UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027315 |
|---|---|
| Receipt number | 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 | 2022/11/17 18:14:06 |
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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
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
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
t.bashi001@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031191
