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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026343
Receipt No. R000030262
Scientific Title Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Date of disclosure of the study information 2017/02/28
Last modified on 2017/02/28

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Basic information
Public title Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Acronym Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Scientific Title Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Scientific Title:Acronym Evaluation replacement accuracy in total knee arthroplasty using JIGEN
Region
Japan

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

Objectives
Narrative objectives1 To evaluate implant replacement accuracy of total knee arthroplasty using JIGEN wchich is computer assisted preoperative planning system/
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee society radiographical implant replacement angke(preoperative, PO1M, PO3Ms, PO6Ms, PO12Ms, PO24Ms)
Key secondary outcomes Clinical outcome-knee society score, KOOS
(preoperative, PO1M, PO3Ms, PO6Ms, PO12Ms, PO24Ms

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Computer assisted operation supported system: JIGEN
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
95 years-old >=
Gender Male and Female
Key inclusion criteria Osteoarthritis of the knee joint
Key exclusion criteria 1)TKA postoperative infection
2)Second sexual gonarthrosis example by primary disease except primary gonarthrosis
3)The patient having affiliation symptom
4)The patient having rheumatic arthritis
5)The patient after high tibial osteotomy
6)The patient having episode of leg fracture
7)Out of gravid or the woman who has pregnant possibilities.The man and woman who do not agree to a woman nursing and contraception studying
8)In addition, the proband whom Rev. study person in charge or doctor in charge judged to be inadequate to carry out this study safely
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Tsukimura
Organization Kitasato insutitite hospital, Kitasato university
Division name Artificial joint and cartilage implantimplantation center
Zip code
Address 5-9-1 shirokane, minato-ku, Tokyo, Japan
TEL 03-3444-6161
Email tsukky@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Tsukimura
Organization Kitasato insutitite hospital, Kitasato university
Division name Artificial joint and cartilage implantimplantation center
Zip code
Address 5-9-1 shirokane, minato-ku, Tokyo, Japan
TEL 03-3444-6161
Homepage URL
Email tsukky@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato insutitite hospital, Kitasato university
Institute
Department

Funding Source
Organization Kitasato insutitite hospital, Kitasato 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
2017 Year 02 Month 28 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
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 28 Day
Last follow-up date
2019 Year 12 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
2017 Year 02 Month 28 Day
Last modified on
2017 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030262

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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