UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2016 Year 10 Month 20 Day
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	2021 Year 09 Month 04 Day

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