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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020463
Receipt No. R000023644
Scientific Title clinical trial of newly developed navigation system for medial surgery
Date of disclosure of the study information 2016/01/06
Last modified on 2016/01/06

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Basic information
Public title clinical trial of newly developed navigation system for medial surgery
Acronym clinical trial of newly developed navigation system for medial surgery
Scientific Title clinical trial of newly developed navigation system for medial surgery
Scientific Title:Acronym clinical trial of newly developed navigation system for medial surgery
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the accuracy of newly developed navigation system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluate the alignment and position of the cutting surface
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 using of newly developed navigation system
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria knee osteoarthritis
Key exclusion criteria none
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Abe
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Orthopaedic surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-223-9727
Email nobuabe@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Yokoyama
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Orthopaedic surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-223-9727
Homepage URL
Email yokoyama@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Ministry of Economy, Tradw and Industry
Organization
Division
Category of Funding Organization
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 YES
Study ID_1 693
Org. issuing International ID_1 Okayama University Graduate School od Medicine, Dentistry and Pharmaceutical Science and Okayama University Hospital, Ethics Committe
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 01 Month 06 Day

Related information
URL releasing protocol
Publication of results 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 Main results already published
Date of protocol fixation
2009 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 06 Day
Last modified on
2016 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023644

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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