[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505619":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Medacta International SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"control study",null,"patients will be operated with conventional instrumentation",[13],"Device: Implantation of GMK Sphere with conventional instrumentation",{"label":15,"type":10,"description":16,"interventionNames":17},"NextAR study","patients will be operated using the NextAR guidance system",[18],"Device: Implantation of GMK Sphere using the NextAR guidance system",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Implantation of GMK Sphere with conventional instrumentation","Implantation of GMK Sphere with conventional instrumentation (control group)",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Implantation of GMK Sphere using the NextAR guidance system","Implantation of GMK Sphere using the NextAR guidance system (NextAR group)",[15],[30],{"name":31,"affiliation":32,"role":33},"Ben Jeffcote","Fremantle Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Arianna Girardi","CONTACT","+41 91 696 60 60","girardi@medacta.ch",[41],{"facility":32,"status":42,"city":43,"state":10,"zip":10,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Fremantle","Australia","AU",{"type":47,"coordinates":48},"Point",[49,50],115.74557,-32.05632,{"lat":50,"lon":49},[53],{"name":31,"role":37,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100505619","clinical-utility-and-gait-analysis-of-nextar-system-aus-100505619",false,"NCT05863741","Clinical Utility and Gait Analysis of NextAR System AUS","Does Personalized Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilized Knee Arthroplasty? A Prospective, Randomized Study Investigating the Clinical Utility of the NextAR Navigation System (NextAR).","Inclusion Criteria:\n\n* End-stage osteoarthritis of the knee suitable for total knee arthroplasty.\n* Aged over 18 years.\n\nExclusion Criteria:\n\n* Unsuitable for TKR due to chronic infection, medical disease, inability to consent, inability to attend for post-operative follow-up, significant psychiatric issues, substance abuse issues\n* Previous reconstructive\u002Ffracture\u002Farthroplasty surgery on affected knee\n* Active inflammation arthropathy\n* Significant extra articular deformity\n* Morbidly Obese (BMI \\>40)\n* Pregnant women","ALL","18 Years",{"count":66,"type":67},100,"ESTIMATED","OBSERVATIONAL","This study titled \"Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)\" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment.",[71],"Total Knee Arthroplasty","2025-09-23",{"date":74,"type":75},"2025-09-29","ACTUAL",{"date":77,"type":75},"2022-05-15",{"date":79,"type":67},"2026-05",{"name":5,"class":6},1]