Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-10 @ 5:42 PM
Study NCT ID:
NCT03193034
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2017-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DSJ-2016-07 ATTUNE® Cementless CR RP Japan
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', 'maskingDescription': 'An independent radiographic reviewer will be assessing all radiographs from the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-reported Outcome:Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living (KOOS ADL)', 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.'}], 'secondaryOutcomes': [{'measure': "Patient-reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)", 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': "The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 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 Likert- like response option."}, {'measure': 'Patient-reported Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': 'The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and include the WOMAC Osteoarthritis index. The KOOS consists of 5 subscales: pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.'}, {'measure': 'Combination of Patient-reported and Clinical-reported Outcome: Knee Society 2011', 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': 'The Knee Society Score is a self-administered questionnaire. The subject completes questions regarding: Symptoms (3 questions), Patient Satisfaction (5 questions), Patient Expectations (3 questions), Functional Activities (5 questions), Standard Activities (6 questions), Advanced Activities (5 questions), and Discretionary Knee Activities ( 4 questions). The surgeon completes questions regarding objective knee indicators. Likert responses are used, typically with five response options.'}, {'measure': 'Patient Reported Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)', 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': 'EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.'}, {'measure': 'Modified VAS Pain Score: Pain and Satisfaction', 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': 'VAS Pain Score is a standardized instrument for use as a measure of pain and satisfaction that is designed for completion by the subject. This modified version has scores that are discrete numbers rather than a continual scale'}, {'measure': 'Type and Frequency of Adverse Events (AEs) for all enrolled subjects', 'timeFrame': 'Pre-op (-180 to -1 days before surgery), 6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)', 'description': 'All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.'}, {'measure': 'Survivorship', 'timeFrame': 'Minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)', 'description': 'Kaplan-Meier survival analysis will be used to calculate the survivorship of configuration (CR RP)'}, {'measure': 'Implant fixation: Radiographic assessment of bone-implant interface performance', 'timeFrame': '6 weeks (1-303 days after surgery), minimum 1 year (304-669 days after surgery), minimum 2 years (670-912 days after surgery)', 'description': 'Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change \\>3degrees in any plane.'}, {'measure': 'Evaluate changes in femoral component and tibial component alignment', 'timeFrame': 'Minimum 2 years (670-912 days after surgery)', 'description': 'Radiographic success is defined as: absence of progressive radiolucent lines greater than or equal to 2mm in any one zone; absence of lytic lesions in any zone; absence of individual component position change \\>3degrees in any plane.'}, {'measure': 'Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.', 'timeFrame': 'Minimum 1 year (304-669 days after surgery)', 'description': 'Evaluate the tilt angle and translational position of the patellar component relative to the trochlear groove.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthroplasty', 'replacement', 'Knee', 'function', 'radiographic', 'survivorship'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The primary objective is to investigate the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score) in the Japanese patient population.', 'detailedDescription': '* Evaluate change from preoperative baseline in post-operative outcomes using additional patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and sub-scores), AKS and EQ-5D-3L.\n* Evaluate change from preoperative baseline in pain and satisfaction over time as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale) at 2yr.\n* Evaluate type and frequency of Adverse Events\n* Evaluate survivorship of the ATTUNE® Primary Cementless TKA system for the CR RP configurations using Kaplan-Meier survival analysis at 1 and 2yrs.\n* Evaluate primary, cementless ATTUNE® TKA fixation through zonal radiographic analysis of the bone-implant interface at 6wk, 1yr, and 2yrs after surgery.\n* Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component alignment at 2 years compared to the first postoperative radiographs.\n* Radiographically characterize the postoperative ATTUNE patellar component alignment and positioning in Japanese population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.\n* Subject was diagnosed with NIDJD.\n* Subject, in the opinion of the Investigator, is a suitable candidate for cementless primary TKA using the devices described in this CIP with either resurfaced or non-resurfaced patellae.\n\nSubject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor .\n\n* Subject is currently not bedridden\n* Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.\n* Subject is able to read, and comprehend the Informed Consent Document as well as complete the required PROs in Japanese.\n\nExclusion Criteria:\n\n* The Subject is a woman who is pregnant or lactating. -Contralateral knee has already been enrolled in this study\n* Subject had a contralateral amputation.\n* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.\n* Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive TKA.\n* Subject has participated in a clinical investig ation with an investigational product (drug or device) in the last three (3) months.\n* Subject is currently involved in any personal injury litigation, medical-legal or Worker's Acc ident Insurance claims (similar to Workers Compensation in USA).\n* Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported question naires or be compliant with follow-up requirements.\n* Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.\n* Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).\n* Subject is suffering from inflammatory arthritis (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).\n* Subject has a medical condition with less than two (2) years life expectancy.\n* Uncontrolled gout"}, 'identificationModule': {'nctId': 'NCT03193034', 'briefTitle': 'DSJ-2016-07 ATTUNE® Cementless CR RP Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'DePuy Orthopaedics'}, 'officialTitle': 'Multi-Center Clinical Evaluation of the ATTUNE® Cementless Rotating Platform Total Knee Arthroplasty in the Japanese Patient Population', 'orgStudyIdInfo': {'id': 'DSJ-2016-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATTUNE Cementless RP TKA', 'description': 'Subjects will receive a cementless, rotating platform total knee arthroplasty.', 'interventionNames': ['Device: Cementless Total Knee Arthroplasty']}], 'interventions': [{'name': 'Cementless Total Knee Arthroplasty', 'type': 'DEVICE', 'description': 'Patients will undergo a primary total knee replacement using the configuration of the ATTUNE Cementless knee (CR RP)', 'armGroupLabels': ['ATTUNE Cementless RP TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '481-0011', 'city': 'Kitanagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya orthopedic Clinic', 'geoPoint': {'lat': 35.24702, 'lon': 136.87832}}, {'zip': '467-8601', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Kobe University Graduate School of Medicine', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '591-8025', 'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Rosai Hospital', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}], 'overallOfficials': [{'name': 'Kirstin Cosgrove', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DePuy Orthopaedics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Johnson & Johnson K.K. Medical Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}