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A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis

Primary Purpose

Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical treatment for lumbar spondylolisthesis
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spondylolisthesis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Lumbar spondylolisthesis,
  • 40 yrs<age< 75yrs
  • fusion levels <2

Exclusion Criteria:

  • greater than Lenke-slivia classification III
  • severe osteoporosis (t value <2.5)
  • ASA 》IV

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    UBE

    MIS-TLIF

    Arm Description

    The patient treated with unilateral biportal endoscopy (UBE)

    The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)

    Outcomes

    Primary Outcome Measures

    ODI score
    the D-value between the preoperative ODI score and 2-year-postoperative ODI score

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2022
    Last Updated
    July 28, 2022
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, RenJi Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05480267
    Brief Title
    A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis
    Official Title
    Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    September 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, RenJi Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique, Surgical Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    340 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    UBE
    Arm Type
    Experimental
    Arm Description
    The patient treated with unilateral biportal endoscopy (UBE)
    Arm Title
    MIS-TLIF
    Arm Type
    Active Comparator
    Arm Description
    The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)
    Intervention Type
    Procedure
    Intervention Name(s)
    surgical treatment for lumbar spondylolisthesis
    Intervention Description
    There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF
    Primary Outcome Measure Information:
    Title
    ODI score
    Description
    the D-value between the preoperative ODI score and 2-year-postoperative ODI score
    Time Frame
    2 year postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Lumbar spondylolisthesis, 40 yrs<age< 75yrs fusion levels <2 Exclusion Criteria: greater than Lenke-slivia classification III severe osteoporosis (t value <2.5) ASA 》IV
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhi-wei WANG, Ph.D and MD.
    Phone
    0571-87783759
    Email
    keyanlunli_zheer@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gang CHEN, MD.
    Organizational Affiliation
    2nd hospital, School of Medicine, Zhejiang University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We have not decided when to share the plan. We plan to share it after the study completion.
    Citations:
    PubMed Identifier
    13287061
    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.
    Results Reference
    result
    PubMed Identifier
    32205705
    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.
    Results Reference
    result
    PubMed Identifier
    35125463
    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.
    Results Reference
    result
    PubMed Identifier
    31542473
    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.
    Results Reference
    result
    PubMed Identifier
    35125462
    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.
    Results Reference
    result
    PubMed Identifier
    31042664
    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.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/31042664
    Description
    Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/35125462
    Description
    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
    Description
    Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial

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    A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis

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