A prospective, randomized study was conducted to assess the efficacy of pulsatile pneumatic plantar compression for prophylaxis against deep venous thrombosis after total knee arthroplasty performed with use of regional anesthesia. One hundred and twenty-two patients (164 knees) who were scheduled to have a unilateral or a one-stage bilateral total knee arthroplasty were separately randomized to be managed with either aspirin alone or the pulsatile pneumatic plantar-compression device and aspirin. The prevalence of deep venous thrombosis was 27% (twenty-two of eighty-one knees) in the group treated with pneumatic plantar compression compared with 59% (forty-nine of eighty-three knees) in the patients managed with aspirin alone (the control group) (p < 0.001). A significant difference was also noted in the group that had had a unilateral arthroplasty (a prevalence of 27% (eleven of forty-one knees) in the group treated with pneumatic plantar compression, compared with 67% (twenty-six of thirty-nine knees) in that treated with aspirin alone; p < 0.006) and in the group that had had a one-stage bilateral procedure (a prevalence of 28% (eleven of forty knees) in the group treated with pneumatic plantar compression, compared with 52% (twenty-three of forty-four knees) in that treated with aspirin alone; p < 0.03). No proximal thrombi were noted in any patient who used the pulsatile pneumatic plantar-compression device, while the prevalence of proximal thrombosis in the popliteal or femoral veins was 14% (twelve of eighty-three knees) in the group treated with aspirin alone (p < 0.0003). In the group treated with a unilateral procedure and aspirin alone the prevalence of proximal thrombosis was 13% (five of thirty-nine knees; p < 0.02), while in the group treated with a bilateral procedure and aspirin alone it was 16% (seven of forty-four knees; p < 0.01). Only in the patients who had had a unilateral procedure was use of the compression device associated with significantly less edema postoperatively than was use of aspirin alone. The change between the preoperative and postoperative circumferences of the thigh and leg was significantly less (9 +/- 4.1 millimeters (mean and standard deviation) less for the thigh (p < 0.01) and 6 +/- 3.9 millimeters less for the leg (p < 0.049)) with the compression device than with aspirin alone. In addition, there was significantly less mean drainage (98 +/- 61.1 milliliters) in the group treated with a unilateral procedure and pneumatic compression, compared with that treated with a unilateral procedure and aspirin alone (p < 0.041). An internal timer of the compression device was used to assess the compliance of the patient with use of the device, and a relationship between deep venous thrombosis and the total duration of treatment with the device was found. The patients in whom deep venous thrombosis did not develop used the device for a mean of 96 +/- 23.4 hours (range sixty to 164 hours) postoperatively, or 19.2 +/- 5.1 hours a day, while those in whom thrombosis developed used it for a mean of 67 +/- 21.1 hours (range twenty-six to 101 hours), or 13.4 +/- 4.3 hours a day (p < 0.001). No untoward effects were noted in any patient who used the device. This study confirms the safety and efficacy of pulsatile pneumatic plantar compression and aspirin compared with aspirin alone and supports the use of mechanical compression for prophylaxis against deep venous thrombosis and for reduction of edema in patients who have had a total knee arthroplasty. In addition, we found a direct relationship between compliance with the use of this device and its efficacy in reducing deep venous thrombosis.

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