Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 8:03 PM
Study NCT ID:
NCT04307251
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2020-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical axis', 'timeFrame': 'Change from baseline mechanical axis at 6 weeks after surgery', 'description': 'Post-operative Mechanical Alignment; Hip-Knee-Ankle angle; If you divide the knee into quadrants, the ideal mechanical axis would bisect the knee (0), with medial zone (-1) or lateral zone (-1) being within physiologic range. With the notable exception of physiologic varus \\<age 2 and physiologic valgus \\<age 6, medial or lateral zones 2 or 3 would likely manifest symptoms and gait disturbance and thereby warrant surgical intervention'}], 'secondaryOutcomes': [{'measure': 'Knee Society and Knee Society function score', 'timeFrame': 'Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery', 'description': 'Knee Society and Knee Society function score (minimum 0, maximum 200)'}, {'measure': 'Range of motion of knee', 'timeFrame': 'Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery', 'description': 'Range of motion of knee (minimum 0, maximum 140)'}, {'measure': 'Oxford knee score', 'timeFrame': 'Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery', 'description': 'Oxford knee score (minimum 0, maximum 48)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty\n* Age 50-80 year\n* Patients with osteoarthritis who voluntarily participated in the project\n\nExclusion Criteria:\n\n* Patients with osteoporosis\n* History of inflammatory arthroplathy\n* Previous fracture or open surgery on the same knee\n* Patients with bilateral total knee arthroplasty\n* Patients osteoarthritis with revision surgery'}, 'identificationModule': {'nctId': 'NCT04307251', 'briefTitle': 'Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Navamindradhiraj University'}, 'officialTitle': 'Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'COA 012/2563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Navio™ Robotics-assisted Surgical System', 'interventionNames': ['Device: Navio™ Robotics-assisted Surgical System, LEGION Total Knee System']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional, non-robotics-assisted total knee surgical system', 'interventionNames': ['Device: Conventional, LEGION Total Knee System']}], 'interventions': [{'name': 'Navio™ Robotics-assisted Surgical System, LEGION Total Knee System', 'type': 'DEVICE', 'description': "Robotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy.", 'armGroupLabels': ['Navio™ Robotics-assisted Surgical System']}, {'name': 'Conventional, LEGION Total Knee System', 'type': 'DEVICE', 'description': 'Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific.', 'armGroupLabels': ['Conventional, non-robotics-assisted total knee surgical system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10300', 'city': 'Dusit', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Navamindradhiraj University', 'geoPoint': {'lat': 13.7775, 'lon': 100.51977}}], 'overallOfficials': [{'name': 'Satit Thiengwittayaporn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navamindradhiraj University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Satit Thiengwittayaporn', 'investigatorAffiliation': 'Navamindradhiraj University'}}}}