Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT04156867
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': '2 year', 'description': 'visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '2 year', 'description': 'Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%.'}, {'measure': 'Intervertebral height', 'timeFrame': '2 year', 'description': 'Intervertebral height in X-ray is for recontruction of the intervertebral space.'}, {'measure': 'Range of motion(ROM)', 'timeFrame': '2 year', 'description': 'ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Disorder of Spine']}, 'descriptionModule': {'briefSummary': 'To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.', 'detailedDescription': 'The study was to explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy. 128 patients with single-segmental LDH were randomly divided into discectomy with Dynesys group(group A) and simple discectomy group(group B). Both groups were evaluated by Visual Analogue Score(VAS), Oswestry Disability Index(ODI), radiological evidence of intervertebral height and range of motion(ROM) of the treated segment at pre- and post-operation. Operation duration and blood loss was recorded. The clinical outcomes and complications were evaluated afterwards. All patients received a 2-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria was Single-segmental LDH with low back pain and radicular pain.\n\nExclusion Criteria:\n\nExclusion criterias were lumbar stenosis(LSS), lumbar spondylolysis and degenerative spondylolisthesis, spinal deformity, lumbar surgery history, obviously osteoporosis, vertebral fracture, cauda equina syndrome, ankylosing spondylitis, tuberculosis, infection, tumor, obesity.'}, 'identificationModule': {'nctId': 'NCT04156867', 'briefTitle': 'Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation: a Prospective Study', 'orgStudyIdInfo': {'id': 'KY201410933-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'simple discectomy', 'description': 'traditional simple discectomy', 'interventionNames': ['Device: Dynesys']}], 'interventions': [{'name': 'Dynesys', 'type': 'DEVICE', 'description': 'discectomy with Dynesys', 'armGroupLabels': ['simple discectomy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}