Multicenter Clinical Randomized Controlled Trial of Unilateral Biportal Endoscopic Spinal Surgery for Degenerative Grade 1 Spondylolisthesis Complicated With Lumbar Spinal Stenosis

Summary

The research objective of this project is to clarify and compare the efficacy of the unilateral biportal endoscopy (UBE) technique and traditional open decompression, fusion and internal fixation surgery in the treatment of patients with Grade Ⅰ degenerative spondylolisthesis complicated with central spinal canal stenosis through high-quality, prospective, multicenter randomized controlled trials (RCTs), so as to provide high-level clinical research evidence for the expansion of UBE technique indications and its technical promotion.

Conditions

• Lumbar Spinal Stenosis (LSS)
• Degenerative Spondylolisthesis G1

Interventions

PROCEDURE

UBE

Unilateral Biportal Endoscopy (UBE) for the treatment of lumbar spinal stenosis combines the advantages of both open surgery and minimally invasive surgery: ① Minimal surgical trauma: Only two small incisions of 0.8 cm are required, resulting in minimal damage to the paraspinal muscles; ② Aqueous medium surgical field: Radiofrequency can be used for effective and precise hemostasis under endoscopy, which significantly reduces blood loss; ③ Endoscopic operation: The surgical field is magnified, allowing clear and adequate exposure of the dura mater and nerves to avoid injury to important structural tissues; ④ Precise decompression: Under the above conditions, traditional surgical instruments and specialized tools such as endoscopic drills can be used to complete bilateral resection of the lamina and ligamentum flavum as well as spinal canal enlargement, achieving meticulous decompression of the central canal and lateral recess.

PROCEDURE

PLIF

Posterior Lumbar Interbody Fusion (PLIF) adopts a midline posterior lumbar approach. On the basis of completing decompression of the spinal canal and nerve root canal, it resects the intervertebral disc tissue of the pathological segment and implants bone grafts (or interbody fusion cages) to achieve intervertebral bony fusion. Meanwhile, it is combined with a pedicle screw internal fixation system to maintain spinal alignment and stability, ultimately aiming to relieve neurological symptoms and restore the mechanical function of the spine.

Sponsors & Collaborators

• Shanghai Changzheng Hospital

  collaborator OTHER

• Shanghai Kaiyuan Orthopedic Hospital

  collaborator UNKNOWN

• Beijing Jishuitan Hospital

  collaborator OTHER

• Guangzhou General Hospital of Guangzhou Military Command

  collaborator OTHER

• Eastern Theater Command Naval Hospital

  collaborator UNKNOWN

• Changhai Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-12-30

Completion

2027-08-01

Countries

• China

Study Locations