NCT05480267

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2.7 years

First QC Date

July 28, 2022

Last Update Submit

July 28, 2022

Conditions

Lumbar SpondylolisthesisUnilateral Biportal EndoscopyMinimally Invasive TechniqueSurgical Treatment

Outcome Measures

Primary Outcomes (1)

  • ODI score

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

    2 year postoperatively

Study Arms (2)

UBE

EXPERIMENTAL

The patient treated with unilateral biportal endoscopy (UBE)

Procedure: surgical treatment for lumbar spondylolisthesis

MIS-TLIF

ACTIVE COMPARATOR

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

Procedure: surgical treatment for lumbar spondylolisthesis

Interventions

surgical treatment for lumbar spondylolisthesisPROCEDURE

There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF

MIS-TLIFUBE

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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: 13287061RESULT

  • 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: 32205705RESULT

  • 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: 35125463RESULT

  • 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: 31542473RESULT

  • 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: 35125462RESULT

  • 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.

    PMID: 31042664RESULT

Related Links

MeSH Terms

Conditions

Spondylolisthesis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Gang CHEN, MD.

    2nd hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-wei WANG, Ph.D and MD.

CONTACT

0571-87783759keyanlunli_zheer@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D and MD.

Study Record Dates

First Submitted

July 28, 2022

First Posted

July 29, 2022

Study Start

September 1, 2022

Primary Completion

May 1, 2025

Study Completion

September 1, 2025

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

We have not decided when to share the plan. We plan to share it after the study completion.