Comparison of fixation of the femoral component without cement and fixation with use of a bone-vacuum cementing technique for the prevention of fat embolism during total hip arthroplasty. A prospective, randomized clinical trial.

BACKGROUND: Acute hypotension, hypoxemia, cardiac arrest, and sudden death are well recognized complications during total hip arthroplasty, and they have been attributed to embolization of fat and bone marrow. An increase in intramedullary pressure in the femur is the most important pathogenic factor for the development of embolic events. Intravasation of fat, bone marrow, and bone debris during the implantation of a femoral component, and the embolization of these elements through the venous system located along the linea aspera and through the metaphyseal vessels, have been demonstrated experimentally and clinically. The purpose of the present study was to compare the effects of fixation of the femoral component without cement with those of fixation with a bone-vacuum cementing technique on the severity of embolic phenomena and cardiopulmonary impairment during total hip arthroplasty. Fixation with a conventional cementing technique was also evaluated as a control.
METHODS: Sixty patients (sixty hips) were entered into a prospective, randomized clinical trial. The patients were assigned to one of three groups. Group 1 consisted of twenty patients who had the femoral component inserted without cement, Group 2 comprised twenty patients who had the component inserted with a conventional cementing technique, and Group 3 included twenty patients who had fixation with the so-called bone-vacuum cementing technique. In the hips in Group 3, a suction of -800 millibars (-80,000 pascals) was applied to a proximal drainage cannula placed along the linea aspera and a distal drainage cannula placed in the diaphysis in order to produce a vacuum in the medullary cavity of the femur during the application of cement and the insertion of the stem. Transesophageal echocardiography and hemodynamic and blood-gas analysis were performed during the operation.
RESULTS: Severe embolic events (defined as a cascade of fine echogenic particles of less than five millimeters in diameter) were observed in seventeen (85 percent) of the twenty patients during insertion of the stem with use of a conventional cementing technique but in none of the patients who had the stem inserted without cement (p < 0.05). Insertion of the femoral component with the bone-vacuum cementing technique prevented embolic phenomena in all but one patient (5 percent). Arterial oxygen saturation decreased significantly (p < 0.05) from a mean of 99.5 to 92.9 percent after insertion of the stem with a conventional cementing technique, but only slight changes were observed in the patients who had fixation of the component without cement and in those who were managed with the bone-vacuum cementing technique. Intraoperative pulmonary shunt values increased a mean of 24 percent (p < 0.05) when the femoral component was inserted with a conventional cementing technique, but with the numbers available we did not detect a significant change in those values when the component was fixed without cement or when it was inserted with use of the bone-vacuum cementing technique.
CONCLUSIONS: The present study showed that severe embolic events and intraoperative pulmonary impairment are common when a femoral component is fixed with use of a conventional cementing technique. The results clearly demonstrated a low risk of embolism during total hip arthroplasty when the femoral component was fixed without cement and when it was fixed with the bone-vacuum cementing technique. The ability of a patient to withstand an embolic event should be considered before fixation of the femoral component with use of a conventional cementing technique is planned.

RCT Entities:   Population Interventions Outcomes