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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027315
Receipt No. R000031191
Scientific Title Quantitative and qualitative analysis of lower limb muscles in knee osteoarthritis patients.
Date of disclosure of the study information 2017/06/01
Last modified on 2019/05/13

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Basic information
Public title Quantitative and qualitative analysis of lower limb muscles in knee osteoarthritis patients.
Acronym Quantitative and qualitative analysis of muscles in knee osteoarthritis patients.
Scientific Title Quantitative and qualitative analysis of lower limb muscles in knee osteoarthritis patients.
Scientific Title:Acronym Quantitative and qualitative analysis of muscles in knee osteoarthritis patients.
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to investigate quantitative and qualitative characteristics of lower limb muscles in knee osteoarthritis patients, and to clarify the effects of total knee arthroplasty on the muscle characteristics.
Basic objectives2 Others
Basic objectives -Others Comparison to healthy individuals and evaluation of effects of surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle cross-sectional area and fat fraction before (3-4 months before), immediately after (2-4 weeks after) and 6 months after total knee arthroplasty.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed with knee osteoarthritis and scheduled for total knee arthroplasty.
Key exclusion criteria Person with contraindication to MRI, such as having cardiac pacemaker or MRI-unsafe device within the body, and claustrophobia.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tetsuya
Middle name
Last name Tomita
Organization Osaka University Graduate School of Medicine
Division name Orthopedic Biomaterial Science
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6210-8444
Email tomita@ort.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Tetsuya
Middle name
Last name Tomita
Organization Osaka University
Division name Graduate School of Medicine
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6210-8444
Homepage URL
Email tomita@ort.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Doshisha University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board of Osaka University Hospital
Address 2-2 Yamadaoka, Suita, JAPAN
Tel 06-6210-8290
Email rinri@hp-crc.med.osaka-u.ac.jp

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
2017 Year 06 Month 01 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
2017 Year 03 Month 01 Day
Date of IRB
2017 Year 09 Month 12 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We investigate cross-sectional area and fat fraction of lower limb muscles in knee osteoarthritis patients and clarify the effects of total knee arthroplasty on the cross-sectional area and fat content of the muscles.

Management information
Registered date
2017 Year 05 Month 12 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031191

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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