[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"instability-lumbar-spine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:instability-lumbar-spine":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Degenerative Lumbar Spinal Stenosis","Facet Joint Arthrosis","Spondylarthritis","Discopathy","Degenerative Spondylolisthesis","Instability Lumbar Spine","RECRUITING","2024-06-21",{"date":36,"type":37},"2024-06-25","ACTUAL",{"date":39,"type":37},"2024-06-04",{"date":41,"type":21},"2031-08-31",{"name":43,"class":44},"SpineSave AG","INDUSTRY",2]