Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-01 @ 1:07 PM
Study NCT ID:
NCT04254757
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2020-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-31', 'studyFirstSubmitDate': '2020-01-15', 'studyFirstSubmitQcDate': '2020-01-31', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified MacNab criteria', 'timeFrame': '1 years after surgery'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'at 1 years after surgery', 'description': 'VAS of leg and back'}, {'measure': 'Oswestry Disability Index(ODI)', 'timeFrame': 'at 1 years after surgery'}], 'secondaryOutcomes': [{'measure': 'Range of motion(ROM)', 'timeFrame': 'at 1 years after surgery', 'description': 'ROM of operated level'}, {'measure': 'Adjacent Segment Disease', 'timeFrame': 'at 1 years after surgery', 'description': 'Measured on CT and MRI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spinal Stenosis', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '35624443', 'type': 'DERIVED', 'citation': 'Zhai S, Zhao W, Zhu B, Huang X, Liang C, Hai B, Ding L, Zhu H, Wang X, Wei F, Chu H, Liu X. The effectiveness of percutaneous endoscopic decompression compared with open decompression and fusion for lumbar spinal stenosis: protocol for a multicenter, prospective, cohort study. BMC Musculoskelet Disord. 2022 May 27;23(1):502. doi: 10.1186/s12891-022-05440-4.'}]}, 'descriptionModule': {'briefSummary': 'Lumbar spinal stenosis (LSS) is the most common spinal degenerative disease. For conservative treatment failure, open lumbar decompression and fusion surgery is the main surgical treatment. After decades of development, open lumbar decompression and fusion surgery has been the standard treatment. However, there are still people and conditions that cannot be covered, such as elderly people who intolerable surgery, severe osteoporosis, and re-stenosis at adjacent segments after fusion. Percutaneous spinal endoscopic lumbar spinal decompression technique could be performed under local anesthesia, soft tissue damage is minimized, and effective spinal decompression can be achieved. There are still some controversial points of LSS decompression under percutaneous endoscope surgery, such as the range of decompression, choice of approach, postoperative spinal stability, learning curve, surgical safety, long-term effects of endoscopic treatment of restenosis at adjacent segments after fusion surgery. The purpose of this study was to solve these controversial points. A multi-center, prospective registration study based on the real world is planned. The total sample size is about 600 cases (300 cases in endoscopic surgery group, 300 cases in open decompression and fusion group). The mid- to long-term clinical efficacy and safety were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; Pathology was confirmed by both computed tomography and magnetic resonance imaging The operative level≤2\n\nExclusion Criteria:\n\n* Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection'}, 'identificationModule': {'nctId': 'NCT04254757', 'briefTitle': 'Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis', 'orgStudyIdInfo': {'id': 'BYSYZD2019001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Percutaneous endoscopic surgery group', 'interventionNames': ['Procedure: Two different treatment']}, {'type': 'OTHER', 'label': 'Open decompression and fusion surgery group', 'interventionNames': ['Procedure: Two different treatment']}], 'interventions': [{'name': 'Two different treatment', 'type': 'PROCEDURE', 'description': 'One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery', 'armGroupLabels': ['Open decompression and fusion surgery group', 'Percutaneous endoscopic surgery group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Zhu, M.D.', 'role': 'CONTACT', 'email': 'liuxgspine@126.com', 'phone': '15201278112'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bin Zhu, M.D', 'role': 'CONTACT', 'email': 'liuxgspine@126.com', 'phone': '15201278112'}], 'overallOfficials': [{'name': 'Xiaoguang Liu, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Shijitan Hospital, Capital Medical University', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, {'name': 'Beijing Changping Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PH.D.,M.D.,Professor', 'investigatorFullName': 'Liu xiaoguang', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}