Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Study Overview
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Brief Summary
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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.

Official Title
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Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Conditions
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Lumbar Spinal Stenosis, Surgery

Intervention / Treatment
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* Procedure: Two different treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; Pathology was confirmed by both computed tomography and magnetic resonance imaging The operative level≤2 Exclusion Criteria: Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Percutaneous endoscopic surgery group<br> | Procedure: Two different treatment<br>* One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery<br>|
| Other: Open decompression and fusion surgery group<br> | Procedure: Two different treatment<br>* One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified MacNab criteria |  | 1 years after surgery | 
| Visual Analog Scale (VAS) | VAS of leg and back | at 1 years after surgery | 
| Oswestry Disability Index(ODI) |  | at 1 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion(ROM) | ROM of operated level | at 1 years after surgery | 
| Adjacent Segment Disease | Measured on CT and MRI | at 1 years after surgery |