Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 6:51 AM
Study NCT ID:
NCT05685693
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-24
First Post:
2022-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROSA Knee System vs Conventional Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2022-11-25', 'studyFirstSubmitQcDate': '2023-01-12', 'lastUpdatePostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gait, walking', 'timeFrame': 'Pre-operative, 12-months post-operative', 'description': 'comfortable walking speed'}, {'measure': 'Gait, sit-to-stand', 'timeFrame': 'Pre-operative, 12-months post-operative', 'description': 'ground reaction force difference between left and right foot during sit-to-stand-transfer'}, {'measure': 'Gait, single-leg-stance', 'timeFrame': 'Pre-operative, 12-months post-operative', 'description': 'standard deviation in center of mass and pressure during single-leg-stance'}, {'measure': 'Proprioception, reaction time', 'timeFrame': 'Pre-operative, 12-months post-operative', 'description': 'Proprioception of the knee will be measured in a motorized carriage. Patients will lay on a hospital bed where their leg is fixed in the motorized carriage. This sled will passively extend and flex the knee. When patients get the sensation of movement, they have to push a button. The reaction time and the angle to sense the movement will be measured digitally.'}, {'measure': 'Proprioception, angle at movement', 'timeFrame': 'Pre-operative, 12-months post-operative', 'description': 'Proprioception of the knee will be measured in a motorized carriage. Patients will lay on a hospital bed where their leg is fixed in the motorized carriage. This sled will passively extend and flex the knee. When patients get the sensation of movement, they have to push a button. The reaction time and the angle to sense the movement will be measured digitally.'}], 'primaryOutcomes': [{'measure': 'Oxford Knee Score', 'timeFrame': '3-months post-operative', 'description': 'The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation.'}, {'measure': 'Oxford Knee Score', 'timeFrame': '12-months post-operative', 'description': 'The Oxford Knee Score (OKS, best to worst 0-48) measures pain intensity and functional limitation of the knee during various activities. The questionnaire consists of 12 items. The maximum total score is 60 and corresponds with the highest pain intensity and functional limitation.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life-Index', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'European Quality of Life-questionnaire-5-dimension-3-level (worst to best, -0.329 to 1.000)'}, {'measure': 'Symptoms', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (worst to best 0-100)'}, {'measure': 'Pain Catastrophizing', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Pain Catastrophizing Scale (best to worst, 0-52)'}, {'measure': 'Pain Sensitivity', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Pain Sensitivity Questionnaire (best to worst, 0-140)'}, {'measure': 'Mobility', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'De Morten Mobility index (worst to best, 0-100)'}, {'measure': 'Complications', 'timeFrame': 'During in-patient stay for indicated surgery (up to 5 days)', 'description': 'Registered complications during hospitalization'}, {'measure': 'Duration of surgery', 'timeFrame': 'During surgery', 'description': 'Registered duration of surgery'}, {'measure': 'Blood loss', 'timeFrame': 'During surgery', 'description': 'Registered blood loss during hospitalization'}, {'measure': 'Length of hospital stay', 'timeFrame': 'During in-patient stay for indicated surgery (up to 5 days)', 'description': 'Duration from patient intake until discharge'}, {'measure': 'Anesthesia', 'timeFrame': 'During surgery', 'description': 'Type of anesthesia used'}, {'measure': 'Stability of the knee', 'timeFrame': 'Immediately after the surgery', 'description': 'Ligament tension, assessed by the ROSA Knee System'}, {'measure': 'Knee implant position', 'timeFrame': 'Immediately after the surgery', 'description': 'Resection, assessed by the ROSA Knee System'}, {'measure': 'Mobility of the knee', 'timeFrame': 'During and immediately after the surgery', 'description': 'Flexion, Extension of knee, assessed by the ROSA Knee System'}, {'measure': 'Mechanical axis of the leg.', 'timeFrame': '3-months post-surgery', 'description': 'Hip-Knee-Alignment, by CT'}, {'measure': 'Implant Survival', 'timeFrame': '90-day and 1-year', 'description': 'Duration until failure (required revision)'}, {'measure': 'Patient Survival', 'timeFrame': '90-day and 1-year', 'description': 'Duration until death'}, {'measure': 'Physical Activity', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Steps per day, assessed for 7 continuous days using hip-worn accelerometer'}, {'measure': 'Metabolic Syndrome', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Metabolic Syndrome Severity Scale (no predefined range, higher scores indicate worse outcome)'}, {'measure': 'Body composition', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Fat mass, measured as % using bioimpedance analysis'}, {'measure': 'Handgrip strength', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'handgrip strength using hand-held dynamometer'}, {'measure': 'Physical condition', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Completed distance in 2-minute walking'}, {'measure': 'Physical strength', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Completed sit-to-stand-transfers within 30 seconds'}, {'measure': 'Physical mobility', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Time to stand up, walk 3m back and forth and sit down again (timed-up-and-go test)'}, {'measure': 'Cost of procedure, implants', 'timeFrame': 'During Surgery', 'description': 'Number implant sizes readily available, and used'}, {'measure': 'Cost of procedure, personnel', 'timeFrame': 'During Surgery', 'description': 'Number of Personnel during surgery'}, {'measure': 'Productivity', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Institute for Medical Technology Assessment Productivity Cost Questionnaire (worst to best, 0-100)'}, {'measure': 'Medical consumption', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Institute for Medical Technology Assessment Medical Consumption Questionnaire (outcome in Euro)'}, {'measure': 'Work Ability Index', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Work Ability Index Questionnaire (worst to best, 0-100)'}, {'measure': 'Work Productivity and Activity Impairment', 'timeFrame': 'Pre-operative, 3-months and 12-months post-operative.', 'description': 'Work Productivity and Activity Impairment-Questionnaire (worst to best, 0-100)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Robotic-assisted arthroplasty', 'Knee arthroplasty', 'Gait', 'Metabolic Syndrome', 'ROSA Knee System', 'Physical Activity', 'Cost-effectiveness'], 'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '39815282', 'type': 'DERIVED', 'citation': 'Eijking HM, Dorling IM, van Haaren EH, Hendrickx R, Nijenhuis T, Schotanus MGM, Bouwman L, Most J, Boonen B. Image-based robotic (ROSA(R) knee system) total knee arthroplasty with inverse kinematic alignment compared to conventional total knee arthroplasty : Study protocol and the inverse kinematic alignment in 8-steps using the ROSA(R) Knee system for knee balancing technique explained. J Orthop Surg Res. 2025 Jan 15;20(1):47. doi: 10.1186/s13018-024-05427-y.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized clinical study, in which 150 patients with end-stage osteoarthritis will be enrolled to ROSA®-assisted knee arthroplasty or conventional knee arthroplasty. Patients are recruited at Zuyderland Medical Center, enrolled pre-operatively and followed up for 12 months post-surgery. In- and exclusion criteria are stated below.\n\nAfter recruitment, participants will be invited for a pre-operative visit. During this pre-operative visit Informed Consent is signed and completion of patient-reported outcome measures (PROMs) is checked. Additionally, measurements regarding body composition, strength and fitness and metabolic outcomes are performed. Participants will have a blood sample taken. Scans, adverse event and medication use will be confirmed. Participants will receive a ActiGraph for collecting data from physical activity. Of all patients, 72 will undergo additional measurements (gait, proprioception).\n\nDuring surgery ROSA- and surgery-data will be collected. Post-operative participants will have a 6-weeks, 3-month and 12-month visit. During these visits pre-operative measurements are repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for primary TKA\n* age 40-90 years\n* Body-Mass-Index 18.5-50.0 kg/m2\n* American Society of Anaesthesiologists Class I-III\n* Willingness and capability to understand and follow protocol\n\nExclusion Criteria:\n\n\\- Rheuma-/trauma-indicated knee arthroplasty'}, 'identificationModule': {'nctId': 'NCT05685693', 'acronym': 'ROSA_RCT', 'briefTitle': 'ROSA Knee System vs Conventional Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Zuyderland Medisch Centrum'}, 'officialTitle': 'The Effect of ROSA®-Assisted Knee Arthroplasty on Clinical Outcomes', 'orgStudyIdInfo': {'id': 'Z2021179'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional TKA', 'description': 'Conventional TKA, with no patient-specific instrumentation or robotic assistance', 'interventionNames': ['Procedure: conventional total knee arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Robotic-assisted TKA', 'description': 'ROSA Knee System assisted TKA', 'interventionNames': ['Procedure: Robotic-assisted total knee arthroplasty (raTKA)']}], 'interventions': [{'name': 'Robotic-assisted total knee arthroplasty (raTKA)', 'type': 'PROCEDURE', 'description': 'Robotic-assisted total knee arthroplasty is an orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic. The robot (ROSA Knee System, Zimmer Biomet, US) assists in planning and placement of the implants and resection sites.', 'armGroupLabels': ['Robotic-assisted TKA']}, {'name': 'conventional total knee arthroplasty', 'type': 'PROCEDURE', 'description': 'total knee arthroplasty is an orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic. In conventional TKAs, no patient-specific instrumentation or robotic assistance is provided.', 'armGroupLabels': ['Conventional TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6162 BG', 'city': 'Sittard', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Zuyderland Medical Center', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}], 'overallOfficials': [{'name': 'Jasper Most, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zuyderland Medical Center'}, {'name': 'Bert Boonen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zuyderland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zuyderland Medisch Centrum', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zimmer Biomet', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}