29
VOLUME 7, ISSUE 11 | MARCH 29, 2011 1-877-817-6450 | www.ryortho.com picture of success week in review breaking news 4 Mutiny at Smith & Nephew Nine former employees of Smith & Nephew’s Visionaire team in Memphis are being sued by the company for conspiring to take company secrets and start their own business. A former colleague blew the whistle on them. See what the Complaint and Affidavits have to say. 9 Are Orthopedic Insiders Buying or Selling? Senior orthopedic company executives are voting with their pocket books on the future of Orthopedics and their specific companies. Based on the most recent public filings, these ultimate insiders are making some surprising bets. 12 Bringing Advanced Ortho- pedics to Africa HVO’s Orthopaedics Overseas pro- gram in Ghana, West Africa, was born of extensive coordination among a number of organizations. The staff and volunteers deal with an inordinate vol- ume of patients…and perform heroic lifesaving and limb salvage every day. 26 Dr. Charles Epps, Part I Dr. Charles Epps, winner of the 2000 AAOS Humanitar- ian Award, has trained more than 4,000 African American and minority medical students. The first African-American president of the AOA, Dr. Epps drove a taxi to finance his education. 16 New Tool for TKA Accu- racy ........................................ Orthopedist Wins Stem Cell Award .......................................................... Overweight Teens and Bone Health .......................................................... Ernest L. Sink, M.D. Joins HSS .......................................................... LDR Submits First 2-Level Cervical PMA .......................................................... New Polymer With Stem Cells .......................................................... Stem Cell Injection for Back Pain? For all news that is ortho, read on.

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Page 1: week in review 4 9 Are Orthopedic Insiders Buying or Selling?ryortho.com/03_29_11_Newsletter.pdf · week in review breaking news 4 ... Company Symbol Price Mkt Cap P/E Company Symbol

VOLUME 7, ISSUE 11 | MARCH 29, 2011

1-877-817-6450 | www.ryortho.com

picture of success

week in review

breaking news

4 Mutiny at Smith & Nephew ◆ Nine former employees of Smith & Nephew’s Visionaire team in

Memphis are being sued by the company for conspiring to take company secrets and start their own business. A former colleague blew the whistle on them. See what the Complaint and Affidavits have to say.

9 Are Orthopedic Insiders Buying or Selling? ◆ Senior orthopedic company executives

are voting with their pocket books on the future of Orthopedics and their specific companies. Based on the most recent public filings, these ultimate insiders are making some surprising bets.

12 Bringing Advanced Ortho-pedics to Africa ◆ HVO’s Orthopaedics Overseas pro-

gram in Ghana, West Africa, was born of extensive coordination among a number of organizations. The staff and volunteers deal with an inordinate vol-ume of patients…and perform heroic lifesaving and limb salvage every day.

26 Dr. Charles Epps, Part I ◆ Dr. Charles Epps, winner of the 2000 AAOS Humanitar-

ian Award, has trained more than 4,000 African American and minority medical students. The first African-American president of the AOA, Dr. Epps drove a taxi to finance his education.

16 New Tool for TKA Accu-racy........................................

Orthopedist Wins Stem Cell Award..........................................................Overweight Teens and Bone Health..........................................................Ernest L. Sink, M.D. Joins HSS..........................................................LDR Submits First 2-Level Cervical PMA..........................................................New Polymer With Stem Cells..........................................................Stem Cell Injection for Back Pain?

For all news that is ortho, read on.

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VOLUME 7, ISSUE 11 | MARCH 29, 20112

Orthopedic Power RankingsRobin Young’s Entirely Subjective Ordering of Public Orthopedic Companies

Rank Last Company TTM Op 30-Day Comment Week Margin Price Change

This Week: As we note in our feature article this week, corporate insiders are buying orthopedic equities. The people who live orthopedic product sales day in and day out are backing up the van and loading up on orthopedic company stocks. They know bargains when they see them.

1 1 Orthofix 14.49% 0.67%The quarter is almost over. Analyst consensus is a

mere 0.50% sales growth rate. Yeah, right.

2 2Wright Medical

7.34 5.04One of the top performers this past month on the strength of renewed interest in extremity products.

3 4 Zimmer 27.38 (3.81)Doesn’t get Astra Tech’s dental deal, but we like

the willingness to bargain shop. This is the right time to buy.

4 3 Medtronic 31.23 (2.03)How can a medical technology company sink to a level where it is referred to as a value and dividend

play? Maybe MDT is too large.

5 5 Stryker 25.61 (3.08)Speaking of dividends, SYK raised its dividend

about 20%. Now yielding 1.2%.

6 6Smith & Nephew

23.22 (4.20)Wound care could deliver upside surprises this

quarter. But analysts are on the record predicting down EPS this quarter.

7 9 Alphatec 1.11 (1.13)About 12% of ATEC’s sales are from Asia Pacific, including Japan. Still, ATEC is gaining market

share across the board.

8 8 NuVasive 6.69 (9.77)Until the spine market’s visibility improves,

most analysts are taking an overly conservative approach to NUVA.

9 7 Exactech 9.66 (3.61)Most analysts expect EXAC to grow about 6% this

quarter and 9% for the year.

10 10Integra

LifeSciences15.18 (5.47)

What’s new? Not much. Most analysts forecasting moderate growth this quarter.

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VOLUME 7, ISSUE 11 | MARCH 29, 20113

Click Here for more detailsor email [email protected] Bishow: 410.356.2455 (office)or 410.608.1697 (cell)

Advertise with Orthopedics This Week

Robin Young’s Orthopedic Universe

Company Symbol Price Mkt Cap 30-Day Chg Company Symbol Price Mkt Cap 30-Day Chg

Company Symbol Price Mkt Cap P/E Company Symbol Price Mkt Cap P/E

Company Symbol Price Mkt Cap PEG Company Symbol Price Mkt Cap PEG

Top Performers Last 30 Days

Lowest Price / Earnings Ratio (TTM)

Lowest P/E to Growth Ratio (Earnings Estimates)

Worst Performers Last 30 Days

Highest Price / Earnings Ratio (TTM)

Highest P/E to Growth Ratio (Earnings Estimates)

Company Symbol Price Mkt Cap PSR Company Symbol Price Mkt Cap PSR

Lowest Price to Sales Ratio (TTM) Highest Price to Sales Ratio (TTM)

1 TranS1 TSON $3.99 $83 18.0%2 RTI Biologics Inc RTIX $2.86 $157 7.9%3 CryoLife CRY $5.71 $158 7.3%4 Wright Medical WMGI $16.88 $641 5.0%5 Tornier N.V. TRNX $19.00 $728 2.8%6 Symmetry Medical SMA $9.48 $341 2.6%7 Mako Surgical MAKO $21.22 $866 2.1%8 ConMed CNMD $26.81 $758 1.0%9 Orthofix OFIX $31.67 $571 0.7%

10 Johnson & Johnson JNJ $58.98 $161,320 -1.1%

1 Bacterin Intl Holdings BONE $3.68 $134 -22.5%2 Orthovita VITA $2.11 $162 -12.8%3 NuVasive NUVA $25.20 $999 -9.8%4 TiGenix TIG.BR $1.85 $58 -8.0%5 Integra LifeSciences IART $46.80 $1,340 -5.5%6 Kensey Nash KNSY $25.44 $217 -4.6%7 Smith & Nephew SNN $55.63 $9,930 -4.2%8 Medtronic MDT $38.36 $41,020 -3.8%9 Exactech EXAC $17.89 $233 -3.6%

10 Stryker SYK $61.12 $23,910 -3.1%

1 Medtronic MDT $38.36 $41,020 11.292 Kensey Nash KNSY $25.44 $217 11.803 Johnson & Johnson JNJ $58.98 161,320 12.704 Average $11,813 13.055 Zimmer Holdings ZMH $60.74 $11,670 13.76

1 Smith & Nephew SNN $55.63 $9,930 75.622 RTI Biologics Inc RTIX $2.86 $157 32.733 ArthroCare ARTC $33.13 $902 24.834 Symmetry Medical SMA $9.48 $341 22.315 ConMed CNMD $26.81 $758 20.90

1 Orthofix OFIX $31.67 $571 0.652 Integra LifeSciences IART $46.80 $1,340 0.663 NuVasive NUVA $25.20 $999 1.114 Exactech EXAC $17.89 $233 1.145 Medtronic MDT $38.36 $41,020 1.23

1 Kensey Nash KNSY $25.44 $217 3.372 CryoLife CRY $5.71 $158 2.963 Johnson & Johnson JNJ $58.98 161,320 2.074 ConMed CNMD $26.81 $758 2.035 Wright Medical WMGI $16.88 $641 1.98

1 Symmetry Medical SMA $9.48 $341 0.932 RTI Biologics Inc RTIX $2.86 $157 0.953 Orthofix OFIX $31.67 $571 1.024 ConMed CNMD $26.81 $758 1.055 Wright Medical WMGI $16.88 $641 1.22

1 Mako Surgical MAKO $21.22 $866 19.622 TiGenix TIG.BR $1.85 $58 17.913 Bacterin Intl Holdings BONE $3.68 $134 10.984 Synthes SYST.VX $134.82 $16,003 4.345 TranS1 TSON $3.99 $83 3.30

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VOLUME 7, ISSUE 11 | MARCH 29, 20114

Austin Bird, a Smith & Nephew vice president in charge of the com-

pany’s Visionaire program in Memphis, received an unusual phone call on March 8, 2011 from Jennifer Griffin, a project engineer.

Griffin told Bird that nearly the entire Visionaire team had been planning to stage a mass resignation and start a new company using the company’s confi-dential information with the purpose of offering consulting services to the com-pany and, eventually, the company’s competitors.

Three days later, March 11, the com-pany filed a lawsuit against the group in the Shelby County Chancery Court.

The company is accusing nine former employees (Defendants) of conspiring to use company trade secrets regarding Visionaire, a patient matched instru-mentation program for knee replace-ment surgeries, to start their own com-peting business.

According to the Complaint and accompanying Affidavits from Bird and Griffin, the Defendants were motivated

by fears that a company reorganization would take the group’s knowledge and then outsource all their work.

The suits asks for $56 million or more over breach of contract, mis-appropriation of trade secrets, civil conspiracy, other allegations and a temporary injunction to prevent the Defendants from taking any action to harm S&N.

Mutiny at Smith & NephewBy Walter Eisner

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Photo manipulation by RRY Publications. Source: Smith & Nephew and Wikimedia

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VOLUME 7, ISSUE 11 | MARCH 29, 20115According to the suit, this is a conspira-cy that "involves several engineers, their managers, the department supervisor and a director who committed overt acts with the collective intent to use S&N's trade secrets and confidential information to start a competing busi-ness and intentionally and maliciously interfere with and disrupt S&N's ongo-ing business."

The Accused

The accused are: David Mehl, Luke Gibson, Megan Rumery, Andrew Wald, Ashley Deken, Carey Bryant, Kaleigh Ross, Patrick Conway and Bonnie Walker.

Wald, Deken, Ross, Conway and Walk-er were product development engineers who reported to their engineering man-agers, Gibson and Rumery. The man-agers in turn, reported to Mehl, the Product Development Manager. Mehl reported to Bryant, the Group Director. Ultimately, Bryant reported to Bird.

Visionaire Beginnings

Visionaire is a system which allows sur-geons to obtain pre-operative images of a patient's anatomy and submit them to product engineers who prepare cus-tomized patient instrumentation. This allows surgeons to remove the correct segments of bone so the knee compo-nents, when attached, fit better.

The company tells surgeons that it can do this within three weeks of receipt

of electronic imaging data. Therefore the company depends "entirely on its ability to properly interpret elec-tronic imaging data and correctly and efficiently manufacture the custom-molded instrumentation...by product development engineers in Memphis."

Griffin has been with the Visionaire program since its inception in February 2008 when the product was in clinical trials and was known as "Fit-U." Vision-aire officially launched in 2009.

Rumery was hired at the same time as Griffin and eventually promoted to the role of supervising product engineers and was Griffin's direct supervisor. According to the Complaint, Rumery was, "instrumental" in creating new code for software called "Mask."

Mehl developed a three-dimensional software called "Unigraphics" which is modified by the output from "Mask," to create specific patient matched instru-mentation.

Both programs are needed to create S&N's Visionaire and, according to the company, only Rumery, Wald, Conway, and Ross can write, modify, or update "Mask" code.

Alleged Conspiracy

Griffin says in her Affidavit that Mehl called her into his office about a month ago. He allegedly explained that a group of engineers and managers "were unhappy and were planning to leave

S&N, form their own corporation, take information from S&N, and consult for S&N and eventually S&N's competi-tors."

Griffin says Mehl told her that Rumery, Gibson and he had devised their plan at the AAOS meeting in San Diego the week of February 14, which the three attended on behalf of S&N.

Griffin heard no more about this until she received a call from Kaleigh Ross on February 27. She said Ross asked her if she had a meeting with anyone about leaving the company. Ross alleg-edly told her that Mehl and Rumery had met with all of the engineers (except Maroun Tarsha) regarding leaving the company to start a new company.

Ross, says Griffin, told her on March 1 that a meeting had been scheduled that evening at Conway's house in down-town Memphis. Griffin chose not to

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VOLUME 7, ISSUE 11 | MARCH 29, 20116attend. However when she got home, she got a call from Mehl, who told her she needed to come to the meeting. She agreed and arrived at the meeting at 7:30 p.m. All the Visionaire engineers and managers were there except for Tarsha and Rumery. Mehl led the meet-ing where, allegedly, a proposed busi-ness plan, exit strategy, and the group’s rationale for leaving the company were discussed.

Outsource Fears

Mehl, according to Griffin, told the group that management was not fight-ing for Visionaire to stay within the group. Mehl said that S&N wanted to keep the Visionaire group as a case processing group, learn what the group knew, and then outsource all of Vision-aire processing, essentially leaving the group without a purpose.

He further allegedly told the group that they could take "Mask" and "Unigraph-ics," and S&N would have to sign a contract with them to design fixes for the software and complete and process Visionaire cases for the company. They would also consult with S&N competi-tors "on how to optimize their training/process and how to increase efficiencies using patient matched technology."

Griffin said Gibson presented a Pow-erPoint presentation on an exit plan strategy and various outcomes depend-ing on whether or not S&N took legal action or enforced the group's non-compete agreements.

Work Slowdown

After the March 1 meeting, Griffin says the team slowed their work and decreased productivity on patient cases in order to increase their worth as a new company. As more cases remained

incomplete, Griffin says the group believed the system would crash.

On March 8, Griffin said Mehl told her that he was not doing any more of S&N's work and was only focusing on the new company. She immediate-ly made notes documenting what had been discussed.

Griffin met with Rumery on the same day for her year-end review. There was no review; Griffin says Rumery only discussed plans to start a new company.

She also states in her affidavit that she had received an email from Walker encouraging the Defendants to copy and delete all info/material from their S&N computers and to come up with new names for the “Mask” software. The next day, she says she copied the software to protect it from sabotage by the Defendants.

Final Meeting

Again, according to information in Griffin’s affidavit, the group met again the evening of March 8 at the Blue Monkey restaurant. All managers and engineers involved in the project, except Bryant, Hartmann and Tarsha, attended.

According to Griffin, Mehl, Rum-ery, and/or Gibson told to her that Bryant was willing to fund the new company with anywhere from $100,000 to $300,000, and that Bryant's legal counsel had advised him that S&N would not pursue the group's non-compete agree-ments, because science and tech-nology is always changing and that Defendants could not be held liable for any process that they were even slightly altering to create new intel-lectual property.

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VOLUME 7, ISSUE 11 | MARCH 29, 20117

The Complaint

The company claims it will suffer immediate and irreparable harm if the confidential information about the pro-prietary process is disclosed or used by a competitor.

The company says its competitive advantage in the marketplace for patient-matched instrumentation is its ability to produce that instru-mentation in three weeks. "The dis-closure of the process which allows

S&N to meet that goal would cause immediate harm to S&N's goodwill in the marketplace and create an irreparable and immeasurable loss of that competitive advantage," states the Complaint.

Furthermore, the company claims that all the Defendants signed Confidential-ity, Non-Compete and Non-Solicitation Agreements.

The company accused the Defendants of the following:

Breach of Contract (Confiden-tiality)—Defendants used and/or disclosed information about the "Mask" system for the purposes of setting up a company to compete with S&N.

"For any provable and proximate damages...S&N seeks damages against the Defendants individu-ally in an amount no less than $1 million.”

Breach of Contract (Non-Com-petition)—Defendants engaged in activities which compete with S&N. The company also seeks $1 million individually against the Defendants.

Procurement of Breach of Con-tract—The company claims each Defendant was aware that every other Defendant (except Carey Bryant) had signed confidentiality and non-competition agreements. “By their actions they attempted to unlawfully induce every other Defendant (except Bryant) to breach their agreements, making them liable for actual and treble damages.”

Misappropriation of Trade Secrets—Defendants misappro-priated trade secrets by "surrepti-tiously making copies of at least the "Mask" program and the 'Unigraph-ics model'...for the use in forming a new company." As a result the com-pany seeks no less than $20 mil-lion from each Defendant individu-ally, plus applicable statutory, treble damages and/or common law puni-tive damages.

Intentional Interference With Business Relations—Each Defen-dant intentionally interfered with

Mike Brown and the Commercial Appeal

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VOLUME 7, ISSUE 11 | MARCH 29, 20118and disrupted S&N's business rela-tions with its customers and sup-pliers with the "malicious intent" to cause harm to S&N. As a result the company seeks damages against each Defendant for no less than $1 million.

Civil Conspiracy—Defendants engaged in a civil conspiracy to, among other things, unlawfully interfere with and disrupt S&N's business relations with its custom-ers and suppliers. That's another $1 million plus punitive damages per Defendant.

Punitive Damages—Defendants were reckless and malicious with the intent to cause harm to the

company. As a result, the compa-ny seeks punitive damages in an amount "sufficient to punish" the Defendants.

Injunctive Relief—The company wants a Restraining Order to enjoin each Defendant from further viola-tions of their agreements with the company and prevent them from rendering any service to anyone competing with S&N.

S&N’s Message

Company spokesman Andrew Burns told OTW that a temporary restraining order was issued on March 11 and will stay in effect until a hearing scheduled for July 14.

A company statement said that all Defendants have been terminated from employment at the company and “have taken this legal action in order to pre-vent further attempts to steal intellec-tual property and to ensure they can-not use Smith & Nephew confidential information for personal benefit.”

The alleged mutiny in Memphis is now public record. The company’s swift and public response likely sends a loud message to the rest of the crew at Smith & Nephew. ◆

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VOLUME 7, ISSUE 11 | MARCH 29, 20119Are Orthopedic Insiders Buying or Selling?By Robin Young

In the U.S. stock market, all players are supposed to be buying and sell-

ing securities based on equal access to material information.

In 2002, ImClone CEO Samuel D. Waksal passed along some key informa-tion to his friends and family about his company’s FDA progress. His daughter, Aliza Waksal, sold $2.5 million of her shares in ImClone stock on Decem-ber 27. Waksal’s father sold $8.1 mil-lion worth of ImClone shares. Even ImClones general counsel, John B. Landes, sold $2.5 million of ImClone shares. Waksal pleaded guilty to illegal insider trading and received a seven-year prison sentence.

Martha Stewart, who knew Waksal and owned ImClone stock also sold, lied about it and was also sentenced to prison.

By definition, company executives or “insiders” have information about a company’s prospects that outsiders do not have. They know, for example, what new products are in the pipeline, how FDA applications are progressing (or not), how product demand is develop-ing, what the competition is doing and so forth.

In one form, as was demonstrated in the Waksal/Stewart case, trading on spe-cific, non-public information is a quick path to prison.

But…there is another, LEGAL way for executives at public companies buy or sell stock in their own company even if they have material non-public information.

Under SEC and other rules and prec-edents, insiders are able to purchase or sell shares in their company’s stock at cer-tain times of the year, by filing with the SEC that they plan to buy or sell shares, by disclosing how many shares and for how much or if these transactions are the exercise of their stock options.

In those cases, insiders can and do buy and sell—despite having insider knowledge of the most sensitive kind. Furthermore, these insiders are perfect-ly within their rights to make these buy-ing and selling decisions based on that information and for their own benefit.

They just have to be transparent about the transactions.

The good news is that non-insiders can watch what the insiders buy or sell and, even though they may not know

Thomas O’Halloran and Wikimedia Commons

Tampa’s Premier Surgical Training Center

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VOLUME 7, ISSUE 11 | MARCH 29, 201110the precise reason for those actions, they can reasonably infer that insiders are acting in their own self interest.

As it happens, there are many studies that support the idea that insider trad-ing is, in fact, based on insider infor-mation.

Former University of Illinois finance Professors Josef Lakonishok and Inmoo Lee, who now work for the private sec-tor, calculated insider trading returns from 1975 to 1995 and found that they were 7.7% higher and 4.8% higher on a risk adjusted basis to either standard returns or naïve returns.

In 1986 University of Michigan Pro-fessor Nejat Seyhun found that insid-ers had received abnormally positive returns of 4.3% for the first 300 days for firms with more insider purchases than sales and a negative 2.2% over the first 300 days for firms with more insider sales than purchases.

Two years after Seyhun’s study, Har-vard University’s Leslie Jeng and Richard Zeckhauser and Yale Univer-sity’s Andrew Metrick studied insider purchases and sales and discovered that, without any sort of screen-ing for size of transaction nor risk adjusting transactions, that insider purchases beat market returns by 11.2% per year.

More recently, there was a fascinat-ing study published last year in the Journal for The Society for Financial Studies which found a strong inverse relationship between insider trading and institutional demand. Turns out institutions provide the liquidity nec-essary for insiders to buy or sell stock. Second, insiders are more likely to buy shares in their companies at times of low valuations and low lag returns

while institutional investors are likely to do the opposite (i.e., buy high and sell low).

The authors' conclusions? Insiders are more likely to view their stocks are

overvalued (or undervalued) following a period when institutions are net buy-ers (or sellers).

In short, insiders know exactly what they are doing.

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VOLUME 7, ISSUE 11 | MARCH 29, 201111Which brings us to insiders at 19 pub-lic manufacturers/suppliers of orthope-dic products. Over the last six months insiders at public orthopedic companies have purchased in either open market purchases or through stock option pro-grams 3.357 million shares of their own company’s stocks while selling a much smaller 1.969 million shares.

Orthopedic company insiders bought 70% more shares than they sold over the past six months.

The following table shows which ortho-pedic companies have had the strongest insider buying:

Of those companies whose insiders are net buyers, the ratio of buys to sell is a whopping 5 to 1.

The following table shows which ortho-pedic companies have had the strongest insider selling of their stock;

There are, of course, many reasons for buying and selling shares of one’s own company. In Stryker’s case, for example, the vast majority of those sales were by Ronda Stryker who is, no doubt, adjusting her estate and as a percent of the roughly 16 million shares the Stryker family holds, these sales are a small percentage.

The aggregate buy/sell pattern is crys-tal clear. Orthopedic insiders are buy-ing orthopedic stocks. Last week, the average P/E for an orthopedic com-pany was 12.93. The average price to sales was 2.66. And the ratio of P/E to expected growth was just 1.17. In short, insiders know bargains when they see them. And they are voting with their pocket book. ◆

Source: Yahoo! Finance/RRY Publications, LLC

Orthopedic Companies With the Strongest Insider Buying

From 10/1/10 to 3/31/11 Insider

BUYS Last Six Months

Insider SELLS Last Six Months

Percent of BUYS to SELLS

1 Alphatec Holdings 109,636 86,423 127%

2 ArthroCare 98,861 14,733 671%

3 CryoLife 201,334 32,502 619%

4 Exactech 193,538 104,874 185%

5 Kensey Nash 27,318 15,950 171%

6 Mako Surgical 1,174,041 179,657 653%

7 NuVasive 175,413 13,462 1303%

8 Orthofix 74,341 1,741 4270%

9 RTI Biologics Inc 283,283 - 100%

10 Symmetry Medical 401,163 - 100%

11 Tornier N.V. 17,500 - 100%

12 TranS1 10,000 - 100%

13 Zimmer Holdings 125,884 103,722 121%

TOTAL 2,892,312 553,064 523%

Source: Yahoo! Finance/RRY Publications, LLC

Orthopedic Companies With the Strongest Insider Selling

From 10/1/10 to 3/31/11 Insider

BUYS Last Six Months

Insider SELLS Last Six Months

Percent of BUYS to SELLS

1 Conmed 117,756 167,213 70%

2 Integra LifeSciences 209,803 619,665 34%

3 Stryker 137,731 625,973 22%

4 Wright Medical - 3,401 0%

TOTAL 465,290 1,416,252 33%

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VOLUME 7, ISSUE 11 | MARCH 29, 201112

If you ever need proof that a good idea won’t die, just look at the Ortho-

paedics Overseas* program in Ghana, West Africa. Born of extensive coordi-nation among a number of organiza-tions, including the American Acad-emy of Orthopaedic Surgeons (AAOS), the Orthopaedic Trauma Association (OTA), and Health Volunteers Overseas (HVO), the program was crafted during the recent economic downturn and is beginning to find its wings.

Dr. Peter Trafton, a semi-retired trau-matologist from Brown University, is the program director of HVO’s Ortho-paedics site in Ghana. He states, “The new residency program at the Komfo Anokye Teaching Hospital (KATH), in Kumasi, Ghana, is an outgrowth of efforts by AAOS, OTA, and the Pediat-ric Orthopaedic Society of North Amer-ica and others—efforts that extend back to the year 2000. Known as the Afri-can Cooperative Education Program, it was a highly developed project with detailed curricula for orthopedic edu-cation that would eventually be avail-able in numerous African countries. As the financial crisis hit in 2007, how-ever, it was clear that the program was not going to be fundable to the level of excellence that was desired.”

Every initiative needs stewards…people who can see a way through the problems and feel a connection to the project. Paying homage to his col-

leagues, Dr. Trafton says, “Lynne Dowl-ing, director of the international depart-ment at AAOS, along with Dr. Oheneba Boachie-Adjei, the esteemed chief of the Scoliosis Service at Hospital for Special Surgery—and a Ghanaian—wouldn’t let go of the possibility of developing a program for Africa. He and Lynne are the godparents of this program.”

An English-speaking country, politically stable with a better-than-average Afri-can economy, Ghana was an obvious choice for those moving this program forward. “The other thing that made it

interesting,” says Dr. Trafton, “was the new national trauma center next door to the teaching hospital. Dick Fisher, the president of HVO’s Orthopaedics Over-seas, and Dr. Boachie worked to obtain approval from the national authorities to establish the residency. The hospital had already hired three German-trained Ghanaian orthopedic trauma surgeons. After the program officially began in fall 2010, I was honored with being the first volunteer.”

Even with volunteers, says Dr. Trafton, this skeleton crew has its hands over-

Bringing Advanced Orthopedics to AfricaBy Elizabeth Hofheinz, M.P.H., M.Ed.

They see between 15 and 20 significant injuries per day (but only have 100 beds). The reality is that people sometimes must be turned away. It is not unusual to have to canvas the wards to see who can be sent home so that someone else can take their place. “

Morning Reports/Dr. Peter Trafton

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VOLUME 7, ISSUE 11 | MARCH 29, 201113

flowing. They are juggling an inordi-nate—by Western standards—number of severe injuries on a daily basis. Dr. Trafton: “Traffic accidents are a major epidemic in this part of the world, with the volume increasing rapidly. They see between 15 and 20 significant injuries per day (but only have 100 beds). The reality is that people sometimes must be turned away. It is not unusual to have to canvas the wards to see who can be sent home so that someone else can take their place.”

With the constant flow of desperately injured patients coming in from two and four wheeled accidents, there is no

coffee break for the weary. “The Gha-naian staff surgeons feel overwhelmed, but are now fortunate to have three orthopedic residents, as well as several general surgery residents who rotate through the orthopedic service. The good news is that the hospital is solidly behind the program, which will hope-fully mean an increasing number of residents and resources being directed to orthopedics.”

And the details of the training pro-gram? “The curriculum, full of hands-on training and in-depth lectures, was established by the Ghanaian College of Physicians and Surgeons, and is fairly

equal to what one would expect in an American orthopedic residency. The differences emerge ‘on the ground’ because the volume of trauma patients is so heavy that the balanced curricu-lum that the Residency Review Com-mittee in the U.S. would want to see is hard to reproduce. Essentially, it is difficult to ensure that trainees receive the full complement of surgical expe-riences. For example, the residents are not usually exposed to the spectrum of treatment for developmental hip dys-plasia; also, they must leave scoliosis care to the visiting surgeons because

Ward Rounds/Dr. Peter Trafton

The goal is to develop skills within the group; to this end we are recruiting plastic surgeon volunteers to come over and teach. In the meantime, the surgeons are making do without things such as negative pressure wound dressings. They are working on ways to improvise this expensive technology, such as use of reversed aquarium pumps and locally available foam, as described on the website, An Orthopod’s Workbench.

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VOLUME 7, ISSUE 11 | MARCH 29, 201114

they are not prepared to deal with spi-nal deformity.”

Breaking down the three types of ortho-pedic trauma and how they are man-aged at Komfo Anokye Teaching Hos-pital, Dr. Trafton notes, “First, there are the lifesaving situations. The Ghanaian orthopedists are routinely encountering patients with multiple severe fractures and/or an unstable bleeding pelvis, cases that are made even more difficult because of a shortage of blood. In the U.S., one might go through 40 units of blood with a bad pelvic fracture; at KATH they have to send out a call for donors. On another note, they can han-dle multiple long bone fractures pretty well at the same time they are resusci-tating patients…I have seen some won-derful ‘saves’ there.”

As for limb salvage, not only are the Ghanaian surgeons accustomed to these procedures, they are adept at

using things that aren’t meant for sur-gery…for surgery. “Limb threatening open fractures are something that these orthopedists handle all the time; the challenge is how to cover the wound so that it won’t get infected. The staff surgeons are quite comfortable with external fixation, however they must often rely on the more junior doctors to handle the debridement. The goal is to develop skills within the group; to this end we are recruiting plastic surgeon volunteers to come over and teach. In the meantime, the surgeons are making do without things such as negative pres-sure wound dressings. They are work-ing on ways to improvise this expen-sive technology, such as use of reversed aquarium pumps and locally available foam, as described on the website, An Orthopod’s Workbench.”

“The third approach, the restoration of function, typically involves trying to achieve better results from articular

fractures. This is harder in Ghana, how-ever, because it requires long, techni-cally challenging procedures done with wounds that may be at risk of getting infected, and without some of the more modern implants and instruments”

Dr. Trafton traveled to Ghana three months ago to volunteer his time and get the lay of the land. “I wanted to try and duplicate what a typical HVO volunteer is going to be doing so that I would understand what was working and what wasn’t. The reality of limited imaging is something that volunteers have to be ready to deal with. The hos-pital has a CT scanner, but because of the expense it is rarely used for any-thing other than head injuries. Most X-rays are usually done in miniature so as to reduce the amount of films used; also, it is unusual to see a comparison view of the other side of the body part

Komfo Anokye Teaching Hospital (KATH)/Dr. Peter Trafton

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VOLUME 7, ISSUE 11 | MARCH 29, 201115being imaged. If you have a bad articu-lar fracture and would like to have a CT scan then you must proceed without this modern convenience. So what do you do? You may need to work through a larger open wound. This lack of imag-ing also precludes the ability to plan out the procedure beforehand, something that is an essential part of complex frac-ture surgery. For those of us who trained many years ago, it may be a bit easier…we can think back to a time before CT scans were available.”

A day in the life of a trauma surgeon at Komfo Anokye Teaching Hospi-tal begins at the 8am morning report. Describing his experience, Dr. Trafton states, “During what is essentially a teaching conference, cases are reviewed

and plans are made for the day. Then we would split off and go to the clinic/OR/or ward; I went to the OR most days and rotated amongst the two sur-gery rooms with a Ghanaian attending orthopedist (we worked with trainees throughout this time). We did this until the late afternoon; nighttime emergen-cies were handled by the trainees. I was really struck by how hard everyone works to take care of these significantly injured patients—and they do a really good job.”

Dr. Trafton has such resounding enthu-siasm for the program in Ghana that while lecturing on-site he actually lost his voice. His message to his colleagues in Topeka and Boston? “This program is an outstanding opportunity for North

American orthopedic surgeons, par-ticularly those with trauma experience, to contribute to the efforts being made by Ghanaian surgeons to develop their skills. These individuals are becoming not only the caregivers for future gen-erations, but the teachers for the many surgeons they will need. We can help the short-handed Ghanaian team with teaching and patient care; we can help them develop skills and techniques that will be safe and self-sustaining in their environment. This may mean avoiding some of our more challenging techniques until all local resources are ready.”

To those who might join the volunteer effort in Ghana, Dr. Trafton says, “I would urge the volunteer to leave his or her high-tech toys and home, and bring basic principles and skills, flexibility, and common sense. While it is always tempting to bring the latest orthopedic gizmos, if what we leave the people with is not something that is self sus-taining then we are not being of assis-tance. It is only by helping to develop the technology locally, and by training future orthopedists that our efforts will mean something. We have to ensure that what we deliver doesn’t depend on our ability to provide the answers.”So come to Ghana, where you will leverage your knowledge, improve your skills, and leave a big, important foot-print.

For additional information about this and other programs, please visit www.hvousa.org. For more information on volunteering, contact Andrea Moody [email protected].

*a division of Health Volunteers Over-seas (HVO) ◆Advertisement

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VOLUME 7, ISSUE 11 | MARCH 29, 201116

LDR Submits First 2-Level Cervical PMA

After submitting a single-level PMA (premarket application) submis-

sion for the Mobi-C cervical artificial disc to the FDA in January, LDR Spine USA, Inc. has quickly followed up with a two-level PMA submission for the same device.

LDR announced on March 22 that the company made the two-level submis-sion to the FDA on March 11. This means the company is the first to announce the submission of such an application to the agency.

“Historic Achievement”

Company President and CEO Chris-toph Lavigne said this was a historic achievement. "LDR is one of only two companies to have completed a two-level randomized IDE [investigational device exemption] trial with two-year

follow up, and is the first to submit its results. This represents the culmination of a five-year, 600-patient, two-arm IDE study and an investment of over $25 million.”

Lavigne added, “We are extremely pleased with the results of both arms of the study and with the two-level data in particular. Mobi-C investigators will be presenting study results next month at the ISASS meeting in Las Vegas.”

Investigator Comments

The other company referenced by Lavi-gne is Medtronic with its Prestige cervi-cal disc.

Reginald Davis, M.D., Chief of Neu-rosurgery and Director of Neurosci-ences at the Greater Baltimore Medical Center, said, “I am very encouraged by the clinical results of my two-level Mobi-C patients from the study, and I am increasingly confident in cervical artificial disc as an attractive treatment option for indicated patients. Given the prevalence of two-level pathology and

the importance of medical evidence in the clinical decision making process, Mobi-C FDA approval for both single- and two-level use could substantially transform the cervical treatment land-scape.”

Another study investigator, Pierce Nun-ley, M.D., at the Spine Institute of Loui-siana said the controlled motion pro-vided by the device's mobile bearing platform has "proved to be suitable for not only single, but two-level cervical arthroplasty as well."

Mobi-C

The device has been implanted in more than 10,000 patients outside the U.S. since 2004.

According to the company, the Mobi-C metal on polyethylene disc is "designed to accommodate the seg-mental instantaneous axes of rotation, thereby reducing the implant to bone stresses which eliminates the need for invasive vertebral anchorage such as screws or keels. Avoiding such viola-

tion of the adjacent vertebral bodies may be a key benefit when treating two levels."

Lavigne concluded, “Achiev-ing the Mobi-C submission milestones after having real-ized 77% growth in the U.S. in 2010 is very exciting. The addition of Mobi-C to our growing U.S. portfolio will greatly strengthen our posi-tion both domestically and globally, providing us the crit-ical mass necessary for long-term growth.”

—WE (March 18, 2011) ◆

company

Mobi-C Cervical Disc/LDR

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VOLUME 7, ISSUE 11 | MARCH 29, 201117

New Polymer With Stem Cells

Researchers from three universities, the School of Medical Sciences of

Bristol, England, Memorial Univer-sity of Newfoundland in Canada and Qatar University are joining forces to develop a biologically engineered synthetic liquid polymer infused with stem cells that could be used to create cartilage implants. The Qatar National Research Fund is funding the research with one million dollars over a period of three years.

The researchers note that, at present, cartilage implants that are created using stem cells can only be constructed as a sold shape. These implants act solely as an interim measure before patients receive a total joint replacement. Dr Wael Kafienah, from Bristol’s School of Medical Sciences, believes his group’s research could represent the next breakthrough in stem cell therapy.

Kafienah’s initial results demonstrated the feasibility of using an injectable gel to form a three-dimensional scaffold. As envisioned by Kafienah, the viscous gel would fill the cartilage defect (s) and, in effect, assume a patient specific, irregu-lar shape thereby matching the defect area. In addition to filling the defect, the scaffold would provide a favorable micro-environment for healthy cellular growth. Of course, if already seeded with stem cells, that would, in theory, accelerate the regenerative process con-siderably, in Kafienah’s opinion.

Kafienah said that if the research proves successful, clinical trials could be car-ried out within five years. “The versa-

tility of injectable polymers and stem cells opens up endless opportunities for cell-based therapies. For instance, the polymer-cell constructs can be used to create cartilage implants that can grow at the defect site without the need for the expensive process of grow-ing the tissue in the lab beforehand.

The technology can also aid bone frac-ture repair where the presence of stem cells is shown to enhance bone repair capacity but require a flexible vehicle to sustain their delivery. There is a rap-idly expanding area of regenerative medicine that is hugely dependent on injectable biomaterials. The novel bio-

materials we are working on would be ideal for this, given what we anticipate to be their superior mechani-cal properties and cell guid-ing chemistry.”

Kafienah’s research builds on the advances already made by Bristol’s team of stem cell and tissue engi-neering experts in creating cartilage from adult human bone marrow stem cells.

—BY (March 24, 2011) ◆

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biologics

Image Credit: Arthroscopist/Wikimedia Commons

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VOLUME 7, ISSUE 11 | MARCH 29, 201118Stem Cells for Critical Limb Ischemia

Harvest Technologies Corp. of Plymouth, Massachusetts, is set

to launch a 210-patient clinical trial at 25 sites in the U.S. of the company’s Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable critical limb isch-emia (CLI).

Mark D. Iafrati, M.D. Chief of Vascu-lar Surgery at Tufts Medical Center, Boston, principal investigator of the FDA-approved trial, said, "The patients enrolled in this study are at high risk for limb loss and death and have no usual treatment options with bypass or catheter-based techniques.”

An earlier 48-patient study suggested that BMAC offered benefits in terms of limb salvage and pain relief. “If the [new] study confirms these findings this would be a dramatic affirmation of the role of autologous cellular therapy in critical limb ischemia. BMAC thera-py is so much faster, less invasive, and less expensive than traditional vascular interventions, that if proven efficacious will certainly result in an immedi-ate change in the standard of care for patients with end stage peripheral vas-cular disease,” Iafrati said.

Critical limb ischemia is a persistent and relentless problem, which is increasing

due to the aging of the population as well as the growth of diabetes mellitus cases. CLI has an annual incidence of 500-1,000 cases per million, severely impairs patients' functional status, and is associated with an increased car-diovascular mortality, morbidity and necrosis in bone. The prognosis of CLI is poor.

Patients are afflicted with intractable pain and a very high risk of limb loss and/or death. A recent consensus document developed by over 16 vas-cular societies stated: "Observational studies of patients with CLI who are not candidates for revascularization sug-gest that a year after the onset of CLI, only about half the patients will be alive with-out a major amputa-tion, although some of these may still have rest pain, gangrene or ulcers. Approxi-mately 25% will have died and 25% will have required a major amputation.”

The Harvest BMAC System is a 15-min-ute point-of-care process that has been used in the treatment of approximately 50,000 patients to date. The System concentrates the cellular composition of the patient's bone marrow, which contains the patient's own stem cells. "The BMAC System's point-of-care approach and its ability to deliver a cellular composition at an affordable price will be a major key in establish-ing this technique as a standard of care," stated Gary Tureski, president of privately-held Harvest Technologies.

—BY March 24, 2011) ◆

Orthopedist Wins Stem Cell Award

Dr. Shinya Yamanaka, who trained in Japan as an orthopedic surgeon,

is one of three scientists to receive the Albany Medical Center Prize in Medi-cine and Biomedical Research, the larg-est award ($500,000) in medicine and science in the United States. The other recipients are Elaine Fuchs, Ph.D., Rockefeller University, and James A. Thomson, V.M.D., Ph.D., University of Wisconsin, Madison, and University of California, Santa Barbara.

Doctors Yamanaka and Thomson are credited with discovering how to genetically re-program adult human cells back to an embryonic state. The discovery was made separately, in each researcher’s lab, and reported in 2007. These so-called iPS (induced pluripo-tent stem) cells, which share nearly all the characteristics of embryonic stem cells, can be made in limitless supply. These cell lines are now used in labora-tories worldwide and promise to speed the progress of stem cell research by offering a complementary or alterna-tive approach to using actual embry-onic stem cells.

Source: U.S. CDC/Wikimedia Commons

Wikimedia Commons/MesserWoland & Szczepan1990

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VOLUME 7, ISSUE 11 | MARCH 29, 201119James J. Barba, president and chief executive officer of the Albany Medi-cal Center, said, "Their discoveries have moved us closer to realizing the regenerative and potentially healing properties of stem cells. Their work has been widely publicized within the scientific stem cell community and lies as a basis for new discoveries being made every day."

Currently, Dr. Yamanaka is collaborat-ing with other researchers in Japan to develop a method for iPS cell genera-tion that would be safe for therapeutic use, including conducting safety testing of iPS cell-based treatments.

"Diabetes, Parkinson's disease, can-cer, spinal cord injury, the solutions to these debilitating diseases and many, many others that plague humans might very well be found through the science of stem cells. That's how important the research of Drs. Fuchs, Thomson and Yamanaka is," said Barba.

Commenting on the “staggering growth” in the field since the initial stem cell discovery less than three years ago, Robert W. Mahley, M.D., Ph.D. professor of pathology and medicine at the University of California, San Fran-cisco, said that “there is no question that reprogramming technology is set to revolutionize basic biological inves-tigations; the understanding of disease mechanisms; and the development of new, safe and effective therapeutics and future stem cell-based therapies."

—BY (March 21, 2011) ◆

Mental State Deter-mines Joint Pain

How patients experience the pain of knee osteoarthritis (OA) may

depend on their state of mind. A study of 660 elderly Korean patients revealed that clinical depression can exacerbate the symptoms of knee osteoarthritis. The study, reported by lead author Tai Kyun Kim, M.D., also found that patients with mild or moderate knee osteoarthritis were more likely to experience a connection between OA symptoms and depression than patients with more severe forms of OA. In patients with severe OA, the pres-ence of a depressive disorder was not associated with any changing risk of symptoms.

“Despite the reported satisfactory out-comes of knee replacement surgery, a percentage of patients will still expe-rience knee pain and impaired move-ment,” Kim stated. “Sometimes pain and disability after surgery is medi-cally unexplained, so in these patients screening for depression might be a very good option.”

The investigators evalu-ated the patients’ radio-graphic severity of knee OA using the Kellgren-Lawrence grading sys-tem and symptom sever-ity using the WOMAC scale. They also con-ducted patient inter-views and administered a questionnaire that made use of a geriatric depression scale to assess depressive disorders.

They performed regression analyses to assess relative contributions by radio-graphic severity and depression sever-ity to WOMAC scores to explore poten-tial associations between radiographic severity and the presence of a depres-sive disorder with regards to the risk of symptomatic knee OA. The study was published in the Journal of Bone and Joint Surgery.

The findings indicate that assessment and management of co-existing depres-sion should be integrated with assess-ment and management of knee OA, the authors wrote, adding that patients who are not experiencing severe OA are particularly at risk.

“The results of this study indicate that depression can play a major role in the way patients experience the symptoms of knee arthritis, and that even when X-rays show the arthritis is not severe, patients with depression may report significant pain,” Kim stated. “The rela-tionship between pain and depression suggests that both should be considered by physicians when treating patients with knee osteoarthritis, particularly in those with X-rays not indicating severe damage to the joint.”

—BY (March 22, 2011) ◆

large joints

Source: grietgriet/morgueFile

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VOLUME 7, ISSUE 11 | MARCH 29, 201120New Tool for TKA Ac-curacy

A tool, called KneeAlign, designed to help surgeons more precisely

align their total knee arthroplasty has

garnered encouraging results in a new clinical study. As reported in the Journal of Arthroplasty by David J. Mayman, M.D. of the Hospital for Special Surgery in New York and the principal investi-gator, the use of the palm-sized surgical navigation system resulted in improved accuracy. Mayman emphasized that the results were interim and that the study was ongoing.

“A total of 42 knees underwent a total knee arthroplasty using KneeAlign,” he said. “Postoperative standing anterio-posterior hip-to-ankle and lateral knee-to-ankle radiographs demonstrated that 97.6% of the tibial components were placed within 90° plus or minus 2° to the mechanical axis in the coronal plane and 96.2% of the components were placed within 3° plus or minus 2° to the mechanical axis in the sagittal plane. The KneeAlign greatly improves the accuracy of tibial component align-ment in TKA."

KneeAlign is manufactured by OrthAl-ign, Inc., a privately held company in Aliso Viejo, California. The company was founded in 2008 and in October 2009 received a clearance letter from the FDA stating that KneeAlign was

“substantially equiv-alent to currently marketed computer-assisted surgery sys-tems.”

—BY (March 22, 2011) ◆

Treating Rotator Cuff Tears

Growing older is tough on shoul-der joints. About 54% of adults

older than 60 have completely or par-tially torn rotator cuffs. By contrast, only 4% of adults between 40 and 60 years old have the same problem. Most tears are due, not to injury from sports or trauma, but to age-related degeneration of the tendon.

Studies show that tears can be man-aged without sur-

gery in approximately half the patients through physical therapy and the use of pain medications. For those patients who want to regain full use of their shoulder, however, the question is not so much whether to have surgery as it is when and how.

A review in the Annals of Internal Med-icine, noted that patients and doctors struggle with knowing when to stop non-operative treatment in favor of surgery. Researchers found that repair-ing a tear earlier rather than later may result in better patient outcomes, earlier return to work and lower costs.

"Many patients who have a tear figure they can take six months and live with it, but left alone the tear will progress and you can get to the point where it is irreparable," says David Altchek, a surgeon at New York's Hospital for Special Surgery. Altchek says repair-ing torn rotator cuffs earlier with a new technique that uses a double row of sutures to fix tendons to bone, rather than a single row, is improving healing rates in his studies.

While some tears may never worsen or need surgery, says Ken Yamaguchi, an orthopedic surgeon at the Washington

OrthoAlign, Inc.

extremities

Source: Medscape/Wikimedia Commons

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VOLUME 7, ISSUE 11 | MARCH 29, 201121University School of Medicine in St. Louis, "the older somebody is when they get a repair, the less likely it is for the repair to heal."

The good news is that surgery results in reduced pain and improved function in 80% to 95% of patients. And open sur-gery with big incisions is being replaced by new, less-invasive techniques which involve less pain and blood loss, short-er hospital stays and a generally easier rehabilitation period, according to the American Academy of Orthopaedic Surgeons (AAOS).

An AAOS review of about 40 published studies showed that as many as 2% of patients have nerve injuries, while 1% may get an infection at the surgical site. About 6% may have a tendon re-tear, though that does not mean that a repeat surgery will be needed or that pain and poor function will result.

—BY (March 24, 2011) ◆

Overweight Teens and Bone Health

In a study of 143 overweight teenagers, researchers from Georgia Health Sci-

ences University have found that adoles-cents with risk factors such as the precur-sor for diabetes and low levels of the HDL cholesterol have less bone mass than their overweight but otherwise healthy peers. And, interestingly, the team found that total body fat didn’t impact bone mass: it was fat around the middle, or visceral fat, that seemed to increase the risk for bad bones—just like it does the risk of diabetes and heart disease.

Other risk factors included high fat levels in the blood, higher blood pres-

sure and a larger waist size, said Dr. Norman Pollock, GHSU bone biologist and corresponding author of the study published in The Journal of Pediatrics. “The more risk factors you have, the less bone mass you have,” Dr. Pollock said in the news release, noting that 62% of the overweight adolescents had at least one risk factor. It also indicates that the concept of “fit and fat” may apply to the bones.

The teens without one or more of these risk factors tended to get slightly more vigorous physical activity although none of the participants got the rec-ommended 60-plus minutes of daily physical activity, Dr. Pollock said. Daily caloric intake for all study participants was in the optimal range.

“This says to kids and their parents that restricting calories is not the answer; we need to focus more on increasing vigorous physical activity,” Pollock added. Vigorous activity is defined as activity that increases the heart rate high enough to cause heavy breath-ing, such as jogging, tennis or jumping jacks. Studies have shown that physical activity prompts bones to release a hor-mone called osteocalcin, which helps

decrease fat-related risk factors such as insulin resistance.

When asked about the chances of increasing the amount of time that teens exercise, Dr. Pollock told OTW, “Given the financing costs associated with the ever-evolving healthcare system com-bined with recent evidence suggesting that quality physical activity programs may reduce disruptive behavior in schools and improve student’s grades and self-esteem, I believe we will see start to see a greater emphasis on phys-ical activity in the school systems. As parents, we must be equally account-able and make sure our children bal-ance out their screen time with fun and enjoyable physical activities.”

“We are now beginning to respect the bones as an endocrine organ like we do now with fat and muscle,” Pol-lock noted. Activity also increases the number of bone-producing cells called osteoblasts.

Dr. Pollack also told OTW, “Over the past decade, pediatric studies on the influence of total body adiposity on bone mass have been mixed. Our study brings new light suggesting that

James Heilman, M.D./Wikimedia Commons

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VOLUME 7, ISSUE 11 | MARCH 29, 201122increased visceral adiposity, which is more clinically relevant for metabolic syndrome-related abnormalities than increased total body adiposity, could play an adverse role in bone health. Of the metabolic syndrome phenotypes explored in the study, we were sur-prised to find that insulin resistance was strongest predictor of lower bone mass, and it may help to explain the visceral adiposity results.”

—EH (March 22, 2011) ◆

Study: Prolia Increases BMD

More support for the data, more support for the spine…Amgen,

Inc. has announced new long-term data showing that during the fourth and fifth years of Prolia (denosumab) treatment, postmenopausal women with osteo-porosis had year-over-year increases in lumbar spine and total hip bone mineral density (BMD). The data, which were statistically significant, showed that after five continuous years of treatment par-ticipants had BMD increases of 13.7% for the lumbar spine and 7% for the hip.

The pivotal FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study established the efficacy and safety of Prolia based on three years of data from approximately 7,800 post-menopausal women. The open-label extension of FREEDOM is evaluating the long-term (up to 10 years) efficacy and safety of Prolia in 4,550 postmeno-pausal women. A full 70% of eligible women from the FREEDOM study continued enrollment in the exten-sion study; 2,343 women continued to receive Prolia treatment, and 2,207 transitioned from placebo to Prolia.

The incidences of new osteoporotic fractures also remained low for women taking Prolia for five years. Those who ended up transitioning from placebo to Prolia showed significant BMD increas-es during the first two years of Prolia treatment: 7.9% increase in lumbar spine BMD and 4.1% increase in total hip BMD.

While no atypical femoral fractures were reported in either group, there were adverse events (AEs)—83.4% for women who continued on Prolia and 82.8% for women transitioned from

placebo to Prolia. Rates of serious AEs were 18.9% and 19.4% for the two groups, respectively. Two subjects in the group that transitioned from placebo to Prolia had AEs adjudicated to osteone-crosis of the jaw that healed without further complications. One of these subjects continued Prolia, and one sub-ject discontinued.

—EH (March 24, 2011) ◆

Ernest L. Sink, M.D. Joins HSS

Ernest L. Sink, M.D., former direc-tor of the Hip Preservation Program

Children’s Hospital in Denver, is join-ing Hospital for Special Surgery (HSS) as co-director of the Center for Hip Pain and Preservation. Dr. Sink, who is widely known for his work in treat-ing complex hip conditions in infants through teens and young adults, will also be a member of the HSS Pediatric Orthopedics Service.Pbroks13/Wikimedia Commons

people

Hospital for Special Surgery

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VOLUME 7, ISSUE 11 | MARCH 29, 201123“Ernest Sink is an outstanding surgeon and teacher,” said Bryan T. Kelly, M.D., in the news release. Dr. Kelly, co-director of the Center for Hip Pain and Preser-vation, added, “His strong background in the area of adolescent hip diagnos-tics and surgical treatment will greatly enhance the work of the Center.”

In his new position, Dr. Sink will treat adolescents and young adults at the Center for Hip Pain and Preservation, along with children as part of the Pedi-atric Service, creating a model transi-tional program for hip care. Since hip disease starts in childhood and often continues into young adulthood, teens will experience no interruption of care as they mature.

Dr. Sink earned a doctor of medicine degree in 1994 at the University of Texas Southwestern Medical School, Dal-

las, and also completed a residency in orthopedic surgery there. He then com-pleted a fellowship in pediatric ortho-pedic surgery at Rady Children’s Hos-pital in San Diego in 2000 and joined the University of Colorado Health Sci-ence Center as assistant professor. In 2004, he participated in an AO fellow-ship/apprenticeship in hip surgery at the University of Berne in Switzerland, studying innovative surgical techniques with Professor Reinhold Ganz, M.D., in the Department of Orthopedic Surgery.

Dr. Sink told OTW, “There was a large demand awaiting my start date so the first steps were to start seeing patients and concurrently setting up a team and system for seamless coordination of care from the assessment, surgical pre-op, peri-op and post-operative time intervals. I’m also developing a work-ing relationship with Dr. Bryan Kelly

and the other members of the Center for Hip Pain and Preservation so we can evaluate the patients and recommend treatment tailored for each individual's hip. For example, since I have a differ-ent skill set than Dr. Kelly we can offer a greater range of treatment than each of us can perform alone. Instead of per-forming the procedure that we are best at performing, we can recommend the procedure that we believe will be best for the individual. Therefore, setting up an efficient system to evaluate patients and get them into the correct treat-ment pathway has been what we have worked on in the few weeks I have been at HSS.”

—EH (March 23, 2011) ◆

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VOLUME 7, ISSUE 11 | MARCH 29, 201124

New Study: Cervical Surgery Safe

Degenerative disease of the cervical spine, and not trauma, appears

to be the underlying factor associated with perioperative cervical spinal cord injuries, according to researchers at the University of Iowa, Iowa City, and Uni-versity of Washington, Seattle. Their conclusion is based on an analysis of cervical spinal cord injury claims in the American Society of Anesthesiologists Closed Claims Database.

“Cervical spinal cord injury is a rare, but catastrophic, complication of sur-gery and anesthesia,” said lead author Bradley J. Hindman, M.D., professor of anesthesia at the University of Iowa. “Patients commonly considered to be at greatest risk are those with cervical spine instability in whom direct laryn-goscopy and intubation may cause pathological cervical spine motion, critical cord compression and injury.”

Three independent teams searched 5,231 general anesthesia claims for the period 1970 to 2007 to identify inju-ries of the cervical spinal cord, roots or bony spine. They reviewed claim summaries for patient characteristics, intraoperative management and injury presentation; each team also judged probable contributors to injury. Two of the three teams were required to agree for an affirmative response.

Hindman reported that 48 cervical injury claims (age, 47±15 years; 73% males) comprised less than 1% of all the general anesthesia claims. “In 90% of all cervical injury claims, the stan-dard of care was considered to be met,

as compared with 55% in other gen-eral anesthesia claims,” Hindman said. A total of 9% of cervical injury claims were considered to be preventable by better monitoring, compared with 22% of other general anesthesia claims.

The cervical spinal cord injuries were more severe than the root/spine injuries and typically resulted in quadriplegia. The majority of cervical spi-nal cord injuries occurred in the absence of traumat-ic injury (81%) or cervi-cal spine instability (76%). By comparison, anatomic abnormalities—primarily cervical spondylosis/stenosis and/or disc disease—were present in 95% of cases of cervical spinal cord injury.

“Our perspective is that most cervical spinal cord inju-ries occur in the absence of trauma, cervical instability or airway difficulties,” Hind-man said. “However, in the absence of instability, cervi-

cal spondylosis was exceedingly com-mon. And it appears to predispose the cervical spinal cord to injury from oth-erwise benign events, such as non-neu-tral head and neck position and relative hypotension.”

—BY March 24, 2011) ◆

spine

F. Lamiot/Wikimedia Commons

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VOLUME 7, ISSUE 11 | MARCH 29, 201125Stem Cell Injection for Back Pain?

A trial to test stem cells as a treat-ment for low back pain due to

facet arthritis will begin soon at Pre-ferred Pain Center, Phoenix and Scott-sdale, Arizona. Preferred is the only Arizona pain center to be involved in the study, said David Greene M.D. and CEO of the Center.

The conventional treatment for low back pain with facet disease has been steroid injections along with a numb-ing medication such as Lidocaine. While this has worked well over 75% of the time, the injections do not alter the course of arthritis, nor can they be administered an unlimited number of times.

"The holy grail of arthritis has been to discover a cell regenerating substance which relieves pain and alters the course of the disease by regenerating the joint. While steroid injections do well with pain relief, we're excited about study-ing a non-steroidal, anti-inflammatory, stem -cell-rich substance that has the potential for cartilage regeneration and pain relief. This is as cutting edge as it gets," said Greene.

The stem-cell-rich injection is FDA reg-ulated and has been injected over 3,000 times in the U.S. for numerous applica-tions, including wound healing, spine fusion, and scar prevention around the spinal cord. Preferred Pain Center will be the first to evaluate the injection product specifically for interventional pain management.

The product is made from the amniotic fluid of live donors, and is not embry-

onic. It is non-steroidal and is processed and packaged at an FDA-registered tis-sue bank that is ISO certified, AATB accredited and adheres to Current Good Tissue Practice Standards.

The lead investigator for the study, Ajay Narwani, M.D., said, "The best interventional treatment we have right now for low back due to facet arthritis, apart from radiofrequency ablations, are steroid injections. I would love it if this study achieves more effec-tive, lasting pain relief with the stem cell injections when compared to ste-roids.” Study enrollment has begun, and prospective low back pain patients can apply at the Stem Cell Study web page (http://www.preferredpaincen-ter.com/stemcells.html).

—BY (March 24, 2011) ◆

Source: Nieuw/Wikimedia Commons

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VOLUME 7, ISSUE 11 | MARCH 29, 201126

THE PICTURE OF SUCCESSDr. Charles Epps, Part I

By Elizabeth Hofheinz, M.P.H., M.Ed.

A man hails a taxi in Washington, D.C. in 1951. Once inside, he

learns that the driver is a magna cum laude medical student named Charles Epps, who—once he hits a red light—studies his biochemistry notes via pen-light. The taxi driver would evolve into Dr. Charles Epps, Professor of Ortho-paedic Surgery at Howard University, Washington, D.C., a standout surgeon who has trained more than 4,000 Afri-can American and minority medical students and 70 orthopedic residents during his career.

The winner of the 2000 Humanitarian Award from the American Academy of Orthopaedic Surgeons (AAOS), Dr. Epps was the Dean of Howard Univer-sity’s College of Medicine for six years and program director of the minor-ity residency program for 24 years. The first African-American president of the American Orthopaedic Associa-tion, Dr. Epps did his training during a time when not everyone was glad to see someone of his race walk through the door. But there would be no stopping the determined Dr. Epps.

“Growing up in Baltimore, my father—an elementary schoolteacher—raised my siblings and me with the philoso-phy of, ‘You do not need to be number one, but you must do your best in all

things at all times.’ I graduated as the valedictorian of my high school class.”

But his father would not be there to see this momentous occasion. “My dad died due to a heart attack when I was 15 years old. Aside from the huge emo-tional cost, losing my father meant that my dream—our dream—of my attend-ing college—was in jeopardy. I just didn’t know how I would afford it.”

At Howard University there is now an endowed chair named for Dr. Epps…he found a way to pay for college—and medical school. Along the way he thought of the compassionate physi-cians who tended to the physical needs of his dying father, and the emotional needs of the entire family. “These doc-tors were kind to our whole family and I couldn’t help notice that the calm, patient way they interacted with us seemed to help our situation; they were the type of person I wanted to be. My dad was only 41 when he passed away…losing him made me determined to suc-ceed in spite of this tragedy.”

“I decided to pursue pharmacy stud-ies at Howard University because it would be less of a financial burden and would require only four years. The class was filled, however, so I enrolled as a pre-med chemistry major, worked in

the summers and saved my money. I then entered Howard’s medical school, despite being concerned about leaving my wonderful mother and my younger siblings. Mom was encouraging, saying, ‘Go ahead…be a good boy and write to me.’ After achieving good grades in my first year I said, ‘Well, if I can do one year of working and studying then I can probably do seven more years. In medi-cal school, after driving the taxi for 18 months, I owned it…and this made my financial situation more secure.'"

Stepping out into the wider world in 1955, the newly minted doctor would find that not all arms were open wide. “Things were very segregated then…all my life I had encountered discrimina-tion and usually just bit my lower lip and moved on. As I moved into resi-dency at D.C. General Hospital, some people (black and white) were outgo-ing and helpful, while others let me know that the color of my skin was an issue. For example, a Christmas party was held at a staff doctor’s home where

Dr. Charles Epps

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VOLUME 7, ISSUE 11 | MARCH 29, 201127

residents and their wives were invited to attend—all except me and my wife. I felt that slight keenly. That, in addi-tion to the fact that local restaurants wouldn’t accept us, made things dif-ficult. At work, however, things were different. African American trainees in all specialties insisted on—and got—equal treatment with regard to rota-tions, promotions, etc. Yet even some of the patients contributed to the overall problem as they didn’t want to be cared for by African American residents. For-tunately, in almost every instance white staff members stepped forward and insisted that we be treated like every-one else.”

Dr. Epps, whose resounding message to young minority orthopedists is, ‘You can succeed in spite of obstacles,’ reflects on a specific instance when his services were not wanted due to the color of his skin. “There was a situation in which I had completed my training and was called to the ER to see a patient. The woman looked at me and as I went about working she began whisper-ing and I was informed that she didn’t want me to treat her. Another physician called the medical director, who knew me well. He came to the ER and told the patient, ‘Dr. Epps is the orthopedic surgeon on duty and if you’re going to get any orthopedic treatment tonight he is the one who is going to do it.’ She agreed reluctantly, I proceeded, and the

treatment was successful. During this uncomfortable situation I remained confident that my training and abilities would see me through.”

Dr. Epps completed his residency pro-gram on a Friday…Monday morning he was on staff at Howard University. One of his proudest moments during this time? “I was only the fifth African American orthopedist in history to be certified, something that gave me an extraordinary sense of accomplishment. And I always felt a special responsibil-ity toward Howard as it was the pre-mier institution for black people. I am proud to say that we admitted some of the first females into our medical school and residency programs.”

In addition to his surgical talents and wisdom, Dr. Epps says that something else has been with him—and many Afri-can Americans—for years. “There was always an acute consciousness of being excluded…of having to stand on the outside. As I grew in my career I strove to make things easier for those individ-uals who were coming up through the ranks. The AAOS Humanitarian Award was in fact recognition of the mentor-ing I have done to help young minority orthopedic surgeons. Today, the ques-tions I most frequently get from these young doctors is, ‘Should I subspecial-ize?’ and ‘Where should I go for train-ing?’ I advise them that if possible, they

should do their residency and subspe-cialty training in the area where they are ultimately going to practice so that they can put down professional roots.”

And what of that segregated Christmas party years ago? Dr. Epps, who now has an annual golf classic in his name, states, “I never made a fuss about it…I just kept working. Years later, however, I encountered the host of that party at an orthopedic meeting. He stopped to talk, shook my hand, and said, ‘By the way, when you were a resident I held a Christmas party at my home. It was in southern Maryland and I knew my neighbors would object to my inviting you and your wife.’ He was flushed, made a few niceties, then turned and rushed away; I realized that he still had some discomfort about the way he had treated me. I was nice to him, as my parents had taught me to be a gentle-man and to treat people fairly—even when they didn’t accord me the same courtesy. I never felt that it enhanced my position to lash out at people; I tell young orthopedists that being courte-ous and fair will always stand them in good stead.” ◆

Next week hear about Dr. Epps’ time as chief of the region’s only free, multidisci-plinary program for limb-deficient chil-dren, as well as his role as an examiner for the American Board of Orthopaedic Surgery.

The woman looked at me and as I went about working she began whispering and I was informed that she didn’t want me to treat her. Another physician called the medical director, who knew me well. He came to the ER and told the patient, ‘Dr. Epps is the orthopedic surgeon on duty and if you’re going to get any orthopedic treatment tonight he is the one who is going to do it.’ She agreed reluctantly, I proceeded, and the treatment was successful. During this uncomfortable situation I remained confident that my training and abilities would see me through.

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VOLUME 7, ISSUE 11 | MARCH 29, 201129

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