UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images
Title of the study (Brief title)	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	Shinro Takai
Organization	Nippon Medical School
Division name	Department of orthopaedic Surgery
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-5814-6209
Email	takai-snr@nms.ac.jp

Public contact
Name of contact person	Mariko Sugimoto
Organization	Nippon Medical School
Division name	Department of orthopaedic Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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