Preventing Atypical Femoral Fractures Related to Bisphosphonates

Physicians worldwide frequently prescribe bisphosphonates such as alendronate (Fosamax) and ibandronate (Boniva) to treat osteoporosis and prevent fragility fractures. Unfortunately, long-term bisphosphonate use has been linked to an increased risk of atypical femoral fractures. In the March 3, 2015 edition of JBJS Reviews, Blood et al. offer some guidance on how to prevent such fractures.

The authors note that prodromal thigh pain and a radiolucent line on X-rays of patients with a history of chronic bisphosphonate use are strong indicators of an impending fracture. Among bisphosphonate users who have an incomplete fracture with little or no pain, the authors recommend a trial of discontinued bisphosphonates, protected weight-bearing, calcium and vitamin-D supplementation, and possible teriparatide (Forteo) therapy. They add that prophylactic fixation should be considered if there is no radiographic or symptomatic improvement after two to three months of that conservative approach. Blood et al. further recommend that patients at high risk for atypical femoral fracture, should consider discontinuing bisphosphonate therapy after five years of continuous use. They also encourage orthopaedists to assess the contralateral femur for signs of impending fracture in patients who have already had an atypical femoral fracture.

The recommendations by Blood et al. notwithstanding, we should stress that the absolute risk of atypical femoral fractures fractures is low (3.2 to 50 cases per 100,000 person-years among short-term bisphosphonate users and about 100 cases per 100,000 person-years among long-term users). Consequently, for most people with osteoporosis, the proven fragility-fracture risk-reduction benefits of bisphosphonates outweigh the risks of atypical femoral fracture.

Readers interested in this subject may want to read a related Case Connections article, which springboards from a January 14, 2015 Case Connector article.

Two New “Solutions” to Prickly Orthopaedic Problems

A study on rat knees in Osteoarthritis and Cartilage suggests that irrigating joints with hyperosmotic saline (600 mOsm) reduced surgically induced chondrocyte death, relative to irrigation with normal saline. Other measures of tissue repair and inflammation were also better in the joints that were irrigated with the hyperosmotic solution, although mild synovitis occurred in all joints regardless of the solution used. In a news release, study co-author Andrew Hall said, “Our study could have major implications for tens of thousands of people…It’s a cheap, simple solution that can protect the cartilage in the joint during arthroscopy and surgery.”

In a study on dog knees in Clinical Orthopaedics and Related Research, osteochondral allografts preserved in a special solution at room temperature yielded greater chondrocyte viability at 60 days than allografts stored within a medical-grade refrigeration unit. Viable grafts from each type of preservation delivered equivalent radiographic and biomechanical outcomes after six months. Commenting on this more than doubling of graft-storage life, study co-author James Stannard, MD, said, “The benefit to patients is that more graft material will be available, and it will be of better quality. This will allow us as surgeons to provide a more natural joint repair option for our patients.”

Readers should remember that these proof-of-concept studies were performed in animal models. Whether these simple “solutions” will work with human bone and cartilage tissue remains to be seen.

Stopping DMARDs Often Unnecessary for RA Patients Prior to Orthopaedic Surgery

Most patients with rheumatoid arthritis (RA) will undergo orthopaedic surgery during the course of their disease, and more than 80% of that cohort will be taking traditional or biologic disease-modifying antirheumatic drugs (DMARDs) at the time of their operations. That presents a dilemma, because stopping DMARDs can raise the risk of a rehab-hampering postoperative RA flare, while continuing the drugs is thought to increase the risk of postoperative infection.

A recent literature review in Seminars in Arthritis & Rheumatism suggests that surgeons should feel comfortable allowing patients to continue taking traditional DMARDs, such as sulfasalazine, as long as renal function is monitored. Emphasizing that more research is needed to pinpoint optimal start and stop dates for other DMARDs, review author Susan Goodman, MD, makes the following suggestions:

–Methotrexate: Continuing is recommended.

–Leflunomide: Discontinue for 1 week prior to surgery.

–Anti-TNF Alpha Drugs: Withhold therapy for 1.5 times the dosing interval.

–Tocilizumab: Exercise increased vigilance due to possible masking of signs of infection.

–Abatacept: Withhold for 2 to 3 weeks prior to surgery.

–Tofacitinib: Withhold for 2 days prior to surgery.

Dr. Goodman also observes that preoperative doses of corticosteroids, often used to cover RA flares in patients who’ve discontinued DMARDS, are often far higher than necessary, which could also increase infection risk.

 

JBJS Editor’s Choice—Knee Fusion: Not a Safety Net after Infection-Related TKA Failures

In the February 18, 2015 issue of The Journal, Rohner et al. report their experience with knee arthrodesis using an intramedullary rod as the definitive treatment for failed total knee arthroplasties (TKAs) related to infection. They report the results for 26 patients treated between 1997 and 2013 who had undergone an average of 6 ±3 knee procedures prior to arthrodesis.

The outcomes for this cohort of patients are sobering. Persistent infection requiring additional surgery remained in 50% of the patients. The health-related quality-of-life measures and functional outcomes were abysmal, and 73% reported persistent pain at greater than 3 on the VAS. Obesity, high blood pressure, and diabetes were strong predictors of reinfection.

Many of us have taken comfort that knee fusion, by whatever surgical technique, is a reliable “bail out” for the problem of recurrent infection following revision of a loose or infected TKA. Nevertheless, any surgeon who has followed a patient with a knee fusion is fully aware of the functional disability associated with the stiff knee. Difficulties using public transportation and impaired sitting are just two inconveniences that these patients express unhappiness about.

Despite its retrospective design and relatively small number of cases, this report may cause the knee-reconstruction community to reconsider knee arthrodesis and instead attempt further staged revisions of the knee prosthesis. It may even prompt a slightly earlier move toward recommending trans-femoral amputation. It certainly will stimulate further research into infection prevention and into developing more predictable approaches for revising infected TKA prostheses.

Marc Swiontkowski, MD

JBJS Editor-in-Chief

Do Frustration and Inconvenience Equal Suffering?

A page-1 article in the February 18, 2015 New York Times caught our eye. It focused on patient “suffering” caused by the often frustrating, inconvenient, and noncommunicative way health care is delivered. Thomas H. Lee, MD, chief medical officer of the patient-satisfaction consultancy Press Ganey, was quoted as saying, “Every patient visit is a high-stakes interaction…And all you have to do is be the kind of physician your patient is hoping you will be.”

However, according to several online comments about the article from clinicians, alleviating this type of patient suffering may not be as simple as Dr. Lee suggests. Here’s a sampling:

MainerMD from Cleveland, OH:

To think that listening and communication will solve all of our problems cited here is horribly naive. Take 4 AM labs, for example. Doctors don’t order 4 AM labs to irritate patients. We do it because labs take time to run…What are we supposed to do? Let the patient sleep in, draw the labs at 8 AM, and then get called out of surgical cases or office visits to interpret the results and make a plan? …Wait until the end of the day to make plans, thereby delaying discharges and lengthening hospital stays? …The point is that these systems are complex, and things which irritate patients are not just the result of a lack of effort or personal shortcomings of doctors or nurses.

Rosy from Newtown, PA:

The bottom line is that we need to spend more time with patients, which is increasingly impossible.

Dr. DR from Texas:

Yes, feedback is great, and I think doctors can learn a lot from some of this data. But we also have to note that patients’ priorities (especially in a post-care survey) are not always in line with the best, evidence-based medical care.

Leo F. Flanagan from Stamford, CT:

It is time training in mindfulness, positive psychology, and hardiness is integrated into medical education. Caregivers who are trained to be resilient will not only be more attentive to patients, they will provide better clinical care.

Gary, an ER physician from Essexville, MI:

Inconvenience does not equate to the stroke or trauma patient’s suffering.

Dr. Abraham Solomon from Fort Myers, FL:

The patient is not his/her disease. The patient is a person with a medical problem. The whole person needs to be considered in solving the problem.

Rick, an ER physician from Pennsylvania:

Using patient surveys creates artificial and arbitrary measures that distract from the real questions of who gets better with the fewest complications, errors and inefficiencies. My highest ratings as an ER doc was when I gave everybody narcotics liberally, and ordered every fancy expensive test I could, “just to be sure” and to convince the patient I was “thorough” and I “cared.”

Regardless of one’s perspective, measuring patient satisfaction with the delivery of medical care is here for the midterm, at least. It would behoove us to consider the patient point of view as we balance how to interpret and respond to these measures.

HHS Targets In-Office Ancillary Services

The proposed fiscal 2016 budget for the US Department of Health and Human Services (HHS) includes a change to existing exceptions in the physician self-referral (Stark) law that could affect some orthopaedic practices. Beginning in 2017, HHS would prohibit many in-office referrals for “therapy services, advanced imaging, and anatomic pathology services.” (See pages 68 and 76 of the budget, specifically.) Such services are currently allowed to enhance patient convenience, but HHS claims that they “are rarely furnished on the same day as the related physician visit.” The HHS budget also points to “evidence that suggests that this exception may have resulted in overutilization and rapid growth of certain services,” and it estimates that implementing this restriction would save more than $6 billion over 10 years.

In a blog post from the law firm of Duane Morris, attorney Matthew Jones says, “While the current political climate in Washington leaves the fate of HHS’s proposed budget far from certain, physicians must once again be on the alert for increased limitations on their ability to provide in-office ancillary services.”

CBO Estimates 10-Year Cost of SGR Repeal at $174.5 Billion

According to the latest Congressional Budget Office (CBO) figures, replacing the SGR-based Medicare physician-reimbursement formula over the next 10 years, as proposed in legislation introduced last year, would cost $174.5 billion. But a closer look at the CBO numbers reveals that the accrued physician-payment costs over the same 10 years would be an estimated $137.4 billion if current reimbursement rates were frozen through 2025. That’s a difference of (only) $37.1 billion.

Under current law, fees that physicians receive for Medicare services will be cut by about 21% beginning on April 1, 2015. Two pending pieces of federal legislation—HR 4015 and S 2000—would repeal the SGR formula, but the bills do not include suggestions for covering the cost of an SGR replacement.

The American Hospital Association has gone on record against the “rob-hospitals-to-pay-doctors” approach that some people have advocated, saying in January that it “cannot support any proposal to fix the physician payment problem at the expense of funding for services provided by other caregivers.”

If a permanent repeal of the SGR formula isn’t politically feasible until after the 2016 presidential election, Congress will probably approve another short-term “patch” this year. That would be the 18th time in 12 years that legislators have kicked this expensive can down the road.

Three New Knee Studies Yield Interesting Results

We stumbled upon three recent studies of knee osteoarthritis (OA) that shed interesting new light on a condition that all orthopaedists deal with.

–A “network” meta-analysis in the Annals of Internal Medicine looked at 137 randomized trials of OA treatments comprising more than 33,000 participants. Treatments analyzed included acetaminophen, diclofenac, ibuprofen, naproxen, celecoxib, intra-articular (IA) steroids, IA hyaluronic acid, oral placebo, and IA placebo. For pain, all active treatments except acetaminophen yielded clinically significant improvement. IA hyaluronic acid came out on top for pain relief, although the authors postulated that an “integrated” placebo effect may explain that finding.

–A cost-modeling study in Arthritis Care & Research, co-authored by JBJS Deputy Editors for Methodology and Biostatistics Jeffrey Katz, MD and Elena Losina, PhD, revealed that the per-patient cost attributable to symptomatic knee OA over 28 years is $12,400. Any expanded indications for total knee arthroplasty (TKA) and a trend toward increased willingness among patients to undergo knee surgery will increase that cost. The researchers found that patients tried nonsurgical regimens for a mean of 13.3 years before opting for TKA, and they stress the need for more effective nonoperative therapies for knee OA.

–Wine drinkers, rejoice! A retrospective case-control study in Arthritis Research & Therapy found that people who drank four to six glasses of wine per week were less likely to develop knee OA than nondrinkers. Meanwhile, beer drinkers may want to switch to wine. The same study found that people who drank 8 to 19 half-pints of suds per week had an increased risk of developing knee OA. Researchers found no link between total alcohol consumption and risk of knee OA. The authors postulate that the resveratrol found in wine may be chondroprotective, and that the linkage between beer and increased blood levels of uric acid may explain the opposite finding. It’s wise to remember that studies investigating one or two dietary items can be less-than-definitive because they are usually retrospective, subject to recall bias, and do not account for complex interactions among many nutrients.

JBJS Classics: Cervical Discectomy and Interbody Fusion

JBJS-Classics-logoEach month during the coming year, OrthoBuzz will bring you a current commentary on a “classic” article from The Journal of Bone & Joint Surgery. These articles have been selected by the Editor-in-Chief and Deputy Editors of The Journal because of their long-standing significance to the orthopaedic community and the many citations they receive in the literature. Our OrthoBuzz commentators will highlight the impact that these JBJS articles have had on the practice of orthopaedics. Please feel free to join the conversation about these classics by clicking on the “Leave a Comment” button in the box to the left.

It is rare that an article published more than 50 years ago continues to have an impact on clinical practice today. But that is the case with “The Treatment of Certain Cervical-Spine Disorders by Anterior Removal of the Intervertebral Disc and Interbody Fusion.” What make this article so unique are the details that Drs. George Smith and Robert Robinson put into describing the procedure and the careful follow-up of their early experience with this technique.

I have had a copy of this article in my files since I was a resident at Yale, training with Wayne Southwick, who had trained with Dr. Robinson at the time this approach to the cervical spine was developed. The two key contributors to anterior cervical spine surgery back in the 1950s were Dr. Robinson and the neurosurgeon Dr. Ralph Cloward.

Dr. Robinson’s technique has the support of biomechanical principles, which makes this particular approach and bone-graft fusion construct inherently stable; hence, its continued use to this very day. However, back in the ‘50s, and even when I trained in the 1970s, hardware to stabilize the spine following discectomy was not available in the US.

The approach that these authors described is very versatile and is utilized for all sorts of anterior procedures, including removal of intervertebral discs, arthrodesis, and vertebrectomy, and it allows for doing multiple-level procedures. The technique I use today is the same one that Dr. Southwick taught me and that he learned directly from Dr. Robinson.

Dr. Robinson has had a major impact on cervical spine surgery, and it was estimated that at one time 33% to 50% of members of the Cervical Spine Research Society were trained by him, by one of his residents or fellows, or by one of their residents or fellows—Dr. Robinson’s “offspring.”

I believe this technique will continue to stand the test of time, as it has during the past half century, and will have a major influence on spine surgery well into the future.

Charles Clark, MD

JBJS Deputy Editor for Adult Reconstruction and Spine

JBJS Reviews Editor’s Choice–Open Tibial Fractures

Orthopaedic surgeons have developed a heightened awareness of the scientific evidence that supports the decisions that they make in the care of patients. Levels of evidence and grades of recommendation have been used in scientific articles in order to frame information in an evidence-based manner. However, despite the substantial strides that have been made in promoting evidence-based practice throughout orthopaedic surgery, some historical dogma still exists and many surgeons do things based on what they were told or taught many years ago. One example is the so-called “six-hour rule,” in which it is considered the standard of care to urgently perform irrigation and debridement of an open tibial fracture within six hours after the time of injury.

Fractures of the tibial diaphysis are among the most common major long-bone fractures treated by orthopaedic surgeons. Up to 24% of these fractures present as open injuries, and a considerable portion are associated with severe soft-tissue compromise. Open tibial fractures receive different levels of treatment based on the severity of the injury according to the Gustilo and Anderson classification system. In the February 2015 edition of JBJS Reviews, Mundi et al. explore the practice patterns and clinical evidence to support four aspects of treatment that are essential to the management of open tibial fractures: irrigation and debridement, antibiotic prophylaxis, fracture stabilization, and wound management.

With regard to irrigation and debridement, although timely treatment within six hours after injury is considered the standard of care, there is insufficient evidence to support this practice. Moreover, the ideal irrigation solution and the optimum pressure of the irrigation are unknown.

Information on the use of antibiotics in the management of open tibial fractures is based on various well-designed studies, so the quality of the evidence to support some of these recommendations is better. Investigators agree that antibiotic prophylaxis should be started as soon as possible after presentation to an emergency department or hospital and that patients should receive antimicrobial coverage against gram-positive bacteria, typically with a first-generation cephalosporin. Gustilo and Anderson type-III injuries require additional antibiotic coverage, and the use of aminoglycosides is indicated, although the optimum regimen has not been established. Local antibiotic administration at the site of the injury (e.g., antibiotic-laden cement beads) is potentially beneficial but is primarily used for patients with type-III injuries.

The optimum time for closure of these wounds has yet to be determined, although primary closure is warranted under specific circumstances. For those injuries that require delayed closure, definitive coverage should not be delayed beyond seven days, even in the setting of negative-pressure wound therapy.

With regard to stabilization, techniques for the operative management of open tibial fractures have evolved and current evidence shows superior outcomes in association with intramedullary nailing as compared with plate fixation. However, there had been a debate regarding reamed versus unreamed intramedullary nailing. Interestingly, a randomized controlled trial was conducted to answer this question, and the results showed that both reamed and unreamed intramedullary nailing are reasonable options for the fixation of open tibial fractures, with the two techniques demonstrating comparable outcomes.

At this time, there remains a need for additional high-quality evidence to clarify the efficacy of specific techniques and treatments. In particular, guidelines detailing the optimal irrigation solution and pressure as well as the ideal duration of antibiotic prophylaxis are needed. Continued efforts to design and organize large-scale randomized clinical trials will be required in order to provide the kind of evidence that orthopaedic surgeons need so that they can provide the best care for their patients.

Thomas A. Einhorn, MD, Editor

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