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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031327
Receipt No. R000035758
Scientific Title Benefits of self-calf massage for the prevention of the vein thromboembolism after total knee arthroplasty
Date of disclosure of the study information 2018/02/16
Last modified on 2018/02/15

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Basic information
Public title Benefits of self-calf massage for the prevention of the vein thromboembolism after total knee arthroplasty
Acronym Benefits of self-calf massage for the prevention of the DVT after TKA
Scientific Title Benefits of self-calf massage for the prevention of the vein thromboembolism after total knee arthroplasty
Scientific Title:Acronym Benefits of self-calf massage for the prevention of the DVT after TKA
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 he purpose of this study was to investigate whether the self-calf massage is effective for preventing deep vein thrombosis after total knee arthroplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes deep vein thrombosis at postoperative 4 days after total knee arthroplasty.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Self-calf massage group performed self-calf massage on the following day and 2days after TKA. In the starting position, the patient was placed in the long-sitting position on the bed while the hip and knee joints were both at approximately 30 degree flexion. The patients were instructed to massage their calf muscles 30 times from the distal to the proximal side. After the self-calf massage, the leg was lowered to the bed for 10 seconds to allow the return of venous blood flow. This procedure was repeated 3 times and was completed in 2 minutes on the following day and 2 days after TKA. The details of this procedure have been outlined in a previous study. The examiner, who was a physical therapist, confirmed whether the patients performed the procedure correctly.
Interventions/Control_2 The control group did not perform it.They started regular physical therapy on the following day after TKA.
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria (i) diagnosis of medial osteoarthritis
(ii) the ability to walk, preoperatively
Key exclusion criteria (i) medical history of DVT
(ii) diagnosis of femur necrosis and rheumatoid arthritis
(iii) long-term use of anticoagulation or antiplatelet agents for pre-existing cardiac or cerebrovascular disease
(iv) coagulation disorder (including antiphospholipid syndrome)
(v) inability to walk because of postoperative pain on the following day after TKA
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Oka
Organization Anshin Hospital
Division name Department of rehabilitation
Zip code
Address 1-4-12, Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo, Japan
TEL 078-305-5252
Email tomohiro1986640@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Oka
Organization Anshin Hospital
Division name Department of rehabilitation
Zip code
Address 1-4-12, Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo, Japan
TEL 078-305-5252
Homepage URL
Email tomohiro1986640@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation, Anshin Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 あんしん病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 16 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 Completed
Date of protocol fixation
2016 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 09 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
2018 Year 02 Month 15 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035758

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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