UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019443 |
|---|---|
| Receipt number | R000022491 |
| Scientific Title | Ideal antero-posterior axis for tibial component in total knee arthroplasty |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2019/04/24 11:47:32 |
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Basic information
Public title
Ideal antero-posterior axis for tibial component in total knee arthroplasty
Acronym
Ideal antero-posterior axis in total knee arthroplasty
Scientific Title
Ideal antero-posterior axis for tibial component in total knee arthroplasty
Scientific Title:Acronym
Ideal antero-posterior axis in total knee arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee, Rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether placeing the femoral and tibial component according to the epicondyle line results in good ROM after total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post operative ROM of the knee
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients for tatal knee arthroplasty in National Defense Medical College Hospital
Key exclusion criteria
No CT or MRI before and after total knee arthroplasty
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
359-8513
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
tkobayas@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
359-8513
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
Homepage URL
tkobayas@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
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
National Defense Medical College
Address
3-2, Namiki, Tokorozawa, Saitama
Tel
04-2995-1511
ins010@ndmc.ac.jp
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
防衛医科大学校
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate whether pre-operative determination of tibial component position using MRI or CT according to the epicondyle axis results in good ROM after total knee arthroplasty.
Subjects are patients performed total knee arthroplasty in accordance with pre-operatively determined antero-posterior axis using MRI or CT from 2016 April 1 to 2018 May 31. We are planning collect 40 subjects.
We evaluate knee joint ROMs 6 months after operation and compare them with the ROMs of knee joints operated before 2016 May 31.
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022491
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
