The Comparative Study About the Effect of Vertebral Body Decompression Procedure

Osteoporotic Vertebral Compression Fracture Clinical Trial

Official title:

The Comparative Study About the Effect of Vertebral Body Decompression Procedure and Conservative Treatment for Benign Vertebral Compression Fracture - Prospective Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902250
• Other study ID #: Decon_001
• Status: Completed
• Phase: N/A
• Start date: June 8, 2017
• Est. completion date: March 20, 2022

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• osteoporotic vertebral compression fracture

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fractures, Compression
• Osteoporotic Vertebral Compression Fracture

Intervention

Procedure:
• Decompression
vertebral body decompression in compression fracture
• Conservative Treatment
Conservative Treatment in vertebral compression fracture

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyounggido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Scale	Pain status	until 3 months after procedure
Secondary	Oswestry Disability Index	Health status	until 3 months after procedure
Secondary	EQ5D-5L	Quality of Life	until 3 months after procedure
Secondary	Leed Dyspepsia Questionnaire	Abdominal discomfort d/t medication and injection	until 3 months after procedure
Secondary	Radiographic outcome	Compression rate	until 3 months after procedure