Osteoporotic Vertebral Compression Fracture
Conditions
Keywords
Vertebroplasty, Core decompression, Osteoporosis
Brief summary
The purpose of this study is to compare the treatment efficacy between vertebral body decompression procedure and conservative treatment with non-inferiority design
Interventions
PROCEDUREDecompression
vertebral body decompression in compression fracture
PROCEDUREConservative Treatment
Conservative Treatment in vertebral compression fracture
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* osteoporotic vertebral compression fracture
Exclusion criteria
* malignancy or inflammatory disease * severe pain in other joints * coagulopathy * an inappropriate person considered by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale | until 3 months after procedure | Pain status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leed Dyspepsia Questionnaire | until 3 months after procedure | Abdominal discomfort d/t medication and injection |
| Radiographic outcome | until 3 months after procedure | Compression rate |
| Oswestry Disability Index | until 3 months after procedure | Health status |
| EQ5D-5L | until 3 months after procedure | Quality of Life |
Countries
South Korea
Outcome results
None listed