[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529345":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":27,"responsibleParty":45,"collaborators":47,"id":50,"slug":7,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":7,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":7,"studyType":61,"phases":7,"briefSummary":62,"conditions":63,"keywords":7,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Signature Orthopaedics","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","Spartan Stem, World Acetabular Cup and World Liner","The Spartan Stem is a wedge-shaped fit and fill design stem with Titanium Plasma Spray(TPS) and Hydroxyapatite (HA) coating.\n\nThe World Acetabular cup is Porous coated and mated with cross-linked polyethylene World Liner",[14],{"name":15,"affiliation":16,"role":17},"Nicolas Piuzzi, MD","The Cleveland Clinic","PRINCIPAL_INVESTIGATOR",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Satish Shejale, MS Ortho","CONTACT","+61 02 9428 5181","satish.shejale@signatureortho.com.au",{"name":25,"role":21,"phone":22,"phoneExt":7,"email":26},"Declan Brazil, PhD","declan@signatureortho.com.au",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States",{"type":36,"coordinates":37},"Point",[38,39],-81.69541,41.4995,{"lat":39,"lon":38},[42],{"name":43,"role":21,"phone":7,"phoneExt":7,"email":44},"Laura Stiegel","STIEGEL@ccf.org",{"type":46,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[48],{"name":16,"class":49},"OTHER","100529345",false,"NCT06172569","Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study","Inclusion Criteria:\n\n* patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g., osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia\u002FDDH)\n* patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient.\n* male and non-pregnant female patients aged 18-75\n* patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up.\n\nExclusion Criteria:\n\n* patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery\n* patient is a female of child-bearing age and not taking and not taking contraceptive pills\n* patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)\n* patient has a known or suspected metal sensitivity\n* patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.\n* patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse\n* patient is severely overweight with a BMI\\>40.","ALL","18 Years","75 Years",{"count":59,"type":60},200,"ESTIMATED","OBSERVATIONAL","The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.",[64],"Hip Replacement","2023-12-07",{"date":67,"type":68},"2023-12-15","ACTUAL",{"date":70,"type":60},"2023-12-08",{"date":72,"type":60},"2028-04-01",{"name":5,"class":6},1]