[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540750":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":79,"collaborators":30,"id":81,"slug":30,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":30,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":30,"overallStatus":51,"whyStopped":30,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"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",[49,68],{"facility":50,"status":51,"city":52,"state":30,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Spital Aarberg","RECRUITING","Aarberg","3270","Switzerland",{"type":56,"coordinates":57},"Point",[58,59],7.27578,47.04439,{"lat":59,"lon":58},[62,66],{"name":63,"role":45,"phone":64,"phoneExt":30,"email":65},"Cathrein","+41323668484","dorsomed@hin.ch",{"name":67,"role":41,"phone":30,"phoneExt":30,"email":30},"Philipp Cathrein, Dr.",{"facility":40,"status":51,"city":69,"state":30,"zip":70,"country":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Biel","2501",{"type":56,"coordinates":72},[73,74],8.21773,46.45587,{"lat":74,"lon":73},[77,78],{"name":63,"role":45,"phone":64,"phoneExt":30,"email":65},{"name":67,"role":41,"phone":30,"phoneExt":30,"email":30},{"type":80,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":91,"type":92},126,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98,99,100,101,102,103],"Degenerative Lumbar Spinal Stenosis","Facet Joint Arthrosis","Spondylarthritis","Discopathy","Degenerative Spondylolisthesis","Instability Lumbar Spine","2024-06-21",{"date":106,"type":107},"2024-06-25","ACTUAL",{"date":109,"type":107},"2024-06-04",{"date":111,"type":92},"2031-08-31",{"name":5,"class":6},2]