From Haiti to PRP, AAOS Now was there

The year 2010 was huge for orthopaedics. It started with a bang—the massive earthquake in Haiti that made heroes out of ordinary orthopaedic surgeons. As the year progressed, we had to contend with healthcare reform, clinical guidelines that could actually change clinical practices, and increased scrutiny on orthopaedic practices—from the use of pain pumps and platelet-rich plasma to the increase in SLAP surgeries and a drop in the use of metal-on-metal hip implants.

Let’s not forget the fingers pointed at surgeons who neglected to disclose their ties to industry. Or the shift in ownership of orthopaedic practices. By my count, we started with at least 20 topics, and ended up with this top 10 list. If you want to submit your own top 10 list, e-mail it to aaoscomm@aaos.org

Red flags for MOM hip implants
It started with an alert in April from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) on a noted increase in the incidence of revisions of metal-on-metal (MOM) hip implants associated with adverse tissue reactions. That was followed by a market withdrawal and device recall in August. Then, in October, an online case report and commentary published by the Journal of Bone & Joint Surgery–American made headlines about the potential for a serious complication—cobalt toxicity—that could be caused by MOM devices.

The AAOS was quick to respond. AAOS Now reported on the MHRA report, and a patient safety member alert was issued on the device recall. A presentation on the potential for cobalt toxicity and the appropriate response was made at the Board of Councilors/Board of Specialty Societies Fall Meeting, and a media alert was issued in cooperation with the American Association of Hip and Knee Surgeons and the Hip Society.

The manufacturer pledged to cover “reasonable and customary costs” of monitoring and treating patients (including testing and revision surgery), and the AAOS recommended that patients with MOM implants discuss any concerns with their orthopaedic surgeons.

Additional Links:
UK alert prompts new scrutiny of MOM hips
Has MOM worn out its welcome?

Strong recommendations from CPGs
Two clinical practice guidelines (CPGs) developed by the AAOS and adopted this year contained “strong” recommendations for tests and treatments that should have a significant impact on orthopaedic practice.

The CPG on the Diagnosis of Periprosthetic Joint Infection of the Hip and Knee focuses on increasing the diagnostic accuracy of these infections before or during surgery so that effective treatment regimens may be implemented. Developed by a multidisciplinary volunteer work group and based on a systematic review of the current scientific and evidence-based data, the guideline includes strong recommendations on the use of erythrocyte sedimentation rate and C-reactive protein testing to diagnose infection, provides an algorithm for determining the probability of infection, and promotes prophylactic antibiotic use in patients with suspected infections.

The CPG on the Treatment of Osteoporotic Spinal Compression Fractures includes a strong recommendation against the use of vertebroplasty for neurologically intact patients with radiographic osteoporotic compression fractures and accompanying clinical signs and symptoms. Kyphoplasty, as a treatment option, received a weak recommendation.

To read the full guidelines, including the evidence reports supporting the recommendations, visit www.aaos.org/guidelines

Additional Links:
New CPG on diagnosing periprosthetic infections
Treating spinal compression fractures

PRP still a newsmaker
Solid evidence to support the multiple uses of platelet-rich plasma (PRP) remains hard to come by, but discussion and debate about its potential and efficacy continued unabated in 2010. Although studies have shown promising results for PRP treatment for some conditions such as lateral epicondylitis and Achilles tendon disorders, its demonstrated benefit in the treatment of other ligament and muscle injuries is still unproven, consisting mainly of case reports.

Media attention, however, has resulted in requests from patients for PRP treatment—even though few insurers pay for it—and physicians continue to apply PRP for a wide range of musculoskeletal conditions. The autologous nature of PRP seems to quell many of the safety concerns that might arise with other new and unproven therapeutic agents.

Surgeons participating in AAOS Now roundtables on PRP expressed opinions ranging from provisional endorsement of some applications to skepticism about many, with a consensus desire for Level I trials. As a result, AAOS Now intends to hold a PRP forum in 2011, bringing together clinicians and researchers from around the world, to discuss this therapy and develop a plan of action.

Additional Links:
Platelet-rich plasma: Clarifying the issues
Treating tendinopathy with PRP
Practical guidelines for using PRP in the orthopaedic office
PRP shows potential for treating Achilles tendinosis
PRP shows little benefit in ACL reconstruction at 6 months
PRP effective in treating chronic Achilles tendinosis
“Bloody” treatment holds promise
Clinical use of platelet-rich plasma in orthopaedics

SLAP repair may be overused
Superior labral anterior to posterior (SLAP) tears and repairs—or, more specifically, the possible overuse of repair—came under scrutiny after a study found that American Board of Orthopaedic Surgery (ABOS) Part II candidates may be performing SLAP repairs at greater rates than warranted, potentially leading to poor outcomes and increased rates of complications.

“ABOS candidates are performing SLAP repairs at a rate three times what the literature would suggest,” noted Stephen Weber, MD, at the 2010 annual meeting of the Arthroscopy Association of North America. From 2003 to 2008, ABOS candidates performed 4,975 SLAP repairs (78.4 percent in male patients), representing 9.4 percent of all shoulder cases reported in the database during the study period. The advanced age of some patients—males were as old as 85 years and females were as old as 88 years—might put them at an increased risk for complications and bad outcomes.

According to Dr. Weber, young orthopaedists must be educated to distinguish between pathologic SLAP lesions and incidental degeneration of the labrum to reduce what he called a “worrisome trend in SLAP repair.”

Additional Links:
A “worrisome” trend in SLAP repair
Pearls and pitfalls of treating SLAP lesions

Pain pumps and chondrolysis
The controversy surrounding the use of pain pumps and the subsequent development of postarthroscopic glenohumeral chondrolysis increased, with several lawsuits filed during the year and the pumps taken off the market. Concern increased to such a degree that orthopaedic surgeons began to question the safety of administering even single intra-articular injections of the anesthetic.

“Intra-articular injections of local anesthetics potentially have toxic effects to articular cartilage,” Constance R. Chu, MD, told AAOS Now in June. Her research, however, also shows that small injections—3 mL to 5mL in the knee, for example—of anesthetic dilute fairly quickly and do not stay in the joint for very long.

The value of her research, Dr. Chu says, is that it raises awareness of the consequences of overuse. She advises physicians to continue administering occasional intra-articular injections of local anesthetic if their patients need it, but to be aware of the toxic effects if too much is used.

Additional Links:
Raising a red flag on intra-articular injections
Leave it under the surface—no one will ever know!!!
Safety and litigation update for shoulder pain pumps
Use of intra-articular continuous infusion pumps and chondrotoxicity

Introducing “Obamacare”
President Obama made good on a campaign promise when he signed into law the Patient Protection and Affordable Care Act (PPACA), the most sweeping healthcare reform legislation in U.S. history. Although the healthcare reform act does extend coverage to millions of Americans and contains a number of positive provisions designed to improve patient access to care and increase insurance coverage, many believe that it will do little to stem rising healthcare costs or improve the quality of care.

PPACA does provide funding for comparative effectiveness research, studies into improving quality of care, and the transition to electronic medical records, but fails to address the issue of comprehensive tort reform and does nothing to fix the broken Medicare Sustainable Growth Rate formula, which regularly threatens physicians with potentially catastrophic cuts to Medicare reimbursement.

The bill also creates an Independent Payment Advisory Board, places restrictions on physician hospital ownership, and mandates participation in the Physician Quality Reporting Initiative.

As of this writing, the future of the PPACA remains unclear. At least 20 states attorneys general have filed suit in federal court seeking to overturn the legislation, which contains a controversial and potentially unconstitutional mandate that will require most U.S. citizens to carry health insurance beginning in 2014.

The recent midterm elections were labeled by many as a referendum on the act, and the new Republican-controlled House has said it intends to repeal and replace PPACA. This is one story we’ll continue to watch.

Additional Links:
Obama gets his wish
Redefining health care in America
States poised to challenge healthcare reform
A timeline for reform
Where are the savings in healthcare reform?
IPOD, IPAD . . . IPAB?
The impact of healthcare reform on orthopaedic surgeons
Medical loss ratios… has the bar been set?
What does the future hold for physicians?

Farewell to the independent physician?
Although the shift to hospital employment of physicians started some time ago, it began to seem inevitable in 2010, spurred in part by provisions in the healthcare reform act. Some experts pointed to younger surgeons who have different priorities than my generation of surgeons and who don’t want to take night or weekend emergency call, do want to work regular hours, and would rather a hospital shoulder the administrative, regulatory, and medical-legal burdens of running a practice. A recent national survey of 2,400 physicians found that nearly 3 out of 4 were planning on retiring, working part-time, closing their practices to new patients, becoming employed and/or seeking nonclinical jobs in the next 1 to 3 years.

The AAOS even released a primer on Hospital Employment of Orthopaedic Surgeons to help educate members on the feasibility, appropriateness, and potential drawbacks to signing on with a hospital. With the demise of fee-for-service payments under PPACA and the changing demographics of both orthopaedic surgeons and their patients, this is a trend that’s likely to continue.

Additional Links:
The changing face of orthopaedic employment
New AAOS primer: Hospital employment

Physician-directed (off-label) use
Off-label use made headlines this year, particularly in the pharmaceutical area, where big cases were decided and hefty fines levied against manufacturers accused of promoting drugs for unapproved uses.

The issue received particular attention at the 2010 AAOS Annual Meeting, where both medical professionals and legal and regulatory experts addressed the pitfalls associated with off-label use. In some ways, physicians may be ahead of regulators in expanding the use of some materials to support patient safety. For example, antibiotic cement has only limited approval for use—in the second stage of a two-stage total knee arthroplasty revision. But in an effort to reduce periprosthetic infections, many surgeons are regularly using it for primary arthroplasties.

In my mind, the most important aspect of this issue is informed consent. There’s nothing wrong with physician-directed use of a drug or device to improve outcomes, but the physician ought to know what he or she is doing, ought to share that information with the patient, and ought to keep the U.S. Food and Drug Administration informed of any problems through its MedWatch system.

Additional Links:
Symposium tackles off-label “conundrum”
DOJ shifting focus to Medicare fraud
AAOS adopts ‘off-label’ statement

“Letting it all hang out”
That leads directly into our next issue—the importance of disclosure. None of us enjoyed reading headlines such as “Doctors given millions fail to disclose device-industry ties, study shows” or “Million-dollar lies and the surgeons who tell them.” Even if the relationship is totally legitimate and, in fact, may be beneficial to patient care, the fact that it wasn’t revealed created problems.

This year, the AAOS unveiled a new online disclosure program. The database can be searched by anyone—your colleagues, your patients, and the media. It’s easy to complete, and for most orthopaedists, can be done in a matter of minutes. All you have to do is tell the truth. About everything. At www.aaos.org/disclosure

Additional Links:
AAOS strengthens disclosure policy
Disclosure reminder
Disclosure is “good” for the soul
Are orthopaedists trustworthy?

Bringing help to Haiti
I saved the best till last—our number 1 story. Who wouldn’t be proud of the hundreds of orthopaedic surgeons who met with their partners; gave up 2 weeks, or a month, or even 2 months of their practice; and went down to the Carribbean—not to vacation, but to work under some of the most appalling conditions imaginable.

Within 48 hours of the massive 7.0 magnitude earthquake on Jan. 12, 2010, AAOS fellows from around the country were either on their way to Haiti or had contacted the Academy about volunteering. According to Haitian government estimates, about 230,000 people were killed in the event and its aftermath, with an additional 300,000 injured. In addition, many of the country’s hospitals were destroyed or rendered unsafe by the quake.

More than 500 AAOS members traveled to the island—often at their own expense—to provide much-needed surgical skills and immediate care. Many physicians, hospitals, and manufacturers donated supplies. In the aftermath of the earthquake, surgeons operated wherever they could, including performing surgery outdoors using car headlights to illuminate the operating field.

For months, the AAOS served as a central clearinghouse, processing volunteer applications, providing information, and facilitating responses. Based on what was learned from this experience, the Academy is developing a more permanent disaster response plan.

The situation is ongoing. Efforts have shifted from trauma care to long-term treatment for the many Haitian citizens who sustained debilitating injuries. Many of the nation’s medical facilities remain closed or operating at limited capacity, and the country is in the midst of a cholera epidemic that has claimed the lives of at least 900 earthquake survivors.

My hat’s off to those fellows who gave of their time, expertise, and, in many cases, their personal funds to save lives and limbs in Haiti. I know many have strong connections to the country and are continuing to participate in recovery efforts. As recent news reports show, there’s a long way to go.

Additional Links:
Orthopaedic surgeons bring healing to Haiti
Revisiting Haiti
AAOS honored for Haiti disaster response
Messages from Haiti
Haitian earthquake challenged responders
AAOS donates $50,000 to Haitian relief efforts

S. Terry Canale, MD, is editor-in-chief of AAOS Now. He can be reached at stcanale@campbellclinic.com