Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-03-08 @ 11:03 PM
Study NCT ID:
NCT03331159
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2017-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-31', 'studyFirstSubmitDate': '2017-10-29', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': '12 months after surgery', 'description': 'Postoperative disability as measured by the Oswestry Disability Index (ODI)'}], 'secondaryOutcomes': [{'measure': 'Fusion rate', 'timeFrame': '12 months after surgery', 'description': 'Postoperative radiographic Fusion rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumbar Fusion', 'Hydroxyapatite'], 'conditions': ['Fusion of Spine, Lumbar Region']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone', 'detailedDescription': 'This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic low back pain\n* sensorimotor deficits\n* radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy\n\nExclusion Criteria:\n\n* previous surgeries in the abdominal Region\n* previous fusion surgery in the lumbar spine.'}, 'identificationModule': {'nctId': 'NCT03331159', 'briefTitle': 'Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'NanoBone - ALIF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NanoBone', 'description': 'The participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2)', 'interventionNames': ['Device: NanoBone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Homologous bone', 'description': 'The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone', 'interventionNames': ['Device: Homologous Bone']}], 'interventions': [{'name': 'NanoBone', 'type': 'DEVICE', 'description': 'Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix', 'armGroupLabels': ['NanoBone']}, {'name': 'Homologous Bone', 'type': 'DEVICE', 'description': 'Cage was filled with homologous bone', 'armGroupLabels': ['Homologous bone']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Mohammad ARAB MOTLAGH', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}