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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026895
Receipt No. R000030854
Scientific Title Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Date of disclosure of the study information 2017/04/14
Last modified on 2017/04/07

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Basic information
Public title Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Acronym Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Scientific Title Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Scientific Title:Acronym Randomized controlled study comparing kinematically aligned technique with mechanically aligned technique in total knee arthroplasty
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Recently, a patient with knee osteoarthritis resistant to conservative therapy has undergone Kinematically aligned total knee arthroplaty. In the present study, the kinematically aligned total knee arthroplasty was compared with mechanically aligned total knee arthroplasty that has been commonly performed in many hospitals.
Basic objectives2 Others
Basic objectives -Others to evaluate the surgical technique in total knee arthroplaty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative patient-derived outcome
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 kinematically aligened total knee arthroplaty
Interventions/Control_2 mechanically aligned total knee arthroplasty
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
65 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. osteoarthritis
2. kellgren-Lawrence grade4
3. patients who agreed the present study
Key exclusion criteria 1. Rheumatoid arthritis
2. revision total knee arthroplasty
3. impossible to gait
4. infection
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Matsumoto
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5111
Email matsun@m4.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Kuroda
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5111
Homepage URL
Email 0321yuichi0321@gmail.com

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
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 04 Month 14 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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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 04 Month 07 Day
Last modified on
2017 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030854

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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