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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05480267
Enrollment
340
Registered
2022-07-29
Start date
2022-09-01
Completion date
2025-09-01
Last updated
2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spondylolisthesis, Minimally Invasive Technique, Surgical Treatment, Unilateral Biportal Endoscopy

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.

Interventions

PROCEDUREsurgical treatment for lumbar spondylolisthesis

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

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ODI score2 year postoperativelythe D-value between the preoperative ODI score and 2-year-postoperative ODI score

Contacts

Primary ContactZhi-wei WANG, Ph.D and MD.
keyanlunli_zheer@163.com0571-87783759

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026