[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460606":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":10,"enrollmentInfo":58,"targetDuration":61,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":10,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"SC Medica","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient with medical device DIVA®",null,"Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with DIVA® implant",[13],"Procedure: Surgery lumbar disc herniation",{"label":15,"type":10,"description":16,"interventionNames":17},"Patient without medical device DIVA®","Adult patient, operated for at least 12 months, having had surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated without DIVA® implant",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Surgery lumbar disc herniation","Surgery for a degenerative or traumatic mono-segmental lumbar disc herniation",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Aurélie MULLER","CONTACT","+33 3 88 23 71 04","dpo@sc-medica.com",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":10,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Hôpitaux Civils de Colmar","RECRUITING","Colmar","France","FR",{"type":38,"coordinates":39},"Point",[40,41],7.35584,48.08078,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":10,"phoneExt":10,"email":46},"Robin SROUR, MD","robin.srour@ch-colmar.fr",{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100460606","post-marketing-clinical-follow-up-of-the-medical-device-diva-100460606",false,"NCT05277818","Post-marketing Clinical Follow-up of the Medical Device DIVA®","Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery","Inclusion Criteria:\n\n* Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant;\n* Patient operated for at least 12 months;\n* Patient able to understand the information related to the study;\n* Patient having indicated his\u002Fher non-opposition to the collection of his\u002Fher personal data.\n\nExclusion Criteria:\n\n* History of pathologies, malformations or surgical interventions on the spine;\n* Patient belonging to the first 30 operated by the surgeon with the DIVA® implant;\n* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);\n* Patient not benefiting from a social security scheme.","ALL","18 Years",{"count":59,"type":60},822,"ESTIMATED","5 Years","OBSERVATIONAL","Observational, ambispective, longitudinal, comparative, open, multicentric study.\n\nThe main objective is to compare the performance of care in patients operated with and without DIVA®.",[65],"Lumbar Disc Herniation","2022-10-27",{"date":68,"type":69},"2022-10-31","ACTUAL",{"date":71,"type":69},"2022-09-07",{"date":73,"type":60},"2027-03-15",{"name":5,"class":6},1]