UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003605 |
|---|---|
| Receipt number | R000002628 |
| Scientific Title | Effectiveness of functional braces for the osteoarthritis of the knee joint |
| Date of disclosure of the study information | 2010/05/12 |
| Last modified on | 2015/05/12 18:17:32 |
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Basic information
Public title
Effectiveness of functional braces for the osteoarthritis of the knee joint
Acronym
Effectiveness of functional braces for the osteoarthritis of the knee joint
Scientific Title
Effectiveness of functional braces for the osteoarthritis of the knee joint
Scientific Title:Acronym
Effectiveness of functional braces for the osteoarthritis of the knee joint
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee joint
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
It aims to verify the utility and validity investigating the effect of various conservative treatments on the transformable knee arthropathy patient including the orthotic treatment and the therapeutic exercise, etc. with the function evaluation standard, and to evaluate utility in the senior citizen's activity of daily life (ADL) improvement appropriately. Moreover, it aims at specific of multi type/mutation of the gene taking part directly in these therapeutic gains.
Basic objectives2
Others
Basic objectives -Others
It aims to verify the utility and validity investigating the effect of various conservative treatments on the transformable knee arthropathy patient including the orthotic treatment and the therapeutic exercise, etc. with the function evaluation standard, and to evaluate utility in the senior citizen's activity of daily life (ADL) improvement appropriately. Moreover, it aims at specific of multi type/mutation of the gene taking part directly in these therapeutic gains.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Clincal evaliuation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
insole/brace
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
OA of the knee
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Uchio |
Organization
Shimane University
Division name
Orthopaedic Surgery
Zip code
Address
89-1 Enya-cho-Izumoshi,Shimane-ken
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University
Division name
Orthopaedic Surgery
Zip code
Address
TEL
0853-23-2111
Homepage URL
Sponsor or person
Institute
Shimane University Orthopaedic SurgeryI
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Address
Tel
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
| 2010 | Year | 05 | Month | 12 | 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
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 12 | Day |
Last modified on
| 2015 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002628
