[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100366285":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":68,"collaborators":29,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":29,"enrollmentInfo":80,"targetDuration":29,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":53,"whyStopped":29,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"JointResearch","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"BiMobile standard cement","ACTIVE_COMPARATOR","25 patients will receive a cemented THA with a BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.",[13],"Procedure: BiMobile standard cement",{"label":15,"type":10,"description":16,"interventionNames":17},"BiMobile larger cement","25 patients will receive a cemented THA with a BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.",[18],"Procedure: BiMobile larger cement",{"label":20,"type":10,"description":21,"interventionNames":22},"Avantage standard cement","25 patients will receive a cemented THA with an Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.",[23],"Procedure: Avantage standard cement",[25,30,33],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.",[9],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.",[15],{"type":26,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.",[20],[37],{"name":38,"affiliation":39,"role":40},"Rudolf Poolman, MD, PhD","OLVG","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":29,"email":46},"Loes van Beers, MSc","CONTACT","+31(0)20-5993653","l.w.a.h.vanbeers@olvg.nl",{"name":48,"role":44,"phone":49,"phoneExt":29,"email":50},"Nienk Willigenburg, PhD","+31(0)20-5992415","n.w.willigenburg@olvg.nl",[52],{"facility":39,"status":53,"city":54,"state":29,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Amsterdam","1091 AC","Netherlands","NL",{"type":59,"coordinates":60},"Point",[61,62],4.88969,52.37403,{"lat":62,"lon":61},[65,66],{"name":43,"role":44,"phone":45,"phoneExt":29,"email":46},{"name":67,"role":44,"phone":49,"phoneExt":29,"email":50},"Nienke Willigenburg, PhD",{"type":69,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100366285","migration-in-total-hip-arthroplasty-with-a-cemented-bimobile-cup-better-stability-with-more-cement-100366285",false,"NCT04049279","Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement?","Migration in Total Hip Arthroplasty with a Cemented BiMobile Cup: Better Stability with More Cement? (Be-Mobile)","Be-Mobile","Inclusion Criteria:\n\n* Patient requiring an elective primary cemented THA.\n* Male patient ≥70 years old and female patient ≥65 years old.\n* Ability and willingness to follow instructions and to return for follow-up evaluations.\n* The patient is able to understand the meaning of the study and is willing to sign informed consent.\n* Understanding the Dutch language.\n\nExclusion Criteria:\n\n* The patient is morbidly obese, defined as Body Mass Index (BMI) of ≥ 40.\n* The patient is expected to need lower limb joint replacement for another joint within one year.\n* The patient has a systemic or metabolic disorder leading to progressive bone deterioration.\n* The patient has a deformity or disease located in other joints than the hip that needs surgery and that is limiting their ability to walk.\n* The patient has an active or suspected latent infection in or around the hip joint.\n* The patient's bone stock is compromised by a disease or infection which cannot provide adequate support and\u002For fixation to the prosthesis.\n* The patient is unable or unwilling to sign informed consent for this study.\n* The patient is deemed unsuitable for participation in the study based on the investigator's judgment.","ALL","65 Years",{"count":81,"type":82},75,"ESTIMATED","INTERVENTIONAL",[85],"NA","Objective: The main objective of this study is to compare the (early) migration of the cemented BiMobile cup at two year post-surgery between two different cup sizes after standard optimal reaming, and consequently adjusting the cement mantle into circa 2 or 4 mm, in patients with a primary cemented total hip arthroplasty (THA). Additionally, the results of the BiMobile cup will be compared to the Avantage cup, which is placed with a standard cup size, resulting in a cement mantle of approximately 2 mm.\n\nStudy design: A prospective single centre blinded randomised controlled trial.\n\nStudy population: All patients who meet the criteria to undergo a cemented THA.",[88,89],"Total Hip Arthroplasty","Osteoarthritis, Hip",[91,92,93,94],"primary total hip arthroplasty","RSA","cement","Dual mobility cup","2025-02-25",{"date":97,"type":98},"2025-02-28","ACTUAL",{"date":100,"type":98},"2019-01-01",{"date":102,"type":82},"2029-05-01",{"name":5,"class":6},1]