Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 12:10 AM
Study NCT ID:
NCT03687593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2018-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2018-09-26', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival 10 years postoperatively', 'timeFrame': '10 years post-op'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \\& Nephew will evaluate the safety and performance of these implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will screen all subjects who underwent TKA with the LEGION™ CR Oxinium and CoCR Femoral Implants', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject received primary TKA with the Legion™ CR Femoral Implant (either Oxinium or CoCr) with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, degenerative arthritis, or rheumatoid arthritis).\n2. Subject received primary TKA between 24 and 66 months prior to the time of consent.\n3. Subject agrees to consent and to follow the study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/EC approved informed consent form.\n4. Subject must be available through ten (10) years postoperative follow-up.\n\nExclusion Criteria:\n\n1. Subject had Body Mass Index (BMI) \\> 40 at time of surgery.\n2. Subject received the Legion™ CR Femoral Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert as a revision surgery.\n3. Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).\n4. Subject has a known allergy to one or more of its components of the study device.\n5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.\n6. Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.\n7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits."}, 'identificationModule': {'nctId': 'NCT03687593', 'acronym': 'Legion Oxinium', 'briefTitle': 'Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Smith & Nephew, Inc.'}, 'officialTitle': 'Safety and Performance of Primary Total Knee Arthroplasty Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts', 'orgStudyIdInfo': {'id': '17-4042-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts', 'type': 'DEVICE', 'description': 'Single arm study, all subjects received the Legion™ CR Femoral Oxinium and CoCr Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55439', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Allina Health Systems', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '89503', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'ROC Foundation', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hawkins Foundation', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Appalachian Orthopedic Associates', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}], 'overallOfficials': [{'name': 'Karlie Morgan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Smith & Nephew, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith & Nephew, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}