[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538145":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":41,"locations":49,"responsibleParty":79,"collaborators":25,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":25,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":52,"whyStopped":25,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Permedica spa","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Jump System Traser® cup","EXPERIMENTAL","25 patients receiving unilateral primary total hip arthroplasty with the Jump System Traser® acetabular cup, a 3D-printed highly-porous titanium cup",[13],"Device: Jump System Traser® cup",{"label":15,"type":16,"description":17,"interventionNames":18},"Jump System HAX-Pore® cup","ACTIVE_COMPARATOR","25 patients receiving unilateral primary total hip arthroplasty with the Jump System HAX-Pore® acetabular cup, a standard hydroxyapatite\u002Ftitanium plasma-sprayed cup",[19],"Device: Jump System HAX-Pore® cup",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Press-fit, cementless, hydroxyapatite\u002Ftitanium plasma-sprayed acetabular cup",[15],[30,34,38],{"name":31,"affiliation":32,"role":33},"Lorenzo Banci, MSc","Permedica Orthopaedics, Merate, Italy","STUDY_DIRECTOR",{"name":35,"affiliation":36,"role":37},"Giuseppe Peretti, MD","IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Paolo Sirtori, MD","Istituto Clinico San Siro, Milan, Italy",[42,46],{"name":31,"role":43,"phone":44,"phoneExt":25,"email":45},"CONTACT","+390399514811","lorenzo.banci@permedica.it",{"name":47,"role":43,"phone":25,"phoneExt":25,"email":48},"Marta Colombo, MSc","marta.colombo@permedica.it",[50,67],{"facility":51,"status":52,"city":53,"state":25,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"IRCCS Istituto Clinico San Siro","RECRUITING","Milan","20148","Italy","IT",{"type":58,"coordinates":59},"Point",[60,61],9.18951,45.46427,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":25,"phoneExt":25,"email":66},"Matteo Del Re, MD","matteodelre91@gmail.com",{"facility":68,"status":52,"city":53,"state":25,"zip":69,"country":55,"countryCode":56,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"IRCCS Ospedale Galeazzi-Sant'Ambrogio","20161",{"type":58,"coordinates":71},[60,61],{"lat":61,"lon":60},[74,77],{"name":75,"role":43,"phone":25,"phoneExt":25,"email":76},"Ricardo Ciliberto, MD","rciliberto@gmail.com",{"name":78,"role":43,"phone":25,"phoneExt":25,"email":25},"Laura",{"type":80,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100538145","bone-remodeling-around-a-trabecular-titanium-cup-in-total-hip-arthroplasty-100538145",false,"NCT06287021","Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty","Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty","Inclusion Criteria:\n\n* Patient candidated to undergo unilateral cementless primary total hip arthroplasty with Jump System Traser® cup or Jump System HAX-Pore® cup by Permedica Orthopaedics (study sponsor).\n* Patient with primary or secondary hip osteoarthritis;\n* Patient who has given informed consent;\n\nExclusion Criteria:\n\n* Male patients younger than 40 years or older than 85 years;\n* Female patients younger than 50 years or older than 85 years;\n* Childbearing;\n* Patients not indicated for receiving the investigational devices;\n* Patients not indicated for receiving cementless metaphyseal short femoral stems by Permedica Orthopaedics as the \"Exacta RS\" or \"Exacta S\" brand;\n* Patients with rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (grade III-IV according to Crowe classification), Perthes disease, Paget disease, femoral neck fracture, pelvic fracture or sequelae of previous surgical procedures or trauma to the ipsilateral hip;\n* Patients with bone disorders;\n* Patients with diabetes;\n* Patients under PTH (parathyroid hormone), corticosteroid, or osteoporosis pharmacological therapy;\n* Patients with disabling disease in the contralateral limb;\n* Patients with BMI \\> 30 or \\\u003C 18;\n* Patients not willing to follow the study protocol;\n* Patients incapable to understand the study protocol;\n* Patients addicted to alcohol or drugs;\n* Patients already enrolled in other clinical investigations;",true,"ALL","40 Years","85 Years",{"count":93,"type":94},50,"ESTIMATED","INTERVENTIONAL",[97],"NA","The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite\u002Ftitanium plasma-sprayed acetabular cup up to 2-year follow-up.",[100],"Total Hip Arthroplasty",[102,103,104,105,106,107],"Bone Mineral Density","DEXA","Additive Manufacturing","3D-Printing","Selective Laser Melting","Highly-Porous Titanium","2025-08-25",{"date":110,"type":111},"2025-09-02","ACTUAL",{"date":113,"type":111},"2024-04-09",{"date":115,"type":94},"2028-06",{"name":5,"class":6},2]