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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026872
Receipt No. R000030835
Scientific Title Study of epigenetic control mechanism on skeletal muscle metabolism with total knee arthroplasty.
Date of disclosure of the study information 2017/04/05
Last modified on 2019/10/07

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Basic information
Public title Study of epigenetic control mechanism on skeletal muscle metabolism with total knee arthroplasty.
Acronym DNA methylation of the skeletal muscle-related gene with total knee arthroplasty.
Scientific Title Study of epigenetic control mechanism on skeletal muscle metabolism with total knee arthroplasty.
Scientific Title:Acronym DNA methylation of the skeletal muscle-related gene with total knee arthroplasty.
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Comparison of Skeletal muscle- related gene DNA methylation with TKA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The measure of skeletal muscle relation genes DNA methylation with osteoarthritis of knee patient.
Key secondary outcomes The measure of Myokine with osteoarthritis of knee patient.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Total knee arthroplasty and rehabilitation
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 Adult person
The consent patient who is performed total knee arthroplasty cause of osteoarthritis of the knee
After receiving a full explanation upon participation in this study, through understanding, those documents consent free will of the person is obtained.
Key exclusion criteria Patient of Cerebrovascular paralytic
Patient of the nerve paralysis
Patient of the nerve paralysis
The patient who it is difficult to judge participation in study for a mental disease
The other reason who principal investigator has determined to be inappropriate as a research subject.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Kimura
Organization Kansai Medical University Hospital
Division name Health science
Zip code 573-1010
Address 573-1010 Hirakata Osaka Shinmachi 2-5-1
TEL 072-804-0101
Email drikimura@alles.or.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Kamo
Organization Kansai Medical University Hospital
Division name Health science
Zip code 573-1010
Address 573-1010 Hirakata Osaka Shinmachi 2-5-1
TEL 072-804-0101
Homepage URL
Email ryusei0819@gmail.com

Sponsor
Institute Kansai Medical University Hospital
Health science center
Institute
Department

Funding Source
Organization None
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 Kansai Medical University ethics committee
Address 573-1010 Hirakata Osaka Shinmachi 2-5-1
Tel 072-804-0101
Email rinri@hirakata.kmu.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
2017 Year 04 Month 05 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 23
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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 17 Day
Date of IRB
2016 Year 12 Month 26 Day
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
2018 Year 11 Month 05 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 07 Month 25 Day
Date analysis concluded
2019 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 05 Day
Last modified on
2019 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030835

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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