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
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
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
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
