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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020442
Receipt No. R000023617
Scientific Title Patients' satisfaction after Physio-Knee total knee arthroplasty -multicenter study-
Date of disclosure of the study information 2016/01/05
Last modified on 2020/08/01

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Basic information
Public title Patients' satisfaction after Physio-Knee total knee arthroplasty -multicenter study-
Acronym Physio-Knee multicenter study
Scientific Title Patients' satisfaction after Physio-Knee total knee arthroplasty -multicenter study-
Scientific Title:Acronym Physio-Knee multicenter study
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the patients' satisfaction after Physio-Knee total knee arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Forgotten Joint Score (12 months after operation)
Key secondary outcomes Ligament balance
Alignment of leg (2-4 weeks after operation)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Candidates for primary total knee arthroplasty using Physio-Knee system
Key exclusion criteria Patients with contra-indication for total knee arthroplasty
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihide Minoda
Organization Osaka City University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3851
Email yminoda@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihide Minoda
Organization Osaka City University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 1-4-3, Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3851
Homepage URL
Email yminoda@msic.med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization KYOCERA Medical Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 01 Month 05 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 250
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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 05 Day
Date of IRB
2016 Year 01 Month 04 Day
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Obseravation

Management information
Registered date
2016 Year 01 Month 05 Day
Last modified on
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023617

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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