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

July 28, 2022 updated by: Li fangcai, Second Affiliated Hospital, School of Medicine, Zhejiang University

Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UBE
The patient treated with unilateral biportal endoscopy (UBE)
Procedure: surgical treatment for lumbar spondylolisthesis
There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF
Active Comparator: MIS-TLIF
The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)
Procedure: surgical treatment for lumbar spondylolisthesis
There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ODI score
Time Frame: 2 year postoperatively
the D-value between the preoperative ODI score and 2-year-postoperative ODI score
2 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

RenJi Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Gang CHEN, MD., 2nd hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

September 1, 2025

Study Registration Dates

First Submitted

July 28, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBE vs. MIS-TLIF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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