[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565329":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":19,"responsibleParty":34,"collaborators":7,"id":36,"slug":7,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":7,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":7,"studyType":48,"phases":7,"briefSummary":49,"conditions":50,"keywords":7,"overallStatus":22,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Medacta International SA","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Total Hip Arthroplasty","Total Hip Arthroplasty with SMS Femoral Stem (Medacta)",[14],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Paul Maisongrosse","CONTACT","0033 05 61 37 85 93","paul.maisongrosse@hotmail.fr",[20],{"facility":21,"status":22,"city":23,"state":7,"zip":24,"country":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Clinique de l'Union","RECRUITING","Saint-Jean","31240","France",{"type":27,"coordinates":28},"Point",[29,30],1.50459,43.66519,{"lat":30,"lon":29},[33],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},{"type":35,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100565329",false,"NCT06640764","Multicentre SMS Study - FR","Étude Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la stabilité de l'Implant fémoral Non cimenté SMS","Inclusion Criteria:\n\n* Patient suffering from a severely painful and\u002For disabling hip joint due to osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head, and requiring a total hip replacement.\n* Patient who will receive a Medacta SMS femoral stem.\n* Patient agrees to comply with the study requirements.\n* Patient has signed the consent form.\n* Patient is affiliated with a social security system.\n* Patient aged 18 to 75 years\n\nExclusion Criteria:\n\n* Participation in biomedical research.\n* Minor patient.\n* Protected adult patient.\n* Vulnerable individuals as defined by Article L1121-6 of the Public Health Code.\n* Pregnant or breastfeeding women.\n* Patient unable to express their non-opposition.\n* Patient refusing the collection of their personal data.\n* Acute, systemic, or chronic infection. Skeletal immaturity.\n* Grossly deformed anatomy (at the surgeon's discretion).\n* Osteomalacia for which the fixation of an uncemented implant is contraindicated.\n* Patient suffering from active rheumatoid arthritis or osteoporosis.\n* Patient with metabolic disorders likely to impair bone formation when the fixation of an uncemented implant is contraindicated.\n* Patient suffering from muscle atrophy or neuromuscular disease.\n* Patient with an allergy to the implant material.\n* Any patient who cannot or does not wish to give their informed consent to participate in the study.\n* Patient whose prospects of regaining independent mobility would be compromised by known coexisting medical problems.\n* Any contraindication mentioned in the instructions for use of the investigational medical device.","ALL","18 Years","85 Years",{"count":46,"type":47},260,"ESTIMATED","OBSERVATIONAL","Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem",[51,52,53,54],"Dysplasia of Hip Joint","Hip Osteoarthritis","Traumatic Arthritis of Hip","Avascular Necrosis of Femur Head","2024-10-11",{"date":57,"type":58},"2024-10-15","ACTUAL",{"date":60,"type":58},"2024-09-01",{"date":62,"type":47},"2037-09-01",{"name":5,"class":6},1]