A randomised clinical trial to compare the AV impulse foot pump with low molecular weight Heparin in the prevention of deep vein thrombosis after total knee replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN51028168

Enrollment

229

Registered

2004-01-23

Start date

1997-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total knee replacement Surgery Total knee replacement

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026