UMIN-ICDS Clinical Trial

Public title

Kanagawa Knee Study Follow-up Study

Acronym

Kanagawa Knee Study Follow-up

Scientific Title

Kanagawa Knee Study Follow-up Study

Scientific Title:Acronym

Kanagawa Knee Study Follow-up

Region

Japan

Condition

Knee osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to quantify knee joint structural changes approximately 8 years after baseline among participants of the Kanagawa Knee Study, using MRI, radiographs, and related clinical information, and to evaluate whether candidate imaging markers of early knee osteoarthritis identified at baseline can predict structural progression, symptom changes, and clinical progression.

Basic objectives2

Others

Basic objectives -Others

Evaluation of predictive validity of imaging markers

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Structural progression, symptom change, and clinical progression of the right knee at approximately 8-year follow-up. Structural progression is defined as an increase of at least one Kellgren-Lawrence grade on follow-up radiographs compared with baseline. Symptom change is evaluated using changes in KOOS. Clinical progression is defined as undergoing total knee arthroplasty or osteotomy of the right knee during the follow-up period.

Key secondary outcomes

Changes in quantitative MRI structural indices, including cartilage thickness and meniscal extrusion; associations between baseline imaging markers and follow-up outcomes; NRS, ME-BYO INDEX, physical activity indices, auxiliary clinical events such as arthroscopic surgery, and characteristics of participants lost to or partially completing follow-up.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Participants of the baseline Kanagawa Knee Study.
2) Participants who provide written informed consent for this follow-up study.

Key exclusion criteria

No exclusion criteria are set for study participation. Participants who underwent right knee surgery after the baseline Kanagawa Knee Study will not undergo further questionnaire surveys or imaging examinations after confirmation of the type and timing of surgery; they will be included in the evaluation of clinical progression.

Target sample size

560

Name of lead principal investigator

1st name	Ichiro
Middle name
Last name	Sekiya

Organization

Institute of Science Tokyo

Division name

Center for Stem Cell and Regenerative Medicine

Zip code

1138510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

81358034017

Email

sekiya.arm@tmd.ac.jp

Name of contact person

1st name	Hisako
Middle name
Last name	Katano

Organization

Institute of Science Tokyo

Division name

Kanagawa Knee Study Office, Center for Stem Cell and Regenerative Medicine

Zip code

1138510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

TEL

81358034139

Homepage URL

https://www.tmd.ac.jp/med/arm/kanagawa_hiza_study.html

Email

kanagawastudy.arm@tmd.ac.jp

Institute

Institute of Science Tokyo

Institute

Department

Personal name

Organization

FUJIFILM Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee of Institute of Science Tokyo

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo

Tel

81358034547

Email

rinri.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

06

Month

10

Day

Date of IRB

2026

Year

06

Month

10

Day

Anticipated trial start date

2026

Year

09

Month

24

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is an observational follow-up study of participants in the baseline Kanagawa Knee Study. Baseline MRI, radiographic, and clinical information will be linked with follow-up non-contrast MRI, knee radiographs, body measurements, and questionnaire data obtained approximately 8 years later to evaluate within-participant structural changes, symptom changes, and clinical progression of the knee. Main explanatory factors include baseline quantitative imaging indices using 3D MRI, radiographic findings, meniscal extrusion, and meniscotibial pocket morphology. Main outcomes include structural progression, KOOS-based symptom changes, and progression to right knee total knee arthroplasty or osteotomy. No therapeutic intervention, allocation, or intervention in clinical management will be performed.

Registered date

2026

Year

09

Month

01

Day

Last modified on

2026

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070741