[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499600":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":42,"collaborators":7,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":7,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":7,"studyType":57,"phases":7,"briefSummary":58,"conditions":59,"keywords":7,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Medacta International SA","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Mpact 3D metal MONOCER cup","adult patients requiring a total hip arthroplasty under 75 years old, will receive the Mpact 3D metal cup, as acetabular sheel device implanted",[14],{"name":15,"affiliation":16,"role":17},"Placido Bartolone, Dr","Hirslanden, Clinique la Colline 76A Av. de la Roseraie 1205 Genève","PRINCIPAL_INVESTIGATOR",[19],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Elisa Bonacina, PhD","CONTACT","+41 91 696 60 60","bonacina@medacta.ch",[25],{"facility":26,"status":27,"city":28,"state":7,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Hirslanden, Clinique la Colline","RECRUITING","Geneva","1205","Switzerland","CH",{"type":33,"coordinates":34},"Point",[35,36],6.14569,46.20222,{"lat":36,"lon":35},[39],{"name":15,"role":21,"phone":40,"phoneExt":7,"email":41},"+41227022585","placido.bartolone@hirslanden.ch",{"type":43,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100499600","a-post-market-surveillance-study-about-the-monocer-cup-100499600",false,"NCT05785364","A Post Market Surveillance Study About the MONOCER Cup","Monocer Cup: Open, Prospective, Multicentric, Non Randomised Observational Study","Inclusion Criteria:\n\n1. Patients undergoing total hip arthroplasty who will receive the Mpact 3D Metal MonoCER acetabular component according to the instructions for use\n2. Patients who have signed the informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Minor patients, patients over 75 years of age at the time of primary surgery;\n2. Any patient who is unable or unwilling to give informed consent to participate in the study.","ALL","18 Years","75 Years",{"count":55,"type":56},250,"ESTIMATED","OBSERVATIONAL","Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion. The history of total hip arthroplasty does not favour large diameter heads, especially as conventional polyethylene has a high risk of wear. The development of hard-on-hard bearings (CoC) with a second generation ceramic material and the introduction of cross-linked PE have led to the reintroduction of this concept. The Mpact 3D Metal MonoCER cup was developed to offer the advantages of accommodating large diameter heads with an external metal cup with a pre-assembled system that avoids the surgical step of insert-cotile coupling.",[60],"Total Hip Arthroplasty","2024-04-30",{"date":63,"type":64},"2024-05-01","ACTUAL",{"date":66,"type":64},"2022-01-25",{"date":68,"type":56},"2050-02-01",{"name":5,"class":6},1]