[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478930":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":58,"collaborators":34,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":34,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":34,"enrollmentInfo":70,"targetDuration":34,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":34,"overallStatus":42,"whyStopped":34,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Exactech","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Restricted Invers Kinematic Knee Alignment Technique","OTHER",[12],"Device: Optetrak Logic CR Knee System",{"label":14,"type":10,"description":14,"interventionNames":15},"Mechanical Knee Alignment Technique",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Optetrak Logic CR Knee System","The OPTETRAK® Comprehensive Knee System consists of the OPTETRAK® Total Knee System and the OPTETRAK Logic® Total Knee System. The OPTETRAK Comprehensive Knee System comprises both non-porous and porous knee prostheses for use in total-knee joint replacement procedures. (In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.) The system includes various sizes and types of modular femoral components, tibial components, patellar components, and accessories for use in primary and revision applications.",[14,9],[23],"Exactech Guided Personalized Surgery",[25],{"name":26,"affiliation":27,"role":28},"David Mateu-Vincent, Medical Degree","Orthpaedic Surgeon Hospital Universitaria Mutua Terrassa","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Alex Knisely, BSBA","CONTACT","352-474-9582",null,"alex.knisely@exac.com",{"name":37,"role":32,"phone":34,"phoneExt":34,"email":38},"Amanda Ford, PhD","amanda.ford@exac.com",[40],{"facility":41,"status":42,"city":43,"state":34,"zip":34,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Fundacio Mutua de Terrassa per a la Docenia i Recera Biomedica i Social, F.P.C.","RECRUITING","Barcelona","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],2.15899,41.38879,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":55,"phoneExt":56,"email":57},"Pilar A Sola","93 736 50 50","11801","parcusa@muturterrassa.es",{"type":59,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100478930","evaluation-of-navigation-assisted-tka-using-mechanical-vs-restricted-kinematic-alignment-100478930",false,"NCT05516381","Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment","Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment on Patient Reported Outcome Measures (PROMs): A Prospective, Randomized Clinical Study","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be included in the study:\n\n  1. Subject must be at least 18 years of age at the time of the surgery (skeletally mature)\n  2. Subject will receive a Optetrak Logic® CR device per the \"Indications for Use\" described above\n  3. Subject must be willing to comply with the pre-operative and post-operative visit requirements\n  4. Subject must be willing and able to provide written informed consent for participation in the study\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if they meet any of the following exclusion criteria:\n\n  1. Subject with a suspected or confirmed systemic infection and\u002For a secondary remote infection\n  2. Subject without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis\n  3. Subject without sufficient soft tissue integrity to provide adequate stability\n  4. Subject with either mental or neuromuscular disorders that do not allow control of the knee joint\n  5. Subjects whose weight, age, or activity level might cause extreme loads and early failure of the system\n  6. Subject is participating in another drug or device study other than knee replacement within the last three (3) months\n  7. Subject has behavioral and\u002For mental issues that may interfere with their ability to follow post-operative instructions\n  8. Subject is a prisoner\n  9. Subject is pregnant\n  10. Subject is undergoing radiation therapy where the targeted field involves the knee joint\n  11. Subjects with malignancy involving proximal tibia, distal femur, or knee joint\n  12. Subjects undergoing active administration of chemotherapy",true,"ALL","18 Years",{"count":71,"type":72},148,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.",[78],"Knee Arthroplasty, Total","2024-06-17",{"date":81,"type":82},"2024-06-18","ACTUAL",{"date":84,"type":82},"2023-05-15",{"date":86,"type":72},"2027-06",{"name":5,"class":6},1]