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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035891
Receipt No. R000040893
Scientific Title Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images
Date of disclosure of the study information 2019/02/15
Last modified on 2019/02/15

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Basic information
Public title Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images
Acronym Knee motion analysis as a development factor of knee osteoarthritis
Scientific Title Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images
Scientific Title:Acronym Knee motion analysis as a development factor of knee osteoarthritis
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the hypothesis that abnormal knee kinematics induces cartilage degeneration using the 3D-to-2D registration technique and MRI T 2 mapping, and to accumulate data on methods for prevention of development and progression of early knee osteoarthritis by restoring knee kinematics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee kinematics using 3D-to-2D registration technique after 6 months exercise intervention
Key secondary outcomes Knee articular cartilage degeneration by MRI T2 mapping after 6 months exercise intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Muscle training and exercise for 6 months
Interventions/Control_2 Adapting knee alignment exercise with a goal of improving knee kinematics for 6 months
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
45 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria X-ray defined early knee osteoarthritis (Kellgren-Lawrence grade I or II)
Key exclusion criteria BMI >= 30, patients with a history of surgery or severe trauma to the legs, patients currently undergoing treatment, and patients whose informed consent could not be obtained.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinro Takai
Organization Nippon Medical School
Division name Department of orthopaedic Surgery
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-5814-6209
Email takai-snr@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Sugimoto
Organization Nippon Medical School
Division name Department of orthopaedic Surgery
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-5814-6209
Homepage URL http://kir192422.kir.jp/project.html
Email riumachi-ka@nms.ac.jp

Sponsor
Institute Nippon Medical School
Department of orthopaedic surgery
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 日本医科大学(東京都)、稲波・脊椎関節病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 11 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 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
2019 Year 02 Month 15 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040893

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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