Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 7:28 PM
Study NCT ID:
NCT00417859
Status:
COMPLETED
Last Update Posted:
2020-04-21
First Post:
2007-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brigitte.jolles@chuv.ch', 'phone': '0213149629', 'title': 'Prof Brigitte Jolles', 'organization': 'University Hospital of Lausanne'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'TKA Mobile', 'description': 'TKA mobile\n\nTotal knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TKA Fix', 'description': 'TKA fix', 'otherNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'postoperative varus knee laxity due to a deficiency in the fibular collateral ligament', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gait Stride Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative', 'description': 'preoperative stride lenght of all participants'}, {'id': 'OG001', 'title': '5 Years', 'description': 'stride lenght at 1 year following TKA of all participants'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '1.3'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.3'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon's signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '5years', 'description': 'distance in meters of gait stride lenght measured by a data logger with five inertial sensors', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'EuroQoL Quality of Life Scale (EQ-5D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TKA Mobile', 'description': 'TKA mobile\n\nTotal knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing'}, {'id': 'OG001', 'title': 'TKA Fix', 'description': 'TKA fix'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '79.9', 'spread': '18.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5years', 'description': 'The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T.\n\nDescriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)'}, {'type': 'SECONDARY', 'title': 'Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TKA Mobile', 'description': 'TKA mobile\n\nTotal knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing'}, {'id': 'OG001', 'title': 'TKA Fix', 'description': 'TKA fix'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '49.3', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5years', 'description': 'Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data collected in 25 patients on each group (as this a patient reported outcome, thr data was missing in some of the cases)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Dislocation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TKA Mobile', 'description': 'TKA mobile\n\nTotal knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing'}, {'id': 'OG001', 'title': 'TKA Fix', 'description': 'TKA fix'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5years', 'description': 'count of numbers of dislocated implants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TKA Mobile', 'description': 'TKA mobile\n\nTotal knee arthroplasty with mobile bearing implant.'}, {'id': 'FG001', 'title': 'TKA Fix', 'description': 'Total knee arthroplasty with fixed bearing implant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '8 patients were excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TKA Mobile', 'description': 'TKA mobile\n\nTotal knee arthroplasty: mobile bearing: Total knee arthroplasty: mobile bearing'}, {'id': 'BG001', 'title': 'TKA Fix', 'description': 'TKA fix'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '70.2', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2007-01-03', 'resultsFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2007-01-03', 'lastUpdatePostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-06', 'studyFirstPostDateStruct': {'date': '2007-01-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Stride Length', 'timeFrame': '5years', 'description': 'distance in meters of gait stride lenght measured by a data logger with five inertial sensors'}, {'measure': 'EuroQoL Quality of Life Scale (EQ-5D)', 'timeFrame': '5years', 'description': 'The EQ-5D is a measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale designed to indicate the level of the problem. Part II uses a vertical graduated VAS (thermometer) to measure health status, ranging from worst imaginable health state to best imaginable health state. T.\n\nDescriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time.'}], 'secondaryOutcomes': [{'measure': 'Semi-objective Evaluation Knee Sciety Score (KSS) Clinical Outcome Measures', 'timeFrame': '5years', 'description': 'Scoring system to clinically rate the knee abefore and after TK, scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.'}, {'measure': 'Number of Participants With Dislocation', 'timeFrame': '5years', 'description': 'count of numbers of dislocated implants.'}]}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to provide gait parameters as a new objective method to assess total knee arthroplasty outcome between patients with fixed- and mobile-bearing, using an ambulatory device with minimal sensor configuration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from a primary unilateral knee osteoarthritis and requiring a knee replacement\n* Informed consent'}, 'identificationModule': {'nctId': 'NCT00417859', 'briefTitle': 'Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Total Knee Arthroplasty: Comparison of Fixed and Mobile Bearings', 'orgStudyIdInfo': {'id': 'HO 218/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TKA mobile', 'description': 'TKA mobile', 'interventionNames': ['Device: Total knee arthroplasty: mobile bearing']}, {'type': 'NO_INTERVENTION', 'label': 'TKA', 'description': 'TKA fix'}], 'interventions': [{'name': 'Total knee arthroplasty: mobile bearing', 'type': 'DEVICE', 'description': 'Total knee arthroplasty: mobile bearing', 'armGroupLabels': ['TKA mobile']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'HOSR', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'B Jolles, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Brigitte Jolles, MD', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}