[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbar-canal-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbar-canal-stenosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100594965","is-it-really-necessary-going-all-over-the-top-in-patients-with-symptomatic-lumbar-spinal-stenosis-100594965",false,"NCT07026305","Is it Really Necessary Going All Over the Top in Patients With Symptomatic Lumbar Spinal Stenosis?","Non-inferiority of Osseous Decompression of the Lumbar Canal Until Normalization of Epidural Pressure Compared to Conventional Open Laminectomy in Patients With Symptomatic Lumbar Spinal Stenosis.","Inclusion Criteria:\n\n* Surgical indication determined by:\n\n  * Lower back pain and\u002For lower extremity pain for more than 3 months.\n  * Pain refractory to conservative medical management (analgesics, physical therapy, epidural block).\n  * Clinical criterion of neurogenic claudication defined as a score ≥11 on the N-CLASS scale.\n  * Preoperative magnetic resonance imaging (MRI) showing lumbar canal stenosis.\n* Patient consents to the proposed surgical intervention.\n* Patient agrees to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Foraminal or lateral recess stenosis.\n* Symptomatic disc herniation at the segment to be treated.\n* Spondylolisthesis \\> Grade I (Meyerding) (translation \\>25% of the vertebra) or spondylolysis.\n* Radiological instability defined as \\>5 mm of anteroposterior translation on dynamic flexion-extension spine X-rays.\n* Scoliosis with Cobb angle \\>30°.\n* Compression fracture at the level to be treated.\n* Prior surgery at the same segment to be treated.\n* Prior infection at the segment to be treated.\n* Contraindication for MRI.\n* Diagnosis of major depressive disorder or dysthymia according to DSM-V criteria.","ALL","50 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the theory of epidural pressure by comparing a surgical procedure that aims to perform less bone resection compared to conventional surgery in patients with lumbar spinal stenosis.\n\nThe main questions it aims to answer is:\n\nIs bony decompression of the lumbar canal performed until normalization of epidural pressure not inferior to conventional surgery in achieving clinical improvement in patients with symptomatic lumbar canal stenosis?\n\nResearchers will:\n\nCompare conventional open laminectomy to bony decompression of the lumbar canal until normalization of epidural pressure is achieved.\n\nParticipants will:\n\n* Be randomized to one of the two surgical interventions: laminectomy guided by epidural pressure measure or conventional laminectomy.\n* Visit the clinic for checkups and tests until 1 year of follow-up.",[26,27,28],"Lumbar Canal Stenosis","Lumbar Spinal Stenosis","Lumbar Spinal Stenosis (LSS)",[30,31,32,33],"lumbar canal stenosis","spinal epidural pressure","lumbar spinal stenosis","LSS","RECRUITING","2025-06-18",{"date":37,"type":38},"2025-06-24","ACTUAL",{"date":40,"type":38},"2025-04-21",{"date":42,"type":20},"2026-10",{"name":44,"class":45},"Universidad Complutense de Madrid","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100410947","lisa-post-market-clinical-follow-up-study-documentation-of-clinical-outcomes-after-surgery-with-lisa-implant-100410947","NCT04631133","LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant","LISA Post Market Clinical Follow-Up Study:Post Marketing Prospective Documentation of Clinical Outcomes (Post-operative, Safety and Performance) After Lumbar Dynamic Stabilization Surgery With LISA Implant","LISA-PMCF","Inclusion Criteria:\n\n* Skeletally mature patients Patient ≥18 years of age\n* Patients with low-back pain caused by degenerative lesions of grade II, III and IV (Pfirrmann MRI classification)\n* Failed conservative treatment for low back pain conducted for at least 6 months\n\nExclusion Criteria:\n\n* Stage V degenerative disk lesions in Pfirrmann's MRI classification\n* Spondylolisthesis\n* Osteoporosis\n* Non-specific back pain\n* Modic 2 and Modic 3 changes\n* L5\u002FS1 segments affected\n* Local or general infections that may compromise the surgical goals\n* Major local inflammatory phenomena\n* Pregnant and lactating Women\n* Immunosuppressive diseases\n* Bone immaturity\n* Severe mental illnesses\n* Bone metabolism diseases that may compromise the mechanical support expected from this type of implant\n* Patient with worker's compensation, under litigation or on disability benefits\n* Excessive physical activities\n* Patients deprived of their liberty in accordance with respective national regulations\n* Protected patients or patients not in a position to declare his or her consent in accordance with respective national regulations","18 Years",{"count":57,"type":20},136,"OBSERVATIONAL","The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). \"Post-market\" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market.\n\nThe LISA device consists of 3 components: A PEEK interspinous spacer, a polyester band, and a titanium blocker. The spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer.\n\nMedical Device manufacturers conduct \"post-market\" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed.\n\nThis study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.",[61,62,63,26],"Chronic Low-back Pain","Herniated Disc","Degenerative Disc Disease",[61,62,63,26,65,66],"Dynamic Stabilization Implants","Post-Market Clinical Follow-Up Study","2022-07-19",{"date":69,"type":38},"2022-07-21",{"date":71,"type":38},"2019-04-17",{"date":73,"type":20},"2028-12-31",{"name":75,"class":76},"BACKBONE","INDUSTRY",5]