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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039794
Receipt No. R000045382
Scientific Title Investigation of patient satisfaction following use of the VERASENSE sensor to monitor operative contact pressure during TKA
Date of disclosure of the study information 2020/03/12
Last modified on 2020/03/12

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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