UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040465 |
|---|---|
| Receipt number | R000046189 |
| Scientific Title | The Efficacy of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty |
| Date of disclosure of the study information | 2020/05/20 |
| Last modified on | 2021/05/28 11:58:03 |
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Basic information
Public title
The Efficacy of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty
Acronym
The Efficacy of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty
Scientific Title
The Efficacy of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty
Scientific Title:Acronym
The Efficacy of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty
Region
| Japan |
Condition
Condition
Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of the tibial extra-medullary guide combined with ultrasonography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of outlier of implant inclination over two degree in coronal plane.
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 who were performed total knee arthroplasty using this rod or the Navigation system(Stryker inc.)
Key exclusion criteria
Patients without a postoperative imaging analyse.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Sugimura |
Organization
Kochi University
Division name
Orthopeadics
Zip code
7838505
Address
185-1 Oko-cho Kohasu, Nankokushi, Kochi
TEL
088-880-2386
jm-snatsuki@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
Zip code
783-8505
Address
185-1 Oko-cho Kohasu, Nankokushi, Kochi
TEL
088-880-2386
Homepage URL
jm-snatsuki@kochi-u.ac.jp
Sponsor or person
Institute
Kochi university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kochi university
Address
185-1 Oko-cho Kohasu, Nankokushi, Kochi
Tel
088-880-2386
jm-snatsuki@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
| 2020 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of Rate of outlier of implant inclination over two degree in coronal plane between the tibial extra-medullary guide combined with ultrasonography and tha navigation system.
Management information
Registered date
| 2020 | Year | 05 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046189
