UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018690 |
|---|---|
| Receipt number | R000021633 |
| Scientific Title | 3D structral analysis using clinical CT in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2015/08/17 |
| Last modified on | 2017/08/21 08:28:41 |
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Basic information
Public title
3D structral analysis using clinical CT in patients with knee osteoarthritis
Acronym
Structral analysis of knee osteoarthritis
Scientific Title
3D structral analysis using clinical CT in patients with knee osteoarthritis
Scientific Title:Acronym
Structral analysis of knee osteoarthritis
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Parameters that obtained from clinical CT and special software in patients with knee osteoarthritis were divided into 3 groups according to severity of knee osteoarthritis. To compare measurement parameters among 3 groups.
Basic objectives2
Others
Basic objectives -Others
Bone morphometry
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of bone volume fraction, trabecular thickness, trabecular number, trabecular separation, structure model index, trabecular bone pattern factor, degree of anisotropy and width of cortical bone
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Knee osteoarthritis
Key exclusion criteria
Past history of operation, trauma and infection
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Akamatsu |
Organization
Yokohama City University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2655
akamatsu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Akamatsu |
Organization
Yokohama City University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-265
Homepage URL
akamatsu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
横浜市立大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients were assinged 3 groups according to the severity of knee osteoarthritis. Measurement parameters were compared among 3 groups.
Our subjects is concecutive patients that visited our Hospital for knee surgerys and were informed consent for this study.
Management information
Registered date
| 2015 | Year | 08 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021633
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
