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

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Zhejiang University

Status

Not yet enrolling

Conditions

Unilateral Biportal Endoscopy
Lumbar Spondylolisthesis
Surgical Treatment
Minimally Invasive Technique

Treatments

Procedure: surgical treatment for lumbar spondylolisthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT05480267
UBE vs. MIS-TLIF

Details and patient eligibility

About

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.

Full 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.

Enrollment

340 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

340 participants in 2 patient groups

UBE
Experimental group
Description:
The patient treated with unilateral biportal endoscopy (UBE)
Treatment:
Procedure: surgical treatment for lumbar spondylolisthesis
MIS-TLIF
Active Comparator group
Description:
The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)
Treatment:
Procedure: surgical treatment for lumbar spondylolisthesis

Trial contacts and locations

0

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Central trial contact

Zhi-wei WANG, Ph.D and MD.

Data sourced from clinicaltrials.gov

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