Tag Archive | NEJM

Hemi vs THA Findings Helpful, But Not Practice-Changing

OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent study in The New England Journal of Medicinethe following commentary comes from Paul E. Matuszewski, MD.

A recent issue of The New England Journal of Medicine published the results from a large, multicenter randomized trial comparing the outcomes of hemiarthroplasty versus total hip arthroplasty (THA) to treat displaced femoral neck fractures in ambulatory adults.

The HEALTH investigators enrolled 1,495 patients in the study, and 85.1% of those patients had complete data for analysis after 2 years. The researchers found no significant differences between the groups with regard to the primary outcome—secondary hip procedures (7.9% in the THA group vs 8.3% in the hemi group). The risk of secondary hip procedures during the first year was higher in the THA group, but the hemiarthroplasty group had a higher risk of secondary procedures in the second year. Open/closed reductions of hip dislocations were the most common secondary procedures among the THA group, and revision to THA was the most common secondary procedure in the hemiarthroplasty group. The THA group had slightly better WOMAC scores, but the difference was not within a clinically significant range. There were no between-group differences noted in other patient-reported outcomes.

The HEALTH investigators followed these patients for only two years, which is notably the standard for many orthopaedic studies, but this short follow-up limits the practical application of these findings. The authors note that after the first year, primary THA was favorable with regard to secondary hip procedures. It is reasonable to think that this difference may become more compelling beyond 2 years, as more patients who received hemiarthroplasty are likely to be converted to THA.

The suggestion that there may not be an early benefit of THA over hemiarthroplasty in the ambulatory adult with a displaced femoral neck fracture contrasts with current recommendations from the American Academy of Orthopaedic Surgeons. However, the 2-year follow-up of this trial represents only a “snapshot” of the continuum of outcomes from these two hip-fracture treatments. The findings may add to our understanding of what our patients can expect during the first 2 years following these procedures, but I would caution surgeons against making any drastic changes to their current practice in response to this data.

Paul E. Matuszewski, MD is the Director of Orthopaedic Trauma Research and Assistant Professor of Orthopaedic Traumatology at the University of Kentucky.

Physician Practice Changes After Paying Malpractice Claims

OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent study in The New England Journal of Medicinethe following commentary comes from Matthew Deren, MD.

Malpractice. The word itself causes a visceral reaction for many of us in medicine. Although the vast majority of physicians will not pay a malpractice claim during their careers, there is still concern about the quality of care provided by doctors with multiple claims paid, either through out-of-court settlements or through court verdicts. The National Practitioner Data Bank (NPDB) was created, in part, to help prevent a doctor with a long list of malpractice claims paid from moving to a new geographic area for a “fresh start” without full disclosure of his or her claims history.

In the March 28, 2019 issue of The New England Journal of Medicine, Studdert et al. examined changes in practice characteristics among physicians who had paid malpractice claims from 2003 through 2015. By linking the NPDB to Medicare data, the authors identified a cohort of >480,000 physicians, 89.0% of whom had paid no malpractice claims. Nearly 9% of physicians had one paid claim, while the remaining 2.3% of physicians had two or more paid claims. That 2.3% accounted for 38.9% of all the claims paid during the study period.

A total of 19,098 (4%) of claims paid were in orthopaedic surgery, which made it the seventh most-sued specialty studied. When evaluating the subgroup of all physicians with ≥3 claims paid, the authors noted that they were more likely to be male, 50 years of age or older, and to practice in surgical specialties. In multivariate analysis, physicians with at least one paid claim were more likely to leave the practice of medicine than those with none. Finally, physicians with multiple paid claims were more likely to switch into small or solo practices, but the study found “no clear association between the number of claims and the propensity to relocate, within or between states.”

To be clear, the number of malpractice claims paid by a doctor is not necessarily a reliable indicator of quality of care, though many patients arrive at that conclusion. Just as important, this study doesn’t conclude that solo practitioners—in orthopaedics or any other specialty—are more likely to have paid a higher number of claims. There are many excellent physicians in solo practices across the United States.

Ultimately, this study shows that the majority of physicians have not paid a single malpractice claim and that physicians who have paid multiple claims are not more likely than other doctors to relocate their practice. These findings should help patients trust the various procedures that are in place to prevent the exceedingly small number of physicians with a long list of malpractice payouts from relocating in an attempt to leave their history behind them. From the physician viewpoint, the findings emphasize that the impact of malpractice claims goes beyond the emotional and personal into the realm of prompting changes in practice environment.

Matthew Deren, MD is an orthopaedic surgeon at UMass Memorial Medical Center, an assistant professor at University of Massachusetts Medical School, and a member of the JBJS Social Media Advisory Board.

Musculoskeletal Infections: Oral Antibiotics Not Inferior to IV

OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent New England Journal of Medicine studythe 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.

Aspirin Noninferior to Rivaroxaban for Anticoagulation after Joint Replacement

Aspirin for OBuzzOrthoBuzz 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 khoshbinam@smh.ca.

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Open Fractures – How Should We Irrigate Them?

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