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

Not Applicable

Not yet recruiting

• Conditions: Unilateral Biportal Endoscopy; Surgical Treatment; Lumbar Spondylolisthesis; Minimally Invasive Technique
• Interventions: Procedure: surgical treatment for lumbar spondylolisthesis

• Registration Number: NCT05480267
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Study Start: 2022-09-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 340

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UBE	surgical treatment for lumbar spondylolisthesis	The patient treated with unilateral biportal endoscopy (UBE)
MIS-TLIF	surgical treatment for lumbar spondylolisthesis	The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)

Primary Outcome Measures

Name	Time	Method
ODI score	2 year postoperatively	the D-value between the preoperative ODI score and 2-year-postoperative ODI score