UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044862 |
|---|---|
| Receipt number | R000051243 |
| Scientific Title | Assessment regarding kinematic alignment in TKA |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/01/15 09:19:32 |
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Basic information
Public title
Assessment regarding kinematic alignment in TKA
Acronym
Assessment regarding kinematic alignment in TKA
Scientific Title
Assessment regarding kinematic alignment in TKA
Scientific Title:Acronym
Assessment regarding kinematic alignment in TKA
Region
| Japan |
Condition
Condition
knee disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment regarding kinematic alignment in TKA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment regarding kinematic alignment in TKA, speciality for knee stability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
change of prosthetic alignment goal
1:mechanical algnment
Interventions/Control_2
change of prosthetic alignment goal
2:kinematic alignment
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 who undergoes TKA
Key exclusion criteria
sever varus deformity
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Osaka Rosai Hospital
Division name
Orthopedics
Zip code
591-8025
Address
Osaka Sakaishi Kitaku Nagasonecho 1179-3
TEL
072-252-3561
ueyama.rosai@gmail.com
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ueyama |
Organization
Osaka Rosai Hospital
Division name
Orthopedics
Zip code
591-8025
Address
Osaka Sakaishi Kitaku Nagasonecho 1179-3
TEL
072-252-3561
Homepage URL
ueyama.rosai@gmail.com
Sponsor or person
Institute
Osaka Rosai Hospital
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
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
Osaka Sakaishi Kitaku Nagasonecho 1179-3
Tel
072-252-3561
ueyama.rosai@gmail.com
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
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
not analysis yet
Publication of results
Unpublished
Result
URL related to results and publications
not analysis yet
Number of participants that the trial has enrolled
50
Results
not analysis yet
Results date posted
| 2025 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Primary TKA
Participant flow
Primary TKA
Adverse events
no
Outcome measures
Muscle strength, ADL, FIM etc
Xp: FTA, HKA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051243
