The Comparative Study About the Effect of Vertebral Body Decompression Procedure
Not Applicable
Completed
- Conditions
- Osteoporotic Vertebral Compression Fracture
- Interventions
- Procedure: Conservative TreatmentProcedure: Decompression
- Registration Number
- NCT02902250
- Lead Sponsor
- Seoul National University Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- osteoporotic vertebral compression fracture
Exclusion Criteria
- malignancy or inflammatory disease
- severe pain in other joints
- coagulopathy
- an inappropriate person considered by investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conservative Treatment Conservative Treatment Conservative Treatment for compression fracture Decompression Decompression bone marrow decompression at fractured vertebral body
- Primary Outcome Measures
Name Time Method Visual Analog Pain Scale until 3 months after procedure Pain status
- Secondary Outcome Measures
Name Time Method EQ5D-5L until 3 months after procedure Quality of Life
Oswestry Disability Index until 3 months after procedure Health status
Leed Dyspepsia Questionnaire until 3 months after procedure Abdominal discomfort d/t medication and injection
Radiographic outcome until 3 months after procedure Compression rate
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyounggido, Korea, Republic of