The Comparative Study About the Effect of Vertebral Body Decompression Procedure

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

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

Study Overview

• Status: Completed
• Conditions: Osteoporotic Vertebral Compression Fracture
• Intervention / Treatment: Procedure: Decompression; Procedure: Conservative Treatment

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyounggido
    • Seongnam-si, Gyounggido, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decompression; bone marrow decompression at fractured vertebral body	Procedure: Decompression; vertebral body decompression in compression fracture
Active Comparator: Conservative Treatment; Conservative Treatment for compression fracture	Procedure: Conservative Treatment; Conservative Treatment in vertebral compression fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale	Pain status	until 3 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	Health status	until 3 months after procedure
EQ5D-5L	Quality of Life	until 3 months after procedure
Leed Dyspepsia Questionnaire	Abdominal discomfort d/t medication and injection	until 3 months after procedure
Radiographic outcome	Compression rate	until 3 months after procedure

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Sang-Min Park, MD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2017
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): March 20, 2022

Study Registration Dates

• First Submitted: September 10, 2016
• First Submitted That Met QC Criteria: September 10, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Osteoporosis; Vertebroplasty; Core decompression
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Compression
• Other Study ID Numbers: Decon_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No