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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: surgical treatment for lumbar spondylolisthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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