UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019442 |
|---|---|
| Receipt number | R000021517 |
| Scientific Title | Retrospective study for best APaxis of tibial side component in total knee arthroplasty |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2016/11/01 22:56:33 |
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Basic information
Public title
Retrospective study for best APaxis of tibial side component in total knee arthroplasty
Acronym
Retrospective study for best APaxis in TKA
Scientific Title
Retrospective study for best APaxis of tibial side component in total knee arthroplasty
Scientific Title:Acronym
Retrospective study for best APaxis in TKA
Region
| Japan |
Condition
Condition
Osteoarthritis and rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determination of ideal antero-posterior axis for total knee arthroplasty
Basic objectives2
Others
Basic objectives -Others
Improvement of ROM after total knee arthroplasty
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
ROM after total knee arthroplasty
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
after total knee arthroplasty
Key exclusion criteria
There are no data more than 6 months after operation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
tkobayas@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
Homepage URL
tkobayas@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College hospital, Department of Rehabilitation
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
Address
Tel
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
| 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 | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
We investigate whether rotational position between femoral component and tibial component influences the ROM after total knee arthroplasty.
Subjects are patients who were performed total knee arthroplasty at National Defense Medical College Hospital more than 6 months before and CT is available and we can get informed consent for research.
We will get data of knee joint ROM more than 6 months after total knee arthroplasty and rotatinal relation between femoral and tibial component using CT.
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021517
