[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540750":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":80,"collaborators":30,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":30,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":30,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":30,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"SpineSave AG","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"SpineShape System IV straight rod elastic","EXPERIMENTAL","Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex)",[13],"Device: SpineShape System IV straight rod elastic",{"label":15,"type":10,"description":16,"interventionNames":17},"SpineShape System IV straight rod medium","Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)",[18],"Device: SpineShape System IV straight rod medium",{"label":20,"type":21,"description":22,"interventionNames":23},"SpineShape System IV straight rod stiff","ACTIVE_COMPARATOR","Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex)",[24],"Device: SpineShape System IV straight rod stiff",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Implantation of SpineShape System IV straight rod elastic",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"Implantation of SpineShape System IV straight rod medium (mid-flex)",[15],{"type":27,"name":20,"description":35,"armGroupLabels":36,"otherNames":30},"Implantation of SpineShape System IV straight rod stiff (low-flex)",[20],[38],{"name":39,"affiliation":40,"role":41},"Philipp Cathrein, Dr.med.","Hirslanden Klinik Linde","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":30,"email":47},"Sarah Abramovic","CONTACT","+41448669280","sarah.abramovic@spinesave.com",[49,69],{"facility":50,"status":51,"city":52,"state":30,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Spital Aarberg","RECRUITING","Aarberg","3270","Switzerland","CH",{"type":57,"coordinates":58},"Point",[59,60],7.27578,47.04439,{"lat":60,"lon":59},[63,67],{"name":64,"role":45,"phone":65,"phoneExt":30,"email":66},"Cathrein","+41323668484","dorsomed@hin.ch",{"name":68,"role":41,"phone":30,"phoneExt":30,"email":30},"Philipp Cathrein, Dr.",{"facility":40,"status":51,"city":70,"state":30,"zip":71,"country":54,"countryCode":55,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Biel","2501",{"type":57,"coordinates":73},[74,75],8.21773,46.45587,{"lat":75,"lon":74},[78,79],{"name":64,"role":45,"phone":65,"phoneExt":30,"email":66},{"name":68,"role":41,"phone":30,"phoneExt":30,"email":30},{"type":81,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100540750","mid--or-high-flex-rods-versus-low-flex-rods-of-spineshape-system-iv-for-treatment-of-degenerative-lumbar-spine-diseases-100540750",false,"NCT06320899","Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases","Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study","Inclusion Criteria:\n\n* degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1\n* signed informed consent of participant\n* confirmation of the participant that the attendance of follow-up visits are intended\n* Body-Mass-Index \\\u003C 32\n* Pedicle screw axis distance \\\u003C 30mm\n* one or more of the following indications:\n\n  * (dynamic) stenosis in the spinal canal\n  * neuroforaminal stenosis\n  * facet joint syndrome \u002F spondylarthrosis\n  * discopathy (recurrent disc hernia)\n  * degenerative spondylolisthesis (Meyerding \\\u003C1)\n  * instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)\n\nExclusion Criteria:\n\n* missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible\n* damaged structural tissue, e.g. due to a bone fracture\n* application to the thoracic or cervical spine\n* pronounced idiopathic scoliosis\n* spondylolisthesis \\> Meyerding grad 1\n* isthmic spondolylysis\n* bone tumor\n* osteochondrosis modic type I, II or III\n* osteoporosis, which could impair screw anchoring\n* history with third party implants\n* patients with an active local or systemic infection\n* known allergy to titatnium alloys\n* skeleton in growth (epiphyseal joints not closed)\n* severe muscular neuronal or vascular disease\n* immunosuppresive therapy\n* long-term therapy with cortisone\n* heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics\n* chronic pain patients\n* incapable of judgment or emergency situation\n* implantation during pregnancy","ALL","18 Years","99 Years",{"count":93,"type":94},126,"ESTIMATED","INTERVENTIONAL",[97],"NA","The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.\n\nThe primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.",[100,101,102,103,104,105],"Degenerative Lumbar Spinal Stenosis","Facet Joint Arthrosis","Spondylarthritis","Discopathy","Degenerative Spondylolisthesis","Instability Lumbar Spine","2024-06-21",{"date":108,"type":109},"2024-06-25","ACTUAL",{"date":111,"type":109},"2024-06-04",{"date":113,"type":94},"2031-08-31",{"name":5,"class":6},2]