UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of association among quadriceps femoris muscle anatomy, knee extension strength and cartilage destruction in patients with knee osteoarthritis.
Acronym	Analysis of association among quadriceps femoris muscle anatomy, knee extension strength and cartilage destruction in patients with knee osteoarthritis.
Scientific Title	Analysis of association among quadriceps femoris muscle anatomy, knee extension strength and cartilage destruction in patients with knee osteoarthritis.
Scientific Title:Acronym	Analysis of association among quadriceps femoris muscle anatomy, knee extension strength and cartilage destruction in patients with knee osteoarthritis.
Region	Japan

Condition
Condition	Knee osteoarthritis
Classification by specialty	Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to analyze association among quadriceps femoris muscle anatomy, knee extension strength and cartilage destruction in patients with knee osteoarthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ultrasonography: muscle thickness, pennation angle
Key secondary outcomes	Magnetic resonance imaging: muscle volume, muscle cross-sectional area Biochemical characteristics: cartilage oligomeric matrix protein (COMP) Muscle strength: knee extension strength height, body mass, lower limb length, age, Japanese Knee Osteoarthritis Measure (JKOM)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Patients with osteoarthritis: Ultrasonography, Magnetic resonance imaging, Biochemical characteristics, Muscle strength, physical examination (height, body mass, lower limb length), Japanese Knee Osteoarthritis Measure (JKOM)
Interventions/Control_2	Control: healthy volunteers (no self-reported history of knee pain):Ultrasonography, Magnetic resonance imaging, Biochemical characteristics, Muscle strength, physical examination (height, body mass, lower limb length), Japanese Knee Osteoarthritis Measure (JKOM)
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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Female
Key inclusion criteria	Patients diagnosed as knee osteoarthritis by X-ray examination, who are able to walk with or without assistive devices (Kellgren-Lowrence scale2, 3). Control: healthy volunteers (no self-reported history of knee pain)
Key exclusion criteria	heart disease (myocardial infarction, angina pectoris, cardiac insufficiency), cerebrovascular disease (cerebral infarction, hemorrhage), extreme hypertension (systolic blood pressure /<=180 mmHg; diastolic blood pressure /<=110 mmHg), dementia, tumor Patients with a history or diagnosis of following disorders were excluded: lower limb or back surgery, anterior cruciate ligament injury, meniscal lesions of the knee
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ishida Koji
Organization	Nagoya University
Division name	Research center of health, physical fitness and sports
Zip code
Address	Furo-cho, Chikusa-ku, Nagoya, Aichi, Japan
TEL	052-788-6258
Email	ishida@htc.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Maeda Hisashi
Organization	Graduate School of Medicine, Nagoya University
Division name	Program in Integrated Medicine
Zip code
Address	65 Tsurumai, Showa-ku, Nagoya, aichi, Japan
TEL	052-788-5927
Homepage URL
Email	maeda.hisashi@nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 04 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	2016 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We analyse cross-sectionally association among quadriceps femoris muscle anatomy, knee, extension strength and cartilage destruction in patients with knee osteoarthritis.

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2017 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026533

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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