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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024092
Receipt No. R000027736
Scientific Title Manual calf massage and passive ankle motion reduce the incidence of deep vein thromboembolism after total hip arthroplasty
Date of disclosure of the study information 2016/10/26
Last modified on 2016/10/26

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Basic information
Public title Manual calf massage and passive ankle motion reduce the incidence of deep vein thromboembolism after total hip arthroplasty
Acronym Prevention of deep vein thromboembolism after total hip arthroplasty by manual massage
Scientific Title Manual calf massage and passive ankle motion reduce the incidence of deep vein thromboembolism after total hip arthroplasty
Scientific Title:Acronym Prevention of deep vein thromboembolism after total hip arthroplasty by manual massage
Region
Japan

Condition
Condition deep vein thrombosis after total hip arthroplasy
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate whether manual calf massage (CaM) and passive ankle motion (PAM) could lower the risk of deep vein thrombosis after total hip arthroplasy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of deep vein thrombosis after total hip arthoplasty of day 7.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
35 years-old <
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria We retrospectively reviewed those cases by consecutive patients undergoing elective primary unilateral THA at our hospitals Between January and October 2014were performed CaM and PAM just finished the operation. The patients of control group were undergone THA using the same surgical approach and pre- and postoperative protocol without performance of CaM and PAM between January and December 2013.
Key exclusion criteria Deep vein thrombosis (DVT) was detected by untrasonography, the patients were excluded from the current study.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norio Imai
Organization Department of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical and Dental Science
Division name Department of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical and Dental Science
Zip code
Address 1-757, Asahimachi dori, Chuo Ward, Niigata Pref. Niigata, Japan
TEL 0252272272
Email imainorio2001@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Imai
Organization Department of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical a
Division name Department of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical a
Zip code
Address 1-757, Asahimachi dori, Chuo Ward, Niigata Pref. Niigata, Japan
TEL 0252272272
Homepage URL
Email imainorio2001@med.niigata-u.ac.jp

Sponsor
Institute Department of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical and Dental Science
Institute
Department

Funding Source
Organization Department of Comprehensive Geriatrics in Community, Niigata University Graduate School of Medical and Dental Science
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 26 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 Main results already published
Date of protocol fixation
2016 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2016 Year 09 Month 17 Day
Last modified on
2016 Year 10 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027736

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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