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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030378
Receipt No. R000034681
Scientific Title A novel system for designing orthosis for muscloskeletal system
Date of disclosure of the study information 2018/01/01
Last modified on 2018/04/19

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Basic information
Public title A novel system for designing orthosis for muscloskeletal system
Acronym A novel system for designing orthosis
Scientific Title A novel system for designing orthosis for muscloskeletal system
Scientific Title:Acronym A novel system for designing orthosis
Region
Japan

Condition
Condition Osteoarthritis of CM joint, Hallux Valugus, Flat foot
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To creat a novel system for designing orhtosis using CAD/CAM system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Range of Motion, Past history, Type of surgery, Date of Surgery, VAS, Radiography, MRI
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Osteoarthritis of CM joint, Halux Valgus and Flat foot.
Healthy controls
Key exclusion criteria Pregnant woman, unable to scan CT or superficial scan, age under 19 or over 71
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Nagura
Organization Keio University, School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3812
Email nagura@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Nagura
Organization Keio University, School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-5363-3812
Homepage URL
Email nagura@z8.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 01 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
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 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 Under revision of IRB

Management information
Registered date
2017 Year 12 Month 13 Day
Last modified on
2018 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034681

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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