Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04079751
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2019-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System
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'], 'maskingDescription': 'The patient will not be informed of their study allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-09-04', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant migration', 'timeFrame': '2 years', 'description': 'Measured via radiosteriometric analysis (RSA)'}], 'secondaryOutcomes': [{'measure': 'Oxford-12 knee score', 'timeFrame': 'Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years', 'description': 'The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Pre-operative, 12 months', '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': 'European Quality of Life (EQ-5D-5L)', 'timeFrame': 'Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 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 generic health status - completed by the subject. The EQ5D uses a Likert scale which assesses five states (mobility, self care, usual care, pain and discomfort and anxiety and depression) at five different levels - none(0), slight(1), moderate(2), severe(3) or unable to perform(5). Levels are coded 1-5 and an index score is then generated.'}, {'measure': "Pre-operative Patient's Knee Implant Performance (PKIP)", 'timeFrame': 'Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 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': '7. University of California at Los Angeles (UCLA) Activity Level scale', 'timeFrame': 'Pre-operative, 6 months, 1 year, 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 VAS', 'timeFrame': 'Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 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: VAS', 'timeFrame': 'Preoperative, 3 Months, 6 Months, 1 Year, 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': 'Patient complications', 'timeFrame': 'Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years', 'description': 'Evaluate the type and frequency of the complications/adverse events.'}, {'measure': 'Hospital stay', 'timeFrame': 'Up to 1 week', 'description': 'Number of days in hospital'}, {'measure': 'Tourniquet time', 'timeFrame': 'Intraoperative', 'description': 'Length of time tourniquet was applied (minutes)'}, {'measure': 'Length of surgery', 'timeFrame': 'Intraoperative', 'description': 'Length of surgery, from open to closing of incision (minutes)'}, {'measure': 'Blood loss', 'timeFrame': 'Intraoperative', 'description': 'Amount of blood loss during the procedure (mL)'}, {'measure': 'Anesthesia type', 'timeFrame': 'Intraoperative', 'description': 'Anesthesia methods (general, spinal, epidural, TXA)'}, {'measure': 'Peri-operative pain management', 'timeFrame': 'Intraoperative', 'description': 'A tabulation of the pain management (Peri-Articular Injection, Femoral Nerve Block, Add. Canal Block or none) used during the procedure.'}, {'measure': 'Soft tissue release', 'timeFrame': 'Intraoperative', 'description': 'A tabulation of the tissue released during the procedure (MCL, LCL, PCL, Posterior Capsule Release).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.', 'detailedDescription': 'This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:\n\n1. Neutral mechanical alignment;\n2. Anatomical alignment.\n\nThe principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.\n\nSecondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty\n2. Varus knee deformity of 0 to 10 degrees\n3. Sufficient ligamentous function to warrant retention of the posterior cruciate ligament\n4. Between the ages of 21 and 80 inclusive\n5. Patients willing and able to comply with follow-up requirements and self-evaluations\n6. Ability to give informed consent\n\nExclusion Criteria:\n\n1. Active or prior infection\n2. Medical condition precluding major surgery\n3. Inflammatory arthropathy\n4. Prior patellectomy\n5. PCL deficiency\n6. Major Coronal plane deformity\n7. Valgus alignment\n8. Bone defects requiring augments, cones and/or stemmed implants\n9. Body Mass Index 45 or more'}, 'identificationModule': {'nctId': 'NCT04079751', 'briefTitle': 'Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Radiostereometric Analysis Network'}, 'officialTitle': 'Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Anatomic (Femur First) to Neutral Mechanical Alignment Techniques', 'orgStudyIdInfo': {'id': 'B2018-139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neutral Mechanical Alignment', 'description': 'Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment', 'interventionNames': ['Procedure: Neutral Mechanical Alignment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anatomical Alignment', 'description': 'Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment', 'interventionNames': ['Procedure: Anatomical Alignment']}], 'interventions': [{'name': 'Neutral Mechanical Alignment', 'type': 'PROCEDURE', 'description': 'Hip-knee-ankle angle of 180° ± 3°.', 'armGroupLabels': ['Neutral Mechanical Alignment']}, {'name': 'Anatomical Alignment', 'type': 'PROCEDURE', 'description': "Restoring a patient's pre-diseased limb alignment", 'armGroupLabels': ['Anatomical Alignment']}]}, '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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Concordia Joint Replacement Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Radiostereometric Analysis Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}