UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043240 |
|---|---|
| Receipt number | R000049348 |
| Scientific Title | The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2022/08/08 11:22:29 |
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Basic information
Public title
The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics
Acronym
The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics
Scientific Title
The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics
Scientific Title:Acronym
The Effect of Posterior Slope of Tibial Component in Unicompartmental Arthroplasty on the Kinematics
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of posterior slope of tibial component in unicompartmental arthroplasty on the kinematics.
Basic objectives2
Others
Basic objectives -Others
none in particular
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of motion
Key secondary outcomes
The difference of the tibial rotation in extension and flexion.
The difference of the tibial antero-postero translation in extension and flexion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To change the tibial surface trial to +-2 degree and +- 4 degree.
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients to take unicompartmental arthroplasty for the knee osteoarthritis
Key exclusion criteria
Cases where stryker navigation system was not used
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | NATSUKI |
| Middle name | SUGIMURA |
| Last name | SUGIMURA |
Organization
Dept. of Orthop. Surg. Kochi Uni.
Division name
Orthopeadics surgery
Zip code
783-8505
Address
185-1 Oko-cho Kohasu
TEL
0888802386
sugimra.n@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | NATSUKI |
| Middle name | SUGIMURA |
| Last name | SUGIMURA |
Organization
Kochi university
Division name
Orthopeadics Surgery
Zip code
783-8505
Address
Nankoku
TEL
0888802386
Homepage URL
sugimura.n@kochi-u.ac.jp
Sponsor or person
Institute
Kochi univerity
Institute
Department
Personal name
Funding Source
Organization
Kochi university
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
Kochi university
Address
Nankoku
Tel
0888802386
sugimura.n@kochi-u.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 10 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2022 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049348
