UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006932
Receipt number R000008192
Scientific Title Prevention of venous thromboembolism using thromboprophylactic- transcutaneous electrical nerve stimulation
Date of disclosure of the study information 2011/12/22
Last modified on 2013/04/07 00:19:32

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Basic information

Public title

Prevention of venous thromboembolism using thromboprophylactic- transcutaneous electrical nerve stimulation

Acronym

Prevention of venous thromboembolism using thromboprophylactic- transcutaneous electrical nerve stimulation

Scientific Title

Prevention of venous thromboembolism using thromboprophylactic- transcutaneous electrical nerve stimulation

Scientific Title:Acronym

Prevention of venous thromboembolism using thromboprophylactic- transcutaneous electrical nerve stimulation

Region

Japan


Condition

Condition

Patients who undergo total knee arthroplasty

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the thromboprophylactic effect of transcutaneous electrical nerve stimulation during total knee arthroplasty

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Incidence of deep venous thrombosis at the postoperative day1

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

S group:
Ten seconds of thromboprophylactic-transcutaneous electrical nerve stimulation (TpTENS) is applied every 10 minutes during total knee arthroplasty.

Interventions/Control_2

C group (control):
No TpTENS applied.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo total knee arthroplasty in department of orthopaedic surgery, Kochi univerity

Key exclusion criteria

Past history of VTE
Preoperative DVT
Preoperative anticoagurant therapy
High risk of VTE
Cardiac pacemaker

Target sample size

86


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Ikeuchi, Masashi Izumi

Organization

Kochi Medical School, Kochi University

Division name

Department of Orthopaedic Surgery

Zip code


Address

Kohasu, Oko-cho, Nankoku city, Kochi prefecture, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kochi Medical School, Kochi University

Division name

Department of Orthopaedic Surgery

Zip code


Address


TEL


Homepage URL


Email

im35@kochi-u.ac.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Kochi Medical School, Kochi University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (KAKENHI)

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

高知大学医学部附属病院(高知県)


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 22 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 12 Month 21 Day

Last modified on

2013 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008192


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name