Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-03 @ 5:56 AM
Study NCT ID:
NCT01705067
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2012-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of the Journey II BCS Total Knee System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-10-10', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of ITB Friction Pain', 'timeFrame': '6 months post-operatively'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively'}, {'measure': 'Radiographic Evaluation', 'timeFrame': 'Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively'}, {'measure': 'Knee Society Score', 'timeFrame': '6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Osteoarthritis', 'Degenerative Knee Disease', 'Total Knee Arthroplasty (TKA)'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.', 'detailedDescription': 'Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects receiving the JOURNEY™ II BCS Total Knee System', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease\n* Subject is willing to sign and date an IRB approved consent form\n* Subject is of legal age to consent\n* Subject plans to be available through ten (10) years postoperative follow-up\n* Subject agrees to follow the study protocol\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\n* Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty\n* Subject possesses a contralateral or ipsilateral revision hip arthroplasty\n* Subject has ipsilateral hip arthritis resulting in flexion contracture\n* At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:\n\n * Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty\n * Contralateral primary total knee or unicondylar knee arthroplasty\n* At the time of surgery, subject had an active infection or sepsis (treated or untreated)\n* At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease\n* At the time of surgery, subject had 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* At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation\n* Subject is pregnant or plans to become pregnant during the study\n* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study\n* At the time of surgery, subject had a BMI\\>40\n* At the time of enrollment, subject has a BMI\\>40\n* Subject is enrolled in another investigational drug, biologic, or device study\n* Subject is facing current or impending incarceration"}, 'identificationModule': {'nctId': 'NCT01705067', 'acronym': 'NIMBLE', 'briefTitle': 'Safety and Efficacy of the Journey II BCS Total Knee System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)', 'orgStudyIdInfo': {'id': '2011JBCK151'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Journey II BCS TKA', 'description': 'Subjects who previously received TKA with Journey II BCS Total Knee System', 'interventionNames': ['Device: TKA with Journey II BCS Total Knee System']}], 'interventions': [{'name': 'TKA with Journey II BCS Total Knee System', 'type': 'DEVICE', 'otherNames': ['Journey II BCS'], 'description': 'TKA with Journey II BCS Total Knee System', 'armGroupLabels': ['Journey II BCS TKA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Joint Replacement Institute at St. Vincent Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Orthopedics', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46280', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Methodist Sports Medicine/The Orthopedic Specialist', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '10021-4892', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OrthoCarolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157-1070', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wellington Orthopaedics', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Orthopaedic Research Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Minimally Invasive Orthopaedics', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37923', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Orthopaedic Clinics', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Orthopaedic Specialists', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Orthopaedic Clinic', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}