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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045739
Receipt No. R000052217
Scientific Title Comparative examination of the validity of the preservation method of treatment to a vertebral fracture
Date of disclosure of the study information 2021/11/30
Last modified on 2021/10/13

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Basic information
Public title Comparative examination of the validity of the preservation method of treatment to a vertebral fracture
Acronym vertebral fracture
Scientific Title Comparative examination of the validity of the preservation method of treatment to a vertebral fracture
Scientific Title:Acronym vertebral fracture
Region
Japan

Condition
Condition vertebral fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Preservation method of treatment is often generally chosen by a vertebral fracture, but it's the purpose of this research to make the validity by each equipment difference clear and to compare and examine improvement of the degree of satisfaction of the patient because the validity of the treatment by each equipment difference isn't clear. I can think these inspection results will be some help of choice of preservation treatment and improvement of patient satisfaction to a vertebral fracture.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vertebral crush rate which depends on backbone x-ray inspection in 3 months after the study starting time and starting (the change amount)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 MAXBELT
Interventions/Control_2 Damen corset
Interventions/Control_3 Jewett type
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) the patient preservation treatment was diagnosed as a new vertebral fracture, and by whom was chosen
2) the age of the time of the agreement merit, more than 65-year-old patient (I don't ask about the gender.)
3)the patient who could get documentary consent by free will of the the back and the patient person himself which had the enough explanation in case of participation of this research
Key exclusion criteria 1)dementia
2)spirit disease
3)The patient for whom walking was difficult before vertebral fracture
4)additionally the patient who judged that a study person in change was unsuitable as a subject of research person
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Mochizuki
Organization Kamagaya General Hospital
Division name Plastic surgery
Zip code 273-0121
Address 929-6 Hatsutomi, Kamagaya-City Chiba
TEL 047-498-8266
Email chiken@kamagaya-hp.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Mochizuki
Organization Kamagaya General Hospital
Division name Plastic surgery
Zip code 273-0121
Address 929-6 Hatsutomi, Kamagaya-City Chiba
TEL 047-498-8266
Homepage URL
Email chiken@kamagaya-hp.jp

Sponsor
Institute Kamagaya General Hospital
Institute
Department

Funding Source
Organization Kamagaya General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address Emina Building 3F, 1-8-7 Koji-machi, Chiyoda-ku, Tokyo
Tel 03-3263-4801
Email mirai-ec4@mirai-iryo.com

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 11 Month 30 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
2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2026 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 10 Month 13 Day
Last modified on
2021 Year 10 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052217

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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