[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603701":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":49,"studyPopulation":49,"armGroups":56,"interventions":62,"overallOfficials":49,"centralContacts":68,"locations":74,"responsibleParty":102,"collaborators":104,"id":108,"slug":49,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":49,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":49,"enrollmentInfo":116,"targetDuration":49,"studyType":119,"phases":120,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":77,"whyStopped":49,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"N.N. Priorov National Medical Research Center of Traumatology and Orthopedics","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":49},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in lumbar balance parameters","To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm","3 months postoperatively",[14,16,19,21,23,25,29,32,36,39,42,45],{"measure":10,"description":11,"timeFrame":15},"12 months postoperatively",{"measure":10,"description":17,"timeFrame":18},"To observe the change from baseline in full balance integrated index by full body X-Ray","3 months and 12 months postoperatively",{"measure":10,"description":20,"timeFrame":18},"To observe the change from baseline in lumbar lordosis (L1-S1) by full body X-Ray, in degrees",{"measure":10,"description":22,"timeFrame":18},"To observe the change from baseline in low lumbar lordosis (L4-S1) by full body X-Ray, in degrees",{"measure":10,"description":24,"timeFrame":18},"To observe the change from baseline in segmental lordosis at operated level by full body X-Ray, in degrees",{"measure":26,"description":27,"timeFrame":28},"Change in the cross-sectional area of the dural sac, mm2","To observe the change in the cross-sectional area of the dural sac at operated lumbar level by MRI","3 months after surgery",{"measure":30,"description":31,"timeFrame":18},"Change from baseline in Oswestry Disability Index","To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms (min - 0 - the best result, patient is active; max - 50 - the worst result, patient is not physically active",{"measure":33,"description":34,"timeFrame":35},"Change from baseline in Numeric Pain Rating Scale","To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms (0 - no pain, 10 - unbearable pain)","2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively",{"measure":37,"description":38,"timeFrame":35},"Change from baseline in Neuropathic Pain 4 Questions","To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms. If the total score is more than 4, the pain is neuropathic.",{"measure":40,"description":41,"timeFrame":35},"Change from baseline in The Health Transition Item from SF-36","To observe the The Health Transition Item as compared to baseline through follow-up terms (Patient's answers range from 2 - ''Much Better,'' 1 -''Somewhat Better,'' 0 - ''About the Same,'' -1 - ''Somewhat Worse,'' to -2 - ''Much Worse.'')",{"measure":43,"description":44,"timeFrame":35},"Change from baseline in posture alignment","To observe the patient's self-assessment of posture changes as compared to baseline (Patient asked: \"How has your posture changed since the surgery?\" 1 - better, 0 - unchanged (don't know), -1 - worse",{"measure":46,"description":47,"timeFrame":48},"Adverse Events","Document Adverse Events (incl. adverse events related to device) occurrence throughout the study","during study, an average of 12 months",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":49,"primaryPurpose":53,"observationalModel":49,"timePerspective":49,"maskingInfo":54},"NA","SINGLE_GROUP","TREATMENT",{"masking":55,"maskingDescription":49,"whoMasked":49},"NONE",[57],{"label":58,"type":6,"description":59,"interventionNames":60},"Cohort","Isolated lumbar decompression",[61],"Procedure: Isolated lumbar decomression",[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":49},"PROCEDURE","Isolated lumbar decomression","All patients will undergo microsurgical decompression of stenosed neural structures of the lumbar canal at all clinically significant levels with saving the posterior spinal column (type of decompression may be as unilateral, bilateral, or bilateral from a unilateral approach (over-the-top)), including endoscopic decompression.\n\nDegenerative lumbar stenosis may be caused by thickened yellow and posterior longitudinal ligaments, facet joints hypertrophy, vertebral body osteophytes posteriorly, synovial (facet joints cysts) and disc cysts.",[58],[69],{"name":70,"role":71,"phone":72,"phoneExt":49,"email":73},"Aleksandr Krutko, MD, PhD","CONTACT","+7 495 744 40 11","ortho-ped@mail.ru",[75,88,94],{"facility":76,"status":77,"city":78,"state":49,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":49},"Pirogov National Medical Surgical Center","RECRUITING","Moscow","105203","Russia","RU",{"type":83,"coordinates":84},"Point",[85,86],37.61781,55.75204,{"lat":86,"lon":85},{"facility":89,"status":77,"city":78,"state":49,"zip":90,"country":80,"countryCode":81,"cosmosGeoPoint":91,"geoPoint":93,"contacts":49},"Burdenko Neurosurgery Institute","125047",{"type":83,"coordinates":92},[85,86],{"lat":86,"lon":85},{"facility":95,"status":77,"city":78,"state":49,"zip":96,"country":80,"countryCode":81,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Priorov National Medical Research Center of Traumatology and Orthopedics","127299",{"type":83,"coordinates":98},[85,86],{"lat":86,"lon":85},[101],{"name":70,"role":71,"phone":72,"phoneExt":49,"email":73},{"type":103,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[105,106],{"name":89,"class":6},{"name":76,"class":107},"OTHER_GOV","100603701",false,"NCT07139938","Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression","Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis","Inclusion Criteria:\n\n* 1\\. Age 45 and over;\n* 2\\. Radicular leg pain and\u002For neurogenic claudication with\u002Fwithout back pain, caused by single- or multi-level degenerative lumbar stenosis with\u002Fwithout spodylolisthesis, confirmed by MRI;\n* 3\\. Planned isolated decompression of the spinal canal without implantation of any devices;\n* 4\\. Symptoms persisting for at least 3 months prior to surgery;\n* 5\\. Given written Informed Consent;\n* 6\\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.\n\nNon-Inclusion Criteria:\n\n* 1\\. Prior any lumbar surgery;\n* 2\\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);\n* 3\\. Degenerative scoliosis \\> 20 degrees;\n* 4\\. Any contraindication or inability to undergo baseline and\u002For follow up MRI or X-ray as required per protocol;\n* 5\\. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;\n\nExclusion Criteria:\n\n* 1\\. Performed intraoperative discotomy;\n* 2\\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)","ALL","18 Years",{"count":117,"type":118},165,"ESTIMATED","INTERVENTIONAL",[51],"Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.",[123,124,125,126],"LUMBAR STENOSIS","Sagittal Imbalance","Degeneration Lumbar Spine","Lumbar Decompression",[128,129,130],"lumbar stenosis","sagittal imbalance","lumbar decompression","2026-07-01",{"date":133,"type":134},"2026-07-02","ACTUAL",{"date":136,"type":134},"2025-10-06",{"date":138,"type":118},"2027-10-06",{"name":5,"class":6},3]