Condition category
Surgery
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David Warwick

ORCID ID

Contact details

Southampton University Hospitals NHS Trust
Department of Orthopaedic Surgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 6245
davidwarwick@handsurgery.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R/41/1.97/Warw

Study information

Scientific title

Acronym

Study hypothesis

What is the relative effectiveness (against deep vein thrombosis [DVT]), safety and cost of Low Molecular Weight Heparin and the AV Impulse Foot Pump after total knee replacement surgery?

Ethics approval

Our study had the approval of the local Medical Research and Ethics Committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Total knee replacement

Intervention

Enoxaparin (40 mg) was administered, subcutaneously, 12 hours before surgery (in accordance with the UK licence) and every 24 hours thereafter until discharge from hospital. The slippers for the foot pump were applied in the recovery room and the controller was then engaged. The foot pump was then used whenever the patient was not weight-bearing until discharge from hospital. The patient lay in bed with the legs parallel to the floor. The controller activated the pump every 20 seconds at a pressure of 130 mmHg for a period of one second.

Intervention type

Drug

Phase

Not Specified

Drug names

Enoxaparin

Primary outcome measures

Frequency of DVT as shown by the results of ipsilateral ascending venography between the sixth and eighth postoperative days.

Secondary outcome measures

1. Perioperative blood loss: a single drain was used routinely and blood loss was derived from a summation of intraoperative blood loss and postoperative drainage at 36 hours
2. Haemoglobin and haematocrit: measured before operation, on the second day after surgery and just before discharge
3. Blood loss index: transfusion requirements of the patients were noted. We recorded whether or not the patient had bruising or oozing from the site of the wound on the fourth and seventh postoperative days.
4. Swelling: assessed by measuring the circumference of the thigh and calf at 10 cm above and below the joint, respectively on the fourth and seventh postoperative days. The level was marked by an indelible pen to maintain consistency.
5. Knee flexion: measured active knee flexion with a goniometer on the fourth and seventh postoperative days. The soft-tissue side-effects were assessed in an open-label manner as it was apparent whether or not the patient was using a foot pump.

Overall trial start date

01/08/1997

Overall trial end date

01/02/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients scheduled for unilateral primary total knee replacement at the Avon Orthopaedic Centre.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

229

Participant exclusion criteria

1. Refusal of consent
2. Long-term warfarin therapy for pre-existing cardiac or cerebral disease
3. A bleeding tendency
4. Painful joints or wounds in the feet which would preclude the use of the foot pump

Recruitment start date

01/08/1997

Recruitment end date

01/02/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/12002490

Publication citations

  1. Results

    Warwick D, Harrison J, Whitehouse S, Mitchelmore A, Thornton M, A randomised comparison of a foot pump and low-molecular-weight heparin in the prevention of deep-vein thrombosis after total knee replacement., J Bone Joint Surg Br, 2002, 84, 3, 344-350.

Additional files

Editorial Notes