Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-31 @ 2:42 PM
Study NCT ID:
NCT01705366
Status:
TERMINATED
Last Update Posted:
2018-09-26
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'whyStopped': 'Changes in funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reduced WOMAC', 'timeFrame': '1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery', 'description': "The Reduced WOMAC is a truncated version of the Western Ontario and McMaster's University Osteoarthritis Index. The questionnaire is designed to assess pain, disability and joint stiffness in the osteoarthritis patient."}, {'measure': 'Knee injury and Osteoarthritis Outcome Score', 'timeFrame': '1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery', 'description': "The KOOS or Knee injury and Osteoarthritis Outcome Score are patient completed questionnaires which assess the patient's opinion regarding their knee and its associated osteoarthritis."}, {'measure': 'EQ-5D', 'timeFrame': '1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery', 'description': 'The EQ-5D is a standardized instrument for use as a measure of health outcome.'}, {'measure': 'Forgotten Joint Score', 'timeFrame': '1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery', 'description': 'The Forgotten Joint Score is a 12-item questionnaire completed by the patient to determine how aware they are of their joint in their everyday life.'}], 'primaryOutcomes': [{'measure': 'Survivorship of Components', 'timeFrame': '10 years', 'description': 'Survivorship of components is defined as knee implant device(s) remaining in patient.'}], 'secondaryOutcomes': [{'measure': 'American Knee Society Knee Score', 'timeFrame': '1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery', 'description': "The American Knee Society Score is an assessment and questionnaire that provides a rating of the pain, function, range of motion, and knee joint stability. It is subdivided into a knee score that rates only the knee joint itself and a functional score that rates the patient's ability to walk and climb stairs."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Joint Disease', 'Arthritis', 'Musculoskeletal Disease'], 'conditions': ['Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.\n\nThe hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All male and non-pregnant females undergoing knee replacement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities\n* has failed non-operative management of their joint disease\n\nExclusion Criteria:\n\n* cognitively unable to complete study health-related quality of life forms\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT01705366', 'briefTitle': 'Clinical Outcomes of Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Northwest Surgical Specialists, Vancouver'}, 'officialTitle': 'Clinical Outcomes of Joint Arthroplasty', 'orgStudyIdInfo': {'id': 'MAKO-01'}, 'secondaryIdInfos': [{'id': 'Borus 2015-005', 'type': 'OTHER', 'domain': 'Stryker'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Knee Arthroplasty', 'description': 'Patients undergoing total knee arthroplasty. This may be Non-MAKO® Robot Assisted Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty or MAKO® Robot Assisted Medial and PF Knee Arthroplasty\n\nThe Non-MAKO® Robot Assisted Total Knee Arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System. The MAKO® Robot Assisted Arthroplasty uses the RESTORIS Multicompartmental Knee System .', 'interventionNames': ['Procedure: Non-MAKO® Robot Assisted Total Knee Arthroplasty', 'Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty', 'Procedure: MAKO® Robot Assisted Medial and PF Knee Arthroplasty', 'Device: RESTORIS Multicompartmental Knee System', 'Device: Depuy Knee Replacement System', 'Device: Stryker® Knee Replacement System']}], 'interventions': [{'name': 'Non-MAKO® Robot Assisted Total Knee Arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['TKA', 'Total Knee Replacement', 'Revision Knee Arthroplasty'], 'description': 'Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.', 'armGroupLabels': ['Knee Arthroplasty']}, {'name': 'MAKO® Robot Assisted Medial Knee Arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['Unicompartmental Knee Arthroplasty (UKA)'], 'description': 'Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.', 'armGroupLabels': ['Knee Arthroplasty']}, {'name': 'MAKO® Robot Assisted Medial and PF Knee Arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['Bi-compartmental Knee Arthroplasty'], 'description': 'Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee', 'armGroupLabels': ['Knee Arthroplasty']}, {'name': 'RESTORIS Multicompartmental Knee System', 'type': 'DEVICE', 'otherNames': ['RESTORIS® MCK MultiCompartmental Knee System', 'FDA 501K number K090763'], 'description': 'The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.', 'armGroupLabels': ['Knee Arthroplasty']}, {'name': 'Depuy Knee Replacement System', 'type': 'DEVICE', 'description': 'The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.', 'armGroupLabels': ['Knee Arthroplasty']}, {'name': 'Stryker® Knee Replacement System', 'type': 'DEVICE', 'description': 'The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.', 'armGroupLabels': ['Knee Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98686', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Rebound Orthopedics and Neurosurgery', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}], 'overallOfficials': [{'name': 'Todd Borus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery'}, {'name': 'Donald Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwest Surgical Specialists, Vancouver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker MAKO Surgical Corp', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}