week in review 4ryortho.com/wp-content/uploads/2012/11/01_04_11... · 2012. 11. 1. · pital...

VOLUME 7, ISSUE 1 | JANUARY 4, 2011

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

picture of success

week in review

breaking news

4Reclaiming the Patient Outcome Argument ◆ This past week two Bloomberg

writers took a tour of one spine surgery center’s poor patient outcomes and then connected those outcomes to the surgeon’s lifestyles. It was one of the ugliest attacks on spine since the pedicle screw litigation days. OTW fights back.

8“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.

12Good Hands? Really? Assessing Surgical skills ◆ Navigation,

object manipulation and the like are skills not traditionally assessed as part of an orthopedics curriculum—at least not thoroughly assessed. That is changing, however, and things such as simulators will make things all the more interesting.

27Dr. 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.

16Smith & 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.


VOLUME 7, ISSUE 1 | JANUARY 4, 20112Orthopedic 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: Great 30-day run for ortho equities. CONMED up 23%. Alphatec up 20%. Even lowly Medtronic rose double digits. Wachovia’s 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.” It’s all about the fundamentals.

1 1 Orthofix 13.51% 6.66%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.

2 2 Medtronic 32.59 10.62Lowest P/E ratio and the lowest future P/E ratio. Clearly oversold. Course, Bloomberg’s hatchet job on spine fusion doesn’t help.

3 6Smith & Nephew

22.83 15.52Buyers unfazed by FDA warning letter. Bottom line, SNN’s market share is strong and aging baby boomers are fueling growth.

4 4 Alphatec 1.59 20.00Nice continuing bounce off the $2/share floor. Street expecting strong earnings pop from ATEC in 2011.

5 3Integra

LifeSciences15.37 9.06

Wall Street is expecting IART to report a strong 22% EPS jump for Q4 on modest 5% sales growth estimate.

6 5 Exactech 10.79 5.61What is the future of the small large joint companies like EXAC? ZMH or SYK or SNN or DPU bolt on?

7 8Wright Medical

6.36 17.74Upgraded to start the year by BMO Capital markets. Up one spot on the Power Rankings.

8 7 Zimmer 27.69 8.97Big Blue is down so low, it’s starting to look like up. Three acquisitions in the closing days of 2010 are a good sign.

9 10 CONMED 9.07 22.87Holy Power Tools Batman! What a run in December. Could hospital buying be back?

10 9 Stryker 24.71 7.57Seventh best in P/E to growth, future P/E and expected earnings change. The market is not seeing the organic growth. Time to buy?


VOLUME 7, ISSUE 1 | JANUARY 4, 20113Robin Young’s Orthopedic Universe

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1 TiGenix TIG.BR $2.91 $90 49.3%2 Mako Surgical MAKO $15.22 $518 32.7%3 Bacterin Intl Holdings BIHI.OB $8.50 $305 28.8%4 CONMED CNMD $26.43 $743 22.9%5 Alphatec Holdings ATEC $2.70 $239 20.0%6 Wright Medical WMGI $15.53 $609 17.7%7 Smith & Nephew SNN $52.55 $9,320 15.5%8 Symmetry Medical SMA $9.25 $332 13.2%9 Medtronic MDT $37.09 $39,820 10.6%

10 NuVasive NUVA $25.65 $1,010 9.8%

1 CryoLife CRY $5.42 $152 -3.9%2 RTI Biologics Inc RTIX $2.67 $146 -1.5%3 Johnson & Johnson JNJ $61.85 169,860 0.5%4 Orthovita VITA $2.01 $155 1.0%5 Kensey Nash KNSY $27.83 $236 2.5%6 ArthroCare ARTC $31.06 $840 2.6%7 Average $11,874 3.7%8 Synthes SYST.VX $123.54 $14,662 4.0%9 Exactech EXAC $18.82 $243 5.6%

10 Orthofix OFIX $29.00 $514 6.7%

1 Medtronic MDT $37.09 $39,820 11.172 Kensey Nash KNSY $27.83 $236 12.193 Zimmer Holdings ZMH $53.68 $10,600 12.514 Average $11,874 13.255 Wright Medical WMGI $15.53 $609 13.31

1 Alphatec Holdings ATEC $2.70 $239 224.122 Smith & Nephew SNN $52.55 $9,320 72.773 RTI Biologics Inc RTIX $2.67 $146 41.584 Symmetry Medical SMA $9.25 $332 27.865 CONMED CNMD $26.43 $743 20.32

1 Orthofix OFIX $29.00 $514 0.592 NuVasive NUVA $25.65 $1,010 0.693 Medtronic MDT $37.09 $39,820 1.194 Zimmer Holdings ZMH $53.68 $10,600 1.295 Smith & Nephew SNN $52.55 $9,320 1.41

1 Alphatec Holdings ATEC $2.70 $239 3.992 Kensey Nash KNSY $27.83 $236 3.533 CONMED CNMD $26.43 $743 2.534 ArthroCare ARTC $31.06 $840 2.325 CryoLife CRY $5.42 $152 2.29

1 RTI Biologics Inc RTIX $2.67 $146 0.912 Orthofix OFIX $29.00 $514 0.913 Symmetry Medical SMA $9.25 $332 0.974 CONMED CNMD $26.43 $743 1.045 Wright Medical WMGI $15.53 $609 1.19

1 TiGenix TIG.BR $2.91 $90 321.162 Bacterin Intl Holdings BIHI.OB $8.50 $305 24.773 Mako Surgical MAKO $15.22 $518 13.514 Synthes SYST.VX $123.54 $14,662 8.135 Kensey Nash KNSY $27.83 $236 3.04

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VOLUME 7, ISSUE 1 | JANUARY 4, 20114Reclaiming the Patient Outcome ArgumentBy Robin Young

This past week two Bloomberg writ-ers took a tour of one spine sur-

gery center’s poor patient outcomes—patients who’d filed lawsuits, patients who’d filed appeals in worker’s comp court and then paired that sad infor-mation with details of the surgeon’s personal lives—including information from divorce proceedings—to paint a damning, even devastating picture of spine surgeons and fusion surgery.

The article, titled “Doctors Getting Rich with Fusion Surgery Debunked by Stud-ies” 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 off—indeed 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 pay-ments from suppliers like Medtronic to spine surgeons. Both articles put surgeons and manufacturers in unfa-vorable 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

was distributed throughout the world and landed, no doubt, on every regula-tor and reimburser’s 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 worker’s comp appeals court data, the authors were able to pull out 11 patients to fol-low. Six made it into the story. All six had poor outcomes. Here, for exam-ple, is what the authors wrote about one patient.

“Jean Kingsley, 57, a patient who had had two previous

Morguefile

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VOLUME 7, ISSUE 1 | JANUARY 4, 20115fusion surgeries and was still suffering back pain.” Accord-ing to a hospital report, her doctor wrote; “that more ‘surgi-cal 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 Sep-tember 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 hos-pital 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 attorney’s fees to Kingsley’s surgeon, which Kingsley said she can’t pay. She has appealed the decision. Her case is a “unique set of events for which even in retrospect there is no obvious explana-tion that one can prove,” her doctor said in his 2008 depo-sition, in which he estimated he performed 400 to 500 back surgeries a year. Abbott and Twin Cities Spine billed a com-bined $239,000 for the surgery, Kingsley’s records show. Insur-er Medica says it paid about a third of that amount after a dis-count. 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 dis-

tances 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 proceed-ings that year. He told state superior court in Minneapolis that he and his wife’s assets included two Porsches; a Fer-rari 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 sur-geon’s 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 arti-cle. It serves literally no purpose.)

What struck us about this was the absence of performance metrics for The Twin Cities Spine Center. Where’s the batting average? If, for example, the TCSC has a 0.850 (85%) rate of delight-ed 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 mea-sure, the writers resorted to expert opin-ion quotes (Sohail Mirza, M.D., Chair of the Department of Orthopaedics at

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VOLUME 7, ISSUE 1 | JANUARY 4, 20116Dartmouth: “It’s amazing how much evidence there is that fusions don’t 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.

Where’s the batting averages for spine surgeons?

What’s the Truth?

Nothing like a tour of a spine center’s failures. The Bloomberg article was ugly. Spine surgery for patients and the surgeons who perform them are routinely getting beat up in the nation’s press. This is serious. If surgeons lose the patient outcome argument then reimbursement, innovation, everything gets tougher.

The truth is that surgical interven-tion works better than conservative care. Don’t 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. Weinstein’s life’s work to show that surgeons have inordinate influence on their patients and that those surgeons tend to perform too many spine surgeries.

Weinstein’s 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-surgi-cal 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 con-servative 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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VOLUME 7, ISSUE 1 | JANUARY 4, 20117Journal of Medicine, May, 2007

•Spinal stenosis, published in The New England Journal of Medicine, February 21, 2008

The first results were from the Interver-tebral 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 sub-stantially greater improvement in pain and function through two-year follow-up compared to patients treat-ed 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 com-parisons with careful control for poten-tially 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 com-pared to patients treated nonsurgi-cally. Because patients in the random-ized 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 con-founding baseline factors.

Surgical intervention - 3 : Conservative Care – 1/2

Wall Street Journal vs. Private Prop-erty

What’s wrong with the Wall Street Jour-nal? Do private property rules only apply to non-surgeons?

Five days before Christmas, John Car-ryrou 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 sur-gery performed and published research on comparative effectiveness. Both the hospital that grants surgical privi-leges to the surgeons and Medtronic have in place several conflict of interest rules to ensure that any payments from Medtronic are proper (as defined, inci-dentally, by the U.S. Attorney) and are not for implants the surgeons use.

But, don’t confuse the Wall Street Jour-nal 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 miss-ing two basic points—one, there is no mention of patient outcomes. By implication, Carryrou and McGinty are saying that patient outcomes were com-promised because of the royalty pay-ments. 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 per-formers receive millions of dollars too. Professional athletes, business people, lawyers. Surgeons are different?

Second, who owns the inventions of these surgeons? Are they not intellec-tual property and do they not have a right to license their property?

If Medtronic paid $7 million in roy-alties 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. It’s called private property.

These are difficult times. The nine-society letter to BCBS of North Caro-lina was a singular bright spot. The next challenge is the patient outcome debate. Spine surgeons must, must win that argument. ◆

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VOLUME 7, ISSUE 1 | JANUARY 4, 20118“Unsettled” Healthcare Law By Walter Eisner

The score is now 2 to 1 in favor of the new healthcare law, as three federal

judges have ruled on the constitutional-ity of the Affordable Care Act (Act).

After Clinton-appointed federal judges Norman Moon in Virginia and George Caram Steeh in Michigan, ruled the Act’s requirement that people buy their own health insurance is constitution-al, 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 Attor-neys 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 deci-sion, unless President Obama and a new Congress reach a new agreement on insurance coverage. No case before the Court will be more watched or politi-cally 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 Falwell’s Liberty University.

The Virginia challenge was brought by the Commonwealth’s Attorney General, Kenneth Cuccinelli. Cuccinelli sued

Kathleen Sebelius, the Secretary of the Department of Health and Human Ser-vices, 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 that’s the Tyler, Texas, surgeons’ challenge to the law’s provision limiting the rights of physi-cians to own their own hospitals. Scott Oostdyk, the constitutional law-yer 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’ chal-lenge because they failed to show that the ownership provision of the law vio-lated a physician’s 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’ argu-ments. The chances for the Tyler rebels seem to be getting slimmer.

However, says Oostdyk, the Attorneys General’s challenge in Florida may accomplish the same result if the judge rules against the Act.

Top Row: Judge George Caram Steeh and Judge Norman Moon. Second Row: Judge Michael Schneider and Judge Henry Hudson.



In Oostdyk’s view the Florida decision, if decided for the challengers, could strike down the entire Act, as opposed to Hudson’s decision in Virginia, which narrowly struck down the part of the Act which mandates insurance cover-age. 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 impor-tant 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 notori-ously 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 depend-ing on Judge Schneider’s decision. He said that his clients have received wide-spread support from their colleagues around the country.

Policy Implications of Decision

Judge Hudson’s 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

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 don’t take effect until 2014. By then the Supreme Court will likely have weighed in with a decision.

The White House insisted a day after Hudson’s ruling that the implementa-tion of the Act will not be affected by a negative federal court ruling, and the Justice Department said it would appeal.

“There’s 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.

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VOLUME 7, ISSUE 1 | JANUARY 4, 201110Mandate Lite

As controversial as the mandated insur-ance requirement is, Daniel McLaugh-lin 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 pen-alty. This penalty applies when you do obtain Part D coverage and it is an addi-tional 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 insur-ance, 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 insur-ance. “For those in the policy business creative solutions are almost always required—this case will not be an exception,” concluded McLaughlin.

A Medicare type requirement is a “man-date 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 don’t have to buy insurance. But if you don’t, the first time you come in, we’re going to add a penalty that you’ll 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 Repub-licans no longer take that position, but Wilensky told the AP she has no prob-lems with the concept.

“As a society, we have made a commit-ment not to let people die in the street because of lack of medical care,” she said, not-ing that hospital emergency rooms have to accept the uninsured. “It’s not unrea-sonable 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 Stol-berg wrote on December 14 that the Florida and Virginia challenges were filed in courthouses where conserva-tive judges prevail, and where appeals would flow to the country’s most con-servative 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 dis-trict court level, there is generally a high degree of consensus among judges in similar cases, except when they con-front polarizing constitutional ques-tions like abortion, campaign finance and now health care,” added Stolberg.

“When the law is fairly clear, politics don’t 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, let’s say, it’s natural that judges’ political, social and economic views will shape how they see things.”

Public Policy and the Constitution

A day after Judge Hudson’s ruling, U.S. Attorney General Eric Holder and Sec-retary Sebelius wrote in a Washington Post editorial:

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VOLUME 7, ISSUE 1 | JANUARY 4, 201111more 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 insur-ance, and that means everyone who can afford coverage needs to carry mini-mum health coverage starting in 2014.”

But as the Tyler rebels reminded us in their challenge, Justice Oliver Wendell Holmes drew a line in the sand…when 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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VOLUME 7, ISSUE 1 | JANUARY 4, 201112Good Hands? Really? Assessing Surgical SkillsBy Elizabeth Hofheinz, M.P.H., M.Ed.

If just a couple of the billionaires giving away their money these days

were to offer funds to orthopedic train-ing programs, there just may be a high flying virtual reality simulator in every school. But alas, we must await the tril-lionaires 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 orthope-dists 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 can’t operate.’) Tra-ditionally, tests in the surgical special-ties are knowledge based…but being able to perform in the OR is a com-pletely 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 evalua-tion scale of 1-5 with 5 being outstand-ing. 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 Ameri-can Board of Orthopaedic Surgery on

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 sta-tion, 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 pre-dict that someone will fail on the tech-nical skills from how well they did on the knowledge test; however, if some-one 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 it’s not enough to only test knowledge—which is what we’ve 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-

Wikimedia Commons

Traditionally, tests in the surgical specialties are knowledge based…but being able to perform in the OR is a completely different issue.“ ”



oped a knee arthroscopy simulator with haptics (meaning that surgeons can have tactile feedback as they oper-ate). At present the company is validat-ing its use in residencies, with our pro-gram 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 resi-dents 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 ortho-pedists in training is also now avail-able. “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 devel-oped something similar for arthroscopy in orthopedics. The important thing is that it is not joint-specific…the 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 retest…after the residents have under-gone 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 Ortho-paedic Residency Directors (CORD) to examine better ways to assess physician training. For four to five years commit-tees 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 assess-ment tool for surgical skills, some-thing that falls under the ‘patient care’ core competency. Our efforts are also clearly ones that will be welcomed by residents…they rate obtaining techni-cal skills as one of the most important things that they need to learn.”

And if young orthopedic trainees confer with their colleagues in other special-ties, they might find the need to play some catch-up when it comes to man-ual skills training. Dr. Marsh: “Ortho-pedics is somewhat behind in both teaching and assessing technical skills, in part due to the complexity and range Wikimedia Commons

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-specific…the goal is to teach the residents how to use the equipment, with a focus on navigation and object manipulation.

“ ”

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of procedures. We are literally teaching hundreds of different surgical proce-dures, in contrast to general surgery, where they ‘contend’ with only a rela-tively 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 train-ing. 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 devel-op our own tools.”

The residents at the University of Iowa are already benefitting from the work of Dr. Marsh and other committee mem-bers. “The Assessment Tools Subcom-mittee 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, essen-tially 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 mea-sures the residents are rated in compari-son 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 environ-ments, says Dr. Marsh, the highest level work is that previously mentioned by Dr. Van Heest. “This technology allows residents to be in a computer environ-ment simulating knee arthroscopy look-ing 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 feel-ing things inside the virtual knee). With this level of sophistication comes an elaborate scoring scale. I don’t, how-ever, think that ten years from now we’ll 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 bet-ter patient outcomes the old fashioned way—with better surgical skills. ◆

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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.

“

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VOLUME 7, ISSUE 1 | JANUARY 4, 201116company

Mesoblast Completes Angioblast Acquisition

Mesoblast Limited has completed the acquisition of its U.S. associ-

ate 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, announce-ment 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 devel-oped over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precur-sor 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 pat-ented adult stem cell technology plat-form under one umbrella. With Meso-blast 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 “sig-nificantly broaden its product portfolio based on 100% ownership of the intel-lectual property underpinning the com-pany’s patented adult stem cell technol-ogy platform. Transforming Mesoblast from a biologics company focused on orthopedic applications to a global leader in the broader regenerative med-icine industry should prove to be a piv-otal event in the company’s evolution.”

“Mesoblast is now a mature multi-product company with products in late, mid, and early stage development. The com-pany’s product pipeline will be significantly extended beyond its orthopaedic focus, including spinal fusion and osteoarthritis, to include products for treat-ing 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 Australia’s Han-son Institute and Institute of Medical and Veterinary Science (IMVS).

—WE (December 28, 2010) ◆

Smith & Nephew Receives FDA Warning

Smith & Nephew’s Chairman in Lon-don, 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 company’s R3 Ceramic Ace-tabular Systems, manufactured in Tut-tlingen, 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 ap-proved according to established procedureMesenchymal stem cell expressing microtubule associ-

ated protein fusion/Wikimedia.org

legal



•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 justifica-tion for use of nonconforming product

•Failure to establish procedures for changes to a specification, meth-od, process, or procedure

The FDA left the following message in Mr. Buchanan’s 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 ComplianceCenter 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, Ten-nessee, and Warwick, England. “We’ve been working with the FDA since the summer,” she said. Another spokes-person 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/Enforce-m 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


That Spare Tire – a Stem Cell Lifesaver?

Flabby hips and thighs could turn out to be assets instead of liabili-

ties, according to Malcolm Alison, pro-fessor of stem cell biology at Barts and the London School of Medicine and Dentistry. As reported in The Austra-lian, 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,

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Smith & Nephew R3 cups/courtesy of Smith & Nephew

biologics

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VOLUME 7, ISSUE 1 | JANUARY 4, 201118waiting days (to extract and grow the cells) would be too late”.

The type of stem cells found in fat, mes-enchymal 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 isn’t 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 Fanconi’s anemia. The procedure aimed to regenerate the boy’s blood and immune cells. From that beginning has sprung the wide spread practice of stor-ing umbilical cord stem cells for treating potential future diseases. Today the col-lection, 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 hospi-tals and other medical centers.

So the template is certainly in place for stem cell banking—whether from adi-pose (fat) tissues or cord blood.

—BY December 28, 2010 ◆

Stem Cells That Refuse to Age

Embryonic stem cells are, by defini-tion, immortal. Once these cells

commit to a particular lineage—like mesenchymal cells which are the pro-genitor cells for bone, nerve tissue and muscles—they begin the process of aging and eventual death.

Scientists are the University of Buffalo, however, have engineered mesenchy-mal stem cells that resist aging. Indeed, in the lab these cells show no evidence

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 chem-ical or biomechanical signals directed at the cells.

A team led by Dr. Techung Lee devel-oped 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 application-driven,” he said. “If you want to make stem cell therapies feasible, affordable and reproducible, you have to over-come a few hurdles. Part of the prob-lem 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 pub-lished in the journal Heart and Circula-tory Physiology.

The University of Buffalo has applied for a patent to protect Lee’s discovery.

—BY December 26, 2010 ◆Wikimedia Commons



FAI Athletes Respond to Surgery

Can high level athletes with femoroac-etabular impingement (FAI) resume

their sport of choice after surgical hip dis-location? 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 sur-geons from the Department of Orthope-dic 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) fol-lowing surgical treatment for hip dis-location. 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 surgi-cal 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 Score–Activities of Daily Liv-ing and Sport subscales were 94.5 and 89.1. Mean scores of the SF-12 physi-cal and mental component summaries

were 51.1 and 54.3.

The conclusion of the study was that surgical hip dislocation for the treat-ment of FAI does allow athletes to resume sports and continue profes-sional careers at the pre-operative, pre-injury level and to maintain that activity for several years. Clinical outcomes in terms of subjective ratings and scores were also favorable.


Tough New CeramicIntroduced

C5 Medical Werks, of Grand Junc-tion, 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 resis-tance in combination with low wear characteristics. The company expects the material to become an ideal choice for ceramic total hip replacement sys-tems as well as next generation knee and femoral resurfacing devices.

Dr. Steve Hughes, Orthopaedic Prod-uct 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 company’s proprietary tech-nology. “In industry standard femo-ral 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.”

large joints

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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 genera-tion ceramic orthopedic implants. “The inherent high strength and fracture toughness of cerasurf allows for great-er design flexibility” said Dr. Hughes, who added that the use of high-purity cerasurf ceramic provides articulat-ing surfaces with a lower friction and reduced wear characteristic when com-pared with metal or poly bearing sur-faces. He believes that these properties may increase the lifetime of the implant as well as reduce the risk of osteolysis (bone degeneration) by reducing poly-ethylene 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 compo-nents with emphasis on ceramic mate-rials certified to ISO 13485:203 and compliant with the FDA’s Quality Sys-tem Regulations. Product lines include ceramic implantable components used in orthopedic and dental applications.


Runners Who Sweat - Win

Perspire 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.

This finding is contrary to the conven-tional 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 run-ners, of whom 560 were men, were weighed before the race’s 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

given exactly the same advice to drink either 250 milliliters of water or energy drink every 20 minutes to avoid dehy-dration. Weather conditions were well suited for running with a temperature range of from 9 to 16 degrees C, mod-erate 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’

C5 Medical Werks

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VOLUME 7, ISSUE 1 | JANUARY 4, 201121athletic 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 con-ditioning 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.”


Too Often Concussive Athletes Go Untested

Injured high school football players are not receiving critical neuropsy-

chological testing, according to a study published December 15, in the Ameri-can Journal of Sports Medicine. High

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 stu-dents injured in other sports.

“Although it is now recognized as one of ‘the cornerstones of concussion evaluation,’ routine neuropsychological testing in the setting of sports-related concus-sion is a relatively new concept,” write the authors of the study, Wil-liam P. Meehan III, M.D., Pierre d’Hemecourt, M.D., and R. Dawn Com-stock, Ph.D. “This is the first study, of which we are aware, to query the use of computerized neuropsychological test-ing in high school athletes using a large, nationally representative sample.”

A total of 544 concussions were recorded by the High School Reporting Informa-tion Online surveillance system during

the 2008-2009 school year. Research-ers 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 conscious-ness

•83.4% experienced resolution of their symptoms within a week, while 1.5% had symptoms that lasted longer than a month

Computerized neuropsychological test-ing 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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VOLUME 7, ISSUE 1 | JANUARY 4, 201122injured football players were less likely to be examined using the computerized neuropsychological testing than were athletes injured while participating in other sports.


Not So Predictive MRI

Magnetic resonance imaging—the MRI—has 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 Medi-cine, 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-

skeletal radiologists could, with good to excellent accuracy, predict the repara-bility 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 mus-culoskeletal radiologists then indepen-dently and blindly reviewed the preop-erative 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 menisco-

synovial 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 cor-rectly estimate reparability was poor. They made correct predictions in only 58.0% and 62.7% of the cases, respec-tively. 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 sig-nificance.

The study’s conclusion? Magnetic reso-nance imaging is not an effective or effi-cient predictor of reparability of menis-cal tears under current arthroscopic criteria.


Runners Butts—Dead or Alive?

When writer Jen Miller consulted her doctor about pain she expe-

rienced 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 physi-cian with Riverside Methodist Hospital in Columbus, Ohio, and medical direc-tor of that city’s marathon, identified as her problem. The technical name is glu-teus medius tendinosis, an inflamma-tion 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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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, we’ve 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 mus-cles 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 pres-sure they weren’t 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, it’s healing gone wrong,” Dr. Bright

said. “That gluteus medius isn’t firing the way it’s supposed to. You’re getting an inhibition of the muscle fibers. It’s 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 maxi-mus muscles,” said Dr. David Webner, a sports medicine doctor at Crozer-Key-stone Health System in Springfield, Pa.

For about 70% of his patients, physi-cal therapy that stretches the muscles in the hip and leg and strengthens the gluteus muscles, along with a tempo-rary reduction in the mileage and inten-sity 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

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 don’t 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) ◆

New Size EGR for Foot Surgeons

Foot surgeons now have a second sized Endoscopic Gastroc Release

(EGR) from Integra LifeSciences Hold-ings 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

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VOLUME 7, ISSUE 1 | JANUARY 4, 201124designed to be employed by podiatrists attempting to perform endoscopic sur-gical correction for posterior heel cord or equinus contracture (EC). Integra’s 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 impair-ment. 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 bal-ance across the foot and ankle.

With Integra’s EGR System physicians can perform the recession of the gas-trocnemius and soleus muscle com-plex endoscopically through a small incision, a minimally invasive and less traumatic procedure that produces a smaller and less apparent scar.

“We’ve 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 Market-ing for Integra Extremity Reconstruc-tion. “The product has exceeded their expectations, not only with its excep-tional 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 Integra’s Extremity Reconstruction sales organi-zation, which focuses on lower extrem-ity fixation, upper extremity fixation, tendon protection, peripheral nerve repair protection and wound repair.


Needling Carpal Tunnel

An 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

hand and wrist. The usual treatment is splinting or steroid injections and, when these fail, surgery.

Dr. Nathan Wei, in a study entitled “Ultra-sound-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 tun-nel release can be performed using a small needle with ultrasound guid-ance. Relief is immediate and recov-ery time is 24 hours or less. Using this new technique, we performed 34 out of 44 wrist procedures after conserva-tive measures had failed. No patient had had previous surgery, and two had had blind carpal tunnel steroid injec-tions. When we measured the patient

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outcomes we found that 29 patients showed improved progress while only 5 had outcomes poor enough to be clas-sified 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-guid-ed hydrodissection and fenestration is a minimally invasive therapy for carpal tunnel syndrome that can result in pro-longed 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 proce-dure can be performed in an office set-ting 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 Michi-gan Medical Center in Ann Arbor, Michigan, and his fellowship in arthri-tis 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.


Hide the Car Keys

The first question a patient asks his doctor after right foot or ankle sur-

gery is, “Doc—How 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 lon-ger to brake when the driver is wear-ing an immobilization device—such as a splint or brace—than it does when wearing normal footwear.

Thomas Dowd, M.D., an orthopedic surgeon in the Department of Orthope-dics 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 indi-viduals wearing a short leg cast, a con-trolled ankle-motion boot, or normal footwear. The results showed that all of the devices—except the normal foot-wear—impaired the drivers’ ability to brake quickly.

“We only tested emergency braking sit-uations, but it is reasonable to assume that if a person cannot stop quickly in

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-ankle-motion 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 driv-ing 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 immo-bilization device on the right foot. Orthopedic surgeons need to educate their patients about these safety con-cerns when discussing the best time to begin driving again.”

The study revealed that more than 90% of orthopedic surgeons would general-ly not recommend that a patient drive

while immobilized in a right lower-extremi-ty short leg cast. Also, under the terms of most insurance poli-cies, the insurer is not obligated to cover accidents in which the driver is still recover-ing from an earlier injury or operation.

—BY (December 23, 2010) ◆

Wikimedia Commons

Wikimedia Commons



Gladney Takes Over Lanx

Dan 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 Part-ner, Dan Gladney, has agreed to become the company’s new CEO. We called to make sure. This ends the curious epi-sode 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 (com-pounded annual growth rates) in spine since 2008 and is one of the top three privately held spinal implant compa-nies (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 (Medtron-ic), himself (Zimmer), and Peter Wil-liams, VP of HR. “Jon has an operations background and was formerly Interim GM for MDT’s surgical navigation busi-ness. 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.

Dan Gladney

Gladney has more than 25 years of experience in the medical device indus-try, founding and leading companies in the orthopedic and cardiology sectors. As an operating partner at Norwest, Gladney evaluated and executed new investment opportunities and add-on 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 co-founded Heartleaflet Technologies, a high-tech cardiovascular device start-up developing a percutaneous aortic heart valve system, which was acquired by Bracco s.P.a.

In addition, Gladney served as Chair-man, 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-

ration. While at Compex, he repositioned and restructured the company, completed sev-eral acquisitions, and drove top line growth from an average of 5% per year to 15% in a declin-ing market. Prior to Compex, Gladney served as President and CEO of Acist Medical Sys-tems, 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

Lanx has a suite of fusion prod-ucts, including the flagship Aspen Spi-nous 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-found-er and Chairman of Lanx, said, “His [Gladney’s] specific operating experi-ence as chief executive of several emerg-ing 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, expe-rienced management team, interesting product pipeline and a new CEO with deep device experience.” Gladney will take his new post on January 10, 2011.


people

Dan Gladney/Norwest Equity Partners



You might say that in North Carolina, Dr. Thomas Fehring, Co-Director of

the Hip and Knee Center at OrthoCar-olina, 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. Feh-ring is also Vice President of the Knee Society, and has a particularly impor-tant long term goal—doing his best to ensure that older patients in the years to come have access to hip and knee replacement.

Many orthopedic surgeons share Dr. Fehring’s 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. Fehring’s 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 grand-mother 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 biomechan-ics, and liked the fact that patients tend to get well (in contrast to other special-ties). It was also helpful that my mom remarried a man who was an obstetri-cian—he 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 bask-ing 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 succeed…I found that at the library. Who knows…if we had been really suc-cessful 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 revi-sions in this area, I see very interesting cases, many of which involve infections. What is especially interesting to me is to take someone who hasn’t walked in a year—and who has been told by other surgeons not to hope for much—and make it possible for them to walk.”

The patient population that receives Dr. Fehring’s skilled, compassionate

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 grandmoth-er. 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 cooperating—in contrast to a 25-year-old who feels invincible, gets fixed, and goes back to being invinci-ble. 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 areas—practice, teaching and research.”

Less concerned about the inflow of income, and more concerned about the outflow of orthopedists, Dr. Fehring is

THE PICTURE OF SUCCESSDr. Thomas Fehring

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

Dr. Thomas Fehring

“We are facing a real crisis that will likely result in patients I care about—patients who have numerous body parts breaking down at once—not being able to get the help they need.” -- Dr. Thomas Fehring.



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 arthro-plasty 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 approxi-mately half a million joint replacements will not be performed because the sup-ply of surgeons will not meet demand.”

Dr. Fehring is also concerned about the effect the Internet has had on the prac-tice 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 unfiltered—marketing pro-cedures 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 prod-ucts 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 problems—pelvic discon-tinuity with a custom triflange implant. Our data showed that this was success-ful 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 debride-ment is not successful. I am working with a consortium around the coun-try to learn more about periprosthetic infections. We have five high volume centers and have thus far published three papers on infection-related top-ics. To date we have found that if irri-gation 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.”

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 Founda-tion. We have launched the program, and are focusing on orthopedic educa-tion, 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 interna-tional 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 every-one 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 wait-ing 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 Over-seas, and have been to Nicaragua each year. I’ve also been pleased that when I have reached out to colleagues around the U.S. they have responded by join-

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 cooperating—in 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.

“ ”



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. Feh-ring relies on a power outside of himself

for guidance. “I am a faith-based per-son, and I don’t for a minute think I am in control of everything. Depending on the patient and the situation, I may even say to the person, ‘Let’s 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 wonder-ful 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 coun-try. I tell kids my kids, ‘I made 950 on my SATs and have still managed to accomplish a few things.’”

Dr. Thomas Fehring…operating in the present and attempting to change the future. ◆

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.

“ ”

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