UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tree dementional motion analyisis of medial pivot type artificialjoint with mobile-bearing
Title of the study (Brief title)	Tree dementional motion analyisis of medial pivot type artificialjoint with mobile-bearing
Region	Japan

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

Objectives
Narrative objectives1	We investigate motion analysis using fuluoroscopy ot medial pivot type artificial joint: Genus with mobile bearing insert
Basic objectives2	Others
Basic objectives -Others	We investigate medial pivot artifical joint motion shows good clinical outcome.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Tree dementional motion analysis
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	total knee arthroplasty
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	35 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	6 months over after total knee arthroplasty using Genus
Key exclusion criteria	1)The patient having affiliation symptom 2)The patient having articular rheumatism 3)The patient after high tibial osteotomy 4)The patient having leg fracture medical history(the patient that a mirror opticociliary neurectomy bottom is postoperative, the patient having bilateral gonarthrosis do not do it with exclusion)
Target sample size	10

Research contact person
Name of lead principal investigator	Yasunori Tsukimura
Organization	Kitasato institute hospital, Kitasato university
Division name	Orthpaedics
Address	1-55-13, Shirokane, Minatoku, Tokyo
TEL	03-3444-6161
Email	tsukky@insti.kitasato-u.ac.jp

Public contact
Name of contact person	Yasunori Tsukimura
Organization	Kitasato institute hospital, Kitasato university
Division name	Orthpaedics
Address	1-55-13, Shirokane, Minatoku, Tokyo
TEL	03-3444-6161
Homepage URL
Email	tsukky@insti.kitasato-u.ac.jp

Sponsor
Institute	Orthpaedics, Kitasato institute hospital, Kitasato university
Institute
Department

Funding Source
Organization	Orthpaedics, Kitasato institute hospital, Kitasato university
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 08 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 09 Day
Anticipated trial start date	2016 Year 11 Month 18 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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 07 Day
Last modified on	2017 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030390