The Comparative Study About the Effect of Vertebral Body Decompression Procedure

NCT ID: NCT02902250

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-08

Study Completion Date

2022-03-20

Brief Summary

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

Detailed Description

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Conditions

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Osteoporotic Vertebral Compression Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Decompression

bone marrow decompression at fractured vertebral body

Group Type EXPERIMENTAL

Decompression

Intervention Type PROCEDURE

vertebral body decompression in compression fracture

Conservative Treatment

Conservative Treatment for compression fracture

Group Type ACTIVE_COMPARATOR

Conservative Treatment

Intervention Type PROCEDURE

Conservative Treatment in vertebral compression fracture

Interventions

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Decompression

vertebral body decompression in compression fracture

Intervention Type PROCEDURE

Conservative Treatment

Conservative Treatment in vertebral compression fracture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* osteoporotic vertebral compression fracture

Exclusion Criteria

* malignancy or inflammatory disease
* severe pain in other joints
* coagulopathy
* an inappropriate person considered by investigator
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin S. Yeom

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-Min Park, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Decon_001

Identifier Type: -

Identifier Source: org_study_id

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