UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039794 |
|---|---|
| Receipt number | 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 18:17:07 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045382
