Skip to main content
Clinical Trials/NCT04254757
NCT04254757
Unknown
Not Applicable

Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Peking University Third Hospital1 site in 1 country600 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
Peking University Third Hospital
Enrollment
600
Locations
1
Primary Endpoint
Visual Analog Scale (VAS)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
December 31, 2023
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Liu xiaoguang

PH.D.,M.D.,Professor

Peking University Third Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

Time Frame: at 1 years after surgery

VAS of leg and back

Modified MacNab criteria

Time Frame: 1 years after surgery

Oswestry Disability Index(ODI)

Time Frame: at 1 years after surgery

Secondary Outcomes

  • Range of motion(ROM)(at 1 years after surgery)
  • Adjacent Segment Disease(at 1 years after surgery)

Study Sites (1)

Loading locations...

Similar Trials