The Comparative Study About the Effect of Vertebral Body Decompression Procedure

Seoul National University

Status: Completed

Conditions: Osteoporotic Vertebral Compression Fracture

Treatments: Procedure: Decompression; Procedure: Conservative Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02902250

Decon_001

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• osteoporotic vertebral compression fracture

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Decompression

Experimental group

Description:

bone marrow decompression at fractured vertebral body

Treatment:

Procedure: Decompression

Conservative Treatment

Active Comparator group

Description:

Conservative Treatment for compression fracture

Treatment:

Procedure: Conservative Treatment