[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545240":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":42,"locations":52,"responsibleParty":89,"collaborators":91,"id":95,"slug":10,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":10,"maxAge":10,"enrollmentInfo":103,"targetDuration":10,"studyType":106,"phases":10,"briefSummary":107,"conditions":108,"keywords":10,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14,18,21,25,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary",null,"Triathlon Hinge Femoral Component + Revision Baseplate",[13],"Device: Triathlon Hinge Knee (THK) System",{"label":15,"type":10,"description":16,"interventionNames":17},"Revision","Triathlon Hinge Femoral Component+ Revision Baseplate",[13],{"label":19,"type":10,"description":20,"interventionNames":10},"Total Stabilized (TS) Revision","Triathlon Total Stabilized (TS) Femoral Component+ Revision Baseplate",{"label":22,"type":10,"description":23,"interventionNames":24},"Revision (Maximum of 80 subjects)","Triathlon Total Stabilized (TS) Femoral Component + Revision Baseplate",[13],{"label":26,"type":10,"description":27,"interventionNames":10},"Modular Rotating Hinge (MRH) Revision","Modular Rotating Hinge (MRH) Femoral Component + Revision Baseplate",{"label":29,"type":10,"description":30,"interventionNames":10},"Global Modular Replacement System (GMRS) Primary or Revision","Global Modular Replacement System (GMRS) Femoral Component + Revision Baseplate",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"DEVICE","Triathlon Hinge Knee (THK) System","Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use",[9,15,22],[38],{"name":39,"affiliation":40,"role":41},"Nicolas Piuzzi, MD","Associate Staff Orthopaedic Surgery","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":10,"email":47},"Laura Stiegel","CONTACT","216-442-5511","stiegel@ccf.org",{"name":49,"role":45,"phone":50,"phoneExt":10,"email":51},"Sanal Krishnan, PHD","216-445-7194","krishns11@ccf.org",[53,73],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Cleveland Clinic Florida","RECRUITING","Weston","Florida","33331","United States",{"type":61,"coordinates":62},"Point",[63,64],-80.39977,26.10037,{"lat":64,"lon":63},[67,71],{"name":68,"role":45,"phone":69,"phoneExt":10,"email":70},"Kaitlin Bernabe","954-610-8016","BERNABK@ccf.org",{"name":72,"role":41,"phone":10,"phoneExt":10,"email":10},"Jorge Manrique-Succar",{"facility":74,"status":55,"city":75,"state":76,"zip":77,"country":59,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":61,"coordinates":79},[80,81],-81.69541,41.4995,{"lat":81,"lon":80},[84,85,87],{"name":44,"role":45,"phone":46,"phoneExt":10,"email":47},{"name":86,"role":45,"phone":50,"phoneExt":10,"email":51},"Sanal Krishnan",{"name":88,"role":41,"phone":10,"phoneExt":10,"email":10},"Matthew Deren, M.D.",{"type":90,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[92],{"name":93,"class":94},"Stryker Orthopaedics","INDUSTRY","100545240",false,"NCT06379321","Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System","A Retrospective\u002FProspective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System","Hinge","Inclusion Criteria:\n\n* The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.\n* The subject has signed an Institutional Review Board (IRB)\u002FEthical Committee (EC)-approved, study-specific Informed Consent Form (ICF).\n* The subject is a male or non-pregnant female at the time of enrollment.\n* The subject agrees to comply with the protocol-mandated clinical evaluations.\n\nExclusion Criteria:\n\n* Any active or suspected latent infection in or about the knee joint; overt infection;\n* Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;\n* skeletally immature patients;\n* Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.\n* Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and\u002For fixation to the prosthesis.\n* Known or suspected sensitivity and\u002For allergy to any material in the device.\n* Conditions presenting an increased risk of failure include:\n* uncooperative patient or patient with neurologic disorder, incapable of following instructions;\n* osteoporosis;\n* metabolic disorders which may impair bone formation or cause bone loss;\n* osteomalacia; and,\n* previous arthrodesis.\n* A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease.\n* Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.\n* The subject is a prisoner","ALL",{"count":104,"type":105},200,"ESTIMATED","OBSERVATIONAL","This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).\n\nClinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.",[109,110,111],"Knee Arthropathy","Recurrence","Knee Infection","2026-02-27",{"date":114,"type":115},"2026-03-02","ACTUAL",{"date":117,"type":115},"2024-05-10",{"date":119,"type":105},"2034-05-10",{"name":5,"class":6},2]