RecruitingNot ApplicableNCT06719037

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

Efficacy and Safety of Endo-Surgi Plus Endoscopy, UBE Endoscopy, and Microdiscectomy Decompression Techniques for the Treatment of Lumbar Spinal Stenosis: A Prospective Multicenter Study


Sponsor

Qilu Hospital of Shandong University

Enrollment

324 participants

Start Date

Dec 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • Diagnosed with single-segment lumbar spinal stenosis through CT and MRI imaging combined with clinical symptoms;
  • Symptoms in the lumbar region and lower extremities corresponding to the imaging findings;
  • Patients who have not responded to three months of conservative treatment;
  • Informed consent from family members regarding the surgical procedure and associated risks.

Exclusion Criteria3

  • Patients with multi-segment lumbar disc herniation, malignant spinal tumors, spinal deformities, and other diseases.
  • Patients with comorbidities such as cardiovascular diseases, cerebrovascular diseases, or those with mental abnormalities, communication difficulties, or other issues that may affect clinical evaluation.
  • Patients with a history of previous lumbar surgery.

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Interventions

PROCEDUREEndo-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.

PROCEDUREUnilateral 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.

PROCEDUREMicrodiscectomy

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.


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06719037


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