[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564373":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":24,"responsibleParty":95,"collaborators":7,"id":97,"slug":7,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":7,"eligibilityCriteria":101,"healthyVolunteers":98,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":7,"studyType":108,"phases":7,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":27,"whyStopped":7,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"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",[25,41,55,69,81],{"facility":26,"status":27,"city":28,"state":7,"zip":7,"country":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Polyclinique de Franche-Comté","RECRUITING","Besançon","France",{"type":31,"coordinates":32},"Point",[33,34],6.01815,47.24878,{"lat":34,"lon":33},[37],{"name":38,"role":21,"phone":39,"phoneExt":7,"email":40},"Antoine Serre, Dr.","+33 (0)3 81 52 47 74","chirurgien.serre@gmail.com",{"facility":42,"status":27,"city":43,"state":7,"zip":44,"country":29,"cosmosGeoPoint":45,"geoPoint":49,"contacts":50},"Clinique Belledonne","Grenoble","38400",{"type":31,"coordinates":46},[47,48],5.71479,45.17869,{"lat":48,"lon":47},[51],{"name":52,"role":21,"phone":53,"phoneExt":7,"email":54},"Christophe Besson, Dr.","+33 (0)4 76 54 40 79","drbesson.christophe@gmail.com",{"facility":56,"status":27,"city":57,"state":7,"zip":58,"country":29,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Clinique Juge","Marseille","13008",{"type":31,"coordinates":60},[61,62],5.38107,43.29695,{"lat":62,"lon":61},[65],{"name":66,"role":21,"phone":67,"phoneExt":7,"email":68},"Thomas Cucurrulo, Dr.","+33 (0)4 91 22 02 03","tcucurulo@gmail.com",{"facility":16,"status":27,"city":70,"state":7,"zip":71,"country":29,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Paris","75014",{"type":31,"coordinates":73},[74,75],2.3488,48.85341,{"lat":75,"lon":74},[78],{"name":15,"role":21,"phone":79,"phoneExt":7,"email":80},"+33 (0)1 44 08 04 00","orthopediste@hotmail.com",{"facility":82,"status":27,"city":83,"state":7,"zip":84,"country":29,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Médipôle Garonne","Toulouse","31100",{"type":31,"coordinates":86},[87,88],1.44367,43.60426,{"lat":88,"lon":87},[91],{"name":92,"role":21,"phone":93,"phoneExt":7,"email":94},"Nicolas Krantz, Dr.","+33 (0)5 82 08 38 93","nicolas.krantz@gmail.com",{"type":96,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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":106,"type":107},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.",[111],"Total Hip Replacement",[113,114,115],"HARMONY","THR","Prosthesis","2024-10-03",{"date":118,"type":119},"2024-10-04","ACTUAL",{"date":121,"type":119},"2023-10-11",{"date":123,"type":107},"2035-03-11",{"name":5,"class":6},5]