UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023697 |
|---|---|
| Receipt number | 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 | 2019/09/06 17:56:58 |
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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
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4020
ynakagawa.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Otabe |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4020
Homepage URL
otabe.orj@tmd.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
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
Institutional Review Board, Tokyo Medical and Dental University Hospital of Medicine
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
Tel
03-5803-5096
info.bec@tmd.ac.jp
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
| 2019 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026731
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
