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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023697
Receipt No. R000026731
Scientific Title A study on component placement in simultaneous bilateral total knee arthroplasy
Date of disclosure of the study information 2016/09/01
Last modified on 2018/08/22

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Basic information
Public title A study on component placement in simultaneous bilateral total knee arthroplasy
Acronym A study on component placement in simultaneous bilateral total knee arthroplasy
Scientific Title A study on component placement in simultaneous bilateral total knee arthroplasy
Scientific Title:Acronym A study on component placement in simultaneous bilateral total knee arthroplasy
Region
Japan

Condition
Condition Osteoarthritis (OA)
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the difference between mechanical alignment and kinematic alignment by performing simultaneous bilateral total knee arthroplasty (TKA) based on the two concepts in each side.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Physical findings and patient-based subjective assessment before and after surgery.
Key secondary outcomes Radiographic and computer tomographic findings, and laboratory data.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Performing simultaneous bilateral TKA based on the concepts of mechanical alignment and kinematic alignment in each side. The mechanical alignment side.
Interventions/Control_2 Performing simultaneous bilateral TKA based on the concepts of mechanical alignment and kinematic alignment in each side. The kinematic alignment side.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Candidates for TKA due to knee osteoarthritis.
Key exclusion criteria No minor is included.
Patients with cognitive impairment and auditory disorder are excluded.
Patients with previous osteotomy around the knee joint, severe varus deformity, massive bone defect, significant femoral or tibial bowing, or extreme flexion or extension contracture.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshifumi Watanabe
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4020
Email watanabe.orj@tmd.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Koji Otabe
Organization Tokyo Medical and Dental University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-4020
Homepage URL
Email otabe.orj@tmd.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 R2016-014
Org. issuing International ID_1 Institutional Review Board, Tokyo Medical and Dental University Hospital of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京医科歯科大学医学部附属病院(東京都)
Tokyo Medical and Dental University Hospital of Medicine (Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 09 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 No longer recruiting
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 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 End of Patient recruitment
46 cases

Management information
Registered date
2016 Year 08 Month 20 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026731

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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