Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06678958
Status:
COMPLETED
Last Update Posted:
2024-11-07
First Post:
2024-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2024-11-06', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functionl hip status', 'timeFrame': '8 years', 'description': 'Functional outcome was assessed by oxford hip score the worst score is 12 and the best score is 60'}, {'measure': 'Survivorship of the construct', 'timeFrame': '8years', 'description': 'The rate of construct survivorship using the kaplan meier survival analysis'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acetabular augments', 'Flying buttress', 'Revision total hip replacement'], 'conditions': ['Acetabular Abnormality']}, 'descriptionModule': {'briefSummary': 'This study hypothesize that trabecular metal augments used in the flying buttress position is a valid option with good results in the management of uncontained acetabular defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both sexes\n* 18 years or older\n* acetabular defect paprosky 2b or 3a segemntal defect reconstructed with trabecualr metal augment in the flying buttress position.\n\nExclusion Criteria:\n\n* patients presented with active infection\n* pathological defects\n* pelvic discontinuity'}, 'identificationModule': {'nctId': 'NCT06678958', 'briefTitle': 'Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Intermediate Term Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position in the Management of Acetabular Defects', 'orgStudyIdInfo': {'id': 'Trabecular metal augments'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult patients with acetabular defects requiring reconstruction', 'description': 'The acetabular defect was reconstructed by tarbecular metal augments in the flying buttress position', 'interventionNames': ['Procedure: Reconstruction of acetabular defect by trabecular metal augment']}], 'interventions': [{'name': 'Reconstruction of acetabular defect by trabecular metal augment', 'type': 'PROCEDURE', 'description': 'The augments were used in the flying buttress position', 'armGroupLabels': ['Adult patients with acetabular defects requiring reconstruction']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of orthopedic surgery', 'investigatorFullName': 'Tony Maher', 'investigatorAffiliation': 'Ain Shams University'}}}}