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 conservative treatment 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: February 15, 2022
Interventions
- Procedure: Decompression
- vertebral body decompression in compression fracture
- Procedure: Conservative Treatment
- Conservative Treatment in vertebral compression fracture
Arms, Groups and Cohorts
- Experimental: Decompression
- bone marrow decompression at fractured vertebral body
- Active Comparator: Conservative Treatment
- Conservative Treatment 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
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