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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032826
Receipt No. R000037299
Scientific Title Cohort study of osteoarthritis by MRI 3D analysis (Kanagawa Knee Study)
Date of disclosure of the study information 2018/09/01
Last modified on 2019/06/01

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Basic information
Public title Cohort study of osteoarthritis by MRI 3D analysis (Kanagawa Knee Study)
Acronym Cohort study of osteoarthritis by MRI 3D analysis (Kanagawa Knee Study)
Scientific Title Cohort study of osteoarthritis by MRI 3D analysis (Kanagawa Knee Study)
Scientific Title:Acronym Cohort study of osteoarthritis by MRI 3D analysis (Kanagawa Knee Study)
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate pathology of osteoarthritis.
Basic objectives2 Others
Basic objectives -Others To obtain fundamental data useful of diagnosis and treatment for osteoarthritis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3D MRI projected cartilage area ratio by generations and transition of projected cartilage area ratio for one year.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 MRI, X-ray survey
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
30 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1) Desk workers who can visit around Tokyo Station by themselves.
2) Workers and resignees at Kanagawa prefecture. People in Kanagawa.
3) People older than 30 years and younger than 79 years.
4) Desk workers.
Key exclusion criteria 1) People who cannot attend the second MRI examination one year later.
2) People who cannot obtain informed consent due to cognitive impairment.
3) People who cannot undergo MRI examination due to claustrophobia.
4) People who cannot undergo MRI examination due to metal in the body.
5) People with a history of surgery in either knee.
6) People who visited hospital for injury in either knee for more three months.
7) People who have osteoarthritis or history of fracture in either lower extremity.
8) People who are diagnosed as collagen disease such as rheumatoid arthritis.
9) People who have any knee injection or arthrocentesis.
10) People who are poor general condition.
11) People who are pregnant or possible pregnant.
12) People who have a consciousness of doing vigorous sports such as full marathon, triathlon, weight lifting.
13) People for whom involved doctors decide as not appropriate to participate in the study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Sekiya
Organization Tokyo Medical and Dental University
Division name Center for Stem cell and Regenerative Medicine
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4017
Email sekiya.arm@tmd.ac.jp

Public contact
Name of contact person
1st name administrator
Middle name
Last name Office
Organization Tokyo Medical and Dental University
Division name Center for Stem cell and Regenerative Medicine
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4017
Homepage URL
Email saisei01.arm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Joint-research grant
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 Tokyo Medical and Dental University Medical School Ethics Committee
Address Tokyo Medical and Dental University
Tel 03-5803-5096
Email syomu1.adm@tmd.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
2018 Year 09 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
2018 Year 05 Month 24 Day
Date of IRB
2018 Year 07 Month 27 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2020 Year 12 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
2018 Year 06 Month 01 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037299

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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