Clinical trials and meta-analyses have suggested that aspirin may be effective for the prevention of venous thromboembolism (proximal deep-vein thrombosis or pulmonary embolism) after total hip or total knee arthroplasty, but comparisons with direct oral anticoagulants are lacking for prophylaxis beyond hospital discharge. We performed a multicenter, double-blind, randomized, controlled trial involving patients who were undergoing total hip or knee arthroplasty. All the patients received once-daily oral rivaroxaban (10 mg) until postoperative day 5 and then were randomly assigned to continue rivaroxaban or switch to aspirin (81 mg daily) for an additional 9 days after total knee arthroplasty or for 30 days after total hip arthroplasty. Patients were followed for 90 days for symptomatic venous thromboembolism (the primary effectiveness outcome) and bleeding complications, including major or clinically relevant nonmajor bleeding (the primary safety outcome). A total of 3424 patients (1804 undergoing total hip arthroplasty and 1620 undergoing total knee arthroplasty) were enrolled in the trial. Venous thromboembolism occurred in 11 of 1707 patients (0.64%) in the aspirin group and in 12 of 1717 patients (0.70%) in the rivaroxaban group (difference, 0.06 percentage points; 95% confidence interval [CI], −0.55 to 0.66; P<0.001 for noninferiority and P=0.84 for superiority). Major bleeding complications occurred in 8 patients (0.47%) in the aspirin group and in 5 (0.29%) in the rivaroxaban group (difference, 0.18 percentage points; 95% CI, −0.65 to 0.29; P=0.42). Clinically important bleeding occurred in 22 patients (1.29%) in the aspirin group and in 17 (0.99%) in the rivaroxaban group (difference, 0.30 percentage points; 95% CI, −1.07 to 0.47; P=0.43). Among patients who received 5 days of rivaroxaban prophylaxis after total hip or total knee arthroplasty, extended prophylaxis with aspirin was not significantly different from rivaroxaban in the prevention of symptomatic venous thromboembolism. (Funded by the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT01720108.)
1 February 2006 in Journal of Bone and Joint Surgery
Background: Although numerous methods of postoperative analgesia have been investigated in an attempt to improve pain control after total knee arthroplasty, parenteral narcotics still play a major role in postoperative pain management. Local anesthetics have the advantage of blocking pain conduction at its origin and minimizing the systemic side effects associated with postoperative narcotic use. This study was performed to evaluate the benefits and safety of a multimodal analgesia protocol that included periarticular injection of large doses of local anesthetics in patients undergoing total knee arthroplasty. Methods: We compared morphine consumption during the first twenty-four hours after unilateral total knee arthroplasty in forty-two patients who had been randomized to receive either (1) a perioperative infiltration mixture, consisting principally of local anesthetic, and self-administered morphine or (2) self-administered morphine only. Narcotics consumption, pain control, medication-related side effects, plasma levels of the local anesthetic (ropivacaine), and postoperative rehabilitation were monitored. Results: Although there was high satisfaction and good pain control in both groups, morphine consumption was significantly lower in the local analgesia group than it was in the control group (28.8 ± 17.4 mg compared with 50.3 ± 25.4 mg twenty-four hours after surgery, and 46.7 ± 19.4 mg compared with 68.6 ± 38.6 mg forty hours after surgery). Both groups achieved a similar amount of knee flexion on the fifth postoperative day. Over the five-day period after the procedure, the patients in the local analgesia group reported a total of 2.6 ± 3.9 hours of nausea compared with 7.1 ± 12.2 hours in the control group. No complications related to the infiltration of the local anesthetic were observed, and all plasma concentrations of the local anesthetic were below the toxic range. Conclusions: This multimodal perioperative analgesia protocol that included infiltration of a local anesthetic offered improved pain control and minimal side effects to patients undergoing total knee arthroplasty. Our study also confirmed the safety of the protocol. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
We have compared the biomechanical nature of the reconstruction of the hip in conventional total hip arthroplasty (THA) and surface replacement arthroplasty (SRA) in a randomised study involving 120 patients undergoing unilateral primary hip replacement. The contralateral hip was used as a control. Post-operatively, the femoral offset was significantly increased with THA (mean 5.1 mm; −2.8 to 11.6) and decreased with SRA (mean −3.3 mm; −8.9 to 8.2). Femoral offset was restored within sd 4 mm in 14 (25%) of those with THA and in 28 (57%) of the patients receiving SRA (p < 0.001). In the THA group, the leg was lengthened by a mean of 2.6 mm (−6.04 to +12.9), whereas it was shortened by a mean of 1.9 mm (−7.1 to +2.05) in the SRA group, compared with the contralateral side. Leg-length inequality was restored within sd 4 mm in 42 (86%) of the SRA and 33 (60%) of the THA patients. The radiological parameters of acetabular reconstruction were similar in both groups. Restoration of the normal proximal femoral anatomy was more precise with SRA. The enhanced stability afforded by the use of a large-diameter femoral head avoided over-lengthening of the limb or increased offset to improve soft-tissue tension as occurs sometimes in THA. In a subgroup of patients with significant pre-operative deformity, restoration of the normal hip anatomy with lower pre-operative femoral offset or significant shortening of the leg was still possible with SRA.
Chinese translation The role of aspirin in thromboprophylaxis after total hip arthroplasty (THA) is controversial. To compare extended prophylaxis with aspirin and dalteparin for prevention of symptomatic venous thromboembolism (VTE) after THA. Multicenter randomized, controlled trial with a noninferiority design based on a minimal clinically important difference of 2.0%. Randomization was electronically generated; patients were assigned to a treatment group through a Web-based program. Patients, physicians, study coordinators, health care team members, outcome adjudicators, and data analysts were blinded to interventions. (Current Controlled Trials: ISRCTN11902170) 12 tertiary care orthopedic referral centers in Canada. 778 patients who had elective unilateral THA between 2007 and 2010. After an initial 10 days of dalteparin prophylaxis after elective THA, patients were randomly assigned to 28 days of dalteparin (n = 400) or aspirin (n = 386). Symptomatic VTE confirmed by objective testing (primary efficacy outcome) and bleeding. Five of 398 patients (1.3%) randomly assigned to dalteparin and 1 of 380 (0.3%) randomly assigned to aspirin had VTE (absolute difference, 1.0 percentage point [95% CI, −0.5 to 2.5 percentage points]). Aspirin was noninferior (P < 0.001) but not superior (P = 0.22) to dalteparin. Clinically significant bleeding occurred in 5 patients (1.3%) receiving dalteparin and 2 (0.5%) receiving aspirin. The absolute between-group difference in a composite of all VTE and clinically significant bleeding events was 1.7 percentage points (CI, −0.3 to 3.8 percentage points; P = 0.091) in favor of aspirin. The study was halted prematurely because of difficulty with patient recruitment. Extended prophylaxis for 28 days with aspirin was noninferior to and as safe as dalteparin for the prevention of VTE after THA in patients who initially received dalteparin for 10 days. Given its low cost and greater convenience, aspirin may be considered a reasonable alternative for extended thromboprophylaxis after THA. Canadian Institutes of Health Research.