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

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

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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