Comparing three surgical techniques for treating 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
This study is testing which of three different surgical methods works best for treating lumbar spinal stenosis in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06719037 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the clinical efficacy of three surgical techniques—Endo-Surgi Plus endoscopic, Unilateral Biportal Endoscopic (UBE), and microdiscectomy—in treating lumbar spinal stenosis. It involves a multicenter approach where patients diagnosed with single-segment lumbar spinal stenosis will be randomly assigned to one of the three surgical groups. The study will evaluate differences in surgical outcomes, complications, and recovery aspects among the techniques. Postoperative care includes low-dose medications and rehabilitation exercises to ensure proper recovery.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with single-segment lumbar spinal stenosis who have not responded to conservative treatment for at least three months.
Not a fit: Patients with multi-segment lumbar disc herniation, spinal tumors, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with lumbar spinal stenosis.
How similar studies have performed: Previous studies have shown varying success with different surgical techniques for lumbar spinal stenosis, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Xinyu Yang, M.D.
- Email: dr_xinyuyang@163.com
- Phone: +8618560089496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.