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Background: Venous thromboembolic events, either deep venous thrombosis or pulmonary embolism, are important complications in patients undergoing knee or hip arthroplasty. The purpose of this study was to evaluate the effectiveness of a mobile compression device (ActiveCare+S.F.T.) with or without aspirin compared with current pharmacological protocols for prophylaxis against venous thromboembolism in patients undergoing elective primary unilateral arthroplasty of a lower-extremity joint. Methods: A multicenter registry was established to capture the rate of symptomatic venous thromboembolic events following primary knee arthroplasty (1551 patients) or hip arthroplasty (1509 patients) from ten sites. All patients were eighteen years of age or older with no known history of venous thromboembolism, coagulation disorder, or solid tumor. Use of the compression device began perioperatively and continued for a minimum of ten days. Patients with symptoms of deep venous thrombosis or pulmonary embolism underwent duplex ultrasonography and/or spiral computed tomography. All patients were evaluated at three months postoperatively to document any evidence of deep venous thrombosis or pulmonary embolism. Results: Of 3060 patients, twenty-eight (0.92%) had venous thromboembolism (twenty distal deep venous thrombi, three proximal deep venous thrombi, and five pulmonary emboli). One death occurred, with no autopsy performed. Symptomatic venous thromboembolic rates observed in patients who had an arthroplasty of a lower-extremity joint using the mobile compression device were noninferior (not worse than), at a margin of 1.0%, to the rates reported for pharmacological prophylaxis, including warfarin, enoxaparin, rivaroxaban, and dabigatran, except in the knee arthroplasty group, in which the mobile compression device fell short of the rate reported for rivaroxaban by 0.06%. Conclusions: Use of the mobile compression device with or without aspirin for patients undergoing arthroplasty of a lower-extremity joint provides a noninferior risk for the development of venous thromboembolism compared with current pharmacological protocols. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence. Peer Review This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.

Background: Warfarin, which requires coagulation monitoring, is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis. This study compared an oral direct thrombin inhibitor, ximelagatran, with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty. Methods: Following surgery, patients were randomly assigned to fixed-dose oral ximelagatran (36 mg twice daily) or warfarin (target international normalized ratio, 2.5), both administered for seven to twelve days in a double-blind, double-dummy design. Warfarin was initiated on the evening of the day of surgery, and ximelagatran, on the morning after surgery. The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography, objectively confirmed symptomatic deep-vein thrombosis or pulmonary embolism, and death from all causes during treatment. Results: Adequate venograms or confirmed symptomatic events (efficacy population) were obtained for 1949 patients. Venous thromboembolism and death from all causes occurred in 22.5% (221) of 982 ximelagatran-treated patients and in 31.9% (308) of 967 warfarin-treated patients (p < 0.001). Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1% (thirty) and 0.2%, respectively, of the patients in the ximelagatran group and in 3.4% (thirty-three) and 0.4%, respectively, of the patients in the warfarin group. The six deaths from all causes included 0.3% (four) of the ximelagatran-treated patients and 0.2% (two) of the warfarin-treated patients. Major bleeding was noted in 1% (twelve) of the ximelagatran-treated patients and in 0.4% (five) of the warfarin-treated patients (p = 0.09). Conclusions: Oral ximelagatran (36 mg twice daily), administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty, demonstrates superior efficacy compared with warfarin prophylaxis, with no wound complications and no significant difference with respect to bleeding events, although the rate of major bleeding events was greater with ximelagatran than with warfarin. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

Unicompartmental replacement can be an alternative to tibial osteotomy in younger, active patients with unicompartmental knee disease. In unicompartmental replacement, the other compartments and knee ligaments are largely untouched. Therefore, it was hypothesized that the knee kinematics after unicompartmental replacement may also be unchanged. To test this hypothesis, knee kinematics and quadriceps tension were recorded before and after replacement with a unicompartmental design and then with a tricompartmental design.Six human cadaver knees were tested before implantation, after implantation with a bicruciate-retaining unicompartmental knee prosthesis, and after implantation with a posterior cruciate-retaining tricompartmental knee prosthesis. The unicompartmental prosthesis was initially implanted, and it was then revised to a total condylar knee replacement. The knee kinematics were measured with use of an electromagnetic tracking device while the knee was put through dynamic simulated stair-climbing under peak flexion moments of approximately 40 N-m. Quadriceps tension was also measured for all three conditions.No significant differences in tibial axial rotation were noted between the intact and unicompartmental conditions. However, tricompartmental replacement significantly affected tibial axial rotation (p = 0.001). Femoral rollback was not significantly affected by either unicompartmental or tricompartmental arthroplasty. Quadriceps tension was also similar among all three conditions.In this in vitro cadaver study, the tricompartmental replacement significantly changed knee kinematics while the unicompartmental replacement preserved normal knee kinematics.

Background: Polyethylene wear contributes substantially to both periprosthetic osteolysis and aseptic loosening after total hip arthroplasty. Acetabular component orientation has been shown to affect the range of motion of the hip as well as contact stresses. A series of studies was designed to test the hypothesis that acetabular component orientation can affect the magnitude and direction of polyethylene wear. Methods: A finite-element model was used to compute contact stresses during a normal gait cycle. Wear at the end of each gait cycle was calculated with use of the sliding-distance-coupled finite-element formulation. The wear that was calculated with use of finite-element analysis was validated by comparison with the findings of hip wear simulator studies with the acetabular liner oriented to simulate 45° and 55° of abduction. In a clinical study, fifty-six patients who underwent sixty hip arthroplasties with use of a single prosthetic design were followed for as long as five years. Radiographs were analyzed to measure the abduction angle of the acetabular component and polyethylene wear. Results: The finite-element analysis predicted increased peak contact stresses with an increased abduction angle and reduced peak contact stresses with an increased anteversion angle. Linear wear rates ranging from 0.036 to 0.045 mm/million cycles were also predicted, and increased acetabular abduction angles were predicted to be associated with higher linear wear rates. In the hip wear simulator studies, significantly different wear rates were found between the cups with acetabular abduction angles of 45° and 55° (mean, 17.2 compared with 21.7 mg/million cycles; p < 0.01). In the clinical study, radiographic analysis revealed significant correlation between the acetabular abduction angle and the linear polyethylene wear rate. A 40% increase in mean linear polyethylene wear was seen in cups with an abduction angle of ≥45°. The direction of wear was more medial (by 9.4°) in cups with an abduction angle of

Background: Erythrocyte salvage, the collection of a patient’s blood shed from the surgical wound, is one aspect of blood management. Previous investigators have examined salvaged blood for content; however, to our knowledge, none have examined the viability of erythrocytes after exposure to the chemical and thermal reactions produced by motorized instruments and polymethylmethacrylate during surgery. The purpose of this study was to determine the viability of salvaged erythrocytes from patients undergoing primary total joint arthroplasty with cement. Methods: Erythrocyte viability studies were performed on specimens from three subjects with use of a double isotope-labeling technique employing chromium-51 and technetium-99m. With use of a fresh blood specimen obtained prior to surgery and a specimen of salvaged blood that had been recycled, washed, and filtered with use of the Cell Saver, the viability of the Cell-Saver-processed erythrocytes, labeled with chromium-51, was calculated on the basis of the technetium-99m-labeled red blood-cell mass. Results: The mean erythrocyte viability (and standard deviation) in blood salvaged with use of the Cell Saver was 88.0% ± 3.8%. The standard of the American Association of Blood Banks for minimum erythrocyte viability in adequately cross-matched allogeneic blood or predeposited autologous blood is 70%. Conclusions: The high rate of viability of the erythrocytes in this study shows that the Cell Saver is a valuable adjunct to other blood management techniques for patients having total joint arthroplasty. We believe that the very high mean rate of erythrocyte viability and the extremely small standard deviation in our three subjects, as compared with the standards of the American Association of Blood Banks, made additional study subjects unnecessary.

Prosthetic impingement due to poor positioning can limit the range of motion of the hip after total hip arthroplasty. In this study, a computer model was used to determine the effects of the positions of the acetabular and femoral components and of varying head-neck ratios on impingement and range of motion.A three-dimensional generic hip prosthesis with a hemispherical cup, a neck diameter of 12.25 millimeters, and a head size ranging from twenty-two to thirty-two millimeters was simulated on a computer. The maximum range of motion of the hip was measured, before the neck impinged on the liner of the cup, for acetabular abduction angles ranging from 35 to 55 degrees and acetabular and femoral anteversion ranging from 0 to 30 degrees. Stability of the hip was estimated as the maximum possible flexion coupled with 10 degrees of adduction and 10 degrees of internal rotation and also as the maximum possible extension coupled with 10 degrees of external rotation. The effects of prosthetic orientation on activities of daily living were analyzed as well.Acetabular abduction angles of less than 45 degrees decreased flexion and abduction of the hip, whereas higher angles decreased adduction and rotation. Femoral and acetabular anteversion increased flexion but decreased extension. Acetabular abduction angles of between 45 and 55 degrees permitted a better overall range of motion and stability when combined with appropriate acetabular and femoral anteversion. Lower head-neck ratios decreased the range of motion that was possible without prosthetic impingement. The addition of a modular sleeve that increased the diameter of the femoral neck by two millimeters decreased the range of motion by 1.5 to 8.5 degrees, depending on the direction of motion that was studied.There is a complex interplay between the angles of orientation of the femoral and acetabular components. Acetabular abduction angles between 45 and 55 degrees, when combined with appropriate acetabular and femoral anteversion, resulted in a maximum overall range of motion and stability with respect to prosthetic impingement.During total hip arthroplasty, acetabular abduction is often constrained by available bone coverage, while femoral anteversion may be dictated by the geometry of the femoral shaft. For each combination of acetabular abduction and femoral anteversion, there is an optimum range of acetabular anteversion that allows the potential for a maximum range of motion without prosthetic impingement after total hip arthroplasty. These data can be used intraoperatively to determine optimum position.

Background: Venous thromboembolic disease in the form of deep venous thrombosis and pulmonary embolism is a major risk after a total hip arthroplasty. Enoxaparin, a low-molecular-weight heparin, has been shown to reduce the prevalence of deep venous thrombosis after total hip arthroplasty. Warfarin, an orally administered anticoagulant, has been used historically to reduce the risk of deep venous thrombosis after total hip arthroplasty. Methods: We compared enoxaparin and adjusted-dose warfarin with respect to their safety and their efficacy in the prevention of clinically important venous thromboembolic disease, defined as distal or proximal deep venous thrombosis or pulmonary embolism, or both, during hospitalization after total hip arthroplasty. We also evaluated the prevalence of complications and mortality from venous thromboembolic disease within three months after discharge. Results: Three thousand and eleven patients at 156 centers were randomly assigned to prophylactic treatment with injection of enoxaparin or oral administration of adjusted-dose warfarin during hospitalization. During the study, fifty-five (3.6 percent) of the 1516 patients who were managed with enoxaparin and fifty-six (3.7 percent) of the 1495 patients who were managed with warfarin had venous thromboembolic disease. Twenty-one patients (0.7 percent), which included four (0.3 percent) of those managed with enoxaparin and seventeen (1.1 percent) of those managed with warfarin (p = 0.0083), had venous thromboembolic disease during hospitalization. After discharge from the hospital, venous thromboembolic disease developed in ninety patients (3.0 percent): fifty-one (3.4 percent) of those managed with enoxaparin and thirty-nine (2.6 percent) of those managed with warfarin. One patient who had been managed with enoxaparin died because of a pulmonary embolism, which was confirmed at autopsy. Three additional patients (one who had been managed with enoxaparin and two who had been managed with warfarin) died, and the deaths were attributed to venous thromboembolic disease; however, no autopsies were performed. Twenty-six patients (0.9 percent) (eighteen managed with enoxaparin and eight managed with warfarin) had clinically important bleeding. Conclusions: Inpatient programs providing treatment with either enoxaparin (thirty milligrams every twelve hours) or adjusted-dose warfarin for a mean of 7.3 days afforded protection against venous thromboembolic disease, with overall rates of morbidity and mortality of 3.7 and 0.6 percent, respectively, and a very low rate of major bleeding complications (0.9 percent) for three months after total hip arthroplasty. During hospitalization, the patients managed with enoxaparin had a lower rate of venous thromboembolic disease than those managed with adjusted-dose warfarin (p = 0.0083). This benefit was lost after the medication was discontinued, with no difference in the prevalences of venous thromboembolic disease between the two groups at three months after discharge from the hospital.

Duplex ultrasonography was used to screen 273 consecutive patients, on the fourth day after a total hip or total knee arthroplasty, for the presence of a distal deep venous thrombosis. Patients who had a history of thromboembolic disease or who had an active neoplasm were excluded from the study. Of the 273 patients, twenty-four (9 per cent) were found to have a proximal deep venous thrombosis (a thrombosis involving the femoral or popliteal veins) and forty-one (15 per cent), a distal deep venous thrombosis (a thrombosis involving the veins of the calf). All of the thromboses were asymptomatic. The forty-one patients in whom a distal deep venous thrombosis had been detected with duplex screening subsequently had serial duplex examinations, on the seventh and fourteenth postoperative days. If a proximal deep venous thrombosis was detected, anticoagulation was begun immediately. If no proximal thrombosis was observed, the distal thrombosis was considered stable, the serial duplex examinations were terminated, and clinical observation was continued. Of the forty-one patients who had serial examinations, seven (17 per cent) had a proximal deep venous thrombosis in the ipsilateral limb by the fourteenth postoperative day; all seven were asymptomatic, and all were managed with anticoagulation. Thirty-four patients (83 per cent) were determined to have a stable distal deep venous thrombosis on the fourteenth postoperative day, and no additional duplex examinations were performed. Thirty-three (97 per cent) of these thirty-four patients remained asymptomatic for deep venous thrombosis thereafter; the remaining patient (3 per cent) had a proximal deep venous thrombosis in the ipsilateral limb eleven months postoperatively.(ABSTRACT TRUNCATED AT 250 WORDS)

A randomized, parallel-group, open-label clinical trial (the physicians, patients, and staff were not blinded with regard to the regimen that had been used) was conducted, between December 1988 and September 1990, to compare the safety and efficacy of enoxaparin, a low-molecular-weight heparin, with the safety and efficacy of unfractionated heparin for the prevention of deep venous thrombosis after elective hip replacement. Six hundred and ten patients were randomized, and 607 patients received one of the study medications. The evaluations of efficacy included contrast-media venography, non-invasive vascular examination, and clinical examination. Data on efficacy were available for 604 patients, who had been assigned to one of three treatment groups: thirty milligrams of enoxaparin every twelve hours (194 patients), forty milligrams of enoxaparin once daily (203 patients), or 5000 units of unfractionated heparin every eight hours (207 patients). All drugs were administered subcutaneously. Dosages were not adjusted on the basis of the results of coagulation tests or the body weight of the patient. Treatment was initiated within twenty-four hours after the operation and continued for a maximum of seven days. The primary safety outcome was the occurrence of bleeding episodes. An intent-to-treat patient analysis revealed that deep venous thrombosis occurred in nine (5 per cent) of the 194 patients who received thirty milligrams of enoxaparin every twelve hours, thirty (15 per cent) of the 203 patients who received forty milligrams of enoxaparin once daily, and twenty-four (12 per cent) of the 207 patients who received unfractionated heparin. The rate of deep venous thrombosis was significantly lower in the group that received thirty milligrams of enoxaparin every twelve hours than in the group that received unfractionated heparin (p = 0.03) and in the group that received forty milligrams of enoxaparin once daily (p = 0.0002). No clinically symptomatic pulmonary embolism was observed during the treatment or follow-up phase of this study in the group that received thirty milligrams of enoxaparin every twelve hours. Analysis of evaluable patients revealed a marked reduction in the rate of deep venous thrombosis in the group that received thirty milligrams of enoxaparin every twelve hours (eight [6 per cent] of 136 patients) compared with the group that received heparin (twenty-one [15 per cent] of 145 patients) (p = 0.10); however, this difference was not significant because of the small number of patients included in this analysis.(ABSTRACT TRUNCATED AT 400 WORDS)