Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-30 @ 9:55 PM
Study NCT ID:
NCT01010269
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2009-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-05', 'size': 630310, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-21T21:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-21', 'studyFirstSubmitDate': '2009-10-26', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Knee Society Knee Score', 'timeFrame': '1 Year postop', 'description': 'Including ROM'}], 'secondaryOutcomes': [{'measure': 'Kinematic Fluoroscopic Analysis', 'timeFrame': '3 yr', 'description': 'Kinematic Fluoroscopic Analysis'}, {'measure': 'Gait Lab Analysis', 'timeFrame': '3 yr', 'description': 'Gait Lab Analysis'}, {'measure': 'EQ5D', 'timeFrame': '3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr', 'description': 'Quality of Life'}, {'measure': 'Radiographic Assessment', 'timeFrame': 'immediate postop, 3 mo, 6 mo, 1 yr, 3 yr, 5 yr, 7 yr, 10 yr', 'description': 'Radiographic Assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Rheumatoid Arthritis', 'Traumatic Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Vanguard High Flex Rotating Platform to Vanguard Complete Knee System in Asian population in terms of early range of motion (ROM), clinical outcomes, and kinetic and kinematic characteristics in relation to healthy knees.', 'detailedDescription': 'The primary objectives of this clinical study include:\n\n* Evaluate size fit and long term performance of Vanguard Complete Knee ("Fixed") System in Asian and Latino population in comparison to competitor\'s similar product.\n* Evaluate efficacy of Vanguard Complete Knee with Microplasty Tibial Tray.\n* Compare Vanguard High Flex Rotating Platform ("High Flex") Knee System to Vanguard Complete Knee System in Asian population in terms of:\n\n * Early ROM\n * Clinical outcomes\n * Kinetic and Kinematic characteristics in relation to Healthy Knees. o\n* Compare current design to new design of Vanguard High Flex Rotating Platform Knee System in terms of :\n\n * Early ROM\n * Clinical outcomes\n * Kinetic and Kinematic characteristics'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful and disabled knee joint resulting form osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.\n* Correction of varus, valgus, or posttraumatic deformity.\n* Correction or revision of unsuccessful osteotomy, or arthrodesis.\n* Need to obtain pain relief and improve function.\n* Ability and willingness of the patient to follow instructions, including control of weight and activity level.\n* Good nutritional state of the patient.\n* Patient must have reached full skeletal maturity.\n\nExclusion Criteria:\n\n* Infection, sepsis, osteomyelitis, and failure of previous joint replacement.\n* Uncooperative patient or patients with neurologic disorders who are incapable of following directions.\n* Osteoporosis\n* Metabolic disorders which may impair bone formation\n* Osteomalacia\n* Distant foci of infections which may spread to the implant site\n* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram\n* Vascular insufficiency, muscular atrophy, neuromuscular disease\n* Incomplete or deficient soft tissue surrounding the knee'}, 'identificationModule': {'nctId': 'NCT01010269', 'briefTitle': 'Vanguard Complete Knee Versus Vanguard High Flex Rotating Platform (RP) Knee Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zimmer Biomet'}, 'officialTitle': 'A Prospective Controlled Multi-center Study on Vanguard Complete Knee and Vanguard High Flex RP Knee', 'orgStudyIdInfo': {'id': 'INT.CR.RROW1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vanguard Complete Knee', 'description': 'Vanguard Completed Knee with Microplasty Tibial Tray is designed to hold the tibial knee bearings in a microplsty knee procedure. The Co-Cro-Mo trays are designed with a shorter stem.', 'interventionNames': ['Device: Vanguard Complete Knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vanguard High Flex RP', 'description': 'VGRD High Flex RP knee is an extension to the exsting Vanguard Knee and has been specifically desinged to facilitate greather than 135 degrees of knee flextion as required by certain patients.', 'interventionNames': ['Device: Vanguard High Flex RP']}], 'interventions': [{'name': 'Vanguard Complete Knee', 'type': 'DEVICE', 'description': 'Vanguard Knee is a metal and polyethylene system indicated for cemented tibial and femoral use.', 'armGroupLabels': ['Vanguard Complete Knee']}, {'name': 'Vanguard High Flex RP', 'type': 'DEVICE', 'description': 'Vanguard High Flex RP is an extension to the existing Vanguard Knee and has been specifically designed to facilitate greater than 135 degrees of knee flexion.', 'armGroupLabels': ['Vanguard High Flex RP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul Nat'l Uni. Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic Uni. of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Myung-Chul Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Chul-Won Ha, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}, {'name': 'Seong-Il Bin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Yong In, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Catholic University Uijungbu St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}