UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Benefits of self-calf massage for the prevention of the vein thromboembolism after total knee arthroplasty
Title of the study (Brief title)	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	Tomohiro Oka
Organization	Anshin Hospital
Division name	Department of rehabilitation
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	Tomohiro Oka
Organization	Anshin Hospital
Division name	Department of rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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