Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

Last updated: January 31, 2020
Sponsor: Peking University Third Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Spinal Stenosis

Spondylolisthesis

Treatment

N/A

Clinical Study ID

NCT04254757
BYSYZD2019001
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with symptomatic lumbar canal stenosis(including central canal, lateralrecess, foraminal and extraforaminal) despite more than 6 weeks of conservativetreatment; Pathology was confirmed by both computed tomography and magnetic resonanceimaging The operative level≤2

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 600
Study Start date:
February 01, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

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