The Comparative Study About the Effect of Vertebral Body Decompression Procedure

January 3, 2023 updated by: Jin S. Yeom, Seoul National University Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: until 3 months after procedure
Pain status
until 3 months after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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