Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT03554720
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2018-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-16', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-06-11', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RSA Migration', 'timeFrame': '2 Years', 'description': 'Migration of the tibial and femoral components between the 2 device designs.'}], 'secondaryOutcomes': [{'measure': 'Knee Replacement Expectation Survey (KRES)', 'timeFrame': 'Preoperative', 'description': 'The KRES is a patient reported questionnaire that consists of 19 questions. The questions ask how each expectation is important in the treatment of the knee. The scale is rated: 1 (Very important) to 5 (This does not apply to me). The score ranges from 19 to 95 with higher scores associated with higher expectations.'}, {'measure': 'European Quality of Life (EQ-5D-5L)', 'timeFrame': 'Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years', 'description': 'Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments. The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.'}, {'measure': 'Pain score', 'timeFrame': 'Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years', 'description': 'Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Preoperative, 6 Months, 1 Year and 2 Years', 'description': 'Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)'}, {'measure': 'Oxford 12 Knee', 'timeFrame': 'Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years', 'description': 'Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome'}, {'measure': 'University of California at Los Angeles (UCLA) Activity Level scale', 'timeFrame': 'Preoperative, 6 Months, 1 Year and 2 Years]', 'description': 'Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Preoperative and 1 Year', 'description': 'The patient are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain. Each PCS item is rated on a 5-point scale: 0 (not at all) to 4 (all the time). The PCS total score is computed by summing responses to the 13 items. PCS total scores range from 0 - 52.'}, {'measure': "Pre-operative Patient's Knee Implant Performance (PKIP)", 'timeFrame': 'Preoperative, 6 Months, 1 Year and 2 Years', 'description': "The Pre-surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient reported questionnaire that consists of 24 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likaert- like response option."}, {'measure': 'Patient complications', 'timeFrame': 'Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years', 'description': 'Evaluate the type and frequency of the complications/adverse events.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.', 'detailedDescription': 'This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, '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': 'NCT03554720', 'briefTitle': 'RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Radiostereometric Analysis Network'}, 'officialTitle': 'Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs', 'orgStudyIdInfo': {'id': 'HS21601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard implants', 'description': 'ATTUNE PS Knee', 'interventionNames': ['Device: ATTUNE PS Knee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced-Fixation', 'description': 'ATTUNE S+ PS Knee', 'interventionNames': ['Device: ATTUNE S+ PS Knee']}], 'interventions': [{'name': 'ATTUNE PS Knee', 'type': 'DEVICE', 'description': 'The ATTUNE PS Knee is the standard implants.', 'armGroupLabels': ['Standard implants']}, {'name': 'ATTUNE S+ PS Knee', 'type': 'DEVICE', 'description': 'The ATTUNE S+ PS Knee is the enhanced fixation.', 'armGroupLabels': ['Enhanced-Fixation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2K 3S8', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Concordia Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Thomas Turgeon, MD MPH FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'Glen Richardson, MD MSc FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University'}, {'name': 'Douglas Naudie, MD FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Radiostereometric Analysis Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Innovation Centre', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}, {'name': 'London Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}