[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512729":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":15,"responsibleParty":32,"collaborators":7,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":7,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":7,"enrollmentInfo":43,"targetDuration":7,"studyType":46,"phases":7,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":18,"whyStopped":7,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},{"fullName":5,"class":6},"Societe dEtude, de Recherche et de Fabrication","INDUSTRY",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":13,"email":14},"Clinical department","CONTACT","0472056010","+33","clinical@serf.fr",[16],{"facility":17,"status":18,"city":19,"state":7,"zip":20,"country":21,"countryCode":22,"cosmosGeoPoint":23,"geoPoint":28,"contacts":29},"CHU St Etienne","RECRUITING","Saint-Priest-en-Jarez","42270","France","FR",{"type":24,"coordinates":25},"Point",[26,27],4.37678,45.4739,{"lat":27,"lon":26},[30],{"name":31,"role":11,"phone":7,"phoneExt":7,"email":7},"Boyer Bertrand",{"type":33,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100512729","hip-prospective-study-100512729",false,"NCT05956236","Hip Prospective Study","Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses","Inclusion Criteria:\n\n* Male or female adults\n* Planned to be implanted with investigational medical devices per the IFUs:\n\n  * Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and\u002For disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months\n  * Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)\n  * For an intended purpose and indication listed in the IFUs\n* Affiliated to French social security\n* Who provided a dated and signed informed consent form\n\nExclusion Criteria:\n\n* Patient protected by a French legal measure\n* Patient not able to express his\u002Fher consent as deemed by the investigator\n* Patient deprived of liberty or hospitalized without consent\n* Pregnant or breastfeeding women\n* Patient contraindicated to investigational medical devices implantation per the IFUs\n* Patient contraindicated to radiographic follow-up\n* Patient a priori not able to meet the follow-up visits as deemed by the investigator\n* Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.","ALL","18 Years",{"count":44,"type":45},5000,"ESTIMATED","OBSERVATIONAL","In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017\u002F745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable.\n\nTherefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses.\n\nHiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.",[49],"Hip Arthropathy",[51,52],"Hip arthropalsty","Hip Prosthesis","2026-04-09",{"date":55,"type":56},"2026-04-14","ACTUAL",{"date":58,"type":56},"2023-04-24",{"date":60,"type":45},"2046-04",{"name":5,"class":6},1]