[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460304":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":79,"collaborators":81,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":25,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Sklifosovsky Institute of Emergency Care","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"decompression group","OTHER","minimally invasive decompression without fusion",[13],"Procedure: decompression",{"label":15,"type":10,"description":16,"interventionNames":17},"fusion group","minimally invasive decompression with trans-foraminal interbody fusion",[18],"Procedure: fusion",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","decompression","laminotomy of the corresponding adjacent vertebrae, partial flavectomy and medial facetectomy are planned to be performed unilaterally. Depending on the surgeon's personal preferences, the following two options are available: 1) equivalent decompression procedure contralaterally and 2) crossover contralateral decompression. Irrespective of the selected option, the spinous process, the interspinous and supraspinous ligaments, part of the facet joints, and the corresponding part of the vertebral arch must be preserved intact in all participants.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"fusion","First, decompression is performed according to one of the above methods. Next, trans-foraminal interbody fusion with a cage (TLIF) and fixation with pedicle screws are performed.",[15],[31],{"name":32,"affiliation":33,"role":34},"Andrey Grin, MD, PhD","Sklifosovsky Research Institute for Emergency Medicine","STUDY_CHAIR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Ivan Lvov, MD, PhD","CONTACT","+79265760074","dr.speleolog@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Anton Kordonskiy, MD, PhD","+79265724547","akord.neuro@mail.ru",[46,67],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Pirogov National Medical and Surgical Center","RECRUITING","Moscow","105203","Russia","RU",{"type":54,"coordinates":55},"Point",[56,57],37.61781,55.75204,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":25,"email":63},"Valeriy Lebedev, MD, PhD","+79264922952","horizont_vbl@mail.ru",{"name":65,"role":66,"phone":25,"phoneExt":25,"email":25},"Dmitriy Epifanov","SUB_INVESTIGATOR",{"facility":33,"status":48,"city":49,"state":49,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"107045",{"type":54,"coordinates":70},[56,57],{"lat":57,"lon":56},[73,74,75,77,78],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},{"name":32,"role":76,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":37,"role":76,"phone":25,"phoneExt":25,"email":25},{"name":42,"role":76,"phone":25,"phoneExt":25,"email":25},{"type":76,"investigatorFullName":37,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Senior fellow",[82,84],{"name":83,"class":6},"Pirogov National Medical Surgical Center",{"name":85,"class":10},"Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine","100460304","necessity-of-fusion-following-decompression-surgery-in-patients-with-single-level-lumbar-stenosis-100460304",false,"NCT05273879","Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis","Necessity of Fusion Following Decompression Surgery in Patients With Single-level Lumbar Stenosis: Study Protocol for an Open-label Multicenter Non-inferiority Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* age of patients from 45 to 75 years;\n* stenosis C or D according to Shizas et al. according to MRI at the level of L2-L3, L3-L4, L4-L5 or L5-S1;\n* clinical manifestations of lumbar stenosis (neurogenic claudication syndrome and\u002For radiculopathy);\n* lack of effect from conservative therapy within 3 months;\n* Informed consent to take part in the study.\n\nExclusion Criteria:\n\n* spondylolisthesis more than 3 mm;\n* spinal instability according to functional radiography;\n* sagittal imbalance (type 4 according to C. Barrey);\n* bone density of the vertebrae at the level of the operation is less than 100 HU;\n* clinically significant spinal stenosis at 2 or more levels;\n* previously performed surgeries on the spine;\n* risk of anesthesia 4 or 5 according to ASA;\n* inability to take part in control examinations within 2 years after the operation;\n* participation in other clinical trials related to surgical or conservative treatment of diseases of the spine.","ALL","45 Years","75 Years",{"count":97,"type":98},86,"ESTIMATED","INTERVENTIONAL",[101],"NA","Long-term clinical results of two methods of surgical treatment (spinal decompression with or without fusion) in patients with single-level lumbar stenosis will be compared. A clear framework for surgical treatment methods and standardized postoperative rehabilitation treatment will be set to obtain the maximum homogeneity of the patient groups.\n\nThis trial should provide the first level of evidence for the need for spinal fusion in patients with single-level lumbar stenosis, subject to the high homogeneous comparison groups. Additional results will allow comparing the economic aspects of different surgical treatments for 2 years after surgery.",[104,105,106],"Lumbar Spinal Stenosis","Spinal Stenosis","Spinal Fusion",[108,109,110,111,112],"lumbar spine","lumbar fusion","laminotomy","decompression without fusion","lumbar stenosis","2025-12-11",{"date":115,"type":116},"2025-12-18","ACTUAL",{"date":118,"type":116},"2022-04-01",{"date":120,"type":98},"2026-12-30",{"name":5,"class":6},2]