The five-item AAOS contribution to the Choosing Wisely list of medical procedures that patients and physicians should question has been criticized from several quarters (see OrthoBuzz post “Do ‘Choosing Wisely’ Lists Protect Physician Income?”).
The latest scrutiny comes from Indiana orthopaedist James Rickert, MD, who founded the Society for Patient Centered Orthopaedic Surgery. Speaking at the recent Lown Institute Annual Conference (dubbed “The Road to RightCare”), Dr. Rickert said that among physicians who succumb to financial interests in recommending and performing procedures of dubious merit, orthopaedists are “one of the worst offenders.” He said it’s especially hard for those who own related businesses that benefit from high surgical volume (such as device distributorships or imaging centers) to set aside financial interests during clinical practice.
Here are five procedures Dr. Rickert thinks should be on the orthopaedic Choosing Wisely list:
- Rotator cuff repairs in asymptomatic/elderly patients
- Clavicle fracture plating in adolescents
- ACL repair in low-risk individuals
- Surgical removal of part of a torn meniscus
In citing the potential risks to patients who receive these procedures, Dr. Rickert admits to getting emails and other “grouchy comments” from fellow orthopaedists who don’t like his self-described “moral persuasion” campaign. What do you think of this list?
With 12 days to spare before a 21% reduction in physician Medicare payments takes effect, a bipartisan coalition of House and Senate lawmakers introduced identical bills that would scrap the SGR-based formula for physician reimbursement. Medscape.com reported that the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 would boost physician pay by 0.5% during the second half of 2015 and in subsequent years from 2016 through 2019. The legislation redesigns the Medicare payment model from fee-for-service to pay-for-performance, and it also merges Medicare’s EHR and quality-reporting programs for easier administration by providers. Later this week or early next week, the House is expected to amend the legislation to extend the Children’s Health Insurance Program (CHIP) for two more years.
For the first time in recent memory, GOP leaders in both houses are indicating they won’t insist on specifying “pay-fors” for the entire cost of the bill. While Tea Party Republicans in the House are still calling for a complete cost offset, House Speaker John Boehner could get the bill passed amid Tea Party objections if he musters enough Democratic support.
In an online statement responding to the legislative filing, AAOS President Frederick Azar, MD, said, “The AAOS commends congressional leadership for introducing legislation to permanently repeal and replace the SGR formula.”
Stay tuned to OrthoBuzz…more will be revealed.
In the March 18 2015 edition of The Journal, Brophy et al. and investigators from the MOON Knee Group focus on that very rare complication of ACL reconstruction surgery: infection. They prospectively followed a large cohort of more than 2,100 patients treated at multiple sites from 2000 to 2005.
The overall infection rate was less than 1%, which is in line with rates found in other studies. What was most notable is that the infection rate among patients with diabetes was 8.7% but only 0.7% in patients without diabetes. Statistically, having diabetes increased the odds of a post-ACL infection by nearly 19 times. Patients with diabetes should be counseled preoperatively so that they can be extra vigilant about detecting early signs of infection. Screening for diabetes prior to ACL surgery is not currently a standard of care, but it might be considered a reasonable approach in light of these findings. Surprisingly age and BMI were not associated with increased infection risk, and there was only a trend toward smokers being at higher risk.
Brophy et al. also found that patients receiving hamstring autografts were more than four times as likely to experience infection as those who received bone-tendon-bone (BTB) autografts. The authors’ hypothesis that the deep dissection required for hamstring harvest might increase infection risk seems plausible. It may also be that younger, healthier, more active patients (with presumably stronger immune systems) were more often offered BTB grafts.
What I like most about this study is that the MOON registry has very accurate clinical data because the investigators are clinicians who are highly invested in data quality. This is in distinction to studies that rely on administrative databases, where the coding of events is done by non-clinicians who may have less interest in entering highly accurate data. Still, as clinically accurate as MOON data are, they are from more than a decade ago. Although the risk of post-ACL infection may be even lower in this decade, with these already-low rates, it would be difficult to statistically prove that progress.
Marc Swiontkowski, MD
Every month, JBJS publishes a Specialty Update—a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Here is a summary of selected findings from Level I and II studies cited in the February 18, 2015 Specialty Update on pediatric orthopaedics:
–The landmark BrAIST study found that bracing helps prevent adolescent idiopathic scoliosis curves from progressing to a surgical range (≥50°), with a number needed to treat of 3. (See related OrthoBuzz article.)
–A randomized trial comparing the SpineCor brace to rigid bracing for correction of scoliosis found that the rate of curve progression was significantly higher in the SpineCor group.
–A study on the role of steroids in patients with Duchenne muscular dystrophy found that glucocorticoid therapy decreased the need for spinal surgery to treat scoliosis.
–A randomized trial among patients 4 to 12 years of age with a distal radial or distal both-bone fracture found that the use of a double-sugar-tong splint for immediate post-reduction immobilization was at least as effective as the use of a plaster long arm cast.
–A randomized controlled trial of 61 patients from 5 to 12 years old who had a supracondylar humeral fracture found no functional or elbow-motion benefits associated with hospital-based physical therapy after short-term casting.
Foot and Ankle
–A randomized trial of 27 children less than 9 months of age who had resistant metatarsus adductus found that a group receiving orthotic treatment had greater improvement in footprint heel bisector measurements than those receiving serial casting. The orthotic program required more active parental participation but was about half the cost of casting.
–A randomized study of children under 3 months of age with idiopathic clubfoot who were treated with the Ponseti method found that the failure rates and treatment times were significantly higher in a below-the-knee casting group than in an above-the-knee casting group.
A large retrospective cohort study analyzing nearly 21,000 patients who underwent primary total hip arthroplasty (THA) found that the 61% who received general anesthesia were much more likely to experience an adverse event within 30 days than the 39% who received spinal anesthesia.
Among the adverse events analyzed, the increased risks associated with general anesthesia were more than five-fold for prolonged postoperative ventilator use and cardiac arrest, and more than two-fold for unplanned intubation and stroke. These findings are generally consistent with those of prior research into this question, but the authors say this is “the largest study to date” looking at the comparison.
The authors analyzed data from the National Surgical Quality Improvement Program (NSQIP), and they found that the increased adverse-event risk with general anesthesia held throughout all ranges of preoperative comorbidity. They therefore contend that while many previous studies have found advantages for spinal anesthesia in “medically complex” joint-replacement patients, “this study indicates that these benefits may also extend to patients with fewer medical comorbidities.”
Despite these findings, the authors stress that spinal anesthesia is not risk-free, with the potential (albeit low) for permanent injury to the spinal cord or spinal nerves. They also note that their 30-day postoperative analysis did not capture patient-centered metrics such as postsurgical pain or longer-term functional outcomes.
The Orthopaedic Research and Education Foundation (OREF) has bestowed its 2015 Clinical Research Award on Stuart Weinstein, MD, professor of orthopaedic surgery at the University of Iowa Hospitals & Clinics and former chair of the JBJS Inc. Board of Trustees.
Dr. Weinstein and his co-investigator Lori Dolan, PhD were recognized for a lifetime of clinical research into adolescent idiopathic scoliosis (AIS). Decades of their work culminated in the landmark BrAIST trial, a randomized/preference-cohort study that compared bracing to watchful waiting in 242 patients with AIS. That study found a treatment success rate of 72% in the bracing group, compared with a rate of 48% in the watchful-waiting group. BrAIST delivered Level I evidence that bracing can substantially reduce the risk of curvature progression to the surgical threshold of 50° or greater, and it has already started to change the way pediatric orthopaedists practice.
“Our research….has given patients and parents a solid evidence base upon which to make informed, patient-centered choices,” Dr. Weinstein told AAOS Now recently.
A “Clinical Therapeutics” article in the March 12, 2015 New England Journal of Medicine focuses on viscosupplementation for knee osteoarthritis (OA). In presenting a case vignette and making a therapeutic recommendation, Australian author David Hunter, MB, PhD, invokes the old, 2008 AAOS clinical practice guideline (CPG), which, according to Dr. Hunter, “determined that the evidence was inconclusive and a recommendation could not be made for or against the use of intraarticular hyaluronate.” However, the AAOS updated CPGs for knee OA in 2013, and the guideline for viscosupplementation changed substantially. It now reads: “We cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee,” and that recommendation receives a “Strong” rating, based on evidence from more recent research studies.
In the end, the patient in the case vignette—a 67-year-old woman with knee pain, radiographic signs of knee OA, and a BMI of 32—was advised not to use hyaluronate injections and instead was encouraged to lose weight and undertake a muscle-strengthening exercise program.
A multisite, randomized trial of 250 patients (mean age of 66) with a displaced fracture of the surgical neck of the humerus found that mean Oxford Shoulder Score (OSS) outcomes were essentially the same among those who had surgery (plate fixation or humeral head replacement) and those who were treated with a sling and physical therapy. The OSS measures were made at 6, 12, and 24 months after randomization.
Proximal humerus fracture account for an estimated 5% to 6% of adult fractures, with most of them occurring in people older than 65. The authors of this study concluded that, amid what appears to be an uptick in surgical management of such fractures, “these results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus.”
Pelvic binders can provide lifesaving compression in patients with hemodynamically unstable pelvic injuries. But a report in the March 11, 2015 JBJS Case Connector by Auston et al. emphasizes that such binders may do more harm than good in patients who have acetabular fractures without hemodynamic instability or other pelvic injuries. Because first responders or community physicians often apply pelvic binders, the authors cite the need for clearer guidelines for these devices and updated training of early clinical caregivers regarding their use. Potential complications of binder use cited previously in the literature include pressure sores, damage to internal organs, and sciatic nerve palsy, and Auston et al. suggest additional ones.
The authors describe three cases in which patients who were hemodynamically stable were placed in a pelvic binder, either during transport or ED evaluation, following blunt trauma sustained in motor-vehicle accidents. All three patients had acetabular fractures but no other abdominal or pelvic injuries. The authors suggest that pelvic binders may contribute to the displacement of acetabular fractures, and although they saw no visible evidence of chondral damage during open reduction and internal fixation of the fractures, they express concern about occult chondral abrasion and possible damage to chondrocytes at the cellular level if binders are used inappropriately.
The authors therefore conclude that while pelvic binders play an important role in patients with severe pelvic ring injuries and hemodynamic instability, “in the setting of a displaced acetabular fracture, we cannot recommend placement of a pelvic binder, even for pain relief or splinting during evaluation or transportation.”
In December 1996, a group of investigators reported the results of the Fracture Intervention Trial, a randomized controlled trial that compared the effect of alendronate plus calcium or calcium supplementation alone on the risk of fractures in women who already had evidence of vertebral fractures. The results showed that in patients managed with alendronate, there was a 51% decrease in the risk of hip fractures, a 46% decrease in the risk of vertebral fractures, and a 44% decrease in the risk of distal radial fractures when compared with patients managed with calcium alone. These results, as well as those from several other reports, supported the regulatory approval of alendronate (marketed under the trade name Fosamax) for the treatment of postmenopausal osteoporosis in the United States and many countries abroad. Alendronate thus became the first drug in a class of compounds known as the nitrogen-containing bisphosphonates to demonstrate these beneficial effects.
Approximately a decade later, and after millions of patients had undergone treatment, some disturbing reports suggested a potential suppression of bone turnover in association with long-term alendronate therapy. Bone biopsies from selected patients suggested diminished kinetic indices of bone formation. This was believed to lead to increased susceptibility to fracture and delayed healing of nonspinal fractures such as fractures of the femoral shaft. Additional reports suggested the occurrence of insufficiency or low-energy fractures in patients who used alendronate for several years. While epidemiological findings suggested that these fractures are very rare even among women who have been managed with bisphosphonates for as long as a decade, the American Society for Bone and Mineral Research convened a task force to understand the pathophysiology of these atypical fractures and to gain further information on the association of these fractures with bisphosphonates. The term “atypical femoral fracture” was adopted to distinguish this type of fracture as a unique entity in order to avoid a suggestion that it is exclusively associated with bisphosphonate use.
Atypical femoral fractures can occur anywhere along the shaft of the femur from just distal to the lesser trochanter to just proximal to the supracondylar flare of the distal femoral metaphysis. They may be transverse or short-oblique in configuration, are typically noncomminuted or minimally comminuted, are associated with minimal or no trauma, and may be associated with a medial spike. Incomplete fractures may involve only the lateral cortex. Because these fractures occur as a result of brittle failure while most osteoporotic patients show some ductility with deformation prior to failure, atypical femoral fractures most likely occur through bone that has undergone alterations in its mechanical and material properties. This further supports the notion that these fractures are unique and distinct from typical osteoporotic fractures of the femur.
While current evidence suggests a strong relationship between the use of bisphosphonates and the genesis of atypical femoral fractures, we now know that denosumab, a drug that inhibits osteoclastogenesis but is unrelated to the bisphosphonates, also may be associated with these fractures. Moreover, some patients who have never taken bisphosphonates or denosumab have presented with what appear to be atypical femoral fractures. Thus, atypical femoral fractures are not exclusive to patients who use osteoclast-inhibiting drugs, and this presents a more complicated picture regarding the etiology of this unique type of fracture.
In the March 2015 issue of JBJS Reviews, Blood et al. summarize current thinking regarding the evaluation and treatment of atypical femoral fractures. The authors note that these fractures can be treated successfully with intramedullary nailing and discontinuation of bisphosphonate therapy. However, there is a potential for a delay in healing. Prodromal thigh pain and radiographic evidence of a radiolucent line in patients with a history of atypical femoral fracture or chronic bisphosphonate use are strong indicators of impending fracture. In these patients, prophylactic fixation should be considered. In addition, patients with prodromal thigh pain who are receiving chronic bisphosphonate therapy but do not have radiographic evidence of incomplete fracture require further workup and may benefit from magnetic resonance imaging. For patients who have incomplete fractures and no pain, the authors recommend a trial of conservative therapy, including protected weight-bearing, discontinuation of bisphosphonate therapy, and supplementation with calcium and vitamin D (800 to 1000 IU) per day. While no recommendation currently exists regarding the duration of bisphosphonate therapy, most experts recommend discontinuation after five years. Moreover, as bisphosphonates are not the only class of compounds that may be associated with these fractures, further information is needed in order to make informed decisions regarding the use of specific drugs and the duration of their use. While treatment of atypical femoral fractures with an anabolic therapy such as parathyroid hormone has been proposed, there are no definitive data to support this suggestion at this time.
The use of bisphosphonates and denosumab to treat osteoporosis represents a major step forward. However, it is possible that there are specific subsets of patients who are more sensitive to pharmacological suppression of bone remodeling and who may not be candidates for this kind of therapy. Further investigation is required to understand the safety of prolonged use of osteoclast-inhibiting drugs.
Thomas A. Einhorn, MD, Editor
Click here for another OrthoBuzz post about this JBJS Reviews article.