Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT05480267
Status:
UNKNOWN
Last Update Posted:
2022-07-29
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013168', 'term': 'Spondylolisthesis'}], 'ancestors': [{'id': 'D013169', 'term': 'Spondylolysis'}, {'id': 'D055009', 'term': 'Spondylosis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ODI score', 'timeFrame': '2 year postoperatively', 'description': 'the D-value between the preoperative ODI score and 2-year-postoperative ODI score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spondylolisthesis', 'Unilateral Biportal Endoscopy', 'Minimally Invasive Technique', 'Surgical Treatment']}, 'referencesModule': {'references': [{'pmid': '13287061', 'type': 'RESULT', 'citation': 'MUTCH J, WALMSLEY R. The aetiology of cleft vertebral arch in spondylolisthesis. Lancet. 1956 Jan 14;270(6907):74-7. doi: 10.1016/s0140-6736(56)92130-4. No abstract available.'}, {'pmid': '32205705', 'type': 'RESULT', 'citation': 'Oster BA, Kikanloo SR, Levine NL, Lian J, Cho W. Systematic Review of Outcomes Following 10-Year Mark of Spine Patient Outcomes Research Trial (SPORT) for Degenerative Spondylolisthesis. Spine (Phila Pa 1976). 2020 Jun 15;45(12):820-824. doi: 10.1097/BRS.0000000000003485.'}, {'pmid': '35125463', 'type': 'RESULT', 'citation': 'Kwon JW, Park Y, Lee BH, Yoon SR, Ha JW, Kim H, Suk KS, Moon SH, Kim HS, Lee HM. Ten-Year Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion in Patients With Single-Level Lumbar Spondylolisthesis. Spine (Phila Pa 1976). 2022 Jun 1;47(11):773-780. doi: 10.1097/BRS.0000000000004334. Epub 2022 Feb 3.'}, {'pmid': '31542473', 'type': 'RESULT', 'citation': 'Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.'}, {'pmid': '35125462', 'type': 'RESULT', 'citation': 'Lightsey HM 4th, Pisano AJ, Striano BM, Crawford AM, Xiong GX, Hershman S, Schoenfeld AJ, Simpson AK. ALIF Versus TLIF for L5-S1 Isthmic Spondylolisthesis: ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures Domains. Spine (Phila Pa 1976). 2022 Jun 1;47(11):808-816. doi: 10.1097/BRS.0000000000004333. Epub 2022 Feb 3.'}, {'pmid': '31042664', 'type': 'RESULT', 'citation': 'Heo DH, Lee DC, Park CK. Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis: biportal endoscopy, uniportal endoscopy, and microsurgery. Neurosurg Focus. 2019 May 1;46(5):E9. doi: 10.3171/2019.2.FOCUS197.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/31042664', 'label': 'Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/35125462', 'label': 'ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/31542473', 'label': 'Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial'}]}, 'descriptionModule': {'briefSummary': 'Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved for the treatment of lumbar spondylolisthesis (LSP). The present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures.', 'detailedDescription': 'Lumbar spondylolisthesis (LSP) is the most common degenerative lumbar disease in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new direction for spinal surgeons to treat LSP. Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved. The results of pilot studies showed that it had the advantages of less traumas, fewer complications, quicker recover，and the clinical and imaging outcome was remarkable. Therefore, the present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish two-year follow-up to further quantify the clinical and imaging outcome of UBE. Therefore, the present study will further verify and quantify the safety and effectiveness of the UBE in the treatment of LSP on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of LSP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lumbar spondylolisthesis,\n* 40 yrs\\<age\\< 75yrs\n* fusion levels \\<2\n\nExclusion Criteria:\n\n* greater than Lenke-slivia classification III\n* severe osteoporosis (t value \\<2.5)\n* ASA 》IV'}, 'identificationModule': {'nctId': 'NCT05480267', 'briefTitle': 'A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'UBE vs. MIS-TLIF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UBE', 'description': 'The patient treated with unilateral biportal endoscopy (UBE)', 'interventionNames': ['Procedure: surgical treatment for lumbar spondylolisthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MIS-TLIF', 'description': 'The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)', 'interventionNames': ['Procedure: surgical treatment for lumbar spondylolisthesis']}], 'interventions': [{'name': 'surgical treatment for lumbar spondylolisthesis', 'type': 'PROCEDURE', 'description': 'There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF', 'armGroupLabels': ['MIS-TLIF', 'UBE']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhi-wei WANG, Ph.D and MD.', 'role': 'CONTACT', 'email': 'keyanlunli_zheer@163.com', 'phone': '0571-87783759'}], 'overallOfficials': [{'name': 'Gang CHEN, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We have not decided when to share the plan. We plan to share it after the study completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D and MD.', 'investigatorFullName': 'Li fangcai', 'investigatorAffiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}}}}