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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018690
Receipt No. 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

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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
Email 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
Email akamatsu@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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