[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529345":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":27,"responsibleParty":46,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":7,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":7,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":7,"overallStatus":30,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"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,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Cleveland Clinic","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-81.69541,41.4995,{"lat":40,"lon":39},[43],{"name":44,"role":21,"phone":7,"phoneExt":7,"email":45},"Laura Stiegel","STIEGEL@ccf.org",{"type":47,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[49],{"name":16,"class":50},"OTHER","100529345","spartan-stem-world-cup-and-world-liner-post-market-clinical-follow-up-study-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":61,"type":62},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.",[66],"Hip Replacement","2023-12-07",{"date":69,"type":70},"2023-12-15","ACTUAL",{"date":72,"type":62},"2023-12-08",{"date":74,"type":62},"2028-04-01",{"name":5,"class":6},1]