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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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