Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-03-05 @ 12:19 AM
Study NCT ID:
NCT02521103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2015-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triathlon Tritanium Cone Augments Outcomes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-01', 'size': 6931406, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-25T11:38', 'hasProtocol': True}, {'date': '2024-08-01', 'size': 368392, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-25T12:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2015-07-31', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of cases with revision of the Femoral Cone Augment or Tibial Cone Augment for aseptic loosening', 'timeFrame': '2 year'}], 'secondaryOutcomes': [{'measure': 'Presence of end-of-stem pain in relation to the Triathlon Tritanium Cone Augments location.', 'timeFrame': '2 year', 'description': 'End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain location.'}, {'measure': 'Severity of end-of-stem pain.', 'timeFrame': '2 year', 'description': 'End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain.\n\nPain for both the shin and thigh are identified using the following categories:\n\n* no pain\n* pain with extreme activity only\n* pain with moderate activity\n* pain with normal activity\n* pain at rest'}, {'measure': 'Anderson Orthopaedic Research Institute (AORI) classification and Femoral Cone Augment size.', 'timeFrame': 'intraoperative', 'description': 'The AORI is a bone defect classification which consists of four Types:\n\nType I: Metaphyseal bone is intact, with minor bone defects not compromising component stability\n\nType IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.\n\nType IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.\n\nType III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed'}, {'measure': 'Anderson Orthopaedic Research Institute (AORI) classification and Tibial Symmetric Cone Augment size.', 'timeFrame': 'intraoperative', 'description': 'The AORI is a bone defect classification which consists of four Types:\n\nType I: Metaphyseal bone is intact, with minor bone defects not compromising component stability\n\nType IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.\n\nType IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.\n\nType III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed'}, {'measure': 'Anderson Orthopaedic Research Institute (AORI) classification and Tibial Asymmetric Cone Augment size.', 'timeFrame': 'intraoperative', 'description': 'The AORI is a bone defect classification which consists of four Types:\n\nType I: Metaphyseal bone is intact, with minor bone defects not compromising component stability\n\nType IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.\n\nType IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.\n\nType III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Arthroplasty', 'Replacement', 'Knee']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.\n* Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation.\n* Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.\n* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.\n\nExclusion Criteria:\n\n* Patient has a Body Mass Index (BMI) \\> 45.\n* Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.\n* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.\n* Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.\n* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \\> 30 days).\n* Patient has a failed unicondylar knee prosthesis.\n* Patient has a known sensitivity to device materials.\n* Patient is a prisoner."}, 'identificationModule': {'nctId': 'NCT02521103', 'briefTitle': 'Triathlon Tritanium Cone Augments Outcomes Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stryker Orthopaedics'}, 'officialTitle': 'A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments', 'orgStudyIdInfo': {'id': '76'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Triathlon Tritanium Cone Augments', 'description': 'Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment', 'interventionNames': ['Device: Triathlon Tritanium Cone Augments']}], 'interventions': [{'name': 'Triathlon Tritanium Cone Augments', 'type': 'DEVICE', 'description': 'The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in primary or revision TKA', 'armGroupLabels': ['Triathlon Tritanium Cone Augments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33542', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Medical Clinic', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Bluegrass Orthopaedics', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '48374', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'The CORE Institute', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Heart, St. Joseph Health System', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Orthopaedic Institute', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '08234', 'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The Orthopaedic Center', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Medical Research Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stryker Orthopaedics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}