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

Not Applicable
Not yet recruiting
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
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
The Oswestry Disability Index scores1 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
NameTimeMethod
The Oswestry Disability Index scorespreoperatively, 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 painpreoperatively, 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 MRIpreoperatively 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 timeImmediate postoperatively
Intraoperative blood lossImmediate postoperatively
Surgical incision lengthImmediate postoperatively
Postoperative hospital stayImmediate postoperatively
Perioperative complication rateImmediate postoperatively
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