Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 2:05 PM
Study NCT ID:
NCT05033457
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-09-02
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cross-sectional area of the preoperative lumbar intervertebral disc', 'timeFrame': 'preoperative', 'description': 'The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.'}, {'measure': 'Cross-sectional area of the preoperative spinal canal', 'timeFrame': 'preoperative', 'description': 'The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the spinal canal of the diseased segment.'}, {'measure': 'Cross-sectional area of the postoperative lumbar intervertebral disc', 'timeFrame': '3 months after surgery', 'description': 'The postoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.'}, {'measure': 'preoperative ODI', 'timeFrame': 'preoperative', 'description': 'According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.'}, {'measure': 'ODI on 3 months after operation', 'timeFrame': '3 months after surgery', 'description': 'According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.'}, {'measure': 'ODI at the final follow-up', 'timeFrame': 'Final follow-up', 'description': 'According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.'}, {'measure': 'preoperative VAS back pain score', 'timeFrame': 'preoperative', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.'}, {'measure': 'preoperative VAS leg pain score', 'timeFrame': 'preoperative', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.'}, {'measure': 'VAS back pain score on postoperative day 1', 'timeFrame': '1 day after operation', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.'}, {'measure': 'VAS leg pain score on postoperative day 1', 'timeFrame': '1 day after operation', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.'}, {'measure': 'VAS back pain score on 3 months after operation', 'timeFrame': '3 months after operation', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on 3 months after operation.'}, {'measure': 'VAS leg pain score on 3 months after operation', 'timeFrame': '3 months after operation', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on 3 months after operation.'}, {'measure': 'VAS back pain score at the final follow-up', 'timeFrame': 'Final follow-up', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants at the final follow-up.'}, {'measure': 'VAS leg pain score at the final follow-up', 'timeFrame': 'Final follow-up', 'description': 'According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants at the final follow-up.'}], 'secondaryOutcomes': [{'measure': 'operation time', 'timeFrame': 'intraoperative', 'description': 'Collect the operation time of participants during the operation.'}, {'measure': 'incision size', 'timeFrame': 'intraoperative', 'description': 'Collect the incision size of participants during the operation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.\n\nMETHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.', 'detailedDescription': 'It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation，accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.\n\nThe investigators performed two kinds of endoscopic lumbar discectomy：unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lumbar spinal stenosis, with low back pain and neurological urgency.The patient cannot relieve symptoms after 3 months or more of conservative treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Single-segment lumbar disc herniation/lumbar spinal stenosis\n\nExclusion Criteria:\n\n* Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes\n\nInclusion Criteria:\n\nInclusion Criteria:\n\nSingle-segment lumbar disc herniation Symptoms of nerve compression\n\nExclusion Criteria:\n\nforaminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis'}, 'identificationModule': {'nctId': 'NCT05033457', 'briefTitle': 'Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis', 'organization': {'class': 'OTHER', 'fullName': "Shaanxi Provincial People's Hospital"}, 'officialTitle': 'Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis', 'orgStudyIdInfo': {'id': 'sxsrmyyjzwc202101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'unilateral biportal endoscopy technique group', 'description': 'Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group', 'interventionNames': ['Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy']}, {'label': 'percutaneous endoscopic transforaminal discectomy group', 'description': 'Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group', 'interventionNames': ['Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy']}], 'interventions': [{'name': 'unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy', 'type': 'PROCEDURE', 'description': 'Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.', 'armGroupLabels': ['percutaneous endoscopic transforaminal discectomy group', 'unilateral biportal endoscopy technique group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'overallOfficials': [{'name': 'Jingpeng Wei', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanxi Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shaanxi Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Rongcan Liu', 'investigatorAffiliation': "Shaanxi Provincial People's Hospital"}}}}