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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028393
Receipt No. R000032395
Scientific Title Three-dimensional motion analysis after FINE total knee arthroplasty with low-constrained polyethylene insert
Date of disclosure of the study information 2017/10/01
Last modified on 2018/07/30

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Basic information
Public title Three-dimensional motion analysis after FINE total knee arthroplasty with low-constrained polyethylene insert
Acronym 3D FINE flat
Scientific Title Three-dimensional motion analysis after FINE total knee arthroplasty with low-constrained polyethylene insert
Scientific Title:Acronym 3D FINE flat
Region
Japan

Condition
Condition Osteoarthritis of the knee (post total knee arthroplasty)
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate tendency of knee motion after FINE knee total knee arthroplasty when using low constrained flat surface polyethylene
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relative position of the femur calculated at each 10 degree of knee flexion angle using the tibia as reference line when conducting walking, squatting, climbing stairs, and descend stairs.
Key secondary outcomes Knee injury and Osteoarthritis Outcome Score
Forgotten Joint Score-12

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 X-ray
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who received total knee arthroplasty with FINE Knee flat surface system
Key exclusion criteria 1) Those who did not consent with the study
2) Post-surgical infection
3) Thrombotic disease after surgery
4) Those who were not adequate for study judged by doctors in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sasho, Takahisa
Organization Chiba University
Division name Center for preventive medical sciences
Zip code
Address 1-8-1, Inohana, Chiba, Cyuou
TEL 043-226-2017
Email sasho@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sasho, Takahisa
Organization Chiba University
Division name Center for preventive medical sciences
Zip code
Address 1-8-1, Inohana, Chiba, Cyuou
TEL 043-226-2017
Homepage URL
Email sasho@faculty.chiba-u.jp

Sponsor
Institute Center for preventive medical sciences
Institute
Department

Funding Source
Organization Center for preventive medical sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Orthopedic Surgery, Osaka University
Name of secondary funder(s) None

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 10 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
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 03 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

Management information
Registered date
2017 Year 07 Month 27 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032395

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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