Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02211794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2014-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Journey II BCS EU Observational Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2014-07-22', 'studyFirstSubmitQcDate': '2014-08-06', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revision for any reason', 'timeFrame': '10Years', 'description': 'The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.'}], 'secondaryOutcomes': [{'measure': 'EQ-5D questionnaire', 'timeFrame': 'pre-op, 3month, 1yr, 2yr, 5yr, 10yr', 'description': "patient's opinion about his state of health, according to a visual analogue scale and 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression, (each dimension having 3 levels: no problems, some problems, extreme problems)"}, {'measure': 'Knee Pain Evaluation Form questionnaire', 'timeFrame': '3month, 1yr, 2yr', 'description': 'Assessment of post-operative knee pain'}, {'measure': '2011 Knee Society Score', 'timeFrame': 'pre-op, 3month, 1yr, 2yr, 5yr, 10yr', 'description': "A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome"}, {'measure': 'radiographic evaluation', 'timeFrame': 'pre-op, discharge, 3month, 1yr, 5yr, 10yr', 'description': 'The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.'}, {'measure': 'complication rate (adverse events and revisions)', 'timeFrame': 'discharge, 3month, 1yr, 2yr, 5yr, 10yr', 'description': 'complications will be assessed at each visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'degenerative joint disease'], 'conditions': ['Degenerative Joint Disease']}, 'descriptionModule': {'briefSummary': 'Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.', 'detailedDescription': "Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's).\n\nTotal study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'a patient population consisting of 150 cases and recruited from 4 different countries, will be followed up when undergoing TKA as part of their standard care', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing\n* subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)\n* subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form\n\nExclusion Criteria:\n\n* age \\> 75 years\n* conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)\n* subject has inadequate bone stock to support the device"}, 'identificationModule': {'nctId': 'NCT02211794', 'briefTitle': 'Journey II BCS EU Observational Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System', 'orgStudyIdInfo': {'id': 'R11009-7'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 cohort', 'description': 'subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis)', 'interventionNames': ['Other: data collection']}], 'interventions': [{'name': 'data collection', 'type': 'OTHER', 'armGroupLabels': ['1 cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'University of Modena and Reggio Emilia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '9500', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Sint Maartenskliniek', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Sandvika', 'country': 'Norway', 'facility': 'Martina Hansens Hospital', 'geoPoint': {'lat': 64.46377, 'lon': 13.59125}}, {'zip': 'RG24 7AL', 'city': 'Basingstoke', 'country': 'United Kingdom', 'facility': 'North Hampshire Hospital', 'geoPoint': {'lat': 51.26249, 'lon': -1.08708}}], 'overallOfficials': [{'name': 'Mike Risebury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Hampshire Hospital'}, {'name': 'Fabio Catani, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Modena and Reggio Emilia'}, {'name': 'Jan Victor, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Ghent'}, {'name': 'Gijs Van Hellemondt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sint-Maartenskliniek Nijmegen'}, {'name': 'Stig Heir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Martina Hansens Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'BSI Publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew Orthopaedics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}