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Percutaneous Endoscopic Decompression for Lumbar Canal Stenosis

NCT04254757 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-02-05

No results posted yet for this 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.

Conditions

  • Lumbar Spinal Stenosis
  • Surgery

Interventions

PROCEDURE

Two different treatment

One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery

Sponsors & Collaborators

  • Beijing Shijitan Hospital, Capital Medical University

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Beijing Changping Hospital

    collaborator UNKNOWN

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Xiaoguang Liu, M.D.,Ph.D. · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04254757 on ClinicalTrials.gov