UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Manual calf massage and passive ankle motion reduce the incidence of deep vein thromboembolism after total hip arthroplasty
Title of the study (Brief title)	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	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
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	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
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027736