The Comparative Study About the Effect of Vertebral Body... | NCT02902250

Studies
The Comparative Study About the Effect of Vertebral Body Decompression Procedure

NCT02902250

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jan 5, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Osteoporotic Vertebral Compression Fracture

Interventions

Decompression
Conservative Treatment

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2017Actual

Primary Completion Date

Feb 15, 2022Actual

Completion Date

Mar 20, 2022Actual

First Submitted Date

Sep 10, 2016

First Submission Date that Met QC Criteria

Sep 10, 2016

First Posted Date

Sep 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2023

Last Update Posted Date

Jan 5, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Decompression	Experimental	bone marrow decompression at fractured vertebral body	Procedure: Decompression
Conservative Treatment	Active Comparator	Conservative Treatment for compression fracture	Procedure: Conservative Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decompression	Procedure	vertebral body decompression in compression fracture	Decompression

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Oswestry Disability Index	Health status	until 3 months after procedure
EQ5D-5L	Quality of Life	until 3 months after procedure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sang-Min Park, MD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyounggido		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003664	Decompression
D000072700	Conservative Treatment

Ancestor Terms

ID	Term
D013812	Therapeutics
D011312	Pressure
D055595	Mechanical Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided