UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of patient satisfaction following use of the VERASENSE sensor to monitor operative contact pressure during TKA
Acronym	Contact pressure in TKA assessed using the VERASENSE sensor
Scientific Title	Investigation of patient satisfaction following use of the VERASENSE sensor to monitor operative contact pressure during TKA
Scientific Title:Acronym	Investigation of patient satisfaction following use of the VERASENSE sensor to monitor operative contact pressure during TKA
Region	Japan

Condition
Condition	Osteoarthritis Rheumatoid Arthritis Osteonecrosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Use the VERASENSE sensor to perform quantitative measurement of contact pressure and contact location of the femorotibial joint surface from the knee in the extended position through to the deep flexion position. This will enable the operator to achieve a better surgical technique. Moreover, identifying the optimum location for contact pressure by evaluating its relationship with postoperative patient satisfaction will improve patient satisfaction levels.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Threshold difference between high- and low-satisfaction groups in contact pressure for the mediolateral surface of the femorotibial joint at 1 year after TKA
Key secondary outcomes	Difference at 1 year after TKA in clinical outcome (ROM, 2011 KSS Total Score) and patient satisfaction (2011 KSS Patient Satisfaction Score) between patients with lower contact pressure difference at the mediolateral surface of the femorotibial joint during surgery (stable group) and those with higher contact pressure difference (unstable group).

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	VERASENSE sensor is inserted temporarily to the position of the artificial knee joint when measuring pressure
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	55 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The case that adapted to total knee arthroplasty. The case who obtained consent by document
Key exclusion criteria	Patients with severe systemic disorders (heart, lung, or cerebrovascular diseases, or psychiatric disorders) and other patients the study investigator and/or study doctor considers as not appropriate
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazue Middle name Last name Hayakawa
Organization	Fujita Health University
Division name	Department of Orthopaedic Surgery
Zip code	4701192
Address	1-98 Dengakugakubo,Kutsukake-cho,Toyoake-city,Aichi,Japan
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	Department of Orthoaedic Surgery
Zip code	4580919
Address	1-98 Dengakugakubo, kutsukake-cho,Toyoake-city,Aichi,japan
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	Self funding
Nationality of Funding Organization	JP

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fujita health university
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	2020 Year 03 Month 12 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	2020 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date	2020 Year 03 Month 25 Day
Last follow-up date	2022 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	2020 Year 03 Month 12 Day
Last modified on	2020 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045382