UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037669 |
|---|---|
| Receipt number | R000042311 |
| Scientific Title | Development of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2019/08/12 20:03:35 |
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Basic information
Public title
Development of Bone Cutting Guide Using Ultrasonography in Total Knee Arthroplasty
Acronym
Bone Cutting Guide Using Ultrasonography
Scientific Title
Development of Tibial Extra Medullary Guide Combined with Ultrasonography in Total Knee Arthroplasty
Scientific Title:Acronym
Tibial Extra Medullary Guide Combined with Ultrasonography
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of ultrasonography combined tibial extramedulary guide in total knee arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Coronal alignment of tibial base plate at one week after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In tibial osteotomy of total knee arthroplasty, an ultrasound combined tibial extramedullary gaide will be used.
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 will be performed total knee arthroplasty.
Key exclusion criteria
Patients who have severe deformity and are impossible to use this guide.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Natsuki |
| Middle name | |
| Last name | Sugimura |
Organization
Kochi university
Division name
Orthopeadics
Zip code
783-8505
Address
185-1 Oko-cho Kohasu, Nankoku, Kochi prefecture
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, Nankoku, Kochi prefecture
TEL
088-880-2386
Homepage URL
jm-snatsuki@kochi-u.ac.jp
Sponsor or person
Institute
Kochi university, Orthopeadics
Institute
Department
Personal name
Funding Source
Organization
none
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
185-1 Oko-cho Kohasu, Nankoku, Kochi prefecture
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
高知大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042311
