Condition category
Circulatory System
Date applied
29/06/2016
Date assigned
08/07/2016
Last edited
07/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Joint diseases, including osteoarthritis (in which the protective cartilage on the end of bones wears away) and rheumatoid arthritis (in which the immune system attacks the body’s own healthy joints) is a major cause of knee replacement surgery. In this type of operation, the diseased cartilage and bone is removed from the surface of the knee joint and replaced with a man-made surface of metal or plastic. This can greatly reduce disability in patients, helping them to enjoy a better quality of life. When a person undergoes the procedure, they often spend a lot of time in bed, putting them at risk of deep vein thrombosis (DVT). DVT is where a blood clot develops in a deep vein in one or both of the legs, causing pain, swelling and long term complications such as leg ulcers. If a DVT is not treated, then there is a risk that part of the blood clot could break off and become stuck in one of the lungs, blocking blood supply (pulmonary embolism, PE). Together, these two conditions are known as venous thromboembolism (VTE), which is a leading cause of death and disability worldwide. Mechanical devices such as the venous foot pump (which helps to pump blood back towards the heart, preventing it from pooling in veins) have been shown to be effective at preventing DVT. The aim of this study is to investigate the effectiveness of using a foot pump to prevent DVT in patients having knee replacement surgery.

Who can participate?
Adults aged 20 years and over who are having knee replacement surgery because of a joint disease.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given edoxaban (an anti-clotting drug) 12 hours after their surgery only. Those in the second group are given edoxaban as well as use of a foot pump. The foot pump machine is attached to slippers which are worn on the feet, to stimulate circulation. The slippers are placed on both feet in the recovery room and nurses are advised to turn on whenever the patient is sitting/lying down. Nurses routinely monitor the pressure provided by the foot pump every three hours until four days after surgery. Participants in both groups wear compression stocking (tight stockings which squeeze the legs to prevent blood pooling in veins) on both legs after surgery. Participants are then followed up after 10 days, when they have an ultrasound scan of their legs to check for DVT. After 28 days, participants have a CT scan to check for PE.

What are the possible benefits and risks of participating?
There are no notable benefits or risks involved with participating in this study.

Where is the study run from?
NHO Nagasaki Medical Center (Japan)

When is the study starting and how long is it expected to run for?
September 2011 to May 2015

Who is funding the study?
Japanese National Hospital Organization (Japan)

Who is the main contact?
Dr Satoru Motokawa
s-motokawa@suga-seikei.jp

Trial website

Contact information

Type

Public

Primary contact

Dr Satoru Motokawa

ORCID ID

http://orcid.org/0000-0002-1895-6081

Contact details

Kubara 2-1001-1
Omura
8568652
Japan
+81 (0)957 52 3121
s-motokawa@suga-seikei.jp

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

N/A

Study information

Scientific title

Effects of a foot pump on the incidence of deep vein thrombosis after total knee arthroplasty in patients given edoxaban: a randomized controlled study

Acronym

NHO-FPDVT

Study hypothesis

Use of a foot pump affects the postoperative DVT incidence under thromboprophylaxis in patients receiving TKA.

Ethics approval

Japanese National Hospital Organization (NHO) Nagasaki Medical Center, 05/09/2011, ref: 2011/23033

Study design

Randomized control study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Deep vein thrombosis

Intervention

Participants are randomized to one of two groups (foot pump or without foot pump). Randomization is performed on the day before the operation using sealed envelopes containing a slip indicating the allocation, derived from a computer-generated sequence.

Group 1: Patients are given edoxaban starting 12 hours after their operation. Patients are given low-dose edoxaban (15 mg once daily for patients <60 kg) or high-dose edoxaban (30 mg once daily for patients weighing ≥60 kg).

Group 2: Patients are given edoxaban starting 12 hours after their operation. Patients are given low-dose edoxaban (15 mg once daily for patients <60 kg) or high-dose edoxaban (30 mg once daily for patients weighing ≥60 kg), plus use of the foot pump. Foot pump slippers are fitted on both feet in the recovery room, and the machine activated. The nurses are advised to activate the foot pump whenever the patient is not bearing weight. The nurses routinely monitor the use of mechanical compression by checking it every 3 hours until postoperative day four. An alarm is also set to sound when the foot pump turned off or pressure did not appear. The pneumatic compression cycle is set at 20/min with a pressure of 130 mmHg applied for 1 second.

All patients wear bilateral knee-high anti-thromboembolic stockings for the prevention of deep vein thrombosis.

Participants in both groups are followed up after 10 days to determine DVT rate via ultrasonography, and after 28 days to determine pulmonary embolism (PE) rat via computed tomography.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

1. Symptomatic DVT rate is detected by ultrasonography at baseline and 10 days postoperative
2. Non-symptomatic DVT rate is detected by ultrasonography at baseline and 10 days postoperative
3. Fatal/nonfatal pulmonary embolism (PE) rate is detected by computed tomography at baseline and 28 days postoperative

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/09/2011

Overall trial end date

31/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults aged 20 and over
2. Undergoing knee replacement surgery for primary joint disease, including osteoarthritis (OA) and rheumatoid arthritis (RA)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Consecutive patients (aged ≥20 years) undergoing knee replacement surgery for primary joint disease, including osteoarthritis (OA) and rheumatoid arthritis (RA) were enrolled. Patients: 150

Participant exclusion criteria

1. Presence of predefined risk factors for bleeding, coagulation disorders, heart failure (New York Heart Association class III or IV), significant renal dysfunction (creatinine clearance <30 mL/min)
2. Abnormalities in biochemical measurements (aspartate aminotransferase or alanine aminotransferase ≥5 times the upper limit of normal or total bilirubin ≥2 times the upper limit of normal)
3. Those scheduled to undergo bilateral joint replacement or reoperation
4. Unable to walk
5. Uncontrolled cardiovascular disease

Recruitment start date

24/01/2012

Recruitment end date

23/03/2015

Locations

Countries of recruitment

Japan

Trial participating centre

NHO Nagasaki Medical Center
Clinical Research Center Kubara 2-1001-1
Omura
856-8562
Japan

Sponsor information

Organisation

Japanese National Hospital Organization

Sponsor details

Kubara 2-1001-1
Omura
8568652
Japan
+81 (0)957 52 3121
s-motokawa@suga-seikei.jp

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Japanese National Hospital Organization

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

01/02/2018

Participant level data

Not expected to be available

Results - basic reporting

See additional file ISRCTN18090286_BasicResults_07Jul16

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27558507

Publication citations

Additional files

Editorial Notes

30/08/2016: Publication reference added.