[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424990":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":65,"collaborators":67,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":25,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":100,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"LifeBridge Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medial-Pivot Knee System","ACTIVE_COMPARATOR","Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.",[13],"Device: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)",{"label":15,"type":10,"description":16,"interventionNames":17},"Single Radius Design Total Knee System","Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.",[18],"Device: Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)","Medial Pivot Knee System",[9],null,{"type":21,"name":27,"description":15,"armGroupLabels":28,"otherNames":25},"Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)",[15],[30],{"name":31,"affiliation":5,"role":32},"James Nace, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Martin Gesheff","CONTACT","410-601-9467","mgesheff@lifebridgehealth.org",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Nirav Patel","410-601-8860","nirpatel@lifebridgehealth.org",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Sinai Hospital of Baltimore","RECRUITING","Baltimore","Maryland","21215","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-76.61219,39.29038,{"lat":56,"lon":55},[59,60,61,63],{"name":35,"role":36,"phone":25,"phoneExt":25,"email":38},{"name":40,"role":36,"phone":25,"phoneExt":25,"email":42},{"name":62,"role":32,"phone":25,"phoneExt":25,"email":25},"James Nace, DO",{"name":64,"role":32,"phone":25,"phoneExt":25,"email":25},"Ronald Delanois, MD",{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[68,71],{"name":69,"class":70},"Rubin Institute for Advanced Orthopedics","UNKNOWN",{"name":72,"class":73},"MicroPort Orthopedics Inc.","INDUSTRY","100424990","prospective-functional-gait-and-outcome-comparison-study-of-medial-pivot-versus-single-radius-design-for-total-knee-arthroplasty-100424990",false,"NCT04814082","Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty","Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot","Inclusion Criteria:\n\n* Subject is male or non-pregnant female aged between 18 and 75 years of age.\n* Subject is willing to provide informed consent to participate in the research study.\n* Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)\n* Subject does not have a history of previous prosthetic replacement device on the operative knee.\n* Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.\n* Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.\n\nExclusion Criteria:\n\n* Subject has a Body Mass Index (BMI) \\>40\n* Subject has a diagnosis of avascular necrosis or inflammatory arthritis.\n* Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.\n* Subject is a prisoner\n* Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.","ALL","18 Years","75 Years",{"count":85,"type":86},100,"ESTIMATED","INTERVENTIONAL",[89],"NA","Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.",[92,93,94,95,96,97,98,99],"Osteoarthritis, Knee","Knee Osteoarthritis","Osteoarthritis Knees Both","Osteoarthritis Knee Left","Osteoarthritis Knee Right","Knee Pain Chronic","Knee Disease","Arthropathy of Knee Joint",[101,102],"Total Knee Arthroplasty","Total Knee Replacement","2025-01-20",{"date":105,"type":106},"2025-01-22","ACTUAL",{"date":108,"type":106},"2021-02-01",{"date":110,"type":86},"2030-07-01",{"name":5,"class":6},1]