UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049164 |
|---|---|
| Receipt number | R000056003 |
| Scientific Title | Evaluation of the effect of improved accuracy of femoral component rotation angle on clinical outcomes in total knee arthroplasty using ROSA Knee, a robotic surgical assistant: A prospective, randomized controlled study with or without the use of the Femoral Rotation Tool |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/09 03:25:59 |
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Basic information
Public title
Evaluation of the effect of improved accuracy of femoral component rotation angle on clinical outcomes in total knee arthroplasty using ROSA Knee, a robotic surgical assistant: A prospective, randomized controlled study with or without the use of the Femoral Rotation Tool
Acronym
Femoral rotation angle in total knee arthroplasty using ROSA Knee, a robotic surgical assistant
Scientific Title
Evaluation of the effect of improved accuracy of femoral component rotation angle on clinical outcomes in total knee arthroplasty using ROSA Knee, a robotic surgical assistant: A prospective, randomized controlled study with or without the use of the Femoral Rotation Tool
Scientific Title:Acronym
Femoral rotation angle in total knee arthroplasty using ROSA Knee, a robotic surgical assistant
Region
| Japan |
Condition
Condition
Osteoarthritis, Rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how a femoral component rotation angle that considers soft tissue balance would affect clinical outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical evaluation (postoperatively at 3 months, 6 months, and 1 year) and a subject questionnaire (6 months, 1 year) in the rotation group, in which the Femoral Rotation Tool was used, and in the 3-degree rotation group.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Clinical evaluation (postoperatively at 3 months, 6 months, and 1 year) and a subject questionnaire (6 months, 1 year) in the rotation group, in which the Femoral Rotation Tool was used.
Interventions/Control_2
Clinical evaluation (postoperatively at 3 months, 6 months, and 1 year) and a subject questionnaire (6 months, 1 year) in the rotation group,in the 3-degree rotation group.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as needing TKA due to disorders of the knee joint
Patients who provided written consent voluntarily with sufficient understanding after being given a thorough explanation regarding participation in this study
Key exclusion criteria
Patients for whom the Persona TM tibial component and CR insert cannot be used
(cases with large bone defects, poor ligament balance, or posterior cruciate ligament injury, and revision cases)
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Hayakawa |
Organization
Fujita health university
Division name
Orthopaedics
Zip code
4701192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi
TEL
0562932169
hkazue@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Hayakawa |
Organization
Fujita health university
Division name
Orthopaedics
Zip code
4701192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi
TEL
0562932169
Homepage URL
hkazue@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita health university
Institute
Department
Personal name
Funding Source
Organization
Fujita health 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
Fujita health univercity
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi
Tel
0562932865
f-irb@fujita-hu.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
| 2022 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 10 | Month | 09 | Day |
Last modified on
| 2022 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056003
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
