[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564373":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":96,"collaborators":7,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":7,"eligibilityCriteria":103,"healthyVolunteers":100,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":7,"studyType":110,"phases":7,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Symbios Orthopedie SA","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","HARMONY EVOLUTION","It is planned to include consecutive eligible subjects which will be treated with the HARMONY EVOLUTION devices.",[14],{"name":15,"affiliation":16,"role":17},"Christophe Castelain, Dr.","Clinique Arago","PRINCIPAL_INVESTIGATOR",[19],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Bojana Gannevat","CONTACT","+41 24 424 26 26","bojana.gannevat@symbios.ch",[25,42,56,70,82],{"facility":26,"status":27,"city":28,"state":7,"zip":7,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Polyclinique de Franche-Comté","RECRUITING","Besançon","France","FR",{"type":32,"coordinates":33},"Point",[34,35],6.01815,47.24878,{"lat":35,"lon":34},[38],{"name":39,"role":21,"phone":40,"phoneExt":7,"email":41},"Antoine Serre, Dr.","+33 (0)3 81 52 47 74","chirurgien.serre@gmail.com",{"facility":43,"status":27,"city":44,"state":7,"zip":45,"country":29,"countryCode":30,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Clinique Belledonne","Grenoble","38400",{"type":32,"coordinates":47},[48,49],5.71479,45.17869,{"lat":49,"lon":48},[52],{"name":53,"role":21,"phone":54,"phoneExt":7,"email":55},"Christophe Besson, Dr.","+33 (0)4 76 54 40 79","drbesson.christophe@gmail.com",{"facility":57,"status":27,"city":58,"state":7,"zip":59,"country":29,"countryCode":30,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Clinique Juge","Marseille","13008",{"type":32,"coordinates":61},[62,63],5.38107,43.29695,{"lat":63,"lon":62},[66],{"name":67,"role":21,"phone":68,"phoneExt":7,"email":69},"Thomas Cucurrulo, Dr.","+33 (0)4 91 22 02 03","tcucurulo@gmail.com",{"facility":16,"status":27,"city":71,"state":7,"zip":72,"country":29,"countryCode":30,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Paris","75014",{"type":32,"coordinates":74},[75,76],2.3488,48.85341,{"lat":76,"lon":75},[79],{"name":15,"role":21,"phone":80,"phoneExt":7,"email":81},"+33 (0)1 44 08 04 00","orthopediste@hotmail.com",{"facility":83,"status":27,"city":84,"state":7,"zip":85,"country":29,"countryCode":30,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Médipôle Garonne","Toulouse","31100",{"type":32,"coordinates":87},[88,89],1.44367,43.60426,{"lat":89,"lon":88},[92],{"name":93,"role":21,"phone":94,"phoneExt":7,"email":95},"Nicolas Krantz, Dr.","+33 (0)5 82 08 38 93","nicolas.krantz@gmail.com",{"type":97,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100564373","post-market-observational-study-of-the-harmony-evolution-implants-and-instruments-100564373",false,"NCT06628336","Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments","Inclusion Criteria:\n\n* Subjects of 18 years of age and older\n* Each subject who is willing to give informed consent\n* Clinically indicated for a Total Hip Replacement\n* Women of childbearing age who are not pregnant and do not expect to become pregnant within 12 months. A pregnancy test should be performed for women of childbearing age\n* Geographically stable and willing to return to the implanting site for all follow-up visits\n\nExclusion Criteria:\n\n* Acute or chronic, local or systemic infection\n* Muscular, neurological, psychological or vascular deficits\n* Poor bone density and quality likely to affect implant stability (severe osteoporosis)\n* Any concomitant condition likely to affect implant integration or function\n* Allergy or hypersensitivity to any of the materials used\n\nSpecific:\n\n• The HARMONY® Evolution Standard stem size 8 shall not be implanted in subjects weighing more than 70 kg.","ALL","18 Years","99 Years",{"count":108,"type":109},264,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.\n\nThe objective is to demonstrate that the evaluated implants are compliant with the state of the art and the performance (PMA score \\> 15 points) \\& safety claims (The expected acceptable revision rate (state of the art with a confidence interval of 95%) is 3% at 3 years, 5% at 5 years, 7% at 7 years and 10% at 10 years).\n\nThe endpoint of this study is to validate the expected performance of the HARMONY® Evolution implants with the PMA score at 10 years and to validate the safety claim with the expected acceptable revision rate at 10 years.",[113],"Total Hip Replacement",[115,116,117],"HARMONY","THR","Prosthesis","2024-10-03",{"date":120,"type":121},"2024-10-04","ACTUAL",{"date":123,"type":121},"2023-10-11",{"date":125,"type":109},"2035-03-11",{"name":5,"class":6},5]