Although a number of agents have been shown to reduce the risk of thromboembolic disease, their use in total hip replacement (THR) remains controversial. Uncertainty exists regarding the safety of chemical prophylaxis as well as the choice of the most effective agent. Previous studies suggested that pneumatic compression with foot-pumps provide the best balance of safety and effectiveness, however too few patients were investigated in randomised clinical trials to draw evidence-based conclusions. The purpose of this randomized clinical trial was to compare the safety and efficacy of pneumatic compression with foot-pumps versus low-molecular-weight heparin (LMWH) for prophylaxis against DVT. Inclusion criteria were hip osteoarthritis and age less than 80 years. Exclusion criteria were history of thromboembolic disease, heart disease, and bleeding diatheses. 216 consecutive patients were considered for inclusion in the trial and were randomized either for management with LMWH (Fraxiparin, Sanofi-Synthelabo, France) or with the A-V Impulse foot-pump (Orthofix Vascular Novamedix, UK). Patients were monitored for DVT using serial duplex sonography and phlebography. DVT was detected in 3 of 100 patients managed with the foot-pump compared with 6 of 100 patients who received chemical prophylaxis (p<
.05). Sixteen patients did not tolerate continuous use of the foot-pump and were excluded from the study. The average postoperative drainage was 259ml in the foot-pump group and 328ml in the LMWH group (p<
.05). Patients with foot-pump had less swelling of the thigh (10mm compared with 15mm) (p<
.05). The patients of the foot-pump group had less postoperative oozing and bruising than did those who had received LMWH. One patient developed heparin-induced thrombocytopenia. This study confirms the safety and efficacy of mechanical prophylaxis of DVT in THR. Some patients cannot tolerate the foot-pump.
Routine prophylaxis for venous thromboembolic disease after total hip replacement (THR) is recommended. Pneumatic compression with foot pumps seems to provide an alternative to chemical agents. However, the overall number of patients investigated in randomised clinical trials has been too small to draw evidence-based conclusions. This randomised clinical trial was carried out to compare the effectiveness and safety of mechanical Inclusion criteria were osteoarthritis of the hip and age less than 80 years. Exclusion criteria included a history of thromboembolic disease, heart disease, and bleeding diatheses. There were 216 consecutive patients considered for inclusion in the trial who were randomised either for management with the A-V Impulse System foot pump. We excluded 16 patients who did not tolerate continuous use of the foot pump or with low-molecular-weight heparin (LMWH). Patients were monitored for DVT using serial duplex sonography at 3, 10 and 45 days after surgery. DVT was detected in three of 100 patients in the foot-pump group and with six of 100 patients in the LMWH group (p <
0.05). The mean post-operative drainage was 259 ml in the foot-pump group and 328 ml in the LMWH group (p <
0.05). Patients in the foot-pump group had less swelling of the thigh (10 mm compared with 15 mm; p <
0.05). One patient developed heparin-induced thrombocytopenia. This study confirms the effectiveness and safety of mechanical prophylaxis of DVT in THR. Some patients cannot tolerate the foot pump.
In relation to the conduct of this study, one or more of the authors is in receipt of a research grant from a non-commercial source.