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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Knee osteoarthritis | |||
Classification by specialty |
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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
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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 |
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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) | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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) |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Nagoya university |
Institute | |
Department |
Funding Source | |
Organization | Japan society for the promotion of science |
Organization | |
Division | |
Category of Funding Organization | Other |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Date of the first journal publication of results | |
Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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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 |
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Last modified on |
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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 |