UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045739 |
|---|---|
| Receipt number | 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 | 2024/03/22 11:52:55 |
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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
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
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
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
1-3-1 Kudanminami, Chiyoda-ku, Tokyo
Tel
03-3263-4801
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 27 | 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
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
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 | |
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| Registered date | File name |
