UMIN-CTR Clinical Trial

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
Email	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
Email	hkazue@fujita-hu.ac.jp

Sponsor
Institute	Fujita health university
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056003