NCT06719037 Comparision of Endoscopic Discectomy and Microdiscectomy for the Treatment of Lumbar Spinal Stenosis
| NCT ID | NCT06719037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Lumbar Spinal Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2024-12-08 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2024-12-08 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06719037 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Lumbar Spinal Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06719037 currently recruiting?
Yes, NCT06719037 is actively recruiting participants. Contact the research team at dr_xinyuyang@163.com for enrollment information.
Where is the NCT06719037 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06719037 clinical trial?
NCT06719037 is sponsored by Qilu Hospital of Shandong University. The trial plans to enroll 324 participants.