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Comparision of Endoscopic Discectomy and Microdiscectomy for the Treatment of Lumbar Spinal Stenosis

NCT06719037 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-01-07

No results posted yet for this study

Summary

The purpose of this study is to conduct a multicenter comparison of the clinical efficacy of Endo-Surgi Plus endoscopic technique, UBE endoscopic technique, and microdiscectomy technique in the treatment of lumbar spinal stenosis, and to compare the differences in the incidence of complications, surgical trauma, and other aspects among the three surgical techniques for the treatment of lumbar spinal stenosis.

Each group of patients received either Endo-Surgi Plus endoscopy, UBE, or microdiscectomy decompression through the Quadrant channel. All patients were routinely administered low-dose hormones, dehydrating agents, and neurotrophic drugs postoperatively. Patients were required to strictly avoid strenuous activities and heavy lifting in the lumbar region for three months after surgery. Upon discharge, patients were provided with the same lumbar and back muscle rehabilitation exercises and other postoperative recovery-related discharge education. Each group of patients was followed up for at least one year, with follow-up including outpatient visits, physical examinations, questionnaire scoring, and necessary auxiliary examinations.

Both two endoscopic surgeries, as surgical techniques that have been used in clinical practice for many years, have their efficacy confirmed by various studies. The investigator proposes that these two techniques may have similar clinical efficacy to microdiscectomy, while also offering the advantage of being less invasive. The aim of this study is to validate these assumptions. At the same time, there may be some differences between the two endoscopic surgeries that require further verification.

Conditions

  • Lumbar Spinal Stenosis

Interventions

PROCEDURE

Endo-Surgi Plus endoscopic surgery

Endo-Surgi Plus endoscopic surgery, as a new type of percutaneous endoscopic lumbar discectomy (PELD), features a larger working channel and represents an optimized single-channel endoscopic technique. However, it still has the limitations inherent in single-channel endoscopy.

PROCEDURE

Unilateral biportal endoscopic surgery

Unilateral biportal endoscopic discectomy (UBE) is characterized by its separate endoscopic and working channels, and the ability to use traditional open instruments, making it a convenient and versatile technique. It is a commonly used spinal endoscopic surgery in clinical practice.

PROCEDURE

Microdiscectomy

Microdiscectomy (MD) is a mature minimally invasive technique that uses a microscope to treat lumbar spinal stenosis. As early as 1999, prospective randomized controlled studies confirmed that it has equally excellent clinical efficacy compared to open surgery, with less surgical trauma. It is currently the classic minimally invasive surgical approach for treating lumbar spinal stenosis.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-08
Primary Completion
2025-06-01
Completion
2025-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719037 on ClinicalTrials.gov