UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032826 |
|---|---|
| Receipt number | 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 | 2024/01/07 14:39:41 |
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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
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
saisei01.arm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
NONE
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-46953-9
Number of participants that the trial has enrolled
573
Results
MME was unchanged in KL grade 1 and KL grade 0, whereas it increased slightly in KL grade 2 and increased moderately in KL grade 3. Cartilage thickness first decreased in the medial tibial region in KL grade 2 subjects and in the medial femoral region in KL grade 3. Cartilage thinning occurred in the anterior central medial femoral subregion and in the anterior and middle external medial tibial subregions in KL grade 1, whereas it diffusely expanded in early and moderate knee OA.
Results date posted
| 2023 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
469 subjects with no lateral OA from the Kanagawa Knee Study (Subjects with a history of knee OA, lower extremity trauma, previous surgery, rheumatoid arthritis, or consecutive visits to one or more hospitals for more than 3 months were excluded to remove any treatment influences).
Participant flow
This study was approved by the IRB of Tokyo Medical and Dental University and was conducted in accordance with the relevant guidelines/regulations. Informed consent was obtained from all participants. In addition, this study was performed in accordance with the Declaration of Helsinki.
Adverse events
NONE
Outcome measures
KL grade assessed using artificial intelligence (AI) software, the MME measured by MRI, and the cartilage thickness evaluated in 18 subregions of the medial femorotibial joint by another AI system.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer 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
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037299
