UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041040
Receipt number R000046604
Scientific Title Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture
Date of disclosure of the study information 2021/04/01
Last modified on 2020/07/09 10:09:07

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Basic information

Public title

Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture

Acronym

Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture

Scientific Title

Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture

Scientific Title:Acronym

Efficacy of early indication of Balloon kyphoplasty for thoracolumbar osteoporotic vertebral body fracture

Region

Japan


Condition

Condition

Osteoporotic vertebral fracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Osteoporotic vertebral fracture (OVF) is one of the factors that require long-term care, but conventionally, rehabilitation is started after long-term bed rest. In recent years, percutaneous vertebroplasty (Balloon Kyphoplasty: BKP) has been widely used with public insurance since January 2011 for cases in which healing of vertebral body fractures is prolonged. Since BKP is expected to be less invasive and can be expected to reduce pain early, it can be expected to return to society sooner, so the treatment is of great significance, but changes in ADL due to early adaptation, changes in the degree of long-term care, etc. are still unknown. The purpose of this study is to examine the effectiveness of early adaptation by observing the postoperative course by returning to society early by applying BKP treatment early.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pain Numerical Rating Scale (NRS) NRS improvement 12 months after admission was improved by 50% or more compared to the time of injury (effective rate of BKP treatment)

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

70 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Osteoporotic vertebral body fracture patients on XP/CT, and T1 low-intensity STIR high-intensity change on MRI.

Key exclusion criteria

Patients with neurological symptoms due to bone fracture, not osteoporotic vertebral body fracture due to high energy trauma, pathological fractures (suppurative spondylitis, spinal tumor, etc.), steroid patients, dialysis patients, bedridden cases, unable to answer questionnaire thing

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Masatoshi
Middle name
Last name Teraguchi

Organization

Wakayama Medical University Kihoku Hospital, Japan.

Division name

Department of Orthopaedic Surgery Spine Care Center,

Zip code

649-7113

Address

Ito gun, Katsuragi town 219

TEL

0736-22-0066

Email

masa_bomgoo7@yahoo.co.jp


Public contact

Name of contact person

1st name Masatoshi
Middle name
Last name Teraguchi

Organization

Wakayama Medical University Kihoku Hospital, Japan.

Division name

Department of Orthopaedic Surgery Spine Care Center

Zip code

649-7113

Address

Ito gun, Katsuragi town 219

TEL

0736-22-0066

Homepage URL


Email

masa_bomgoo7@yahoo.co.jp


Sponsor or person

Institute

Wakayama Medical University Kihoku Hospital, Japan.

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University Kihoku Hospital, Japan.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Wakayama medical university

Address

Kimiidera 811-1

Tel

073-447-2300

Email

wa-rinri@wakayama-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2020 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Report progress as appropriate.


Management information

Registered date

2020 Year 07 Month 09 Day

Last modified on

2020 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046604


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name