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The Comparative Study About the Effect of Vertebral Body Decompression Procedure

Primary Purpose

Osteoporotic Vertebral Compression Fracture

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Decompression
Conservative Treatment
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporotic Vertebral Compression Fracture focused on measuring Vertebroplasty, Core decompression, Osteoporosis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decompression

Conservative Treatment

Arm Description

bone marrow decompression at fractured vertebral body

Conservative Treatment for compression fracture

Outcomes

Primary Outcome Measures

Visual Analog Pain Scale
Pain status

Secondary Outcome Measures

Oswestry Disability Index
Health status
EQ5D-5L
Quality of Life
Leed Dyspepsia Questionnaire
Abdominal discomfort d/t medication and injection
Radiographic outcome
Compression rate

Full Information

First Posted
September 10, 2016
Last Updated
January 3, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02902250
Brief Title
The Comparative Study About the Effect of Vertebral Body Decompression Procedure
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2017 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporotic Vertebral Compression Fracture
Keywords
Vertebroplasty, Core decompression, Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decompression
Arm Type
Experimental
Arm Description
bone marrow decompression at fractured vertebral body
Arm Title
Conservative Treatment
Arm Type
Active Comparator
Arm Description
Conservative Treatment for compression fracture
Intervention Type
Procedure
Intervention Name(s)
Decompression
Intervention Description
vertebral body decompression in compression fracture
Intervention Type
Procedure
Intervention Name(s)
Conservative Treatment
Intervention Description
Conservative Treatment in vertebral compression fracture
Primary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
Pain status
Time Frame
until 3 months after procedure
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Health status
Time Frame
until 3 months after procedure
Title
EQ5D-5L
Description
Quality of Life
Time Frame
until 3 months after procedure
Title
Leed Dyspepsia Questionnaire
Description
Abdominal discomfort d/t medication and injection
Time Frame
until 3 months after procedure
Title
Radiographic outcome
Description
Compression rate
Time Frame
until 3 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: osteoporotic vertebral compression fracture Exclusion Criteria: malignancy or inflammatory disease severe pain in other joints coagulopathy an inappropriate person considered by investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Min Park, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyounggido
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Comparative Study About the Effect of Vertebral Body Decompression Procedure

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