[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594965":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":35,"locations":45,"responsibleParty":59,"collaborators":62,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":24,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":24,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Universidad Complutense de Madrid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pressure-guided laminectomy (PGL)","EXPERIMENTAL","Osseous resection of the lamina and ligamentum flavum until the epidural pressure reaches a normal value at the stenotic segment.",[13],"Procedure: Pressure-guided laminectomy (PGL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-pressure-guided laminectomy (NPGL)","ACTIVE_COMPARATOR","Complete resection of both the lamina and the ligamentum flavum at the stenotic segment.",[19],"Procedure: Laminectomy without pressure guidance (LWPG)",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"PROCEDURE",[9],null,{"type":22,"name":26,"description":17,"armGroupLabels":27,"otherNames":24},"Laminectomy without pressure guidance (LWPG)",[15],[29,32],{"name":30,"affiliation":5,"role":31},"Juan P Castaño-Montoya, M.D.,M.Sc.","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":5,"role":34},"Angela M Carrascosa-Granada, M.D.,M.Sc.,Ph.D.","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Juan P Castaño-Montoya, M.D., M.Sc.","CONTACT","+34669345474","juanpcas@ucm.es",{"name":42,"role":38,"phone":43,"phoneExt":24,"email":44},"Angela M Carrascosa-Granada, M.D., M.Sc.,Ph.D.","+34654849458","amaca3582@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":24,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":24},"Hospital Clínico San Carlos","RECRUITING","Madrid","28040","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],-3.70256,40.4165,{"lat":57,"lon":56},{"type":31,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Juan Pablo Castaño Montoya","M.D., M.Sc.",[63,65],{"name":64,"class":6},"Hospital San Carlos, Madrid",{"name":66,"class":6},"FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS","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":77,"type":78},24,"ESTIMATED","INTERVENTIONAL",[81],"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.",[84,85,86],"Lumbar Canal Stenosis","Lumbar Spinal Stenosis","Lumbar Spinal Stenosis (LSS)",[88,89,90,91],"lumbar canal stenosis","spinal epidural pressure","lumbar spinal stenosis","LSS","2025-06-18",{"date":94,"type":95},"2025-06-24","ACTUAL",{"date":97,"type":95},"2025-04-21",{"date":99,"type":78},"2026-10",{"name":5,"class":6},1]