[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575701":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":40,"collaborators":10,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":10,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":10,"studyType":55,"phases":10,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Medacta International SA","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ROMAX",null,"Patients undergoing hip resurfacing surgery with ROMAX system",[13],"Device: Hip resurfacing system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Hip resurfacing system","Hip resurfacing with ROMAX system",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Marco Viganò, PhD","CONTACT","+41 0916966060","m.vigano@medacta.ch",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"Centre Hospitalier Universitaire de Lille","RECRUITING","Lille","59000","France","FR",{"type":35,"coordinates":36},"Point",[37,38],3.05512,50.63391,{"lat":38,"lon":37},{"type":41,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100575701","clinical-and-radiological-outcomes-of-the-romax-hip-resurfacing-system-100575701",false,"NCT06775704","Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System","Résultats Cliniques et Radiologiques du Dispositif de resurfaçage de Hanche ROMAXTM Medacta","Inclusion Criteria:\n\n* Patients eligible for hip resurfacing, suitable for the implantation of a Medacta ROMAX hip resurfacing system according to the manufacturer's defined indication for use.\n* Aged between 18 and 65 years at the time of surgery.\n* Ability and willingness to provide written informed consent for participation.\n\nExclusion Criteria:\n\n* Active infection\n* BMI \\> 40\n* Mental illness, when the known pathology is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress, or complete follow-up appointments and exams.\n* Significantly deformed anatomy (at the surgeon's discretion)\n* Osteomalacia where the fixation of an uncemented implant is contraindicated\n* Active rheumatoid arthritis\n* Osteoporosis\n* Metabolic disorders likely to impair bone formation and for which the fixation of an uncemented implant is contraindicated\n* Muscle atrophy or neuromuscular disease\n* Known allergy or hypersensitivity to the implant material\n* Any patient who cannot or does not wish to give informed consent to participate in the study\n* Patients whose chances of regaining independent mobility would be compromised by known concomitant medical issues.","ALL","18 Years","65 Years",{"count":53,"type":54},150,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to collect clinical and radiological data to monitor the safety and performance of the ROMAX hip resurfacing system. The main parameter that will be measured is the rate of revisions at 10 years.",[58,59],"Arthritis (Hip)","Hip Dysplasia, Congenital",[61],"resurfacing","2025-09-22",{"date":64,"type":65},"2025-09-25","ACTUAL",{"date":67,"type":65},"2025-07-14",{"date":69,"type":54},"2037-04-01",{"name":5,"class":6},1]