Other Articles

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.

What Complaint is Numero Uno in the PearlDiver Database?
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.

Arthroscopic Treatment for Tennis Elbow: Coming on Strong
“Tennis elbow” or lateral epicondylitis is, according to our PearlDiver database, one of the most reported diagnosis for problems with the elbow. Lately clinical evidence has shown that arthroscopic treatment for tennis elbow can provide long-term stability and, in most cases, return of the elbow to its optimal function. Check out the data from PearlDiver.

Do Republicans Make Better Orthopedic Surgeons?
A recent Nature Neuroscience journal study of the decision making differences between liberals and conservatives appears to argue in favor of Republican surgeons! Which, frankly, explains a lot—to BOTH sides and, to stretch an analogy almost to its breaking point, it may also explain why McCain’s health care plan is different from Obama’s. Read OUR take here.

"Sound of Music" Turns to Greek Tragedy for Smith & Nephew
Smith & Nephew’s Swiss (mis)adventure with Plus Orthopaedics is turning into a Greek Tragedy. The company’s whole acquisition strategy is being called into question. Read how CEO Illingworth explained it to the brutal British press.

“Dear John Letter” for Hip Resurfacing?
“Dear John H. Resurfacing: I hope this little note finds you well. We certainly have had some great times and, gosh, I’ll never forget those wonderful moments when the FDA approved your PMA. We’ve just celebrated our second anniversary together and, well, I’m just not feeling the magic anymore….” Two years after FDA approval, how happy are orthopedists with hip resurfacing? Read our analysis here.

In the Beginning, There Was the End: Manuscripts 101
Dr. Paul Manske, Professor of Orthopaedic Surgery at Washington University School of Medicine in St. Louis and Editor-in-Chief of The Journal of Hand Surgery, shares his thoughts and experience on the details of shepherding a manuscript through publication.

Did ConMed Get Re-Wired?
Ever hear about the neurosurgeon who used an $80 Bosch power drill to do brain surgery? It really happened. Surgeons like their power tools. Increasingly they also like a particular line of sterilizeable power tools from ConMed’s Linvatec unit. Did ConMed get re-wired? We have the details here.

May 9, 2008, marked a significant orthopedic anniversary—the second year since the FDA approved the first hip resurfacing product for use in the United States. As is true at the beginning of most relationships, surgeons were hopeful and expectant about working with the new device. But after two years of experience, are orthopedists still happy with their hip resurfacing relationship?

The product that started it all in the U.S. was, of course, Smith and Nephew’s BIRMINGHAM HIP™ Resurfacing System (BHR™), which gained FDA approval in 2006. Since that time only one other product in this space has gained FDA approval—the Corin Group’s Cormet™ Hip Resurfacing System marketed by Stryker Corporation.

Surgeons in Europe were implanting the BHR as early as 1997, giving U.S. surgeons almost a decade in which to observe and build up expectations prior to the FDA approval.

Among the expectations for the hip resurfacing procedure were:

• A 98% success rate (less than 2% revised).
• A length of stay of three to five days, or significantly less than that typically required for total hip replacement.
• Fewer dislocations than with total hip replacements.
• Decreased amounts of pain throughout recovery.
• Shorter recovery times as compared with total hip replacement.
• Bone preservation.
• Increased time before a patient would require a total hip replacement.

In Australia, according to the Australian Orthopaedic Association’s 2007 National Joint Registry, from 2002 through 2006 the BHR averaged a 2.5% revision rate. Out of 6,773 procedures, there were 166 revisions with the BHR—a better revision rate than that for competing resurfacing systems.

How has the BHR lived up to expectations in the United States? Using the PearlDiver database containing over 116 million patient records of 6.99 million patients, a sample was created to compare actual results to the expectations for the BHR. The sample consisted of 324 patients who had the hip resurfacing procedure performed between May 9, 2006, and June 30, 2007.

The first comparison was against the expected success rate of the BHR. The expectation at the time of FDA approval was for a success rate of 98%. Of the 324 patients in the sample, seven had procedures that proved to be unsuccessful, resulting in the BHR being converted to a total hip replacement. The resulting failure percentage of 2.16% is less than the experience reported in the Australian Registry but very close to the U.S. expectations.

A closer examination of the seven patients reveals why the hip resurfacing was converted to a total hip replacement.

• Two patients were given a total hip replacement after being diagnosed with dislocation of the prosthetic joint.
• One patient had a mechanical loosening of the prosthetic joint.
• One patient was diagnosed with an unspecified mechanical complication.
• Three patients were found to have other non-prosthetic complications that affected the outcome of the hip resurfacing procedure.

The second comparison was made against the expectation of a shortened length of stay in the hospital with BHR versus a total hip replacement. The U.S. expectation was that, with BHR, the patient’s length of stay in the hospital would range between three and five days and would be significantly shorter than the average length of stay for a total hip replacement. The results for our sample, since the approval of the BHR through June 30, 2007, are shown in Table 1.

Table 1: Average Length of Stay (in Days), Hip Resurfacing and Total Hip Replacement

Source: PearlDiver Patient Records Database, 2004 – June 2007

The results are good news for hip resurfacing. The average length of stay for both male and female patients never goes above 3.39 days. By the second quarter of 2007, male patients were staying in the hospital at the low end of the time frame at 3.02 days.

While the hospital stay for a patient undergoing BHR is short and within the time of the original expectations, it is not all that much shorter than the length of stay for a total hip replacement. In 2004 the PearlDiver database shows that the average hospital stay for a female patient having a total hip replacement was 4.33 days, considerably longer than the 3.29 days for a female patient undergoing hip resurfacing in the second quarter of 2007. However, since 2004, the average length of stay for a total hip replacement has been shortened to the point that, by the second quarter of 2007, a female patient getting a total hip replacement was staying in the hospital an average of only 0.37 days longer than a female hip resurfacing patient.

The third expectation of hip resurfacing was that, because the hip resurfacing procedure uses a larger ball and socket, there would be fewer dislocations than occur in a total hip replacement. Using PearlDiver data, quarterly samples of patient dislocation data were created for both procedures, as shown below in Table 2. The figures represent the number of patients that had the procedure in a given quarter, and then went on to experience a dislocation at any time after the procedure.

Table 2: Yearly Dislocation to Procedure Ratios

Source: PearlDiver Patient Records Database, 2004 – June 2007

It appears that, in the short term, a patient is less likely to have a dislocation after hip resurfacing than after a total hip replacement. However, as time passes, the advantage that hip resurfacing holds in the early stages disappears. As shown in Table 2, while only 0.8% of the patients who had the hip resurfacing procedure in the second quarter of 2007 suffered a dislocation, those for whom more time had passed between the procedure and the end date of the sample set—such as those who had a procedure in the fourth quarter of 2006—actually had a higher percentage of dislocation than those who had a total hip replacement.

As the number of hip resurfacing procedures performed in the U.S. increases, it will be interesting to see if this continues. It is important to keep in mind that hip resurfacing has been available in the U.S. market for only two years. As time passes and the market grows, this may change.

But how much market growth can be expected? An examination of the PearlDiver data of patients who underwent a total hip replacement from 2004 through the second quarter of 2007 reveals most would not have qualified for the hip resurfacing procedure. These included patients who had infections, not fully grown bones, blood vessel disease, muscle-related disease, nerve- and muscle-related disease, avascular necrosis, multiple fluid-filled cavities (cysts), impaired kidney function, metal sensitivity, HIV, or AIDS; were females of child-hearing age, or were overweight. The hip resurfacing procedure is also typically performed on males under the age of 65 and females under the age of 55.

When the 17,777 patients in the PearlDiver database who had total hip replacements from 2004 through 2Q07 were analyzed to see how many would have qualified for a hip resurfacing procedure had it been available to them, 2,561, or just 14.4%, fell within the criteria for hip resurfacing. In 2005 alone, 238,130 patients had a total hip replacement, according to the American Academy of Orthopaedic Surgeons’ Facts on Hip Replacements web publication (http://www.aaos.org/Research/stats/Hip%20Facts.pdf). Had the hip resurfacing procedure been approved at that time, 34,290 patients would have qualified. By the end of the second quarter of 2007, only 7.8% of potential patients were having hip resurfacing instead of a total hip replacement. Much of the market remains to be captured.

One reason for the slower growth of hip resurfacing in the marketplace is that the procedure is more complex than a total hip replacement, and surgeons performing it require additional training. Around 1,000 surgeons have been specifically trained for the BHR procedure but only about half are performing the procedure on a regular basis. Patients are reluctant to have the operation performed by a doctor who does only a dozen or so resurfacing procedures a year.

Are orthopedists happy with their relationship with hip resurfacing? While every relationship has its growing pains, this relationship shows tremendous promise for many patients. The ability of hip resurfacing to preserve bone provides patients with years of activity before a total hip revision could become necessary. The possibility of offering patients an improved quality of life should only strengthen the orthopedists’ bond with this procedure.