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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024038
Receipt No. R000027682
Scientific Title Motion analysis of Balanced knee TriMax PS-type and CR-type TKA
Date of disclosure of the study information 2016/09/13
Last modified on 2019/03/19

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Basic information
Public title Motion analysis of Balanced knee TriMax PS-type and CR-type TKA
Acronym TriMax motionanalysis
Scientific Title Motion analysis of Balanced knee TriMax PS-type and CR-type TKA
Scientific Title:Acronym TriMax motionanalysis
Region
Japan

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

Objectives
Narrative objectives1 We investigate motion analysis after the TKA whether Balanced knee Trimax gaines normal knee joint motion.
Basic objectives2 Others
Basic objectives -Others Motionnanalysiis date is comparewwd with clinical outcome scale.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3 dimensional knee motion analysis using 2D/3/D registration method at walking, step and kneing 6 months over postoperatively after the TKA.
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
Device,equipment
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
100 years-old >
Gender Male and Female
Key inclusion criteria Osteoarthritic patients were underwent Trimax total knee arthroplasty 6 months over postoperatively, and gained normal AD./
Key exclusion criteria Osteoarthritic patients were not underwent Trimax total knee arthroplasty, or within 6 months

RA
osteoarthritis patient with fracture, inflammational disease, gene disease
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasunori Tsukimura
Organization Kitasato insutitute hospital, Kitasato university
Division name Artificial joint and chondral implantation center
Zip code
Address 1-55-13, Shirokane, Minatoku, Tokyo
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 insutitute hospital, Kitasato university
Division name Artificial joint and chondral implantation center
Zip code
Address 1-55-13, Shirokane, Minatoku, Tokyo
TEL 03-3444-6161
Homepage URL
Email tsukky@insti.kitasato-u.ac.jp

Sponsor
Institute Kitasato insutitute hospital, Kitasato University
Institute
Department

Funding Source
Organization Orthpaedic, Kitasato insutitute 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
2016 Year 09 Month 13 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 09 Month 13 Day
Date of IRB
2016 Year 08 Month 14 Day
Anticipated trial start date
2016 Year 10 Month 20 Day
Last follow-up date
2019 Year 08 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2019 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027682

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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