UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051779 |
|---|---|
| Receipt number | R000059009 |
| Scientific Title | A prospective observational study of clinical outcome and prognostic factor of fragility fractures of the pelvis |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/01/31 20:57:15 |
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Basic information
Public title
A prospective observational study of clinical outcome and prognostic factor of fragility fractures of the pelvis
Acronym
A prospective observational study of clinical outcome and prognostic factor of fragility fractures of the pelvis
Scientific Title
A prospective observational study of clinical outcome and prognostic factor of fragility fractures of the pelvis
Scientific Title:Acronym
A prospective observational study of clinical outcome and prognostic factor of fragility fractures of the pelvis
Region
| Japan |
Condition
Condition
fragility fractures of the pelvis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An objective of this study is to investigate the factors influencing clinical outcomes in fragility fractures of the pelvis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Majeed pelvic score
Key secondary outcomes
Barthel Index, Numeric Rating Scale (NRS), dislocation, refracture, bone fusion, nonunion, mortality, living situation, gripping
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
fragility fractures of the pelvis
Key exclusion criteria
Not applicable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobutoshi |
| Middle name | |
| Last name | Takamatsu |
Organization
Tokushima Prefectural Miyoshi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
778-8503
Address
815-2 Shima Ikeda Miyoshi Tokushima Japan
TEL
0883721131
nobutoshi_takamatsu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobutoshi |
| Middle name | |
| Last name | Takamatsu |
Organization
Tokushima Prefectural Miyoshi Hospital
Division name
Department of Orthopaedic Surgery
Zip code
778-8503
Address
815-2 Shima Ikeda Miyoshi Tokushima Japan
TEL
0883721131
Homepage URL
nobutoshi_takamatsu@yahoo.co.jp
Sponsor or person
Institute
Tokushima Prefectural Miyoshi Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Tokushima Prefectural Miyoshi Hospital
Address
815-2 Shima Ikeda Miyoshi Tokushima Japan
Tel
0883721131
miyoshibyouin@pref.tokushima.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
| 2023 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An objective of this study is to investigate the factors influencing clinical outcomes in fragility fractures of the pelvis.
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059009
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
