The Comparative Study About the Effect of Vertebral Body Decompression Procedure

Overview

The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and vertebroplasty with non-inferiority design

Full Title of Study: “The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture – Prospective Randomized Control Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2020

Interventions

  • Procedure: Decompression
    • vertebral body decompression in compression fracture
  • Procedure: vertebroplasty
    • vertebroplasty in vertebral compression fracture

Arms, Groups and Cohorts

  • Experimental: Decompression
    • bone marrow decompression at fractured vertebral body
  • Active Comparator: vertebroplasty
    • vertebroplasty for compression fracture

Clinical Trial Outcome Measures

Primary Measures

  • Visual Analog Pain Scale
    • Time Frame: until 3 months after procedure
    • Pain status

Secondary Measures

  • Oswestry Disability Index
    • Time Frame: until 3 months after procedure
    • Health status
  • EQ5D-5L
    • Time Frame: until 3 months after procedure
    • Quality of Life
  • Leed Dyspepsia Questionnaire
    • Time Frame: until 3 months after procedure
    • Abdominal discomfort d/t medication and injection
  • Radiographic outcome
    • Time Frame: until 3 months after procedure
    • Compression rate

Participating in This Clinical Trial

Inclusion Criteria

  • osteoporotic vertebral compression fracture

Exclusion Criteria

  • malignancy or inflammatory disease
  • severe pain in other joints
  • coagulopathy
  • an inappropriate person considered by investigator

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin S. Yeom, professor – Seoul National University Hospital
  • Overall Official(s)
    • Sang-Min Park, MD, Principal Investigator, Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Sang-Min Park, MD, +82 31 787 7208, psmini@naver.com

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