NCT02902250

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

June 8, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

4.7 years

First QC Date

September 10, 2016

Last Update Submit

January 3, 2023

Conditions

Osteoporotic Vertebral Compression Fracture

Keywords

VertebroplastyCore decompressionOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Pain Scale

    Pain status

    until 3 months after procedure

Secondary Outcomes (4)

  • Oswestry Disability Index

    until 3 months after procedure

  • EQ5D-5L

    until 3 months after procedure

  • Leed Dyspepsia Questionnaire

    until 3 months after procedure

  • Radiographic outcome

    until 3 months after procedure

Study Arms (2)

Decompression

EXPERIMENTAL

bone marrow decompression at fractured vertebral body

Procedure: Decompression

Conservative Treatment

ACTIVE COMPARATOR

Conservative Treatment for compression fracture

Procedure: Conservative Treatment

Interventions

DecompressionPROCEDURE

vertebral body decompression in compression fracture

Decompression
Conservative TreatmentPROCEDURE

Conservative Treatment in vertebral compression fracture

Conservative Treatment

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteoporotic vertebral compression fracture

You may not qualify if:

  • malignancy or inflammatory disease
  • severe pain in other joints
  • coagulopathy
  • an inappropriate person considered by investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyounggido, South Korea

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

DecompressionConservative Treatment

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Officials

  • Sang-Min Park, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 10, 2016

First Posted

September 15, 2016

Study Start

June 8, 2017

Primary Completion

February 15, 2022

Study Completion

March 20, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Locations

KR(1)