Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Not Applicable

• Conditions: Lumbar Spinal Stenosis; Surgery
• Interventions: Procedure: Two different treatment

• Registration Number: NCT04254757
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study Start: 2020-02-01
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

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Exclusion Criteria

• Segmental instability Simple disc herniation Coexisting pathological conditions, such as tumor and infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous endoscopic surgery group	Two different treatment	-
Open decompression and fusion surgery group	Two different treatment	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	at 1 years after surgery	VAS of leg and back
Modified MacNab criteria	1 years after surgery
Oswestry Disability Index(ODI)	at 1 years after surgery

Secondary Outcome Measures

Name	Time	Method
Range of motion(ROM)	at 1 years after surgery	ROM of operated level
Adjacent Segment Disease	at 1 years after surgery	Measured on CT and MRI

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China