Lumbar spinal stenosis (LSS) is the most common spinal degenerative disease. For conservative treatment failure, open lumbar decompression and fusion surgery is the main surgical treatment. After decades of development, open lumbar decompression and fusion surgery has been the standard treatment. However, there are still people and conditions that cannot be covered, such as elderly people who intolerable surgery, severe osteoporosis, and re-stenosis at adjacent segments after fusion. Percutaneous spinal endoscopic lumbar spinal decompression technique could be performed under local anesthesia, soft tissue damage is minimized, and effective spinal decompression can be achieved. There are still some controversial points of LSS decompression under percutaneous endoscope surgery, such as the range of decompression, choice of approach, postoperative spinal stability, learning curve, surgical safety, long-term effects of endoscopic treatment of restenosis at adjacent segments after fusion surgery. The purpose of this study was to solve these controversial points. A multi-center, prospective registration study based on the real world is planned. The total sample size is about 600 cases (300 cases in endoscopic surgery group, 300 cases in open decompression and fusion group). The mid- to long-term clinical efficacy and safety were evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGModified MacNab criteria
Time frame: 1 years after surgery
Visual Analog Scale (VAS)
VAS of leg and back
Time frame: at 1 years after surgery
Oswestry Disability Index(ODI)
Time frame: at 1 years after surgery
Range of motion(ROM)
ROM of operated level
Time frame: at 1 years after surgery
Adjacent Segment Disease
Measured on CT and MRI
Time frame: at 1 years after surgery
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