UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035891 |
|---|---|
| Receipt number | R000040893 |
| Scientific Title | Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2019/02/15 22:15:36 |
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Basic information
Public title
Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images
Acronym
Knee motion analysis as a development factor of knee osteoarthritis
Scientific Title
Analysis of knee rotatory instability as a development factor of knee osteoarthritis using 3D images
Scientific Title:Acronym
Knee motion analysis as a development factor of knee osteoarthritis
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the hypothesis that abnormal knee kinematics induces cartilage degeneration using the 3D-to-2D registration technique and MRI T 2 mapping, and to accumulate data on methods for prevention of development and progression of early knee osteoarthritis by restoring knee kinematics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee kinematics using 3D-to-2D registration technique after 6 months exercise intervention
Key secondary outcomes
Knee articular cartilage degeneration by MRI T2 mapping after 6 months exercise intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Muscle training and exercise for 6 months
Interventions/Control_2
Adapting knee alignment exercise with a goal of improving knee kinematics for 6 months
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
X-ray defined early knee osteoarthritis (Kellgren-Lawrence grade I or II)
Key exclusion criteria
BMI >= 30, patients with a history of surgery or severe trauma to the legs, patients currently undergoing treatment, and patients whose informed consent could not be obtained.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinro Takai |
Organization
Nippon Medical School
Division name
Department of orthopaedic Surgery
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-5814-6209
takai-snr@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mariko Sugimoto |
Organization
Nippon Medical School
Division name
Department of orthopaedic Surgery
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-5814-6209
Homepage URL
http://kir192422.kir.jp/project.html
riumachi-ka@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Department of orthopaedic surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
日本医科大学（東京都）、稲波・脊椎関節病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 11 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040893
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
