Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 3:54 PM
Study NCT ID:
NCT03292003
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2017-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1694}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2017-05-20', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revision Rate of Total Knee System', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Number of revisions'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Number of adverse events reported per ISO 14155 guidelines'}, {'measure': 'Health care utilization: Hospitalization', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Length of hospital stay for primary (index) surgery'}, {'measure': 'Health care utilization: Hospitalization', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay)'}, {'measure': 'Health care utilization: Rehabilitation', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'number of sessions and duration of rehabilitation in weeks'}, {'measure': 'Health care utilization: Outpatient visits', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Number and type of outpatient visits'}, {'measure': 'Health Care Utilization: Re-operations', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'number of re-operations and revisions'}, {'measure': 'Patient reported outcomes', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'EQ-5D-3L'}, {'measure': 'Clinical outcomes', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Knee Society Score'}, {'measure': 'Return to Work', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Changes in employment status will be recorded with the date on which the change occurred and the change status.'}, {'measure': 'Technical Difficulties Encountered During Device Implantation', 'timeFrame': 'implantation through study completion, approximately 3 years', 'description': 'Number of technical difficulties encountered with the device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'post-traumatic arthritis', 'osteoarthritis', 'degenerative arthritis', 'failed osteotomy'], 'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to estimate the safety and performance of Journey II BCS TKS.', 'detailedDescription': 'The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sites will identify potential subjects by retrospectively reviewing their source documents in order to identify all patients who received TKA with the Journey II BCS TKS.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication\n* The TKA occurred at least 12 weeks prior to enrollment\n* Subject records contain Patient Reported Outcome data obtained ≤3 months prior to as well as ≥6 months post-enrollment.\n\nExclusion Criteria:\n\n* Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty'}, 'identificationModule': {'nctId': 'NCT03292003', 'briefTitle': 'Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study', 'orgStudyIdInfo': {'id': '16-4049-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Journey II BCS Total Knee System', 'description': 'Subjects having TKA with Journey II BCS Total Knee System', 'interventionNames': ['Device: Journey II BCS Total Knee System']}], 'interventions': [{'name': 'Journey II BCS Total Knee System', 'type': 'DEVICE', 'armGroupLabels': ['Journey II BCS Total Knee System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Orthopaedics', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32571', 'city': 'Gulf Breeze', 'state': 'Florida', 'country': 'United States', 'facility': 'Andrews Research and Education Foundation', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}, {'zip': '46280', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Sports Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '16602', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopaedics Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TN Orthopaedic Foundation for Education and Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Orthopaedic Specialists', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98021', 'city': 'Everett', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Regional Medical Center', 'geoPoint': {'lat': 47.97898, 'lon': -122.20208}}, {'zip': '26003', 'city': 'Wheeling', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Marra Knee and Shoulder Center', 'geoPoint': {'lat': 40.06396, 'lon': -80.72091}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jesse Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Pellenberg', 'country': 'Belgium', 'facility': 'UZ Leuven Campus', 'geoPoint': {'lat': 50.87245, 'lon': 4.79394}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Christen Ortho AG', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Beate Hanson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vice President, Global Clinical Strategy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}