Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-09 @ 7:04 AM
Study NCT ID:
NCT02921594
Status:
WITHDRAWN
Last Update Posted:
2018-08-17
First Post:
2016-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'NCT02921594 was not a RCT but a secondary pilot study designed to establish a fluoroscopic test-set up on 10 selected patients from another RCT.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior-posterior translation of the femoral component with respect to the tibia component', 'timeFrame': 'at least one year post surgery', 'description': 'Group mean in millimeters (mm)'}, {'measure': 'Axial rotation of the femoral component with respect to the tibia component', 'timeFrame': 'at least one year post surgery', 'description': 'Group mean in degrees (°)'}], 'secondaryOutcomes': [{'measure': 'Traveled distance of center of pressure', 'timeFrame': 'at least one year post surgery', 'description': 'Group mean in centimeters (cm)'}, {'measure': 'Velocity of center of pressure', 'timeFrame': 'at least one year post surgery', 'description': 'Group mean in mm/second'}, {'measure': 'Rambling-trembling distance', 'timeFrame': 'at least one year post surgery', 'description': 'Group mean in mm'}, {'measure': 'Isometric quadriceps muscle strength', 'timeFrame': 'at least one year post surgery', 'description': 'Group mean in newton meter pr. kilograms weight (Nm/kg)'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.\n\nSecondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in the XP vs. CR study (inherited traits from study inclusion)\n* Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement\n* Are able to perform the tasks\n* Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)\n\nExclusion Criteria:\n\n* Knee pain above 20 on a 0-100 visual analogue scale\n* Any clinical relevant pain from adjacent joints\n* Active Knee flexion below 100\n* Signs of implant migration, loosening, and implant mal-alignment'}, 'identificationModule': {'nctId': 'NCT02921594', 'briefTitle': 'Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties: A Cross Sectional Pilot Study Evaluating Intraarticular Kinematics and Standing Balance by Dynamic Fluoroscopy and Force Plate Examination', 'orgStudyIdInfo': {'id': 'XPvsCR_Fluoroscopi_v.1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Total knee arthroplasty with Vanguard XP', 'description': 'The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved.', 'interventionNames': ['Device: Total knee arthroplasty with Vanguard XP', 'Device: Total knee arthroplasty with Vanguard CR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Total knee arthroplasty with Vanguard CR', 'description': 'Total knee arthroplasty system without preservation of the anterior cruciate ligament', 'interventionNames': ['Device: Total knee arthroplasty with Vanguard XP', 'Device: Total knee arthroplasty with Vanguard CR']}], 'interventions': [{'name': 'Total knee arthroplasty with Vanguard XP', 'type': 'DEVICE', 'armGroupLabels': ['Total knee arthroplasty with Vanguard CR', 'Total knee arthroplasty with Vanguard XP']}, {'name': 'Total knee arthroplasty with Vanguard CR', 'type': 'DEVICE', 'armGroupLabels': ['Total knee arthroplasty with Vanguard CR', 'Total knee arthroplasty with Vanguard XP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD, dr.med', 'investigatorFullName': 'Anders Troelsen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}