01 04 11 Newsletter

VOLUME 7, ISSUE 1 | JANUARY 4, 2011
4 8
week in review
Reclaiming the Patient Outcome Argument This past week two Bloomberg writers took a tour of one spine surgery centers poor patient outcomes and then connected those outcomes to the surgeons lifestyles. It was one of the ugliest attacks on spine since the pedicle screw litigation days. OTW fights back. Unsettled Healthcare Law While federal judges issue highly publicized different rulings on ObamaCare, physicians are also waiting to hear if a provision limiting their ownership in hospitals violates their right to due process and equal access of the law. Read how the cases all fit together. Good Hands? Really? Assessing Surgical skills Navigation, object manipulation and the like are skills not traditionally assessed as part of an orthopedics curriculumat least not thoroughly assessed. That is changing, however, and things such as simulators will make things all the more interesting.
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27
picture of success
Dr. Thomas Fehring Dr. Thomas Fehring, Co-Director of the Hip and Knee Center at OrthoCarolina and VP of the Knee Society, is focused focused on doing his utmost to ensure that older patients will always able to be able to get the surgery they need.
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breaking news
Smith & Nephew Receives FDA Warning .......................................... FAI Athletes Respond to Surgery ............................................................ Mesoblast Completes Angioblast Acquisition ............................................................ Too Often Concussive Athletes Go Untested ............................................................ Tough New Ceramic Introduced ............................................................ Not So Predictive MRI ............................................................ Gladney Takes Over Lanx
For all news that is Ortho, read on.
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Orthopedic Power Rankings
Robin Youngs Entirely Subjective Ordering of Public Orthopedic Companies
This Week: Great 30-day run for ortho equities. CONMED up 23%. Alphatec up 20%. Even lowly Medtronic rose double digits. Wachovias Biegelsen reminds us 65+ population could boost sales and earnings growth by 60-80 bps and 100-150 bps. Our analysis suggests a 13% valuation increase for med tech stocks. Its all about the fundamentals.
Rank
Last Week
1
Company
TTM Op Margin
13.51%
30-Day Price Change

6.66%
Comment
OFIX has THE lowest Price-to-sales, lowest P/E to Growth Rate ratio and the 8th lowest P/E. Still #1 in the Power Rankings. Lowest P/E ratio and the lowest future P/E ratio. Clearly oversold. Course, Bloombergs hatchet job on spine fusion doesnt help. Buyers unfazed by FDA warning letter. Bottom line, SNNs market share is strong and aging baby boomers are fueling growth. Nice continuing bounce off the $2/share floor. Street expecting strong earnings pop from ATEC in 2011. Wall Street is expecting IART to report a strong 22% EPS jump for Q4 on modest 5% sales growth estimate. What is the future of the small large joint companies like EXAC? ZMH or SYK or SNN or DPU bolt on? Upgraded to start the year by BMO Capital markets. Up one spot on the Power Rankings. Big Blue is down so low, its starting to look like up. Three acquisitions in the closing days of 2010 are a good sign. Holy Power Tools Batman! What a run in December. Could hospital buying be back? Seventh best in P/E to growth, future P/E and expected earnings change. The market is not seeing the organic growth. Time to buy?
Orthofix
Medtronic
32.59
10.62
Smith & Nephew Alphatec Integra LifeSciences Exactech Wright Medical Zimmer
22.83
15.52
1.59
20.00
15.37
9.06
6 7
5 8
10.79 6.36
5.61 17.74
27.69
8.97
10
CONMED
9.07
22.87
10
Stryker
24.71
7.57
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Top Performers Last 30 Days
Company 1 2 3 4 5 6 7 8 9 10 TiGenix Mako Surgical Bacterin Intl Holdings CONMED Alphatec Holdings Wright Medical Smith & Nephew Symmetry Medical Medtronic NuVasive Symbol TIG.BR MAKO BIHI.OB CNMD ATEC WMGI SNN SMA MDT NUVA Price $2.91 $15.22 $8.50 $26.43 $2.70 $15.53 $52.55 $9.25 $37.09 $25.65 Mkt Cap $90 $518 $305 $743 $239 $609 $9,320 $332 $39,820 $1,010 30-Day Chg 49.3% 32.7% 28.8% 22.9% 20.0% 17.7% 15.5% 13.2% 10.6% 9.8% 1 2 3 4 5 6 7 8 9 10 Company
Robin Youngs Orthopedic Universe

Worst Performers Last 30 Days
Symbol CRY RTIX JNJ VITA KNSY ARTC SYST.VX EXAC OFIX Price $5.42 $2.67 $61.85 $2.01 $27.83 $31.06 $123.54 $18.82 $29.00 Mkt Cap $152 $146 169,860 $155 $236 $840 $11,874 $14,662 $243 $514 30-Day Chg -3.9% -1.5% 0.5% 1.0% 2.5% 2.6% 3.7% 4.0% 5.6% 6.7% CryoLife RTI Biologics Inc Johnson & Johnson Orthovita Kensey Nash ArthroCare Average Synthes Exactech Orthofix
Lowest Price / Earnings Ratio (TTM)

Company 1 2 3 4 5 Medtronic Kensey Nash Zimmer Holdings Average Wright Medical Symbol MDT KNSY ZMH WMGI Price $37.09 $27.83 $53.68 $15.53 Mkt Cap $39,820 $236 $10,600 $11,874 $609 P/E 11.17 12.19 12.51 13.25 13.31 1 2 3 4 5
Highest Price / Earnings Ratio (TTM)

Company Alphatec Holdings Smith & Nephew RTI Biologics Inc Symmetry Medical CONMED Symbol ATEC SNN RTIX SMA CNMD Price $2.70 $52.55 $2.67 $9.25 $26.43 Mkt Cap $239 $9,320 $146 $332 $743 P/E 224.12 72.77 41.58 27.86 20.32
Lowest P/E to Growth Ratio (Earnings Estimates)

Company 1 2 3 4 5 Orthofix NuVasive Medtronic Zimmer Holdings Smith & Nephew Symbol OFIX NUVA MDT ZMH SNN Price $29.00 $25.65 $37.09 $53.68 $52.55 Mkt Cap $514 $1,010 $39,820 $10,600 $9,320 PEG 0.59 0.69 1.19 1.29 1.41 1 2 3 4 5
Highest P/E to Growth Ratio (Earnings Estimates)

Company Alphatec Holdings Kensey Nash CONMED ArthroCare CryoLife Symbol ATEC KNSY CNMD ARTC CRY Price $2.70 $27.83 $26.43 $31.06 $5.42 Mkt Cap $239 $236 $743 $840 $152 PEG 3.99 3.53 2.53 2.32 2.29
Lowest Price to Sales Ratio (TTM)

Company 1 2 3 4 5 RTI Biologics Inc Orthofix Symmetry Medical CONMED Wright Medical Symbol RTIX OFIX SMA CNMD WMGI Price $2.67 $29.00 $9.25 $26.43 $15.53 Mkt Cap $146 $514 $332 $743 $609 PSR 0.91 0.91 0.97 1.04 1.19 1 2 3 4 5
Highest Price to Sales Ratio (TTM)

Company TiGenix Bacterin Intl Holdings Mako Surgical Synthes Kensey Nash Symbol TIG.BR BIHI.OB MAKO SYST.VX KNSY Price $2.91 $8.50 $15.22 $123.54 $27.83 Mkt Cap $90 $305 $518 $14,662 $236 PSR 321.16 24.77 13.51 8.13 3.04
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Click Here for more details or email tom@ryortho.com Tom Bishow: 410.356.2455 (office) or 410.608.1697 (cell)
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By Robin Young
Reclaiming the Patient Outcome Argument

was distributed throughout the world and landed, no doubt, on every regulator and reimbursers desk. No Batting Average The spine surgeons mentioned in the Bloomberg piece work at TCSC. The Center performs roughly 3,000 spine surgeries annually. Using workers comp appeals court data, the authors were able to pull out 11 patients to follow. Six made it into the story. All six had poor outcomes. Here, for example, is what the authors wrote about one patient. Jean Kingsley, 57, a patient who had had two previous
Morguefile
his past week two Bloomberg writers took a tour of one spine surgery centers poor patient outcomes patients whod filed lawsuits, patients whod filed appeals in workers comp court and then paired that sad information with details of the surgeons personal livesincluding information from divorce proceedingsto paint a damning, even devastating picture of spine surgeons and fusion surgery. The article, titled Doctors Getting Rich with Fusion Surgery Debunked by Studies was published online in Bloomberg News on December 30, 2010. In the article, authors Peter Waldman and David Armstrong used several patient cases from the Twin Cities Spine Center (TCSC), which is affiliated with Abbott Northwestern Hospital, to argue that
the Center was performing too many spine fusion surgeries, that the surgeons were getting rich and that patients who underwent spine fusion surgery were often worse offindeed the article gave six examples of a poor outcome and one example of a favorable outcome. The Bloomberg article came two weeks after the Wall Street Journal published a story highlighting the size of payments from suppliers like Medtronic to spine surgeons. Both articles put surgeons and manufacturers in unfavorable lights. This Bloomberg article, however, was particularly damaging because it focused on patient outcomes and then linked poor outcomes to the lifestyles of the surgeons. The Bloomberg article
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fusion surgeries and was still suffering back pain. According to a hospital report, her doctor wrote; that more surgical treatment could provide her with some relief of her pain if her symptoms were extremely severe, unrelenting and had failed extensive conservative care, which appeared to be the case. Her third operation, a daylong procedure in September of that year, fused 13 vertebrae along her entire spine and was a disaster. Kingsley, of Milaca, Minnesota, returned home paralyzed from the waist down, according to hospital records in a lawsuit she brought against her surgeon. A jury in Minnesota state court found earlier this year that her surgeon was not negligent in the case. The judge awarded $46,616 in attorneys fees to Kingsleys surgeon, which Kingsley said she cant pay. She has appealed the decision. Her case is a unique set of events for which even in retrospect there is no obvious explanation that one can prove, her doctor said in his 2008 deposition, in which he estimated he performed 400 to 500 back surgeries a year. Abbott and Twin Cities Spine billed a combined $239,000 for the surgery, Kingsleys records show. Insurer Medica says it paid about a third of that amount after a discount. Kingsley arrived home in a wheelchair, wore a diaper for two and a half years and had a home health aide visiting to bathe her in bed, she said in a deposition in the case. As her condition improved, she said she was able to move short distances with the aid of leg braces and a walker.
Then here is what the authors wrote about one of the surgeons from the Spine Center. Porsches, Ferrari, Mercedes. One Twin Cities Spine surgeon earned $1.85 million from the practice in 2007, according to filings in his divorce proceedings that year. He told state superior court in Minneapolis that he and his wifes assets included two Porsches; a Ferrari 430 coupe; a Mercedes Benz; two other cars; three boats and proceeds from the $1 million sale of a farm where he bred Lusitano horses. The surgeons 7,185-square-foot house presides over a wooded prom-
ontory on Lake Minnetonka. Valued at $4 million in 2007, the house has a swimming pool and 50 yards of beach. (We are not mentioning the names of the surgeons from the Bloomberg article. It serves literally no purpose.) What struck us about this was the absence of performance metrics for The Twin Cities Spine Center. Wheres the batting average? If, for example, the TCSC has a 0.850 (85%) rate of delighted patient outcomes and the rest of the spine community had a 0.650 (65%) rate, then 6 or 7 poor outcomes would not drive the narrative. In the absence of a performance measure, the writers resorted to expert opinion quotes (Sohail Mirza, M.D., Chair of the Department of Orthopaedics at
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Dartmouth: Its amazing how much evidence there is that fusions dont work, yet surgeons do them anyway.), and cherry-picked negative studies in Spine, Pain and the British Medical Journal between 2003 and 2006. The average major league baseball player makes $5.1 million a year. The average NFL player makes more than $1 million per year. What separates the highest paid players from the average? Batting averages. On base percentages. Passing yards. Receiving yards. Sacks per game.
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Wheres the batting averages for spine surgeons? Whats the Truth? Nothing like a tour of a spine centers failures. The Bloomberg article was ugly. Spine surgery for patients and the surgeons who perform them are routinely getting beat up in the nations press. This is serious. If surgeons lose the patient outcome argument then reimbursement, innovation, everything gets tougher. The truth is that surgical intervention works better than conservative care. Dont believe it? Neither did Dr. Weinstein at Dartmouth. So he orga-
nized the definitive study to, once and for all, put the stake in spine surgery. It has been Dr. Weinsteins lifes work to show that surgeons have inordinate influence on their patients and that those surgeons tend to perform too many spine surgeries. Weinsteins SPORT study (Spine Patient Outcomes Research Trial) was a five-year study that looked at three of the most common back conditions and compared surgical and non-surgical treatments. Approximately 2,500 patients took part in the study, which was conducted at 13 sites across the country.
This NIH (National Institute of Health) sponsored study was the largest, most rigorous effort ever launched to study the effects of spine surgery versus conservative care. What Are the Results of SPORT? The results of SPORT were released in three phases, in the order of the three conditions studied: Intervertebral disc herniation, published in JAMA, November, 2006 Degenerative spondylolisthesis, published in The New England
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Journal of Medicine, May, 2007 Spinal stenosis, published in The New England Journal of Medicine, February 21, 2008 The first results were from the Intervertebral Disc Herniation trial. The study found that while both groups improved substantially after treatment, the improvement from standard surgery, a procedure called discectomy, was more rapid. Patients who had surgery also reported better results in physical function and satisfaction one and two years after the operation. The second results were from the trial for Degenerative Spondylolisthesis. The study found that patients with spinal stenosis accompanied by degenerative spondylolisthesis who were treated surgically showed substantially greater improvement in pain and function through two-year follow-up compared to patients treated nonsurgically. Because patients in the randomized cohort crossed over either from the non-operative arm to have surgery or from the surgery arm to remain non-operative, the analyses were non-randomized, as-treated comparisons with careful control for potentially confounding baseline factors. The third results were from the trial for Spinal Stenosis. The study found that patients with spinal stenosis who were treated surgically showed significantly greater improvement in pain, function and disability through two-year follow-up compared to patients treated nonsurgically. Because patients in the randomized cohort crossed over either from the non-operative arm to have surgery or from the surgery arm to remain non-operative, the analyses were nonrandomized, as-treated comparisons
with careful control for potentially confounding baseline factors. Surgical intervention - 3 : Conservative Care 1/2 Wall Street Journal vs. Private Property Whats wrong with the Wall Street Journal? Do private property rules only apply to non-surgeons? Five days before Christmas, John Carryrou and Tom McGinty wrote that five surgeons in Louisville, Kentucky, had received about $7 million from Medtronic for an invention they had licensed to the company. These same surgeons are among the most prolific in the U.S. in both amount of spine surgery performed and published research on comparative effectiveness. Both the hospital that grants surgical privileges to the surgeons and Medtronic have in place several conflict of interest rules to ensure that any payments from Medtronic are proper (as defined, incidentally, by the U.S. Attorney) and are not for implants the surgeons use. But, dont confuse the Wall Street Journal with facts. Huge dollars are being paid to surgeons who perform lots of spine surgeries. The WSJ is shocked. Shocked! Well, it seems to us, the WSJ is missing two basic pointsone, there is no mention of patient outcomes. By implication, Carryrou and McGinty are saying that patient outcomes were compromised because of the royalty payments. Really? The only point of the WSJ article was that these five surgeons were paid millions of dollars. Some from royalties. Some from hospitals and insurance companies for perform-
ing spine surgery. Many other top performers receive millions of dollars too. Professional athletes, business people, lawyers. Surgeons are different? Second, who owns the inventions of these surgeons? Are they not intellectual property and do they not have a right to license their property? If Medtronic paid $7 million in royalties to these five surgeons for their invention, the only conclusion that makes sense is that it must have been a great invention since obviously many surgeons are using it. Remember, this invention did not belong to Medtronic. It belonged to the inventing surgeons. Its called private property. These are difficult times. The ninesociety letter to BCBS of North Carolina was a singular bright spot. The next challenge is the patient outcome debate. Spine surgeons must, must win that argument.
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Unsettled Healthcare Law
By Walter Eisner
he score is now 2 to 1 in favor of the new healthcare law, as three federal judges have ruled on the constitutionality of the Affordable Care Act (Act).
After Clinton-appointed federal judges Norman Moon in Virginia and George Caram Steeh in Michigan, ruled the Acts requirement that people buy their own health insurance is constitutional, a third judge in Virginia, Henry E. Hudson, appointed by George H.W. Bush, ruled otherwise on December 13 in Cuccinelli v. Sebelius. We now have unsettled law. There is a fourth case brought by Attorneys General from 20 states waiting to be decided in Florida by Judge Roger Vinson, a Reagan appointee. Settling Unsettled Law The decisions will likely be pushed upstream to the Federal Appeals Court where the constitutional questions will be teed up for a Supreme Court decision, unless President Obama and a new Congress reach a new agreement on insurance coverage. No case before the Court will be more watched or politically charged since the Court decided the 2000 presidential election. The Virginia case was the first one where the challenger was a state. The two previous cases were brought by private parties, one of whom was Jerry Falwells Liberty University. The Virginia challenge was brought by the Commonwealths Attorney General, Kenneth Cuccinelli. Cuccinelli sued
Top Row: Judge George Caram Steeh and Judge Norman Moon. Second Row: Judge Michael Schneider and Judge Henry Hudson.
Kathleen Sebelius, the Secretary of the Department of Health and Human Services, challenging, among other things, the constitutionality of the minimum essential insurance requirement of the new law. The Tyler Texas Rebels There is however, another important constitutional challenge to the Act for physicians to watch and thats the Tyler, Texas, surgeons challenge to the laws provision limiting the rights of physicians to own their own hospitals. Scott Oostdyk, the constitutional lawyer representing the Tyler surgeons, including Mike Russell, M.D. and Charley Gordon, M.D. of the Texas
Spine and Joint Hospital, told OTW that the parties expect to hear soon from the federal judge hearing the case. The government is asking the judge to summarily dismiss the physicians challenge because they failed to show that the ownership provision of the law violated a physicians constitutional right to equal protection and due process. Oostdyk said Judge Michael Schneider has telegraphed that, so far, he has not been convinced by the physicians arguments. The chances for the Tyler rebels seem to be getting slimmer. However, says Oostdyk, the Attorneys Generals challenge in Florida may accomplish the same result if the judge rules against the Act.
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you are healthy and know that you can buy insurance anytime you get sick at the same price as everyone else, you are likely to hold off buying insurance. If that happens, supporters of the Act fear that only the sick will buy insurance at very high rates. Central provisions of the Act dont take effect until 2014. By then the Supreme Court will likely have weighed in with a decision. The White House insisted a day after Hudsons ruling that the implementation of the Act will not be affected by a negative federal court ruling, and the Justice Department said it would appeal. Theres no practical impact at all as states move forward in implementing... the law that Congress passed and the president signed, White House press secretary Robert Gibbs told reporters.
Texas Spine and Joint Hospital/courtesy of TSJH
In Oostdyks view the Florida decision, if decided for the challengers, could strike down the entire Act, as opposed to Hudsons decision in Virginia, which narrowly struck down the part of the Act which mandates insurance coverage. Judge Hudson severed part of the law, which Oostdyk believes was not intended by Congress when it passed the Act. The Texas case is perhaps more important to physicians because it addresses the rights of physicians to participate in their own means of production, that is, owning the property which allows them to deliver services to patients. If they win in Texas, the equal protection and due process precedent will be there for future challenges to physician-owned distributorships, manufacturers and other healthcare delivery mechanisms. Physician-owned hospitals are notoriously popular with patients and rate high on quality measurements, while
physician-owned distributorships have shown an ability to squeeze costs out of the system. Of the 5,815 hospitals in America, 265 are owned by physicians. Oostdyk says his clients will make a decision about how to proceed depending on Judge Schneiders decision. He said that his clients have received widespread support from their colleagues around the country. Policy Implications of Decision Judge Hudsons ruling does not stop implementation of other provisions of the Act, like preventative care coverage and the mandate that adult children can stay in parents employer-sponsored plans until age 27. The ruling may, however, bear heavily on the financial underfooting of the Act. The Act requires insurance companies to offer health insurance to anyone without regard to prior condition. If
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Mandate Lite As controversial as the mandated insurance requirement is, Daniel McLaughlin writes in a University of St. Thomas (St. Paul, Minnesota) blog on December 14 that Medicare has had an insurance mandate for Medicare Part D (the drug benefit) since 2005. When you are eligible for Medicare, you must enroll in Part D or pay a penalty. This penalty applies when you do obtain Part D coverage and it is an additional payment for those months you do not have Part D. However, if you continue to work and can demonstrate creditable coverage for drug coverage through your employer-based insurance, the penalty does not apply. Technically, the Part D penalty is not a mandate, write McLaughlin, but it comes pretty close. He believes if the Supreme Court ultimately sides with Judge Hudson, the Health Insurance Exchange enrollments may unravel as more healthy and young individuals defer purchasing insurance until they are sick.
If this happens, McLaughlin looks for Congress, supported strongly by the health plans, to enact a Part D-style penalty for those who do not buy insurance. For those in the policy business creative solutions are almost always requiredthis case will not be an exception, concluded McLaughlin. A Medicare type requirement is a mandate lite, said economist Gail Wilensky, who ran Medicare for President George H.W. Bush, in a December 16 AP story. A modification of what is done with seniors on Medicare would be a much more powerful tool. You dont have to buy insurance. But if you dont, the first time you come in, were going to add a penalty that youll have to pay for the next four or five years. The same AP article pointed out that requiring individual responsibility was the Republican alternative during the 1990s healthcare debate. Most Republicans no longer take that position, but Wilensky told the AP she has no problems with the concept. As a society, we have made a commitment not to let people die in the street because of lack of medical care, she said, noting that hospital emergency rooms have to accept the uninsured. Its not unreasonable to say that people be required to carry some sort of coverage. Politics Massachusetts enacted an individual requirement in 2006, after a compromise between then-Republican Governor Mitt Romney and Democratic state legisla-
tors. As a candidate, President Obama opposed the individual requirement as too costly for the average household. He accepted it after it became the only approach that could pass both the House and Senate. New York Times writer Sheryl Gay Stolberg wrote on December 14 that the Florida and Virginia challenges were filed in courthouses where conservative judges prevail, and where appeals would flow to the countrys most conservative circuits. Although the science is imprecise and often disputed, some scholars have found patterns of partisan divisions at all levels of the federal judiciary, based on the appointing president. At the district court level, there is generally a high degree of consensus among judges in similar cases, except when they confront polarizing constitutional questions like abortion, campaign finance and now health care, added Stolberg. When the law is fairly clear, politics dont matter much, said Mark A. Hall, a professor of law and public health at Wake Forest University in the Times article. But when the law is unsettled, inchoate, undeveloped, lets say, its natural that judges political, social and economic views will shape how they see things. Public Policy and the Constitution A day after Judge Hudsons ruling, U.S. Attorney General Eric Holder and Secretary Sebelius wrote in a Washington Post editorial: The majority of Americans who have health insurance pay a higher price because of our broken system. Every insured family pays an average of $1,000
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more a year in premiums to cover the care of those who have no insurance. Everyone wants health care to be affordable and available when they need it. But we have to stop imposing extra costs on people who carry insurance, and that means everyone who can afford coverage needs to carry minimum health coverage starting in 2014. But as the Tyler rebels reminded us in their challenge, Justice Oliver Wendell Holmes drew a line in the sandwhen he wrote, [A] strong public desire to improve the public condition is not enough to warrant achieving the desire by a shorter cut than the constitutional way of paying for the change.
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By Elizabeth Hofheinz, M.P.H., M.Ed.
Good Hands? Really? Assessing Surgical Skills
f just a couple of the billionaires giving away their money these days were to offer funds to orthopedic training programs, there just may be a high flying virtual reality simulator in every school. But alas, we must await the trillionaires club. Ann Van Heest, M.D., is a hand surgeon at the University Minnesota, and has been the Residency Program Director for 12 years. She states, The ACGME (Accreditation Council for Graduate Medical Education) announced six areas of core competencies for orthopedists in 2001. While there is no specific core competency for technical skills, they do fall under the competency of patient care. We orthopedic surgeons spend about 50% of our time in the OR, but as it has been for so long, when residents are assessed on motor skills the comments are not specific (She has great hands or He cant operate.) Traditionally, tests in the surgical specialties are knowledge basedbut being able to perform in the OR is a completely different issue. Not awaiting a commandment from any governing body, Dr. Van Heest and her team took the initiative and added technical skills as an area of resident evaluation. We established an evaluation scale of 1-5 with 5 being outstanding. While initially we just used the scale on rotation reviews, the faculty wanted to expand that to include a high stakes test. Using data from the American Board of Orthopaedic Surgery on
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the 25 most common procedures, we selected the top three upper extremity procedures in order to develop a skills test. The test involves three stations, one for carpal tunnel release, one for distal radius plating, and another for trigger finger release. After each station there is a debriefing, which is really where the trainees learn the most. The faculty members go around to each station, have the students open things up again, and then immediately address any issues. This test is given each year starting in the second year of residency, thus making it possible for students to improve over time. Dr. Van Heest has a front row seat to the learning process. She notes, My
research has shown that you can predict that someone will fail on the technical skills from how well they did on the knowledge test; however, if someone does well on the knowledge test it does not necessarily mean that they will do well on the technical skills portion. Yes, residents must have a baseline of knowledge, but its not enough to only test knowledgewhich is what weve been doing for years. Now, thanks to a visionary company, ToLTech, and the American Academy of Orthopaedic Surgeons (AAOS), some orthopedic residents can train in a high tech, high touch environment. Dr. Van Heest says, AAOS has partnered with ToLTech, a company that has devel-
Traditionally, tests in the surgical specialties are knowledge basedbut being able to perform in the OR is a completely different issue.
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My colleagues and I have obtained an Innovation Grant from the American Orthopaedic Association (AOA), and have taken the same principles from the general surgery assessment and developed something similar for arthroscopy in orthopedics. The important thing is that it is not joint-specificthe goal is to teach the residents how to use the equipment, with a focus on navigation and object manipulation.
oped a knee arthroscopy simulator with haptics (meaning that surgeons can have tactile feedback as they operate). At present the company is validating its use in residencies, with our program being one of the test sites. These machines, which are costly, measure residents ability to do knee arthroscopy on a simulator. We have a group of residents who perform the surgery on a live patient and also have a control group that does not have a knee simulator. The data is still out, however. But a less expensive option for orthopedists in training is also now available. General surgery has adopted the requirement that all residents do a simulator program on the basic skills
of laparoscopic surgery. These training boxes cost a mere $300 per box and thanks to a grant, they are affordable and available for every surgical training program in the country. Residents train on six tasks that correlate to things they do in surgery; this way, they learn the basic skills of laparoscopy before they do it in the OR. My colleagues and I have obtained an Innovation Grant from the American Orthopaedic Association (AOA), and have taken the same principles from the general surgery assessment and developed something similar for arthroscopy in orthopedics. The important thing is that it is not joint-specificthe goal is to teach the residents how to use the
equipment, with a focus on navigation and object manipulation. At this point we have developed the prototype and are beginning to work with residents to get them to a more advanced level on the box. In the spring we will do a retestafter the residents have undergone significant training. Larry Marsh, M.D., a professor at the University of Iowa, and former Chair of the AAOS Evaluation Committee, was also awarded an AOA Innovation Grant. For several years I have worked with the AOA and the Council of Orthopaedic Residency Directors (CORD) to examine better ways to assess physician training. For four to five years committees of these organizations have worked on developing assessment tools in the six core competencies, but in the last year we have tried to create an assessment tool for surgical skills, something that falls under the patient care core competency. Our efforts are also clearly ones that will be welcomed by residentsthey rate obtaining technical skills as one of the most important things that they need to learn. And if young orthopedic trainees confer with their colleagues in other specialties, they might find the need to play some catch-up when it comes to manual skills training. Dr. Marsh: Orthopedics is somewhat behind in both teaching and assessing technical skills, in part due to the complexity and range
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The Assessment Tools Subcommittee of CORD has developed a seven question form that is now loaded into our hospital wide electronic system. Starting with the questions from the general surgery form, we then tailored the questions to orthopedics, essentially creating a tool that is meant to assess the basic skills that are common to hundreds of procedures. Some of these include, Was the resident well prepared? Did he or she know how to prep and drape the patient? How were their hand movements and dissecting abilities? etc.
of procedures. We are literally teaching hundreds of different surgical procedures, in contrast to general surgery, where they contend with only a relatively smaller number of procedures. In addition, perhaps orthopedists have not pushed for dedicated time for motor skills training because we are so busy that we have not taken the time to step back and engage in this detailed training. Compare our situation with that of general surgery, which even back in the mid 90s had publications assessing the use of simple questionnaires and scales to evaluate motor skills. We are just starting this process now and actually, we have used information from general surgery as a springboard to help develop our own tools. The residents at the University of Iowa are already benefitting from the work of Dr. Marsh and other committee members. The Assessment Tools Subcommittee of CORD has developed a seven question form that is now loaded into our hospital wide electronic system. Starting with the questions from the general surgery form, we then tailored the questions to orthopedics, essentially creating a tool that is meant to assess the basic skills that are common to hundreds of procedures. Some of these include, Was the resident well prepared? Did he or she know how to prep and drape the patient? How were their hand movements and dissecting abilities? etc. On each of these measures the residents are rated in comparison to their peers. We think that the questions, which each have a four-point scale, can be used to detect resident outliers who might need additional training. The scale was designed to have no in between options, i.e., the raters can choose between two satisfactory options (highly skilled or skilled) and two unsatisfactory options (less skilled or beginner). We have just begun using the form and are aiming to have faculty do three evaluations per resident per rotation. The questionnaire was designed to be easy and quick and to not interfere with surgeons daily routines. By the June 2011 meeting of the AOA we should have a good idea as to its utility. In the push toward simulated environments, says Dr. Marsh, the highest level work is that previously mentioned by Dr. Van Heest. This technology allows residents to be in a computer environment simulating knee arthroscopy looking at a screen with their hands on the handles. They are viewing the inside of a knee, moving the handles and using the haptics in the system (actually feeling things inside the virtual knee). With this level of sophistication comes an elaborate scoring scale. I dont, however, think that ten years from now well have a virtual reality simulator
in all orthopedic training programs. But the future is in better assessment and feedback regarding manual skills. Just as we now have mandated faculty assessments of resident performance in other competencies, in several years we will have mandated, formal assessment of motor skills. With new simulation and assessment tools future orthopedists can drive better patient outcomes the old fashioned waywith better surgical skills.
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company
Mesoblast Completes Angioblast Acquisition
esoblast Limited has completed the acquisition of its U.S. associate company, Angioblast Systems, Inc. The acquisition, first announced in May, was completed after the expiration of the required period for any anti-trust objection which may have been raised under the Hart-Scott-Rodino Act. The December 23, 2010, announcement stated that Mesoblast Limited is a world leader in commercializing biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). The company issued 90.8 million newly issued Mesoblast shares to new and existing investors, bringing the total number of company shares to 253.8 million.
Mesoblast Chairman Brian Jamieson said back in May, We are delighted to bring the commercial rights to the patented adult stem cell technology platform under one umbrella. With Mesoblast moving to 100% ownership of Angioblast, Mesoblast shareholders will derive much greater potential benefit from product commercialisation, and from the broader strategic partnerships or collaborations Mesoblast will now be able to conclude. From Biologics to Regenerative Medicine Professor Silviu Itescu is the recently appointed CEO and Managing Director of Mesoblast Limited. When the deal was first announced in May, Itescu said the acquisition would enable the Mesoblast Group to significantly broaden its product portfolio based on 100% ownership of the intellectual property underpinning the companys patented adult stem cell technology platform. Transforming Mesoblast from a biologics company focused on orthopedic applications to a global leader in the broader regenerative medicine industry should prove to be a pivotal event in the companys evolution. Mesoblast is now a mature multi-product company with products in late, mid, and early stage development. The companys product pipeline will be significantly extended beyond its orthopaedic focus, including spinal fusion and osteoarthritis, to include products for treating diverse conditions such as congestive heart failure, heart attacks, eye diseases, diabetes, and bone marrow repair, added Itescu.
Mesoblast was established in 2004 to develop therapies for patients with bone and joint diseases, and has acquired the worldwide license to commercialize orthopedic applications of proprietary adult stem cell technology developed by scientists at South Australias Hanson Institute and Institute of Medical and Veterinary Science (IMVS). WE (December 28, 2010)
legal
Smith & Nephew Receives FDA Warning
mith & Nephews Chairman in London, John G.S. Buchanan, received a lump of coal in his Christmas stocking from the FDA. Buchanan received a warning letter from the agency on December 21 that said the companys R3 Ceramic Acetabular Systems, manufactured in Tuttlingen, Germany, are not in conformity with the Current Good Manufacturing Practices (CGMP) requirements. The facility was inspected by FDA investigators on July 12, 2010. The FDA received a response from Les Sprinkle, Senior Vice President of Global RA/QA, dated August 11, 2010, in response to the observations made by the FDA from their inspection. The primary violations cited by the FDA include: Failure to adequately ensure that the process is validated with a high degree of assurance and approved according to established procedure
Mesenchymal stem cell expressing microtubule associated protein fusion/Wikimedia.org
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WE (December 29, 2010)
biologics
That Spare Tire a Stem Cell Lifesaver?

labby hips and thighs could turn out to be assets instead of liabilities, according to Malcolm Alison, professor of stem cell biology at Barts and the London School of Medicine and Dentistry. As reported in The Australian, on December 26, he recommends extracting stem cells from excess fat to keep on hand as a personal body repair kit. He notes that the beauty of human body fat is that, unlike existing sources of stem cells, including embryos, it is in plentiful supply and does not raise ethical concerns. Storing these cells is worthwhile because scientists are showing these are very versatile cells and it is best to use your own cells [in treatment], Alison said. He recommends that people store the cells before they fall ill because if you needed them for acute liver failure,
Smith & Nephew R3 cups/courtesy of Smith & Nephew
Failure to establish and maintain adequate procedures to verify or validate corrective action Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements Failure to document the justification for use of nonconforming product Failure to establish procedures for changes to a specification, method, process, or procedure The FDA left the following message in Mr. Buchanans stocking: We reviewed your responses and found [them] inadequate. A follow up inspection will be required to assure that corrections are adequate and an FDA trip planner will be in touch with to arrange a mutually convenient date for this inspection. The letter was signed: Sincerely yours, Steven D. Silverman
Director, Office of Compliance Center for Devices and Radiological Health Warning letters from the FDA are not legally binding, but the agency can take companies to court if they are ignored. Liz Hewitt, a spokeswoman for the company, reportedly said the warning has no effect on customers or product supply because the company makes the same parts at plants in Memphis, Tennessee, and Warwick, England. Weve been working with the FDA since the summer, she said. Another spokesperson reportedly told Reuters that the company has put in place remedial action; however, Presumably, the FDA is not happy. The spokesperson said there had been no reports of patient incidents. You can read the Warning Letter here: http://www.fda.gov/ICECI/Enforcem e n t A c t i o n s / Wa r n i n g L e t t e r s / ucm238125.htm
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waiting days (to extract and grow the cells) would be too late. The type of stem cells found in fat, mesenchymal stem cells, can develop into bone, fat or cartilage. Professor Alison is working on converting stem cells in fat into beta cells, which make and release insulin, a hormone that controls the level of glucose in the blood. Other researchers in his department are working at turning the stem cells in fat into cells to repair the liver and to treat central nervous system disorders. This isnt the first time, of course, that stem cell banking has been proposed. In 1988 the first successful cord blood transplant was made to a six-year-old boy in Paris to treat a blood disorder called Fanconis anemia. The procedure aimed to regenerate the boys blood and immune cells. From that beginning has sprung the wide spread practice of storing umbilical cord stem cells for treating potential future diseases. Today the collection, banking and transfusion of cord blood stem cells is used to treat more than 70 kinds of diseases including vari-
ous blood diseases, cancers and genetic disorders. As of last year, more than 400,000 cord blood stem cell units were banked at the Cord Blood Registry for use in more than 120,000 clients including hospitals and other medical centers. So the template is certainly in place for stem cell bankingwhether from adipose (fat) tissues or cord blood. BY December 28, 2010
of aging in culture. While retaining their youth they function as normal mesenchymal stem cells (MSC) and can differentiate into muscle, bone or nerve tissue depending on the range of chemical or biomechanical signals directed at the cells. A team led by Dr. Techung Lee developed the new cell lines by genetically engineering mesenchymal stem cells from bone marrow. He has named the new cells MSC Universal. According to Lee, the MSC Universal cell line can be sourced from any donor. Our stem cell research is applicationdriven, he said. If you want to make stem cell therapies feasible, affordable and reproducible, you have to overcome a few hurdles. Part of the problem is that you have a treatment, but it often costs too much. In the case of stem cell treatments, isolating stem cells is very expensive. The cells we have engineered grow continuously in the laboratory, which brings down the price of treatments. One of the mechanisms by which adult stem cells help regenerate or repair damaged tissues is by releasing growth factors that encourage existing cells in the human body to function and grow. Lee has previously published research that showed evidence that injecting adult stem cells into cardiac muscle can stimulate repair of the heart. More recently his lab has identified some of the factors involved in the stimulation of repair, information which was published in the journal Heart and Circulatory Physiology. The University of Buffalo has applied for a patent to protect Lees discovery.
Stem Cells That Refuse to Age

mbryonic stem cells are, by definition, immortal. Once these cells commit to a particular lineagelike mesenchymal cells which are the progenitor cells for bone, nerve tissue and musclesthey begin the process of aging and eventual death. Scientists are the University of Buffalo, however, have engineered mesenchymal stem cells that resist aging. Indeed, in the lab these cells show no evidence
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BY December 26, 2010
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large joints
FAI Athletes Respond to Surgery
an high level athletes with femoroacetabular impingement (FAI) resume their sport of choice after surgical hip dislocation? Even more to the point, can they even resume professional careers for any significant amount of time? As reported in the American Journal of Sports Medicine, published online December 20, four surgeons from the Department of Orthopedic Surgery, Spital Netz Bern-Ziegler, of Berne, Switzerland, developed a test to answer that very question. Twenty-two professional male athletes, average age 19, were evaluated for an average time period of 45.1 months (the range was 12 to 79 months) following surgical treatment for hip dislocation. Their Hip Outcome Scores
were SF-12 on the UCLA (University of California, Los Angeles) activity scale. The mean activity level was 7.6 on the Hip Sports Activity Scale and pain levels were at 1.8 on the visual analog scale during sporting activities. The primary outcome variable was the athletes return to professional sports. The clinical result was the secondary outcome variable. The study found that 21 of the 22 patients (96%) were still competing professionally, 19 at their previous level and 2 in minor leagues post surgical intervention. Eighteen (82%) were satisfied with their hip surgery and 19 (86%) with their sports ability. Their mean activity levels were 9.8 per the UCLA scale and 7.6 per the Hip Sports Activity Scale. Mean scores of the Hip Outcome ScoreActivities of Daily Living and Sport subscales were 94.5 and 89.1. Mean scores of the SF-12 physical and mental component summaries
were 51.1 and 54.3. The conclusion of the study was that surgical hip dislocation for the treatment of FAI does allow athletes to resume sports and continue professional careers at the pre-operative, preinjury level and to maintain that activity for several years. Clinical outcomes in terms of subjective ratings and scores were also favorable. BY December 28, 2010
Tough New Ceramic Introduced
5 Medical Werks, of Grand Junction, Colorado, a manufacturer of advanced ceramic components for the medical device industry, announced the launch, December 21, of cerasurf, a new high strength biocompatible ceramic material. The company called cerasurf a breakthrough material that delivers high strength and high fracture resistance in combination with low wear characteristics. The company expects the material to become an ideal choice for ceramic total hip replacement systems as well as next generation knee and femoral resurfacing devices. Dr. Steve Hughes, Orthopaedic Product Manager at C5 Medical Werks, said that cerasurf was an alumina matrix composite ceramic material which had been developed and produced in house using the companys proprietary technology. In industry standard femoral head burst tests he said, we are typically seeing values of greater than two times when compared to the FDA guidance figures. For the patient, this greatly reduces the risk of failure in vivo without compromising biological and tri-biological performance.
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Runners Who Sweat - Win

erspire a lot if you want to win the race! Runners who lost 3% or more of their body weight during a marathon finished faster, according to research published online December 21 in the British Journal of Sports Medicine.
C5 Medical Werks
given exactly the same advice to drink either 250 milliliters of water or energy drink every 20 minutes to avoid dehydration. Weather conditions were well suited for running with a temperature range of from 9 to 16 degrees C, moderate humidity although wind was a factor. The fastest runners were those who lost the most weight. Those who completed in four hours or more lost, on average, less than 2% of their body weight while those runners who required less time to finish the race (between three to four hours) lost an average of 2.5%. Competitors who completed the course in less than three hours lost 3% or more of their total body weight. Neither age nor gender had any impact on weight loss during the race, and there was no evidence that higher levels of weight loss impaired these runners
The company reported that, in addition to providing benefits to existing designs of femoral head and acetabular liner products, cerasurf is also being used as the material of choice for next generation ceramic orthopedic implants. The inherent high strength and fracture toughness of cerasurf allows for greater design flexibility said Dr. Hughes, who added that the use of high-purity cerasurf ceramic provides articulating surfaces with a lower friction and reduced wear characteristic when compared with metal or poly bearing surfaces. He believes that these properties may increase the lifetime of the implant as well as reduce the risk of osteolysis (bone degeneration) by reducing polyethylene particle generation. C5 Medical Werks is a wholly owned subsidiary of CoorsTec, the largest manufacturer of technical ceramics in North America. The publically owned company makes medical grade components with emphasis on ceramic materials certified to ISO 13485:203 and compliant with the FDAs Quality System Regulations. Product lines include ceramic implantable components used in orthopedic and dental applications. BY December 28, 2010
This finding is contrary to the conventional belief that a weight loss in excess of 2% impairs athletic performance. The study consisted of 643 contestants who completed the 2009 Mont Saint Michel Marathon in France. The runners, of whom 560 were men, were weighed before the races start, and immediately after to assess weight loss, and to determine whether such weight loss had any bearing on finishing times. The degree of weight change among the runners ranged from 8% loss of body weight to a 5% gain (how does that happen?). These body changes occurred even though all runners were
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athletic performance. On the contrary, the study results suggest that those who gained the most weight by drinking the most (9.5% of competitors), performed worse. The authors note that the body does not signal the intake of more water than it requires, and so overdrinking may be the result of behavioral conditioning. The authors suggested that such conditioning could be due to messaging from the sports drinks industry. Well, with this study in hand no doubt more runners will find the intestinal fortitude to just say no. BY December 26, 2010 school athletes who experience a sports-related concussion are less likely to return to play within one week of their injury if they receive computerized neuropsychological testing. Unfortunately, concussed football players are less likely to have this testing done than are students injured in other sports.
Too Often Concussive Athletes Go Untested
njured high school football players are not receiving critical neuropsychological testing, according to a study published December 15, in the American Journal of Sports Medicine. High
Although it is now recognized as one of the cornerstones of concussion evaluation, routine neuropsychological testing in the setting of sports-related concussion is a relatively new concept, write the authors of the study, William P. Meehan III, M.D., Pierre dHemecourt, M.D., and R. Dawn Comstock, Ph.D. This is the first study, of which we are aware, to query the use of computerized neuropsychological testing in high school athletes using a large, nationally representative sample. A total of 544 concussions were recorded by the High School Reporting Information Online surveillance system during
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the 2008-2009 school year. Researchers looked at each of those instances to determine what might have caused the injury, which sport was being played at the time of the injury, what symptoms did the athlete experience, what type of testing was employed, and how soon after the injury was the athlete allowed to return to play. When looking at the causes and duration of concussions, the investigators found that: 76.2% of the concussions were caused by contact with another player, usually a head-to-head collision 93.4% of concussions caused a headache 4.6% resulted in loss of consciousness 83.4% experienced resolution of their symptoms within a week, while 1.5% had symptoms that lasted longer than a month Computerized neuropsychological testing was used in 25.7% of concussions. In those cases, athletes were less likely to return to play within one week than those athletes for whom it was not used. The researchers did not discover why
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injured football players were less likely to be examined using the computerized neuropsychological testing than were athletes injured while participating in other sports. BY December 26, 2010
skeletal radiologists could, with good to excellent accuracy, predict the reparability of meniscal tears using the MRI. Fifty-eight patients whose meniscal tears had been treated with repair were matched by age and gender with 61 patients whose tears had been treated with meniscectomies. Two senior musculoskeletal radiologists then independently and blindly reviewed the preoperative MRIs of these 119 meniscal tears. Using established arthroscopic criteria, the radiologists graded each tear on a scale from 1 to 4, with one point for each of the following: a tear larger than 10mm a tear within 3mm of the meniscosynovial junction a tear greater than 50% thickness and tears with an intact inner meniscal fragment. Only a tear with a score of 4 would be predicted to be reparable. The two radiologists ability to correctly estimate reparability was poor. They made correct predictions in only 58.0% and 62.7% of the cases, respectively. The raters agreed on a score of reparable versus not reparable 73.7% of the time but came to identical scores only 38.1% of the time. Determining the status of the inner fragment was the most predictive individual criterion and the only one to reach statistical significance. The studys conclusion? Magnetic resonance imaging is not an effective or efficient predictor of reparability of meniscal tears under current arthroscopic criteria.
Runners ButtsDead or Alive?
Not So Predictive MRI

agnetic resonance imagingthe MRIhas often been the tool of choice for diagnosing of meniscal tears in the knee. But how good is the MRI at predicting whether a meniscal tear is reparable? To answer that question, six surgeons from the Department of Orthopaedic Surgery, David Geffen School of Medicine, UCLA, Los Angeles, California, and one from the Richmond Bone and Joint Clinic of Katy, Texas, joined together to conduct a major test of the imaging as reported in the American Journal of Sports Medicine, this past December 23. The test was to check the validity of the hypothesis that experienced musculo-
hen writer Jen Miller consulted her doctor about pain she experienced while training for a marathon, she did not expect he would tell her that her butt was dead. But dead butt syndrome is what Dr. Darrin Bright, a sports medicine physician with Riverside Methodist Hospital in Columbus, Ohio, and medical director of that citys marathon, identified as her problem. The technical name is gluteus medius tendinosis, an inflammation of the tendons in one of the three large muscles that form the butt. It can be prevented by cross and strength training. A new thought in running medicine is that almost all lower extremity injuries,
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BY December 26, 2010
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uses ultrasound to identify the affected muscles and injections of centrifuged blood products . Those runners who do multiple types of exercising are less prone to have weakness than runners who do just running, said Dr. Webner. Triathletes who come into my office dont have as much weakness as just solo runners. Jen is now biking, rowing and sweating through elliptical workouts at the gym. BY (December 23, 2010)
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extremities
New Size EGR for Foot Surgeons
whether they involve your calf, your plantar fascia or your iliotibial band, are linked to the gluteus medius, said Dr. Bright. In the last five to 10 years, weve just realized how much of an important role the gluteus medius plays in stabilizing the hips and the pelvis in running. As Bright explained to author Jen Miller in her December 21 New York Times article When the Diagnosis Is Dead Butt Syndrome: If you think of the pelvis as a cup, the muscles that attach to it, including the three gluteal muscles and the lower abdominals, interact in an intricate choreography to keep the cup upright when you run or walk. If these muscles are strong, the cup stays in place with no pain. If one or more of those muscles is weak, the smaller muscles around the hip take on pressure they werent designed to bear. The cup still stays up, but at a price. First come muscle tears and inflammation, followed by scar tissue in the muscle. If left untreated, this process becomes a cycle that keeps feeding into itself. For people who have persistent pain, its healing gone wrong, Dr. Bright
said. That gluteus medius isnt firing the way its supposed to. Youre getting an inhibition of the muscle fibers. Its kind of dead. Many runners experiencing pain adjust their strides in a way that can lead to problems in the quads, hamstrings, Achilles tendons, heels, calves, ankles, feet or toes. The majority of runners I see have weak gluteus medius and gluteus maximus muscles, said Dr. David Webner, a sports medicine doctor at Crozer-Keystone Health System in Springfield, Pa. For about 70% of his patients, physical therapy that stretches the muscles in the hip and leg and strengthens the gluteus muscles, along with a temporary reduction in the mileage and intensity of running, resolves the problem. Deep tissue massage, which sends more blood to the area to break up scar tissue, along with strength training may also help to break the cycle of inflammation and scarring. More advanced approaches include ultrasound guided tenotomy, which
oot surgeons now have a second sized Endoscopic Gastroc Release (EGR) from Integra LifeSciences Holdings Corporation to choose from. The Plainsboro, New Jersey, company announced on December 14 that its engineering team was ready to kick a second size of its Endoscopic Gastroc Release (EGR) System out the door and into the hands of podiatrists across the United States. The original EGR system was launched this past August. The EGR System, for those among our readers who are not familiar with the nuts and bolts of foot surgery, is an instrument
Morguefile
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designed to be employed by podiatrists attempting to perform endoscopic surgical correction for posterior heel cord or equinus contracture (EC). Integras EGR comes with an articulating blade that allows surgeons to more selectively cut soft tissues. Equinus contracture is a condition that limits ankle motion and has long been associated with spasticity in individuals with neurological impairment. Some researchers have also written that it may play a role in foot ulceration and in the development of other disorders, such as flatfoot. Since the first description of tendoachilles lengthening in the early 1800s by Delpech, release or attenuation of the superficial posterior compartment of the leg has been performed to relieve EC and improve gait and muscle balance across the foot and ankle.
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With Integras EGR System physicians can perform the recession of the gastrocnemius and soleus muscle complex endoscopically through a small incision, a minimally invasive and less traumatic procedure that produces a smaller and less apparent scar. Weve been very pleased with the response from surgeons, since the original launch of the EGR System in August 2010, said Pete Ligotti, Vice President of Sales and Marketing for Integra Extremity Reconstruction. The product has exceeded their expectations, not only with its exceptional visualization, but also by giving them more cutting control with our retractable blade system. Gastrocnemius recession is being used increasingly as a component in the surgical treatment of posterior tibial tendon dysfunction (PTTD), diabetic
forefoot ulcers, symptomatic acquired flatfoot, and hallux valgus. The EGR System will be sold by Integras Extremity Reconstruction sales organization, which focuses on lower extremity fixation, upper extremity fixation, tendon protection, peripheral nerve repair protection and wound repair. BY December 26, 2010
hand and wrist. The usual treatment is splinting or steroid injections and, when these fail, surgery. Dr. Nathan Wei, in a study entitled Ultrasound-Guided Percutaneous Injection, Hydrodissection, and Fenestration for Carpal Tunnel Syndrome: Description of a New Technique, recently published in the Journal of Applied Research proposes a new treatment. My colleagues and I feel carpal tunnel release can be performed using a small needle with ultrasound guidance. Relief is immediate and recovery time is 24 hours or less. Using this new technique, we performed 34 out of 44 wrist procedures after conservative measures had failed. No patient had had previous surgery, and two had had blind carpal tunnel steroid injections. When we measured the patient
Needling Carpal Tunnel
n ultrasound-guided needle may change the way carpal tunnel syndrome is treated. Carpal tunnel syndrome is caused when the median nerve, which runs from the forearm into the hand, becomes pressed or squeezed at the wrist. The result can be pain, weakness and numbness in the
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Hide the Car Keys
T
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an emergency, it may not be safe for that person to be driving, he said. The differences in time were significant. An individual traveling at a speed of 60 miles per hour traveled an additional 9.2 feet during emergency braking when wearing a right controlled-anklemotion boot. A driver wearing a right short leg cast traveled an additional 6.1 feet before coming to an emergency stop as did a driver using a left-foot braking adapter. The effect of immobilization devices on fine braking scenarios such as driving in stop-and-go traffic is not known, but study authors believe it is likely to be greater. Based on our findings, Dr. Dowd said, We cannot recommend that any patient return to driving using a brake adapter or wearing an immobilization device on the right foot. Orthopedic surgeons need to educate their patients about these safety concerns when discussing the best time to begin driving again. The study revealed that more than 90% of orthopedic surgeons would generally not recommend that a patient drive while immobilized in a right lower-extremity short leg cast. Also, under the terms of most insurance policies, the insurer is not obligated to cover accidents in which the driver is still recovering from an earlier injury or operation. BY (December 23, 2010)
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he first question a patient asks his doctor after right foot or ankle surgery is, DocHow soon can I drive? Though doctors want to see their patients resume normal activities as quickly as possible, they would do well to caution patience. A new study from the Journal of Bone and Joint Surgery (JBJS) shows that it takes much longer to brake when the driver is wearing an immobilization devicesuch as a splint or bracethan it does when wearing normal footwear. Thomas Dowd, M.D., an orthopedic surgeon in the Department of Orthopedics and Rehabilitation at Brooke Army Medical Center in Fort Sam Houston, Texas, measured emergency braking time in people using a brake adapted for use by the left foot, and for individuals wearing a short leg cast, a controlled ankle-motion boot, or normal footwear. The results showed that all of the devicesexcept the normal footwearimpaired the drivers ability to brake quickly. We only tested emergency braking situations, but it is reasonable to assume that if a person cannot stop quickly in
outcomes we found that 29 patients showed improved progress while only 5 had outcomes poor enough to be classified as failures. We encountered no complications and none of the patients in this study reported a worsening of their carpal tunnel symptoms. Dr. Wei believes that ultrasound-guided hydrodissection and fenestration is a minimally invasive therapy for carpal tunnel syndrome that can result in prolonged symptom relief, and may be a way to postpone, or even eliminate, the need for open release. The study notes that this new technique reduces the level of invasiveness and promotes faster recovery. The procedure can be performed in an office setting with no general anesthesia. Nathan Wei, M.D. is a graduate of Swarthmore College and the Jefferson Medical College. He completed his residency at the University of Michigan Medical Center in Ann Arbor, Michigan, and his fellowship in arthritis at the National Institutes of Health in Bethesda, Maryland. Dr. Wei is a national expert in rheumatoid arthritis and osteoarthritis and is the author of more than 500 publications. BY December 26, 2010
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people
Gladney Takes Over Lanx
an Gladney is Lanx, Inc.s new leader. Has the company finally put its CEO house in order? The company announced on December 15 that Norwest Equity Operating Partner, Dan Gladney, has agreed to become the companys new CEO. We called to make sure. This ends the curious episode earlier in the year when former Medtronic executive Michael DeMane had been announced as the new CEO. Shortly after the initial announcement, the company said DeMane would not be the new CEO. Lanx CFO Steve Deitsch told OTW, While the DeMane situation certainly was newsworthy for Lanx in 2010, I would submit that the bigger story for Lanx is the rapid growth and market share gains experienced over the last few years. Lanx has one of the highest, if not the highest, sales CAGR (compounded annual growth rates) in spine since 2008 and is one of the top three privately held spinal implant companies (and is profitable). Deitsch said that during 2010 Lanx was led by recently added management team members, and medical device industry veterans: Jon Scott, Interim President (Medtronic), Lance DeNardin SVP of Sales and Marketing (Medtronic), himself (Zimmer), and Peter Williams, VP of HR. Jon has an operations background and was formerly Interim GM for MDTs surgical navigation business. Lance for the last several years was SVP of Sales for MDT. I spent seven years with Zimmer, most recently as VP of Finance, Global Reconstructive & Operations, added Deitsch.
ration. While at Compex, he repositioned and restructured the company, completed several acquisitions, and drove top line growth from an average of 5% per year to 15% in a declining market. Prior to Compex, Gladney served as President and CEO of Acist Medical Systems, a cardiovascular device start-up that was acquired by Bracco s.P.a. Gladney has also worked with Baxter and The Kendall Company, and was named as one of the Top 40 CEOs to Watch in 2004 by The Business Journal. Lanx in 2011
Dan Gladney/Norwest Equity Partners
Dan Gladney Gladney has more than 25 years of experience in the medical device industry, founding and leading companies in the orthopedic and cardiology sectors. As an operating partner at Norwest, Gladney evaluated and executed new investment opportunities and addon acquisitions within the healthcare products, services, and distribution industry sectors. He is Founder and Chairman of DGIMED ORTHO, a company focused on developing Orthopedic Trauma Implant products. Gladney also cofounded Heartleaflet Technologies, a high-tech cardiovascular device startup developing a percutaneous aortic heart valve system, which was acquired by Bracco s.P.a. In addition, Gladney served as Chairman, CEO, and President of Compex Technologies, a public company in the orthopedic and health and wellness electro therapy industry which was acquired by Encore Medical Corpo-
Lanx has a suite of fusion products, including the flagship Aspen Spinous Process Fixation System. Deitsch added, With thousands of successful Aspen implantations in the U.S. and in Europe, Aspen is the clear leader in the spinous process fixation market. In addition, Lanx is currently conducting a prospective, randomized clinical trial for Aspen. The company is scheduled to launch half a dozen new products in 2011. Jeffrey Thramann, M.D., Co-founder and Chairman of Lanx, said, His [Gladneys] specific operating experience as chief executive of several emerging medical technology companies and public company experience makes him an ideal fit for our organization. In short, Deitsch told OTW, Lanx has a proven product portfolio, experienced management team, interesting product pipeline and a new CEO with deep device experience. Gladney will take his new post on January 10, 2011. WE (December 28, 2010)
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THE PICTURE OF SUCCESS Dr. Thomas Fehring

By Elizabeth Hofheinz, M.P.H., M.Ed.
We are facing a real crisis that will likely result in patients I care about patients who have numerous body parts breaking down at oncenot being able to get the help they need. -- Dr. Thomas Fehring.
ou might say that in North Carolina, Dr. Thomas Fehring, Co-Director of the Hip and Knee Center at OrthoCarolina, is the last orthopedist standing. As the revision guy in his part of the country, Dr. Fehring takes patients who have been told not to hope for much and he makes them walk again. Dr. Fehring is also Vice President of the Knee Society, and has a particularly important long term goaldoing his best to ensure that older patients in the years to come have access to hip and knee replacement. Many orthopedic surgeons share Dr. Fehrings concerns and commitment to address the issue of accessibility to quality care in the United States. His concern for the elderly has its roots in Dr. Fehrings early years. Born on an Air Force base in Virginia, a young Thomas Fehring lost his father early in life, but he was blessed to have a devoted grandmother to guide him (and perhaps toss in a bit of gentle brainwashing). My grandmother said repeatedly, You are going to become a doctor and I never set my sights on anything else. I played college football at Wake Forest, and by the time I graduated had undergone four open operations. Not only did I see medicine as an opportunity to get up every day and help someone, but
as I began to learn about orthopedics, I found enjoyment in the biomechanics, and liked the fact that patients tend to get well (in contrast to other specialties). It was also helpful that my mom remarried a man who was an obstetricianhe was very encouraging of my goal to become a physician. Fumbles and interceptions in one arena would result in success in another. Dr. Fehring states, When I arrived at Wake Forest the football team was still basking in its league championship. Things went south, however, and we only won a couple of games during my first year. I was disheartened, and I needed a place to succeedI found that at the library. Who knowsif we had been really successful on the football field perhaps I would not have applied myself as much in the academic realm. As one of the go-to surgeon for revisions in this area, I see very interesting cases, many of which involve infections. What is especially interesting to me is to take someone who hasnt walked in a yearand who has been told by other surgeons not to hope for muchand make it possible for them to walk. The patient population that receives Dr. Fehrings skilled, compassionate
Dr. Thomas Fehring
treatment every day is no mistake. Yes, selecting joint replacement as a career probably has something to do with the fact that I was raised by my grandmother. In general, I am drawn to working with older patients. These patients are very appreciative, in part because they have multiple medical problems to deal with. They have body parts that are no longer cooperatingin contrast to a 25-year-old who feels invincible, gets fixed, and goes back to being invincible. We are all going to be old someday, and I get to see my future every day in the office. In part, says Dr. Fehring, he can thank a few mentors for helping him learn how to be of service to his patients. Dr. Neil Green at Vanderbilt used the Socratic method in order to force me to think deeply about clinical issues. Dr. Chit Ranawat made sure I understood the value of a balanced career, spending time in three areaspractice, teaching and research. Less concerned about the inflow of income, and more concerned about the outflow of orthopedists, Dr. Fehring is
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In general, I am drawn to working with older patients. These patients are very appreciative, in part because they have multiple medical problems to deal with. They have body parts that are no longer cooperatingin contrast to a 25-year-old who feels invincible, gets fixed, and goes back to being invincible. We are all going to be old someday, and I get to see my future every day in the office.
trying to bring attention to a looming crisis in hip and knee surgery. I have recently published an article in the Journal of Arthroplasty regarding the nearly inevitable manpower issue that is staring us in the face. A great many orthopedists who do high volume joint replacement are going to retire in the not too distant future. Also, residents are not selecting hip and knee arthroplasty careers as often as they used to, most likely because these surgeries are not highly reimbursed in contrast to spine and sports medicine. These factors combined mean that by 2016 approximately half a million joint replacements will not be performed because the supply of surgeons will not meet demand. Dr. Fehring is also concerned about the effect the Internet has had on the practice of medicine. Direct to consumer advertising has not necessarily been positive for the practice of medicine. Patients come to their physician asking for a certain technology or procedure that they have encountered during their research on the Internet. They fail to realize that the information they have obtained is unfilteredmarketing procedures and/or technologies that have not been proven to be as effective as existing technology. We as orthopedists have a responsibility to our patients to be the arbitrators of such information, distinguishing for them real advances from merely marketing hype. Dr. Fehring is doing his part to innovate through his research on hip and knee implants. I have been fortunate to help design a number of hip and knee products with some talented engineers. What is most important is to critically look at how the implants we are using today are performing in order to improve results for future patients. My research interests have focused on how to treat hip and knee implants that have failed, that is, revision surgery. We recently presented our multicenter study on treating one of the most difficult types of acetabular problemspelvic discontinuity with a custom triflange implant. Our data showed that this was successful in over 90% of cases. I have also done research on infections, finding that these conditions need to be treated aggressively to obtain the best results (usually with implant removal). In most cases, irrigation and debridement is not successful. I am working with a consortium around the country to learn more about periprosthetic infections. We have five high volume centers and have thus far published three papers on infection-related topics. To date we have found that if irrigation and debridement fails and the situation goes on to involve a two-stage reimplantation, then the failure rate is three times higher than if you do a twostage implantation right away. When Dr. Fehring sat down last year to make his list of annual goals, there was one that captured his attention and imagination more than any other. I felt a strong urge to give back, and moved forward with plans to start the OrthoCarolina Charitable Foundation. We have launched the program, and are focusing on orthopedic education, both in the U.S. and abroad. We have established multiple Allied Health scholarships for needy physical therapy, nursing, and surgical tech students, and are also sponsoring nurses to obtain their Orthopaedic certification. I am particularly excited about our international fellowship. We have just hosted our first international fellow, a surgeon from Tanzania. In April 2011 we have two orthopedic surgeons coming from Nicaragua, one of whom has excellent manual skills. I am proud that everyone in our group has made a significant donation of funds to make this program a reality. There are still challenges, of course. International fellows come here and train on Cadillac equipment and then must return to their countries and adjust to whatever they have. Hopefully we are teaching them techniques they can apply at home. Just as he thinks about the long-term well being of the patients in his waiting room, Dr. Fehring takes pains to ensure that his efforts abroad are also as lasting as possible. I always wanted to be involved in teaching rather than swooping into a country and doing a few procedures. Three years ago I began working with Health Volunteers Overseas, and have been to Nicaragua each year. Ive also been pleased that when I have reached out to colleagues around the U.S. they have responded by join-
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I am working with a consortium around the country to learn more about periprosthetic infections. We have five high volume centers and have thus far published three papers on infection-related topics. To date we have found that if irrigation and debridement fails and the situation goes on to involve a two-stage reimplantation, then the failure rate is three times higher than if you do a two-stage implantation right away.
ing me on trips. These experiences have only made me a better surgeon because I get to see how surgeons there are able to do so much with so little. The first case I did was billed as a routine total hip, but in fact the patient had a fused hip. I encountered bleeding, asked for suction and was handed a little towel. When I asked for suction again I was handed another towel. Fortunately, the patient ended up doing very well. When things are challenging, Dr. Fehring relies on a power outside of himself
for guidance. I am a faith-based person, and I dont for a minute think I am in control of everything. Depending on the patient and the situation, I may even say to the person, Lets just pray about your situation. And the personality traits that have made him a success? Experience has taught me the value of persistence I am a grinder and somewhat of a bulldog when it comes to setting and achieving goals. It has been a wonderful surprise to look back and see my
journey from private practitioner who started in a seven man group and who then helped build one of the biggest joint replacement centers in the country. I tell kids my kids, I made 950 on my SATs and have still managed to accomplish a few things. Dr. Thomas Fehringoperating in the present and attempting to change the future.
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Orthopedics This Week | RRY Publications LLC

Robin R. Young, CFA Editor and Publisher robin@ryortho.com Elizabeth Hofheinz, M.P.H., M.Ed. Senior Writer elizabeth@ryortho.com Walter Eisner Senior Writer walter@ryortho.com Tom Bishow Vice President of Sales tom@ryortho.com Biloine W. Young Writer bgwy@msn.com Suzanne Kirchner Production Manager suzanne@ryortho.com Jayme Johnson Production Coordinator jayme@ryortho.com Dana Bader Graphic Designer dana@ryortho.com
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VOLUME 7, ISSUE 1 | JANUARY 4, 2011

For all news that is Ortho, read on.

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Robin Youngs Entirely Subjective Ordering of Public Orthopedic Companies

30-Day Price Change

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Robin Youngs Orthopedic Universe

Lowest Price / Earnings Ratio (TTM)

Highest Price / Earnings Ratio (TTM)

Lowest P/E to Growth Ratio (Earnings Estimates)

Highest P/E to Growth Ratio (Earnings Estimates)

Lowest Price to Sales Ratio (TTM)

Highest Price to Sales Ratio (TTM)

Advertise with Orthopedics This Week

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Reclaiming the Patient Outcome Argument

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

The Change is Natural.

Allograft Membrane Transplants for Surgical Coverings

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

6th Annual Stem Cell Summit

Register Early and Save

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Experience it for yourself at www.nuvasive.com/experience

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Texas Spine and Joint Hospital/courtesy of TSJH

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Good Hands? Really? Assessing Surgical Skills

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Mesenchymal stem cell expressing microtubule associated protein fusion/Wikimedia.org

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

WE (December 29, 2010)

That Spare Tire a Stem Cell Lifesaver?

Smith & Nephew R3 cups/courtesy of Smith & Nephew

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Stem Cells That Refuse to Age

BY December 26, 2010

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Tough New Ceramic Introduced

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Runners Who Sweat - Win

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Too Often Concussive Athletes Go Untested

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Runners ButtsDead or Alive?

Not So Predictive MRI

BY December 26, 2010

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Needling Carpal Tunnel

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

THE PICTURE OF SUCCESS Dr. Thomas Fehring

Dr. Thomas Fehring

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

Let the Data Guys tune-up those old forecasts with: