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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023025
Receipt No. R000026533
Scientific Title Analysis of association among quadriceps femoris muscle anatomy, knee extension strength and cartilage destruction in patients with knee osteoarthritis.
Date of disclosure of the study information 2016/11/04
Last modified on 2017/01/13

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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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