Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-28 @ 12:31 PM
Study NCT ID:
NCT04254250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-14
First Post:
2020-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}, 'targetDuration': '6 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2020-02-01', 'studyFirstSubmitQcDate': '2020-02-01', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reherniation rate', 'timeFrame': 'at 3 years follow-up term postoperatively', 'description': 'Rate of lumbar disc reherniation, symptomatic presence of disc herniation confirmed by MRI at the previously operated level and side'}], 'secondaryOutcomes': [{'measure': 'Improvement of Oswestry Disability Index (ODI)', 'timeFrame': '6, 12, 18, 24, 30, 36 months follow up', 'description': 'To observe the improvement of ODI as compared to baseline through follow-up terms Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 % (the best result, the patient has no limitations in physical activity). Maximum - 100% (the worst result, patient is not physically active at all).'}, {'measure': 'Improvement of Visual analog scale (VAS) leg pain intensity', 'timeFrame': '6, 12, 18, 24, 30, 36 months follow up', 'description': 'To observe the improvement of VAS leg pain as compared to baseline through follow-up terms.'}, {'measure': 'Change from baseline in EQ-5D (EuroQl - 5 dimensional)', 'timeFrame': '6, 12, 18, 24, 30, 36 months follow up', 'description': 'To observe change in EQ-5Dl as compared to baseline'}, {'measure': 'HTI Item (from SF-36)', 'timeFrame': '6, 12, 18, 24, 30, 36 months follow up', 'description': 'To observe the HTI Item (from SF-36) as compared to baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intervertebral Disc Herniation']}, 'descriptionModule': {'briefSummary': 'This study will be conducted at Research Institute of Traumatology and Orthopedics (NRITO) n.a. Ya.L.Tsivyan, Novosibirsk, Russia.\n\nThe current study is prospective observational study to evaluate the efficacy of preoperative estimation of disc herniation recurrence among patients with lumbar disc herniation using predictive mathematical model at terms 3 years postoperatively .\n\nIt is expected to enroll 350 patients aged 18-70 with lumbar disc herniation. Risk estimation of disc herniation recurrence will be evaluated preoperatively, then patient will undergo conventional microdiscectomy. Postoperative eximanation will include Visits every 6-months during 3 years to evaluate clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with radicular leg pain with or without back pain secondary to single level disc herniation with neural compression confirmed on MRI and symptoms persisting for at least four weeks prior to surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age 18 to 60 years;\n\nSingle level lumbar disc herniation with neural compression confirmed on MRI at one level of L4-L5 or L5-S1;\n\n1. Radicular leg pain with or without back pain;\n2. Symptoms persisting for at least four weeks prior to surgery;\n3. Given written Informed Consent;\n4. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements;\n5. Visual Analogue Scale score at least 40/100 at baseline.\n\nExclusion Criteria:\n\n1. More than one symptomatic level requiring multilevel surgical decompression\n2. Stenosis any etiology at the same level;\n3. Spondylolisthesis any etiology at the same level;\n4. Prior lumbar spinal surgery at any level;\n5. Other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study\n6. Concurrent participation in another clinical study that may confound study results.'}, 'identificationModule': {'nctId': 'NCT04254250', 'briefTitle': 'Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan'}, 'officialTitle': 'Observational Cohort Study Of The Efficacy Of Preoperative Estimation Of Disc Herniation Recurrence In Patients With Lumbar Disc Herniation', 'orgStudyIdInfo': {'id': 'NS02-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk recurrence group', 'description': 'Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk.', 'interventionNames': ['Diagnostic Test: Preoperative risk estimation of disc herniation recurrence']}, {'label': 'Low risk recurrence group', 'description': 'Due to preoperative risk estimation each patient will be assigned to one of two groups - with high risk and low risk.', 'interventionNames': ['Diagnostic Test: Preoperative risk estimation of disc herniation recurrence']}], 'interventions': [{'name': 'Preoperative risk estimation of disc herniation recurrence', 'type': 'DIAGNOSTIC_TEST', 'description': 'Risk estimation of disc herniation recurrence will be evaluated preoperatively, depend on the risk significance each patient will be assigned to one of two groups - with high risk and low risk. Then each patient will undergo conventional one-level microdiscectomy.', 'armGroupLabels': ['High risk recurrence group', 'Low risk recurrence group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '127299', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Priorov National Medical Research Center of Traumatology and Orthopedics', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '630091', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}