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Procedure of the Month

This is the case of a 68 year-old male suffering from severe back pain for 3 months. Patient failed conservative treatment with high doses of analgesics. MRI was performed, as shown in Figure 1 below. This T2-weighted image clearly revealed evidence of acute fracture with bone marrow edema at the L1 level. Which choice do you think best describes the patient's treatment options (click on the x-ray below to take the multiple choice/guess test)?

Figure 1: Preoperative T2-weighted sagittal MRI showed evidence of bone marrow edema indicative of acute fracture at the L1 level (arrow).

Case review and x-rays courtesy of
Dr. Bassem A Georgy.
Interventional Radiologist Valley Radiology Consultants Assistant Clinical Professor University of California, San Diego

SPONSORED BY:


Procedure of the Month Sponsored by DePuy Spine, Inc.


 

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Biologics for Spine: Where We Are Now
Dr. Jeffrey Wang, Chief of the UCLA Spine Service and Director of the UCLA Spine Surgery Fellowship, discusses the exciting happenings in spine biologics, including growth factors, the use of different genes, and injecting stem cells into the disc. And then there are the challenges, namely the disc environment and the funding environment.

Physician Medicare Payments: Grandma vs. Docs
The fight over Medicare physician payments in Congress has been reduced to a fight over limited public dollars between Grandma and her physician. Is this a prelude to how public health care policy will be decided in the future? Read about the tussle here.

Spine Niche! Opportunity in the Spinal Deformity Market
Given the myriad of start-up companies pursuing the same patients, product differentiation and solutions for specific target markets could be the key in the future. Using the PearlDiver Patient Records Database we estimate procedure volumes for posterior fusion as a treatment for scoliosis—followed by the results of a study identifying complications associated with instrumented posterior thoracic fusion in treating scoliosis.

AAOS Political Action Committee
Active players in the orthopedic field know the importance of the AAOS Political Action Committee (PAC). On the cusp of hot topics affecting physicians and patients, the AAOS PAC works diligently to provide data to members of Congress and improve the present and future of orthopedics.

Who ARE These Guys?
Every 60 seconds or so a surgeon tears the cover off an Integra LifeSciences package. Quietly, this company has become the seventh largest medical implant manufacturer serving orthopedic surgeons in the world. Where to now? Would you believe $1 billion in two years? How about $2 billion by 2015?

Redemption in a Mechanism of Failure: The TOPS™ Story
Impliant’s TOPS™ System had a “squeaker” in its clinical study. After a voluntary suspension of the study by the company and finding the mechanism of failure, the FDA has approved a resumption of the study. What insider lessons were learned? Class starts here.

Who is Numero Uno in the PearlDiver Database!! Are You Surprised?
The answer may surprise you. Is it sore backs, aching hips, sore knees, fingers? PearlDiver details 3.8 million spine related complaints—complete with demographic information and charging information. But that’s not #1. PearlDiver also lists 3.5 million large joint complaints. Sorry, still not #1. What could the most common orthopedic complaint possibly be? To get the surprising answer…read on.

What the Knees Need: Baby Boomers and Their Options
Knee patients often show up at the doctor’s office with recurrent mechanical symptoms. It is up to the orthopedist, says Dr. Giles R. Scuderi, Director and orthopedic surgeon with the Insall, Scott & Kelly Institute in Manhattan, to thoroughly assess the patient and then determine if nonoperative treatment will do, or if the person needs a unicompartmental or total knee procedure.

Physician: Report Thyself
The government says its healthcare anti-fraud efforts are working and it wants to encourage physicians to self-report possible fraud. How well did the government do in 2007 and what about those deferred-prosecution deals with undisclosed evidence? Read about it here.

Revising the Statistics
The word that orthopedic patients least want to hear is “revision.” Who, in the universe of large joint patients, do we expect to see on the receiving end of this news? If you guessed “the elderly” you would have been wrong. The reality of who is hearing “revision” may come as a surprise. Read what we found when probing PearlDiver’s database.

Where Is Ben Now? Trends in Venture Capital
What is being funded by VCs and why? First of all, spine is having to share the spotlight, says Gary Stevenson, Managing Partner at MB Venture Partners, LLC. Here Stevenson outlines what constitutes an attractive investment…he also highlights issues that are affecting the distribution of VC funding.

The Hounds of Wall Street
Conventional wisdom on Wall Street is that ArthroCare is in a bare-knuckle fight to the finish with short sellers. Which leaves us with the dominating question: If ArthroCare is essentially a “lame duck” growth stock, then why are sales, earnings, and the stock price contradicting the short seller’s dire predictions and even outperforming consensus analyst forecasts? We have the answer.

The Era of “Tell Me Right Now” Dawns at FDA
The FDA wants the next phase of post-market oversight to change from self reporting to proactive surveillance. How? Through the Sentinel Initiative. Read what it means to device manufacturers here.

The Day After Tomorrow: Complication Rates and Instrumentation Trends in Posterior Lumbar Fusion
Could PearlDiver be the Nostradamus of spinal instrumentation? This most commonly performed surgery on the lumbar region of the spine increases fusion rates and improves spinal stability—but what about complications? Using PearlDiver’s database we find the answers. Are you ready for some quatrains about what happens next?

You Try It. No You Try It First: New Technology Adoption
What are the forces working for and against new technology adoption? Youth versus age, risk taking versus conservatism, and the economic realities of the day, says Dr. Rick Guyer, President of the Texas Back Institute.

Cheaper, Thinner, Faster, Stronger
In this, the second of our series of three articles on innovation, we tackle the question: How do you measure medical technology innovation? While difficult, measuring innovation is NOT impossible. Why? Well to start, and in the immortal words of Supreme Court Justice Potter Stewart, “We know it when we see it.”

SAS Crosses the Rubicon in Miami Beach
The SAS 8th Annual Global Symposium in Miami Beach may have crossed the Rubicon. How? Read about the Society’s opportunities for growth and collaboration as its new President lays out a vision for the future.

The AAOS Patient Safety Committee: An End-of Term Interview With Dr. David Wong
By Elizabeth Hofheinz, MEd, MPH
July 17, 2007

It’s a basic patient right ... the need to feel safe when you walk in a hospital or a doctor’s office. Normally, in addition to their fears and questions, patients bring along with them the expectation of high-quality, safe treatment. And most of the time, they are not disappointed.

Says Dr. David Wong, former chair and now consultant to the American Academy of Orthopaedic Surgeons (AAOS) Patient Safety Committee, “In 1999, the Institute of Medicine released a report that was essentially the impetus for more focus on patient safety issues. Their data included a worst-case-scenario estimate that between 44,000 and 98,000 people died in hospitals yearly because of medical errors. There was a lot of press about this, of course, but there were also countervailing arguments against those numbers. Lawmakers began paying closer attention to the issue of patient safety. For some time, AAOS had been addressing these issues through an internal task force. With the increased focus on these matters, however, the AAOS board of directors decided to establish a standing committee. The first meeting was September 20, 2002.”

And they have been busy ever since. Dr. Wong: “With such a dynamic field, there is never any shortage of patient safety issues to address. In 2002, the committee created an action plan for 10 patient safety initiatives, which all fall under the following categories: member communication, education, research, advocacy, and outreach. From the beginning we knew that communicating with physicians about safety issues was critical. We now have patient safety notices such as fax blasts and email alerts that let doctors know, for example, that an allograft ACL tissue is contaminated. We use these means when things are potentially life or limb threatening. In 2006 when we found out that a number of vials of cefazolin, the antibiotic most frequently used in orthopedic surgery, had been contaminated, we immediately sent out a patient safety alert. The distribution center for the contaminated vials was in Denver, so I called the pharmacy at the hospital and found that they had not heard the news. This is likely because manufacturers typically notify pharmacies of problems by registered mail. On the immediacy scale, the next tier down is when things are very important, but not quite as critical as the top tier. This includes, for example, news about a new side effect of a drug. In that instance, we would announce it in a publication like the AAOS bulletin.”

Perhaps the most well known patient safety initiative to emerge in recent years is the "Sign Your Site" program. This effort, part of the Joint Commission’s (formerly the Joint Commission on Accreditation of Healthcare Organizations), implementation of its universal protocol to enhance patient safety, is an attempt to prevent wrong site surgery. States Dr. Wong, “AAOS found that an orthopedic surgeon has a 1 in 4 chance of performing a wrong site surgery in a 35-year career. To address this, the Academy and the North American Spine Society (NASS) worked with the Joint Commission to establish a pre-op safety protocol. Using data from the Commission’s sentinel events program, a universal protocol was established that is soon to be mandated in all Joint Commission-accredited hospitals.”

Continues Dr. Wong, “There are three parts to the protocol. The first is patient identification. When we examined the sentinel events program, we found that instead of everything being a wrong-site issue, some were actually wrong-patient issues or wrong-procedure issues. In the orthopedic world, the issue is often one of wrong side or level, but using their statistics, which are more population-based, we saw that some were person- or procedure-related. Thus the first step is patient identification. The second action step is site marking. Using an indelible pen, surgeons sign their initials to the site that is to undergo surgery. The last safety checkpoint is to call a time-out just before the procedure to double-check the patient identification, verify that the consent forms include the right procedure, the marking is correct, and that the X-rays are up correctly. This last point can be especially important. Years ago there was a case where a surgeon operated on the wrong side of the brain because the X-rays were placed incorrectly. These are systems solutions that over time should have a significant impact on wrong-site surgeries. This could take a while, however. After establishing the universal protocol, we examined the first two quarters of statistics on sentinel events and found that the incidence of wrong-site surgery was in fact diminished. When the first-year statistics came out, however, it was up. The Joint Commission is looking into the reason(s) for this. Perhaps it can be attributed to increased awareness that has resulted in better reporting. It is true that sometimes hospitals are reluctant to report such things. Also, the systems haven’t traditionally been in place to report them.”

And the role of education in patient safety? “There is now a curriculum that is CME-accredited and fulfills the requirements of most states in patient-safety hours. Also, some states require CME for licensure in patient safety. Additionally, there are patient-safety questions on the orthopedic in-training exams for residents. This work is being linked to the Accreditation Council for Graduate Medical Education' six general competencies for residents. It’s slow going sometimes, however, as it can take residents a long time to realize they need to read about these issues. Additionally, our committee is working with the AAOS Evidence-Based Practice Committee on a ‘Positive Practices’ program to give surgeons practical measures to incorporate into their practices to enhance patient safety. For example, there is a set of nine postoperative order forms and a patient/consumer brochure on medication errors prepared by the Patient Safety Committee. This program will provide surgeons with solid guidelines for questions such as, ‘Do you give an antibiotic after a total joint replacement when someone has to go for a dental procedure?’ To address the issue of how best to talk to patients, we have developed a program entitled ‘Physician/Patient Communications Training.’ Along with the Bayer Institute, we found that not letting the patient talk is a big mistake. We held mock physician/patient sessions at Bayer and found that within a minute most doctors interrupted the patient’s story to try to move on to specifics. While the doctor may save a few minutes, he or she may miss a critical piece of information coming from the patient. Not to mention the fact that the patient doesn’t feel heard.”

Speaking of patients, Dr. Wong says, “In 2003 AAOS launched a public campaign entitled ‘Patient Safety Is No Accident.’ The initiative included a public service announcement with print, radio, and airport ads, as well as posters and postcards. The campaign has appeared thousands of times in magazines, weekly and daily newspapers, and in more than 100 airports nationwide.”

To advance the patient safety arena through research, AAOS has developed a number of initiatives. One such effort is the Critical Incidence Research Project: Surveying Patient Safety Near Misses. Says Dr. Wong, “Let’s say someone writes a medication down that the patient is allergic to, but the nurse catches it before it is administered. That is a near miss. We began with a pilot study and found enough issues to go on and conduct a phone survey. Such an effort helps everyone learn from near misses. Additionally, our committee’s Team on Ambulatory Surgery Center (ASC)/Practitioner Office Errors prepared pre- and postoperative patient safety checklists specifically designed for use in the ASC. Realizing the value of member participation, we recently completed a member survey on medical errors. A total of 5540 surveys were mailed to a random selection of AAOS members; 917 were returned identifying almost 500 instances of medical error. We will do a subanalysis on how many were doctor error, nurse error, medication errors, broken or missing equipment, the wrong implant, etc. An overview of the results thus far show that equipment errors constituted the largest proportion (30%) followed by communications (26%) and technical (13%). Medication errors and wrong site surgery constituted about 9% each.”

The AAOS Patient Safety Committee is in the business of transforming orthopedic care. Significant efforts, however, are often met with significant challenges. States Dr. Wong, “Our biggest issue is getting the membership to buy into these programs. Although the Joint Commission is telling us that pushback is rare, when it comes, it includes comments such as, ‘Why should I change my routines, it’s worked well like this forever.’ Fortunately, the overall rate of significant medical mistakes is low. Given that, however, we are in the position of having to convince people to make systematic changes to avoid a rare occurrence. We have to stress the gravity of the mistakes when they do happen.”

We have focused on the effects these changes can have on physicians and patients. But how about manufacturers? States Dr. Wong, “The manufacturers have opportunities in terms of patient safety systems. For example, one manufacturer has a knife blade with a plastic cover that says, ‘time out.’ Before the cover comes off, the surgeon sees that and is cued to go through the safety steps. AAOS and NASS have a joint task force that includes representatives from manufacturers. There are frequent discussions about how, in developing new technology, we can incorporate the appropriate safety measures.”

Regarding the patients and physicians of the future, what can they expect? “I can foresee a time when surgeons will receive notification of a critical laboratory result or X-ray via a handheld device or cellular telephone,” states a hopeful David Wong. “And in about five years we will have technological verifications of issues like sign-your-site and universal-protocol compliance.”

As for 2007, patients and physicians alike can be grateful to those who lead the way in patient safety. More than ever, patients will get what they expect and deserve.

For additional information on the AAOS Patient Safety Committee, please visit http://patientsafety.aaos.org or contact the new chair, Dr. Bob Brooks.

 

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