Comparision of Endoscopic Discectomy and Microdiscectomy for the Treatment of Lumbar Spinal Stenosis
- Conditions
- Registration Number
- NCT06719037
- Lead Sponsor
- Qilu Hospital of Shandong University
- 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 tec...
- Detailed Description
The lumbar spine is the part of the spine that bears the most weight, consisting of five vertebrae. Each vertebra is connected by an intervertebral disc, and together they form a barrier to protect the spinal cord nerves within the spinal canal. Lumbar spinal stenosis refers to the reduction of space within the lumbar spinal canal, which compresses the spina...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 324
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method The Oswestry Disability Index scores 1 year postoperatively The maximum score is 100 points, and the minimum score is 0 points. The higher the score, the more severe the functional impairment.
- Secondary Outcome Measures
Name Time Method The Oswestry Disability Index scores preoperatively, 1 day, 3 months, and 6 months postoperatively The maximum score is 100 points, and the minimum score is 0 points. The higher the score, the more severe the functional impairment.
Visual Analogue Score for lower limb pain/lumbar back pain preoperatively, 1 day, 3 months, 6 months, and 1 year postoperatively The maximum score is 10 points, and the minimum score is 0 points. A higher score means a worse outcome and a more severe pain.
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36 score) preoperatively, 1 day, 3 months, 6 months, and 1 year postoperatively The scales was divided into 9 parts. For each part, the maximum score is 100 points, and the minimum score is 0 points. A higher score means the better outcome.
Dural sac cross-sectional area calculated from lumbar MRI preoperatively and at 1 year postoperatively The Dural sac cross-sectional area (DCSA) refers to the two-dimensional area enclosed by the outer boundary of the dural sac as seen on imaging, typically measured in square millimeters (mm²). A reduced DCSA is often used to diagnose spinal stenosis.
Anterior Boundary: The posterior longitudinal ligament and the vertebral body or intervertebral disc.
...Creatine kinase-MB (CK-MB) preoperative and immediate postoperative preoperative and immediate postoperative changes in creatine kinase-MB (CK-MB)
Surgery time Immediate postoperatively Intraoperative blood loss Immediate postoperatively Surgical incision length Immediate postoperatively Postoperative hospital stay Immediate postoperatively Perioperative complication rate Immediate postoperatively