UMIN-CTR Clinical Trial

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	300

Research contact person
Name of lead principal investigator	1st name Teruya Middle name Last name Ishibashi
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	t.bashi001@gmail.com

Public contact
Name of contact person	1st name Teruya Middle name Last name Ishibashi
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	t.bashi001@gmail.com

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	Completed
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	2022 Year 09 Month 11 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	2022 Year 11 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031191