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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/12002490
Publication citations
-
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.