OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent New England Journal of Medicine study, the following commentary comes from Daniel Leas, MD and Joseph R. Hsu, MD.
Deep infections continue to be one of the most resource-intensive problems that orthopaedic surgeons face. Long-standing dogma has favored 6 or more weeks of intravenous (IV) antibiotics, resulting in increased healthcare costs during both the inpatient and outpatient treatment periods.
To explore the possibility of utilizing targeted oral antibiotics as an alternative, effective treatment for musculoskeletal infections, the OVIVA (Oral versus Intravenous Antibiotics) multicenter research collaboration conducted a prospective, randomized controlled trial. A total of 1,054 patients with deep musculoskeletal infections were randomized to oral or IV arms for 6 weeks of antibiotic treatment and followed for 1 year to determine treatment efficacy. The primary end point was treatment failure within 1 year, defined as the presence of predefined clinical symptoms of deep infection, microbiologic evidence of continued infection, or histologic presence of microorganisms or inflammatory tissue. Secondary outcomes included catheter-associated complications, discontinuation of therapy, and Clostridium difficile diarrhea.
Of the 1,054 patients enrolled, 909 patients were included in the final analysis. Treatment failure occurred in 14.6% of patients treated with IV antibiotics and 13.2% of patients in the oral-therapy group. This -1.4% difference indicated noninferiority based on the predetermined 7.5% noninferiority margin. Secondary outcomes between the groups differed only in catheter-related complications being more common in the IV group (9.4% vs 1.0% in the oral group).
These findings and conclusions should challenge us to re-evaluate the basis for extended IV antibiotics to treat complex musculoskeletal infections, and to consider a greater role for oral antibiotics for such infections. Further study of this question focused on patients with retained hardware is warranted.
Daniel P. Leas, MD is a PGY-5 orthopaedic resident at Carolinas Medical Center.
Joseph R. Hsu, MD is a Professor of Orthopaedic Trauma and Vice Chair of Quality at the Atrium Health Musculoskeletal Institute.
OrthoBuzz occasionally receives posts from guest bloggers. This guest post comes from Amir Khoshbin, MD in response to a recent randomized trial in the New England Journal of Medicine.
The ideal anticoagulation protocol for patients who have received a total knee or hip replacement remains controversial. Results from the recently published “Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty (EPCAT) II” trial add some clarity to this topic.
This large double-blind, randomized noninferiority trial compared two outpatient anticoagulation regimens after elective unilateral primary or revision hip or knee arthroplasty. Almost 3,500 patients were enrolled, and they all received 10 mg of rivaroxaban daily until postoperative day five. After that, 1,707 patients were randomized to receive 81 mg of aspirin daily, while the remaining 1,717 patients received 10 mg of rivaroxaban daily. Per previous recommendations, total knee arthroplasty patients received anticoagulation for a total of 14 days, and total hip arthroplasty patients continued anticoagulation for 30 days.
Twelve patients in the rivaroxaban group (0.7%) had a venous thromboembolism event in the 90-day postsurgical period, versus 11 patients (0.64%) in the aspirin group (p >0.05). In terms of complications from anticoagulation treatment, 5 patients (0.29%) in the rivaroxaban group and 8 patients in the aspirin group (0.47%) had a major bleeding event (p >0.05). It is worth noting that there were multiple different implants, approaches, and perioperative protocols followed in the study. Also, very few patients with a history of venous thromboembolism (81 patients, 2.4%), cancer (80 patients, 2.3%) or smoking (319 patients, 9.3%) were included in the study. These patients would be considered at higher risk for venous thromboembolism after joint replacement.
These limitations notwithstanding, the results from prophylaxis with aspirin after an initial five days of rivaroxaban were not significantly different from results with continued rivaroxaban. Institutional prices vary, but in this time of bundled care, the financial implications of studies like this one could be great. Anecdotally, in our institution the price of rivaroxaban is 140 times that of aspirin.
This is not the first study whose findings support the use of aspirin for venous thromboembolism prophylaxis, but it is one of the largest. It appears that such findings are starting to change the practice of some orthopaedic surgeons. We expect that additional large studies will provide further insight into this question.
Amir Khoshbin, MD is an assistant professor of orthopaedics at the University of Toronto and a member of the JBJS Social Media Advisory Board. He can be reached at email@example.com.
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Irrigation and debridement of open fractures have been standard practices since the late 1800s. However, the finer details have not been agreed upon. For example, should we use higher pressures with pulsatile lavage devices? And will adding soap to standard saline irrigation solution get better results? Answers to those two questions from lab and animal studies over the years have been limited and contradictory. The goal of the recently reported FLOW study (Fluid Lavage of Open Wounds) was to answer those questions definitively.
Initially, a pilot study with just over 100 patients suggested that using soap might yield fewer adverse events requiring a return to the OR. Little difference was noted between high and low pressures using a pulsatile lavage device. Most importantly, the pilot showed that a definitive study was feasible.
FLOW investigators, of which I was one, then began pursuing a multicenter, international, randomized, controlled study to evaluate the effects of irrigation pressure and solutions on open fractures. The US Department of Defense (DoD), the Canadian Institutes of Health Research, and others supported us in the definitive trial. From what we learned in the pilot study and from DoD input, we added a third arm to the pressure investigation and included gravity flow, which is essentially a bag of fluid run through quarter-inch tubing into the wound.
We collected data for five years from 2,447 patients at 41 sites worldwide and achieved a 90% 12-month follow-up. The results demonstrated that reoperation rates for the three different pressures were similar. But unlike the size-limited data from the pilot study, using soap in the irrigation solution resulted in a significantly higher reoperation rate than normal saline.
This second finding should convince us that saline is the irrigation solution of choice and that by avoiding soap, adverse outcomes can be diminished and costs lowered for institutions. The discrepancy between the soap findings in the pilot data and the full study may simply reflect the need for larger numbers. Intuitively, we might think that soap, which we use all the time for hand-washing, would be better because it helps remove debris and bacteria. However, the FLOW findings suggest that soap may have a negative impact on soft tissues and bone, making reoperation rates significantly higher. In regard to pressures, the use of a pulsatile lavage with high or low pressures offered no apparent benefit compared to irrigation with gravity flow. This should allow sites to avoid the cost of using pulsatile lavage devices.
Taken together, these findings should reassure institutions worldwide that do not have access to soap or pulsatile lavage devices that their wound-irrigation practices are not compromised and may indeed be the standard of care based on the FLOW data.
Kyle Jeray, MD
Greenville Health System
Vice-Chairman of Academics, Department of Orthopaedic Surgery
JBJS Associate Editor