timeFrame': '6 months'}, {'measure': 'Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms.', 'timeFrame': '48 hours post-operative'}, {'measure': 'Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.', 'timeFrame': '6 months'}, {'measure': 'Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.', 'timeFrame': '6 months'}, {'measure': 'Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.', 'timeFrame': '6 months'}, {'measure': 'Description of osteointegration with CT and bone scan six months post-operative in both groups', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['skull defects', 'Hydroxylapatite implant', 'Titanium implant', 'calotte defects without the possibility to be covered with the missing own bone'], 'conditions': ['Skull Defects', 'Cranioplasty']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Eufinger H, Weihe S, Scherer P, Rasche C, Wehmöller M. Management of cranial and craniofacial bone defects with prefabricated individual titanium implants: follow-up and evaluation of 166 patients with 169 titanium implants from 1994 to 2000. Int. J. CARS 2006; 1: 197-203'}, {'pmid': '26918471', 'type': 'DERIVED', 'citation': 'Lindner D, Schlothofer-Schumann K, Kern BC, Marx O, Muns A, Meixensberger J. Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial. J Neurosurg. 2017 Jan;126(1):175-183. doi: 10.3171/2015.10.JNS151245. Epub 2016 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.', 'detailedDescription': 'Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Skull defects without the possibility to be covered with the missing own bone\n2. Size of the defect ≥ 16 cm2\n3. Age ≥ 18\n4. Written informed consent of the patient\n\nExclusion Criteria:\n\n1. Active tumor\n2. ASA 4 classification\n3. Allergic disposition to ceramic or titanium\n4. Concomitant participation in other clinical trials\n5. Pregnant or nursing women\n6. Expected low compliance\n7. HIV positive\n8. Active drug abuses'}, 'identificationModule': {'nctId': 'NCT00923793', 'briefTitle': 'Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial', 'orgStudyIdInfo': {'id': 'CustomBone vs. Titanium'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Titanium', 'description': 'Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit.', 'interventionNames': ['Device: Titanium implant (CranioConstruct™)']}, {'type': 'EXPERIMENTAL', 'label': 'Hydroxylapatite', 'description': 'Hydroxylapatite (CustomBone) implant Hydroxylapatite implants are used since about 3 years in Germany. As this material is very similar to human bone structure an improved osteointegration has been observed.', 'interventionNames': ['Device: Hydroxylapatite (CustomBone)']}], 'interventions': [{'name': 'Titanium implant (CranioConstruct™)', 'type': 'DEVICE', 'otherNames': ['CranioConstruct™'], 'description': 'One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.', 'armGroupLabels': ['Titanium']}, {'name': 'Hydroxylapatite (CustomBone)', 'type': 'DEVICE', 'otherNames': ['CustomBone'], 'description': 'Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.', 'armGroupLabels': ['Hydroxylapatite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04107', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Dirk Lindner, Dr. med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitätsklinikum Leipzig', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dirk Lindner', 'investigatorAffiliation': 'University of Leipzig'}}}}