UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023025 |
|---|---|
| Receipt number | 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 | 2020/03/17 10:49:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
maeda.hisashi@nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 11 | Day |
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
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026533
