UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000031327
Receipt number 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 22:24:33

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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 or person

Institute

Department of Rehabilitation, Anshin Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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