Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-13 @ 7:19 AM
Study NCT ID:
NCT02103504
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2014-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DePuy Attune Total Knee Arthroplasty RSA Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2014-03-28', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant migration', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Functional range of motion', 'timeFrame': '2 years'}, {'measure': 'Self-reported health status', 'timeFrame': '2 years', 'description': 'EQ-5D score'}, {'measure': 'Self-reported joint status', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The DePuy Attune knee system incorporates several key features aimed at improving kinematics of the knee joint, range of motion, and smoothness of use compared to existing total knee replacement technologies. As this is a newly approved medical device, clinical testing in patients using high precision diagnostics is important to evaluate the stability of implant fixation and in vivo function. We propose a multi-centre consecutive series study examining the stability of the Attune posterior-stabilized knee design in 30 patients undergoing total knee arthroplasty for a follow-up period of 2 years. Radiostereometric analysis (RSA) will be utilized to identify the micromotion of the tibial tray with respect to the surrounding bone. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at follow-up intervals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty\n* Between the ages of 21 and 80 inclusive\n* Patients willing and able to comply with follow-up requirements and self-evaluations\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Active or prior infection\n* Medical condition precluding major surgery'}, 'identificationModule': {'nctId': 'NCT02103504', 'briefTitle': 'DePuy Attune Total Knee Arthroplasty RSA Study', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Roentgen Stereophotogrammetric Analysis (RSA) of the ATTUNETM Posterior Stabilized Fixed Bearing Knee System', 'orgStudyIdInfo': {'id': 'DEP ATT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DePuy Attune TKA', 'description': 'DePuy Attune posterior stabilized fixed bearing total knee replacement', 'interventionNames': ['Device: DePuy Attune posterior stabilized fixed bearing total knee replacement']}], 'interventions': [{'name': 'DePuy Attune posterior stabilized fixed bearing total knee replacement', 'type': 'DEVICE', 'armGroupLabels': ['DePuy Attune TKA']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Concordia Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Capital District Health Authority', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Michael Dunbar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital Health, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Dunbar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Concord Hospital', 'class': 'OTHER'}, {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon', 'investigatorFullName': 'Michael Dunbar', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}