[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659298":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":43,"studyPopulation":31,"armGroups":44,"interventions":56,"overallOfficials":62,"centralContacts":67,"locations":72,"responsibleParty":92,"collaborators":31,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":31,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":75,"whyStopped":31,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Uppsala University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Wear performance","To compare the in vivo wear performance of a VEPE liner versus a conventional PE liner using CT-RSA in patients undergoing total hip arthroplasty with a dual mobility cup.","Two years postoperatively.",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Long-term wear performance","To evaluate the in vivo wear performance of the VEPE liner versus the conventional PE liner using CT-RSA.","Five years postoperatively.",{"measure":19,"description":20,"timeFrame":21},"Cup stability","To evaluate stability of the cup by measuring degree of migration using CT-RSA.","Two and five years postoperatively.",{"measure":23,"description":24,"timeFrame":21},"Harris Hip Score","Harris Hip Score (HHS), a clinician-completed tool scored from 0 to 100, will be used to evaluate hip function, pain, and mobility after hip replacement.",{"measure":26,"description":27,"timeFrame":21},"Hip Disability and Osteoarthritis Outcome Score","The Hip Disability and Osteoarthritis Outcome Score (HOOS), a 40-item, patient-reported questionnaire, will be used to assess the participant's opinions about their hip symptoms and functional limitations.",{"measure":29,"description":30,"timeFrame":21},"Patient Reported Outcome Scores","The EQ-5D form will be used to evaluate the participant's quality of life across five dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":38,"whoMasked":39},"TRIPLE","The surgeons cannot be blinded to the allocation since Vitamin E liners are slightly yellow. The primary analyser of the CT-RSA measurements and the physician carrying out the clinical follow-ups will be blinded to treatment.",[40,41,42],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Dual-mobility cups (DMCs) were introduced to reduce the risk of dislocation after total hip arthroplasty (THA) by improving stability while maintaining a large range of motion. Concerns remain regarding polyethylene liner wear due to the larger articulating surface, as wear rates exceeding 0.1 mm\u002Fyear have been associated with osteolysis and aseptic loosening. Vitamin E-infused highly crosslinked polyethylene (VEPE) has been developed to improve wear resistance, and CT-based radiostereometric analysis (CT-RSA) provides a validated method for assessing implant wear and migration.\n\nThe BiMobile Dual Mobility System (Waldemar LINK GmbH) is designed to enhance stability and wear resistance through biocompatible materials and self-centering liners. Although clinical evidence specifically for the BiMobile cup is limited, studies of dual-mobility implants have reported low wear, limited migration, high implant survival, and low rates of loosening.\n\nThis study aims to evaluate the performance of the BiMobile dual-mobility cup with a VEPE liner compared with a conventional polyethylene (PE) liner. In a single-centre, randomized, double-blinded non-inferiority trial, patients undergoing THA will be followed for up to five years. The primary objective is to compare in vivo liner wear at two years using CT-RSA. Secondary objectives include evaluation of wear at five years, cup migration and fixation, patient satisfaction, adverse events, and patient-reported outcomes.\n\nAll participants will receive a BiMobile dual-mobility cup and will be randomized to either a VEPE or conventional PE liner. CT-RSA examinations will be performed postoperatively and at 6 months, 2 years, and 5 years to measure polyethylene wear, cup migration, and radiological signs of loosening. The study will provide important post-market evidence regarding the long-term safety, fixation, and wear characteristics of the BiMobile system and may help determine whether dual-mobility cups can be more widely used in younger and more active patients.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"VEPE liner","ACTIVE_COMPARATOR","Participants are randomized to the BiMobile Dual Mobility System with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner (E-Dur, Waldemar Link GmbH, Hamburg, Germany).",[50],"Device: Total Hip Arthroplasty",{"label":52,"type":53,"description":54,"interventionNames":55},"PE liner","EXPERIMENTAL","Participants are randomized to the BiMobile Dual Mobility System with a conventional highly crosslinked polyethylene (PE) liner (Waldemar Link GmbH, Hamburg, Germany).",[50],[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":31},"DEVICE","Total Hip Arthroplasty","All patients will be operated with an anterolateral or posterior approach using a cemented or uncemented cup (BiMobile, Waldemar Link GmbH, Hamburg, Germany).",[52,46],[63],{"name":64,"affiliation":65,"role":66},"Anders Brüggemann, MD, PhD","Department of Surgical Sciences, Uppsala University","PRINCIPAL_INVESTIGATOR",[68],{"name":64,"role":69,"phone":70,"phoneExt":31,"email":71},"CONTACT","+46 707-498242","anders.bruggemann@uu.se",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Uppsala University Hospital","RECRUITING","Uppsala","Uppsala County","751 85","Sweden","SE",{"type":82,"coordinates":83},"Point",[84,85],17.63889,59.85882,{"lat":85,"lon":84},[88],{"name":89,"role":69,"phone":90,"phoneExt":31,"email":91},"Ulla Ann-Charlotte Claesson, RN","+46 734-697197","ann-charlotte.claesson@uu.se",{"type":93,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100659298","phase-4-e-type---early-wear-of-polyethylene-liners-used-in-dmc-100659298",false,"NCT07863557","E-Type - Early Wear of Polyethylene Liners Used in DMC","Early Wear Patterns Detected With CT RSA in Vitamin E-infused Liner Versus Conventional Highly Crosslinked Liner After Total Hip Arthroplasty With Dual Mobility Cups: a Randomized Controlled Trial","E-type","Inclusion Criteria:\n\n* Age 18-75 years\n* Written informed consent\n* Eligible for a Total Hip Arthroplasty according to local guidelines and appropriate candidate for a dual mobility concept\n* Diagnosis: Symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement\n\nExclusion Criteria:\n\n* Confirmed dementia or cognitive impairment\n* Unwillingness to give written informed consent\n* Age \\\u003C18 or \\>75 years\n* Hip fracture (traumatic or pathological) in need of a Total Hip Arthroplasty\n* Patients who are not deemed suitable for a THA with a Dual Mobility Cup according to local guidelines and routines\n* Comorbidities that are contraindicators for hip replacement surgery","ALL","18 Years","75 Years",{"count":106,"type":107},40,"ESTIMATED","INTERVENTIONAL",[110],"PHASE4","This is a single-centre, randomized, double-blinded controlled non-inferiority trial that will be conducted at the Orthopaedic Department at Uppsala University Hospital, Uppsala. The aim of the study is to evaluate the performance of a dual mobility acetabular component with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner compared to a conventional polyethylene (PE) liner in adult patients with symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement. The assessments will focus on early wear, cup migration, adverse events, and clinical outcomes. Measurements will be conducted using Computed Tomography Radiostereometric Analysis (CT-RSA) instead of traditional radiostereometric analysis. The study hypothesis is that the PE liner will be non-inferior to the VEPE liner in terms of early wear over a two-year period.",[113,114,115],"Osteoarthritis","Osteonecrosis","Dysplasia; Hip",[117,59,118,119],"BiMobile Dual Mobility System","Vitamin E-infused highly crosslinked polyethylene","Computed Tomography-based Radiostereometric Analysis","2026-10-08",{"date":122,"type":123},"2026-10-09","ACTUAL",{"date":120,"type":123},{"date":126,"type":107},"2033-10-01",{"name":5,"class":6},1]