Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-01-24 @ 1:22 PM
Study NCT ID:
NCT03908203
Status:
WITHDRAWN
Last Update Posted:
2020-09-11
First Post:
2019-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The Study will be conducted in another research center. The Sponsor has changed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2019-04-06', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angle change at lumbar spine segment', 'timeFrame': 'At 1 Day of hospital discharge or 14th day of hospital stay (depends on what event comes first)', 'description': 'Angle between endplates at the treated level of lumbar spine'}], 'secondaryOutcomes': [{'measure': 'Improvement of Visual analog scale (VAS) back pain intensity', 'timeFrame': '3, 6, 12 months', 'description': 'To observe the improvement of VAS back pain as compared to baseline through follow-up terms.\n\nVisual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).'}, {'measure': 'Improvement of Visual analog scale (VAS) leg pain intensity', 'timeFrame': '3, 6, 12 months', 'description': 'To observe the improvement of VAS leg pain as compared to baseline through follow-up terms.\n\nVisual Analogue Scale (VAS) - patient-reported pain intensity (0 - no pain, 10 - unbearable pain).'}, {'measure': 'Improvement of Oswestry Disability Index (ODI)', 'timeFrame': '3, 6, 12 months', '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': 'Fusion rate success', 'timeFrame': '12 months', 'description': 'To observe the Fusion rate (I, II, III or IV grade according to Tan).\n\nGrade I - complete fusion; Grade II - partial fusion; Grade III - unipolar pseudarthrosis; Grade IV - bipolar pseudarthrosis.'}, {'measure': 'Range of Motion', 'timeFrame': 'At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months', 'description': 'To observe the disc mobility at the treated level'}, {'measure': 'Sagittal balance parameters', 'timeFrame': 'At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months', 'description': 'To observe sagittal balance as compared to baseline'}, {'measure': 'Disc height', 'timeFrame': 'At 1 Day of hospital discharge or 14th day of hospital stay depends on what event comes first, 12 months', 'description': 'To observe disc height at the treated level as compared to baseline'}, {'measure': 'Blood loss', 'timeFrame': 'Day of surgery', 'description': 'Blood loss'}, {'measure': 'Surgery duration', 'timeFrame': 'Day of surgery', 'description': 'Surgery duration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intervertebral Disc Degeneration', 'Spinal Fusion']}, '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 pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of MIS TLIF, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine.\n\nIt is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Given written Informed Consent;\n* Single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine L4-L5 or L5-S1;\n* Mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain;\n* Symptoms persisting for at least three months prior to surgery;\n* Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.\n\nExclusion Criteria:\n\n* Lumbar deformation of non-degenerative etiology;\n* Spondylolisthesis grade II or higher (25% slip or greater) of any etiology;\n* Patient that has already undergone a lumbar fusion surgery;\n* 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\n* Concurrent participation in another clinical study that may confound study results.'}, 'identificationModule': {'nctId': 'NCT03908203', 'briefTitle': 'Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan'}, 'officialTitle': 'Minimally Invasive Surgery Techniques for One-level Degenerative Lumbar Deformities Correction', 'orgStudyIdInfo': {'id': 'NS02-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment Arm', 'interventionNames': ['Procedure: Minimally invasive one-level lumbar deformity correction']}], 'interventions': [{'name': 'Minimally invasive one-level lumbar deformity correction', 'type': 'PROCEDURE', 'description': 'The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion.', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'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}}], 'overallOfficials': [{'name': 'Aleksandr V Krutko, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novosibirsk Research Institute of Traumatology and Orthopaedics n.a. Ya.L. Tsivyan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'DePuy International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}