week in review 4 Carragee’s Mismeasure of rhBMP2 and...

VOLUME 7, ISSUE 33 | OCTOBER 18, 2011

1-888-749-2153 | www.ryortho.com

20 UK Opens Stem Cell Research Center..........................................

Ortho Surgeons’ Incomes near Top............................................................Alphatec Back in FDA Good Graces............................................................Faster Hospital Discharge, Better Out-comes?............................................................Medical Device Makers Shun U.S.............................................................FDA and CMS Offer Concurrent Review............................................................McMillan Becomes Orthofix Spine Chief

For all news that is ortho, read on.

week in review

breaking news

4 Carragee’s Mismeasure of rhBMP2 and Spine Surgeons ◆ How did The

Spine Journal’s peer review process miss glaring errors in fact as well as judgment and scientific method in its June 2011 issue? We think there are two basic reasons. And both were under Carragee’s control.

8 Wall Street Journal Bungles Surgeon Story ◆ Gary Moore died at St. Dominic’s

Hospital in Jackson, Mississippi on April 7, 2011. The Wall Street Journal says it is partly due to the surgeon’s ownership in a medical device company. But the facts don’t match the accusation. It’s another bungled, misleading story from WSJ. We set the record straight.

13 Orthopaedic Cross-fire: The Bearing Sur-face Conundrum ◆ A

Current Concepts in Joint Replacement debate between Henrik Malchau, M.D., Ph.D. and Michael D. Ries, M.D. Hear what each party has to say about Cross-Linked Polyethylene.

17 Reporter’s Notebook ◆Industry reshaping itself into three big players? East

Coast not gotten the message about metal on metal? MedPAC doing a “di-vide and conquer” of doctors? Oh, and what execs are going where…read on…



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: Buyers outnumbered sellers for the second week in a row for most companies, but not for orthopedic stocks. Zimmer, the least expensive but one of the most profitable companies in orthopedics, could find no favor. SYK is now #1 on the Power Rankings. WMGI, CNMD, IART and KNSY all moved higher in advance of earnings calls.

1 4 Stryker 25.23% 3.07%Two news stories last week reinforced the view that SYK will report double-digit sales growth for Q3.

New #1.

2 1 Zimmer 27.75 -5.19Big Blue not getting the love it deserves from Wall Street. At these valuations, all downside is built in.

3 2 Medtronic 28.63 -2.74Flat earnings are the call for current quarter.

On just 4% sales growth. But growth rates should pick up in 2012.

4 9 Kensey Nash 34.24 5.23Streaky KNSY is back on the upside as buyers

look past this quarter and focus on a big earnings pop in Q4.

5 5Johnson &

Johnson26.33 1.55

Synthes shareholder record date is set for the merger with DePuy. This mash up is a seismic event

for orthopedics.

6 3Smith & Nephew

22.8 -2.28Wall Street must think margins are softening at

SNN since earnings are forecast to grow 3% vs. 8% for sales.

7 8 Integra 15.38 1.12IART ascended to BUY from HOLD in Citigroup’s

report to institutions.

8 6 Orthofix 14.72 -4.12New CEO Vaters building his team. Latest is a new leader for spine. Wall Street not paying

attention. Typical.

9 10 Conmed 9.65 12.08Suddenly buyers like CNMD. But it may be

passing fancy. Financials need help from hospital spending trends.

10 7Wright Medical

8.76 25.2Wall Street’s buying of WMGI looks overheated tous and therefore vulnerable. No doubt rumors of

buyout are the fuel.



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 Bacterin Intl Holdings BONE $2.29 $91 30.11%2 Wright Medical WMGI $18.33 $722 25.20%3 RTI Biologics Inc RTIX $3.74 $206 12.65%4 Conmed CNMD $25.80 $737 12.08%5 MAKO Surgical MAKO $41.50 $1,720 10.34%6 Exactech EXAC $14.99 $197 10.22%7 Symmetry Medical SMA $8.64 $314 8.14%8 Kensey Nash KNSY $27.35 $236 5.23%9 Stryker SYK $50.02 $19,424 3.07%

10 TiGenix TIG.BR $0.98 $90 2.42%

1 NuVasive NUVA $17.49 $698 -18.31%2 TranS1 TSON $3.22 $90 -13.21%3 Alphatec Holdings ATEC $2.24 $200 -11.81%4 CryoLife CRY $4.74 $133 -5.39%5 Zimmer Holdings ZMH $52.96 $10,088 -5.19%6 Orthofix OFIX $34.68 $638 -4.12%7 Medtronic MDT $33.10 $34,953 -2.74%8 Smith & Nephew SNN $46.40 $8,286 -2.28%9 Synthes SYST.VX $164.77 $19,570 -0.71%

10 ArthroCare ARTC $30.28 $831 0.20%

1 Medtronic MDT $33.10 $34,953 10.062 Zimmer Holdings ZMH $52.96 $10,088 11.413 Johnson & Johnson JNJ $64.72 $177,356 13.244 Smith & Nephew SNN $46.40 $8,286 13.475 CryoLife CRY $4.74 $133 13.94

1 Wright Medical WMGI $18.33 $722 26.192 NuVasive NUVA $17.49 $698 21.863 ArthroCare ARTC $30.28 $831 21.174 Synthes SYST.VX $164.77 $19,570 20.865 Exactech EXAC $14.99 $197 19.72

1 Orthofix OFIX $34.68 $638 0.842 Integra LifeSciences IART $38.80 $1,068 0.873 Kensey Nash KNSY $27.35 $236 1.174 Zimmer Holdings ZMH $52.96 $10,088 1.215 Stryker SYK $50.02 $19,424 1.32

1 ArthroCare ARTC $30.28 $831 3.532 NuVasive NUVA $17.49 $698 3.363 Johnson & Johnson JNJ $64.72 177,356 2.384 Wright Medical WMGI $18.33 $722 2.135 CryoLife CRY $4.74 $133 1.99

1 Symmetry Medical SMA $8.64 $314 0.872 Exactech EXAC $14.99 $197 1.033 Conmed CNMD $25.80 $737 1.034 Orthofix OFIX $34.68 $638 1.135 CryoLife CRY $4.74 $133 1.14

1 TiGenix TIG.BR $0.98 $90 144.272 MAKO Surgical MAKO $41.50 $1,720 38.833 Bacterin Intl Holdings BONE $2.29 $91 5.894 Synthes SYST.VX $164.77 $19,570 5.315 Tornier N.V. TRNX $21.80 $854 3.76

PSR: Aggregate current market capitalization divided by aggregate sales and the calculation excluded the companies for which sales figures are not available.

http://www.ryortho.com/advertise.php


VOLUME 7, ISSUE 33 | OCTOBER 18, 20114Carragee’s Mismeasure of rhBMP2 and Spine SurgeonsBy Robin Young

Stanford University’s Dr. Eugene Carragee joined a long, distin-

guished line of academicians when he published his controversial June 2011 issue of The Spine Journal (TSJ). Under his direction, the Journal dedicated its entire issue to seeking out and correct-ing perceived flaws in the early studies of rhBMP-2—better known as InFuse.

Carragee and his colleagues also raised the issue of bias in those early studies and directed readers to consider the role of industry sponsorship of those studies as well as payments made directly to the investigators of those studies.

Orthopedics This Week found that Car-ragee and his colleagues had omit-ted key information from their study

which could arguably have changed the author’s conclusions. (See Under Car-ragee The Spine Journal Lives Danger-ously: Orthopedics This Week; Septem-ber 13, 2011)

Confirming Stereotypes

Stepping back from the specific prob-lems that have emerged from Carra-gee’s June TSJ study and considering more broadly the meaning of Carragee’s study, we are reminded of other famous and accomplished academicians who also fell into the intellectual sand trap that now holds Carragee.

We’ll start with the eminent Dr. Samuel George Morton, professor of anatomy at the University of Pennsylvania and

author of the then standard anatomy text book. Dr. Morton was interested in conducting a study regarding the sources of intelligence in humans. Dr. Morton’s hypothesis was that the dif-ferences he noticed between different human beings were due to a difference in species, not variability within a spe-cies. He was particularly interested in the concept of polygenism, which is the theory of multiple racial creations.

Dr. Morton then set as his dependent variable, human intelligence. He set as his independent variable, the dimen-sions of the human cranium. As a prelude to the big study, Dr. Morton inspected the skulls of three mummies from ancient Egyptian catacombs and

US Army Corps of Engineers/Wikimedia Commons

Advertisement

http://www.alphatecspine.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 20115concluded that the dimensions of the Caucasian skull were different three thousand years ago from the dimen-sions of the Negro skull. Since the Bible pegged Noah’s Ark as having occurred one thousand years ago and since Noah was Caucasian, the Negro must there-fore be a distinct species from the Cau-casian—reasoned Dr. Morton.

Morton’s hypothesis, it is important to note, was consistent with the best sci-entific thinking in the U.S. in 1839.

Dr. Morton measured thousands of skulls and reported in his classic work Crania Americana that the Caucasians had the biggest brains, averaging 87 cubic inches (1,426 cc), Indians were in the middle with an average of 82 cubic inches (1,344 cc) and Negroes had the smallest brains with an average of 78 cubic inches (1,278 cc). Morton believed that the skulls of each race

were different because a wise creator had created each race and positioned them in separate homelands to dwell in from the beginning.

Two separate studies, one conducted in 1988 and the other in 2011, show that Morton’s work was, in so far as his measurements of the craniums were concerned, accurate. Dr. Morton’s study was careful, rigorous and his data was strong. As the professor of anatomy at the University of Pennsylvania—at the time the leading medical school in the United States—Dr. Morton’s study was widely praised. The anthropologist Alex Hrdicka called Morton “the father of American physical anthropology.”

In retrospect, Dr. Morton made an ele-mentary mistake. He failed to isolate his independent variables. Had he con-trolled for every independent variable except cranium size (like education

level, socio-economic factors and stan-dardized intelligence tests) , he would have had a study that might well have discovered the relationship (or lack thereof) between head size and intel-ligence.

Instead, Dr. Morton’s flawed study gave scientific rigor and academic standing to institutional racism and its logical variants— slavery, oppression and, in our lifetimes, a tragically “separate but equal” educational system.

Harvard’s Stephen Jay Gould Joins the Fraternity

Harvard University’s Stephen Jay Gould was a lifelong civil rights advocate and spoke out frequently against cultural oppression in all its forms. In 1978 Dr. Gould wrote a paper which was later expanded into his monograph: The Mismeasure of Man (1981), where he asserted that Dr. Samuel George Morton had selectively reported data, manipu-lated sample compositions, made ana-lytical errors, and mismeasured skulls in order to support his prejudicial views on intelligence differences between dif-ferent populations.

Dr. Gould’s paper confirmed the then prevailing wisdom in 1981 that the United States had been treating dif-ferent population segments differently based on race and that there had been pseudoscience used in the service of racism and sexism. Dr. Gould’s study was very popular and received fawn-ing and uncritical attention in the mass media.

In 2011, six anthropologists in a paper titled, “The Mismeasure of Science: Ste-phen Jay Gould versus Samuel George Morton on Skulls and Bias” agreed that there was bias—but that the bias had come from Gould, who failed to exam-advertisement

THE IMPLANT SURFACE TECHNOLOGY COMPANY

REDEFINING THE ROLE OF INTERBODY FUSION DEVICES

Please visit www.titanspine.com orNASS Booth #1019 to learn more

INTERBODY FUSION DEVICES

http://www.titanspine.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 20116ine, let alone remeasure, the crania to determine Morton’s level of accuracy.

Morton’s measurements were, in fact, spot on.

But who is going to challenge Harvard University’s eminent and powerful Ste-phen Jay Gould when he presents a sci-entific paper which claims that a study from 1839 had measurement error? Everyone knows Morton was racist and Harvard is confirming it.

Well, someone checked the data. Drs. Lewis, DeGusta, Meyer, Monge, Mann and Holloway remeasured the original Morton craniums and 33 years after Gould’s famous study was published in Science, showed conclusively that it was Gould who was biased.

Columbia University Joins the Fra-ternity

Columbia University’s Sherry Glied, Ph.D. professor of Health Policy and Management, who is currently on leave to serve as the Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Ser-vices (HHS), conducted a study in 2011 to determine, in part, whether hip sur-geon fees contributed to higher health care spending in the U.S. Her co-author for the study was Miriam Laugesen. Ph.D.

Their conclusion? Higher fees paid to orthopedic surgeons for performing hip replacement surgery in the U.S. is a “main driver” of higher health care spending in the U.S.

While picky skeptics may argue that individual orthopedic surgeons would have to be collecting $40 million annual-ly to sway the trillion dollar U.S. health-care system, there was a more urgent problem with the Columbia University study—they used the wrong data.

Drs. Glied and Laugesen based their study on data from the Medicare Physi-cian Fee Schedule which is the maxi-mum allowable orthopedic surgeon payment—not the actual paid. The fig-ure for the actual amount paid is to be found in the CMS (Centers for Medi-care and Medicaid Services) Carrier Standard Analytical Files.

How far off were the Columbia Uni-versity (one of whom is now a policy maker at HHS) professors? About 67% or $1,600 versus the actual $960. Turns out, contrary to an increasingly popular stereotype, U.S. hip surgeons are likely paid LESS per procedure than their counterparts in Australia, Germany or the UK. Yes, U.S. hip surgeons are paid less than their colleagues in socialist medicine UK.

But because the Columbia University study was consistent with today’s pre-vailing stereotype of an overcharging, overpaid, industry sponsored ortho-pedic surgeon, no one challenged the stereotype.

As we saw with Morton and Gould, when a powerful academic institution lends its standing to confirm pre-exist-ing stereotypes, no one checks. No one challenges. No one dares say that the emperor has no pants, no shirt, and no shame.

Carragee Joins the Fraternity

Much as Morton, Gould and others wrote about subjects which, in their times, were accepted wisdom, so too, we think, did Carragee issued the June 2011 The Spine Journal into a similarly stereotyped environment. Carragee quite purposefully we think, jumped into the middle of the popular narrative that spine surgeons perform too much surgery, seek to curry favor with man-ufacturers and rely on clinical studies

that have been influenced by implant and drug companies.

As we saw with the previous examples, presenting scientifically flawed studies under the imprimatur of institutions like Harvard University, University of Pennsylvania, Columbia University and, now, Stanford University, but which confirm existing stereotypes, practically guarantees minimal critical review.

Take for example the following quote by Carragee from his June 2011 edito-rial in The Spine Journal. “In the case of rhBMP-2, 13-peer-reviewed articles by industry-sponsored authors did not report a single adverse event asso-ciated with rhBMP-2.” (Emphasis added.)

We checked and contrary to Carra-gee’s assertion, we found specific and numerous examples of cases where the authors of those same studies did report adverse events associated with rhBMP-2 and in one case (Dimar et al. study of 53 patients treated with rhBMP2) published a table that listed numerous adverse events associated with using rhBMP2.

It is hard to miss a table that lists adverse events.

What Happened to The Spine Jour-nal’s Peer Review Process?

How did The Spine Journal’s peer review process miss these errors in fact—but also, we think, errors in intellectual judgment and scientific method.

(Specifically, in our review of Carragee et al. review of the 13 early rhBMP2 studies we found that Carragee, like Morton 170 years ago, failed to isolate his independent variables. Carragee and his fellow authors created a kind


VOLUME 7, ISSUE 33 | OCTOBER 18, 20117of gumbo of unrelated data points and then presented them as if they showed, at a minimum, correlation between the allegedly flawed studies and investiga-tor fees or royalties.)

What was The Spine Journal’s peer review process? Did it comport with the process that the publisher, Elsevier, states is standard operating procedure? Did it comport with the process that peer review journals generally adopt in order to squeeze out bad science and bias?

Elsevier, the publisher of The Spine Journal, says; “Peer review (known as refereeing in some areas) is an essen-tial dividing line for judging what is scientific and what is speculation. The process screens article submissions and requires that authors meet the standards of their discipline and achieve scientific objectivity. This means that science is more than just another opinion.”

As described by Elsevier, the National Institutes of Health, the American Med-ical Association and numerous other commentators, the typical medical peer review process is supposed to function as follows:

1. The peer review process begins when a journal’s editor sends cop-ies of an author’s work to two or three researchers or scholars who are experts in the field (known as “referees” or “reviewers”) to evalu-ate.

2. The reviewers read and evalu-ate the author’s work, return their evaluation of the author’s work to the editor, noting weaknesses or problems along with suggestions for improvement.

3. Eventually, though not immediate-ly, most of the reviewer’s comments are seen by the author. Frequently, reviewers are anonymous and inde-

pendent in order to avoid cronyism and to encourage unvarnished crit-icism.

4. The editor, who is usually familiar if not also an expert in the subject matter of the manuscript (although typically not in as much depth as the referees, who are specialists), then evaluates the referees’ com-ments, her or his own opinion of the manuscript, and the context of the scope of the journal or level of the book and readership, before passing a decision back to the author(s), usually with the referees’ comments.

When it works, the peer review process ensures that authors do not dissemi-nate irrelevant findings, unwarranted claims, unacceptable interpretations, and personal views.

When it does not work (and peer review failures do occur—as for example when

a peer-reviewed article contains obvi-ous fundamental errors that undermine at least one of its main conclusions) then the main procedure to deal with those failures is publishing letters to the editor.

Of course, in the case of The Spine Jour-nal, the editor was also the author.

Key questions that need answering are: Did Carragee select his own special edi-tor for the manuscript that he submit-ted to The Spine Journal? Did Carragee select the peer reviewers who reviewed his manuscript for the June 2011 issue? Did Carragee have any role in the edi-torial or peer review process that ulti-mately resulted in June 2011 special edition of The Spine Journal?

Stay tuned. ◆

Advertisement

https://www.xiaflex.com/hcp/index.jsp


VOLUME 7, ISSUE 33 | OCTOBER 18, 20118Wall Street Journal Bungles Surgeon StoryBy Walter Eisner

Gary Moore died at St. Dominic’s Hospital in Jackson, Mississippi

on April 7, 2011 after undergoing a 360-degree spinal fusion procedure performed by his neurosurgeon, Adam Lewis, M.D.

This tragic event was then compounded by Wall Street Journal article on Octo-ber 8, 2012, titled, “Taking Double Cut, Surgeons Implant Their Own Devices.”

Rosen: Unnecessary Surgery

The Journal article implied that Moore died because Dr. Lewis performed unnecessary surgery due his undis-closed ownership in Spinal USA, LLC. the company that supplied some of the devices used for the procedure.

As evidence of Moore’s unnecessary surgery, John Carreyrou and Tom

McGinty, the writers of the WSJ story, cite two spine surgeons, “who later reviewed [Moore’s] medical records,” and said Moore’s history of heart dis-ease and bowel obstruction “made him a poor candidate for a 360-degree spi-nal fusion.” One of those reviewing surgeons was none other than Charles Rosen, M.D., the founder of the Asso-ciation for Medical Ethics. The Asso-ciation is an advocacy organization that

Wikimedia Commons/RRY Photo Creation



has been hyperbolically critical of sur-geon/industry relationships. The other reviewer was not named.

Rosen, according to the story said, “No operation of any kind could be justified.” The other surgeon said a less aggressive procedure might have been warranted, although the patient’s records don’t suggest it was needed. Rosen reviewed Moore’s medical records and films for the Journal.

Dr. Lewis’s lawyer said in the story that his client’s financial interest in Spinal USA had nothing to do with his deci-sion to operate on Moore. He said Dr. Lewis used the implants because he helped design them and believed they were the best on the market for the pro-cedure.

Surgeon Quotes in “Bad Context”

Another surgeon interviewed by the writers was California neurosurgeon Scott Lederhaus, a member of Rosen’s Association.

Carreyrou and McGinty write that rather than use spinal implants from third-party manufacturers, “scores” of

surgeons have started their own device makers to “churn out similar products, putting themselves in a position to benefit financially from the hardware they insert into patients.” They write that “critics” of such arrangements say surgeon ownership gives surgeons an incentive to perform more operations, and that the conflict of interest has led to a “spate of unnecessary back surgeries that waste health-care dollars and often do patients more harm than good.”

They quote Dr. Lederhaus as tell-ing them that, “Patients are having huge operations that are un-indicated because of conflicts of interest.”

We called Dr. Lederhaus to ask him if he thought that Moore’s surgery was “un-indicated” and whether he thought Dr. Lewis operated on Moore because of his ownership in Spinal USA.

Dr. Lederhaus told us that he did not review Moore’s medical records, nor was he speaking specifically about Dr. Lewis. He told us that his comments in the article could have been put in better context and that the writers did not tell him that his general comments would be attributed to a specific situation.

The Journal’s Failure

And there we have the critical journalis-tic dishonesty of the Journal article. The writers have taken a specific case and linked it, without direct evidence, to a general proposition that has been pur-sued by the Journal. That being, that physician ownership in the business of healthcare leads to medical decisions being made for the physician’s own financial interests at the expense of the patients and payers.

That’s a fair public policy question and debate. But that debate must be held with facts, data and honest reporting. The Journal failed here.

Confuses Distributors for Manufac-turers

The writers also failed to get basic infor-mation correct regarding the supplier of

Charles Rosen

Ti 6AI-4V ELI centerless ground rod

restored my life.

When you need the highest grade centerless ground rod and wire products for your orthopaedic application, call the world leader.

Advertisement

http://www.fwmetals.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 201110the implants, Spinal USA, the company in which Dr. Lewis has a minority own-ership stake.

The Wall Street Journal’s Carreyrou and McGinty erroneously describe Spinal USA as a POD (physician-owned dis-tributor) and link a request by some U.S. Senators to the Office of Inspector General to look into the expansion of PODs and getting additional guidance for their legal structures.

Write the reporters, “The inherent conflict of interest is fueling concern. In June, five U.S. senators asked the Inspector General of the Department of Health and Human Services to open an investigation into physician-owned device companies, citing concerns that the surgeons involved have a financial incentive to ‘perform more procedures than are medically necessary.’”

They go on to write that a report pro-vided to the agency by Utah Sen. Orrin Hatch, the senior Republican on the Senate Finance Committee, “identified at least 20 states where surgeon-owned implant companies are present, and

warned that they were spreading from spine surgery to other areas of medicine such as hip, knee and cardiac surgery.”Just one problem here, Hatch was writing about physician-owned dis-tributors, not “surgeon-owned implant companies” as Carreyrou and McGinty report.

In an interview with OTW on October 10, Jim Pastena, the president and CEO of Spinal USA since July 2011, told us.

“In some respects, the article is sen-sationalized, in that it mixes different issues and statistics that are general in nature, but made to look like they are Spinal USA’s numbers. An example of this is that we are not a POD, but a small manufacturer that designs, manufac-tures, and sells our own products, very similar to a number of other fine com-panies like K2M, Kyphon, and Globus. When those companies were small, they had a large percentage of doctor ownership, and as they matured, that ownership became less dominant.

“Overall, the article focused on the potential conflict of interest that can

arise when a doctor has ownership in a company that makes medical device products that he or she may use in surgery. We understand this issue and we have done everything possible to ensure that Spinal USA is structured in a way to prevent any possible conflict of interest.

“Our doctor investors are kept at arm’s length -- we don’t get involved in their medical practice and we don’t advise them on any product usage. They pro-vide technical expertise to us and help us develop new products that give hope for better surgical results.”

Wrong City?!

Another insinuation of the Journal story is that the number of spinal fusion sur-geries performed in the area served by Spinal USA has increased because of the surgeon owners.

Advertisement

Morguefile/Spinal USA/RRY Photo Creation

http://www.pioneersurgical.com/index.php?option=com_content&view=article&id=58&Itemid=64


VOLUME 7, ISSUE 33 | OCTOBER 18, 201111Carreyrou and McGinty write that at Huntsville Hospital [Alabama], one of the city’s two hospitals, “351 spinal-fusion surgeries were performed on Medicare patients in 2009, up from 333 in 2006, before Spinal USA came to town, a Wall Street Journal analysis of Medicare claims data shows. At Crest-wood Medical Center, the city’s other hospital, there were 187 such opera-tions on Medicare patients in 2009, up from 107 in 2006, the analysis shows. Huntsville Hospital says it spent $5.6 million on Spinal USA products in its most recent fiscal year.”

Again, we have a bait and switch sce-nario. The hospital where Dr. Lewis performed the surgery on Moore was St. Dominic’s Hospital in Jackson, Mis-sissippi, not in Huntsville, Alabama.

We asked Spinal USA about the alleged overutilization of spinal surgery in the area.

A written response from the company stated, “All market data in the spine market historically show an increas-ing growth in spine surgery procedures projected to continue for years to come. This is primarily related to the aging of the population. As such, surgery will increase from a procedural standpoint necessitating by default, an increase in products used to do these procedures.”

The company told us that an internal analysis of shareholder procedural vol-ume at one of their accounts “interest-ingly revealed that within the last four years, there was a 22% decline in sur-geries dropping from 435 procedures in 2007 (January – June) to 341 proce-dures on 2011 (January-June)

Who are these reporters?

We don’t know why the Journal is con-ducting this investigation with a suspect methodology that wouldn’t pass muster

in a freshman journalism class. By all measures, these appear to be qualified reporters.

According to the UCLA Anderson School of Management, The Wall Street Journal’s John Carreyrou was part of a team of Journal reporters who won the Pulitzer Prize in Explanatory Reporting for their coverage of corporate scandals in 2003. He has also won the German Marshall Fund’s Peter R. Weitz junior prize for excellence in European report-ing. In 2007, he was part of a team of Journal reporters who won the New York Press Club’s consumer award for

Vertebral Technologies, Inc.

www.vti-spine.com

Visit VTI at NASS booth #2746

The Footprint You Need. The Approach You Know.

Finally, FusionWithout Compromise™

Advertisement

John Carreyrou/ucla.edu

http://www.vti-spine.com



its coverage of health care. In 2008, he was named a Gerald Loeb Award final-ist in the feature writing category for a series on the broken U.S. health-care system. In 2009, Carreyrou and a team of reporters won the award for distin-guished investigative reporting from the New York Newspaper Publishers Association for a series of articles on nonprofit hospitals.

Shifting Surgeon Roles and Respon-sibilities

As more surgeons become employees of hospitals and healthcare systems, their ability to select the implants or instru-ments to use in surgery is declining.

The rules and laws governing how phy-sicians will be compensated for their intellectual property contributions to improve medical devices and their rights to own hospitals, manufacturing companies and distributors will con-tinue to evolve.

Spinal USA’s Pastena says as a manufac-turing company that has investors who are doctors who serve on the board the company is in full compliance with all the laws and guidelines that are part of the everyday operation of a medical device company. “We know the laws, we know the regulations, and we know what we need to do to compete in this market. Whatever changes are made in

Washington, we will work within that framework.”

No doubt, changes will come. Let’s hope the changes are based on integrity, honesty and accurate data. This story by the Wall Street Journal meets none of those criteria. It is demonstrably wrong, misleading and the sensational-ized tabloid type of reporting that other Rupert Murdoch owned publications are famous for. ◆

Advertisement

http://www.osteomed-spine.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 201113Orthopaedic Crossfire: The Bearing Surface ConundrumBy Elizabeth Hofheinz, M.P.H., M.Ed.

Image created by RRY Publications, LLC. Source: Wikimedia - KaihsuTai

TopicCross-Linked Polyethylene: Stickin’

With the Enemy We Know

This debate was held in December 2008 in an Orthopaedic Crossfire ses-sion at the 25th Annual Current Con-cepts in Joint Replacement™ (CCJR) Winter meeting in Orlando, Florida. The CCJR meetings are organized by A. Seth Greenwald, D.Phil. (Oxon) and the Orthopaedic Crossfire debates serve to frame contemporary controversies and contribute information and enter-tainment highlights of the very popu-lar CCJR meetings (www.CCJR.com). OTW is proud to present some of the best of these debates as part of an excit-

ing new column by Elizabeth Hofheinz entitled: Orthopaedic Crossfire.

FOR the proposition was Dr. Henrik Malchau.

AGAINST the proposition was Dr. Michael D. Ries.

Dr. Malchau won the coin toss and came out swinging!

Dr. Malchau: “Highly cross-linked polyethylene (PE) has been used for nearly a decade and with good results. Michael Ries will claim that the prob-lem is crescent shaped fracture frag-ments (as was noted in Orthopedics

Today in October 2008). But if you look at the peer reviewed literature on these fractures what do you find? One publication…an article published in the Journal of Bone and Joint Surgery in 2007 that did not focus on fractures but on surface cracking, mechanical prop-erties, and one case.”

Dr. Malchau also cited work by Harry McKellop, Ph.D., who said that data from laboratory hip simulation stud-ies conducted 10 years ago accurately predicted the clinical results seen as of 2008. “In a database study up to May 2008, McKellop found that only 22 fractures of the 141 reported failures of hips using highly cross-linked PE cups

Henrik Malchau, M.D., Ph.D.Massachusetts General Hospital

Vs

Michael D. Ries, M.D.University of California San Fran-

cisco Medical Center

Moderator: Thomas S. Thornhill, M.D. Harvard Medical School


VOLUME 7, ISSUE 33 | OCTOBER 18, 201114were attributed to liner fractures. McK-ellop told Orthopedics Today that after several million implantations the total number of fractures to date was small.”

“Dr. Ries cautioned that the tradeoffs for wear resistance are decreases in the mechanical properties. In his own study however, Dr. Ries found four fractures that occurred in patients with highly cross-linked PE…all had cres-cent shaped fracture fragments and the breaks started on the outer surface of the liner. I’m quoting Dr. Ries: ‘Some of the cups were malpositioned, but there were also some implant design factors such as 2mm thickness in the rim and 7.5mm of overhanging PE, which likely contributed to the fracture rate.’”

“So, Mike,” said Dr. Malchau, “is this a typical case?” “There was a 65- degree latero-version. Some of the four cups were malpositioned, Mike, and some were thin and some had overhang…how many are ‘some’ of 4…more than 1 and less than 4? And what about p-val-ues? If we estimate that there have been four million re-melted highly cross-linked PE cups implanted worldwide then the incidence of liner fracture is close to zero.”

“At MGH [Massachusetts General Hos-pital] we are looking at the status of re-melted highly cross-linked PE with a focus on wear and osteolysis. We have been using the Martell Hip Analysis Suite which uses edge detection of the femoral head and shell to measure 2-D head penetration from AP radiographs. After analyzing 80 hips and with more than 7 years of follow up, we have had no components revised due to PE frac-ture or wear. There have been no indi-cations of osteolysis (on plain radio-graphs) in either the standard or large (femoral) head size groups.”

“There was a Swedish study of a cemented cup with 61 hips, all of which were osteoarthritic and evaluated by

RadioStereometric Analysis (RSA) at 3 months, 6 months and 1, 2, 3, 5, and 7 years. We have 0.1 mm head penetra-

Advertisement

http://www.orthofix.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 201115tion, which, at up to 5 years was no problem. All of a sudden past 5 years the highly cross-linked PE runs parallel with the conventional materials.”

“So,” summarizes Dr. Malchau, “what is the clinical implication of this? Could highly cross-linked PE suffer from accel-erated wear past 5 years or does this represent a change in creep properties? We don’t know…and part of the rea-son that we don’t know is because most series on wear of highly cross-linked PE are underpowered and have too short of a follow up. The problem thus far is not related to liner fractures—it’s the increased head penetration that is caus-ing concern. Bottom line…we need more data, which we are collecting.”

The diplomatic Dr. Ries waited patient-ly while Dr. Malchau built his case. And when he was done, Dr. Ries came back with vigor. Dr. Malchau had at the outset gone after Dr. Ries’ crescent the-ory, but Dr. Ries did not take the bait.

Dr. Ries: “Henrik has shown that cross linking is associated with a decrease in wear, but cross linking also reduces the mechanical properties which can occa-sionally lead to in vivo fracture. Wear is reduced more with increased doses of radiation, but this reduction reaches a maximum at 10 Megarads; most mate-rials we use are in the 5 to 10 Megarad range.”

“There have been reports in the litera-ture of rim or crescent shaped fractures initiating at the locking mechanisms or on one of the corners that is used to provide rotational control of the liner. The fracture may occur along the rim and then propagate inside producing a crescent shaped fracture—which is dif-ferent from fractures that occurred in gamma irradiated PE with earlier cup designs.”

“The processing methods affect the mechanical properties as well as the wear; increases in radiation result in decreased wear but also a decrease in mechanical properties. The irradiation used to produce highly cross-linked PE also produces free radicals, which can oxidize in vivo. If the material is annealed above the melt temperature, then the free radicals are neutralized so no oxidization can occur in vivo. But there is also a decrease in crystallinity and mechanical properties. Alternative-ly, it can be annealed below the melt temperature. This reduces the mechan-ical properties less, but leaves behind free radicals that can oxidize later.”

“The series that Henrik is referring to is the one we presented at AAOS [American Academy of Orthopaedic Surgeons]. There were four fractures in four different cup designs and with different material processing methods. There are some similarities: they seem to produce a crescent shaped fracture;

three out of four were malpositioned; all had some evidence of impingement which contributed to the fractures; all had areas of thin PE and PE protruding above the rim.”

“As (femoral) heads have gotten bigger in order to maintain adequate thickness at the dome, many heads have moved outward, which results in contact with the PE above the rim. This is a rela-tively thin area that—if impingement occurs—can result in cantilever stress-es and a crack initiating at the locking mechanism.”

Dr. Ries’ ultimate solution? Newer, bet-ter, implants with enhanced material properties.

A Melancholic Swede and a Laconic Californian

Moderator Dr. Thornhill: “We’ve got a melancholic Swede and a laconic Cali-fornian here! Henrik, for your routine

7th Annual Stem Cell Summit Register Early and Save

If you havenÕt already saved the date of February 21, 2012, mark your calendar now. And if you want to ensure your spot at 2012Õs Stem Cell Summit AND save more than $500, take advantage of our low early bird registration rate today.

Preregistration is now open!www.stemcellsummit.com

Advertisement

http://www.stemcellsummit.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 201116total hip what is the head size you pre-fer and the minimum thickness of PE that you allow?

Dr. Malchau: “I prefer 6mm PE and whatever head size that would accom-modate. I am trying to do a 32 mm head, but I won’t do that and trade off going down to 3mm PE.”

Dr. Ries: “We agree on thickness…5 or 6mm. But, I will ream more bone to get a larger cup and accommodate a larger head when appropriate. And I don’t use an elevated lip liner. If you have a 36mm head why would you need an elevated lip liner these days?”

Moderator Dr. Thornhill: “And the verticality of the cup…is it important, and what do you shoot for? Henrik?

Dr. Malchau: “That is the most impor-tant issue today…how to put the cup in. It doesn’t matter what kind of bear-ing you use, you’re going to get squeak, stripe wear, and fatigue failure of the PE. And there is little data saying how good we are at this. In our work at MGH I thought we’d have a narrow shaped bell curve, but we haven’t, so maybe naviga-tion could do something for us.”

But don’t blame malpositioning of implants, says Dr. Ries: “Whatever cup you put in you want to optimize the position and the bearing surface. Even with navigation we’re not going to be perfect. Most retrieval studies show a high amount of impingement so I don’t think we can blame malpositioning for the adverse effects. Our materials and implant design should be able to accom-modate some impingement that occurs in vivo even in well positioned cups.”

Moderator Dr. Thornhill: “Let’s talk about impingement…What is the most common cause of this—is it over-rota-

tion of the acetabular shell, head to neck/ratio, is it prosthesis specific?”

Dr. Ries: “It’s probably primarily relat-ed to head/neck ratio and implant posi-tioning, but it’s also affected by range of motion [ROM]. Some female patients have wide ROM of the hip and they’re going to impinge more…even in well positioned cups they’ll impinge.”

Dr. Malchau wanted to stay on his earlier point: “That means that nobody really knows what the problem is because there is no data supporting that. My fear is that malpositioning does have a prominent role. If you look at the Scandinavian registries you see that recurrent dislocation as a reason for admission is the second most frequent issue. There must be a way to prevent that—maybe through optimal implant design or going to larger heads.”

Moderator Dr. Thornhill: “Let’s dis-cuss material properties. Mike, you showed that wear goes down as you increase the Megarads up to about ten. The downside is the mechanical prop-erties, so how critical is it to be oxida-tively stable?”

Dr. Ries: “Definitely important. The first generation submelt annealed cross-linked PE material is no longer avail-able and retrieval studies show more oxidation than previously utilized PE. It requires an above melt annealed pro-cess for the stabilizing effect to reduce the concentration of free radicals and we just don’t have long-term in vivo data.”

Moderator Dr. Thornhill: “If we want to crush free radicals using antioxidants or triple annealed material, is that going to solve this problem, Henrik?”

Dr. Malchau: “Well there are still free radicals. What you need is to prevent

the oxidation because what’s been det-rimental prior to highly cross-linked PE is the incidence of osteolysis. We haven’t seen osteolysis so far up to 7 to 9 years…even 10, but what’s hap-pening beyond that point I don’t know. Will it stay stable? We don’t know what is going on, including why we see that increase in head penetration in the Swedish study. I think it’s real but we don’t understand what it is.”

Moderator Dr. Thornhill: “So if you look at 5 to 7 years you begin to see an increase in head penetrations. Mike, can you speculate as to what causes that?”

Dr. Ries: “I’m not really sure. Perhaps if the femoral head roughens in vivo and that increases the wear rate due to coun-terface roughening that could occur…or maybe it’s creep. Henrik knows more than I’ve mentioned on this topic.”

Moderator Dr. Thornhill: “Thank you both for a nice and informative debate.” ◆

Please visit www.CCJR.com to register for the upcoming 2011 CCJR Winter Meeting, December 7-10 in Orlando, Florida and the 2012 CCJR Spring Meeting, May 20-23 in Las Vegas, Nevada.


VOLUME 7, ISSUE 33 | OCTOBER 18, 201117Reporter’s NotebookBy Elizabeth Hofheinz

Dear OTW Reader:

Industry reshaping itself into three big players? East Coast not gotten the message about metal on metal? Med-PAC doing a “divide and conquer” of doctors? Oh, and what execs are going where…read on…

Acquisition Frenzy? An industry insider tells OTW, “A lot of people are keeping a close eye on how the ortho-pedic market is reshaping itself through acquisitions. Large companies are sit-ting on piles of cash and investors want them to put that money to work. It seems that the timing is right for the industry to reshape itself to three big players…J&J and Stryker have made a number of acquisitions lately; Zimmer will likely do the same. And, when you look at how the market has matured you can see that it has become more of a distribution play (as opposed to inno-vation). If you have any doubt, just look at manufacturers in other specialties; cardiology is now controlled by three companies. Ultimately, I think this is good for all parties…for example, you don’t have surgeons in one hospital sys-tem clamoring for numerous implant systems—and often, as with knee sys-tems, it is hard to find any real differ-ence between them anyway.”

East Coast Lagging Behind Re: Metal on Metal? An orthopedist tells OTW, “There are a lot of centers that did scores of metal on metal implants that—at first—looked good. The prob-lem now is that there are these waves of popularity traveling across the coun-

try…I’ve seen that it often means that the East Coast lags behind…people haven’t really gotten the message that these are not a good idea. Those sur-geons who have not been exposed to the results of research are more likely to continue putting them in because they don’t know not to. Getting the message out is proving to be an issue.”

Michael Harrer, M.D. Joins Rothman. Michael F. Harrer, M.D., is the newest joint surgeon at the Rothman Insti-tute in Philadelphia, Pennsylvania. Dr. Harrer received an AB in biology from Princeton University, and while there also made time for varsity football. Dr. Harrer, who was previously Joint Direc-tor at Our Lady of Lourdes in Camden, New Jersey, earned his medical degree from Jefferson Medical College in Phila-delphia. He completed his orthopedic

surgical residency at UMDNJ Robert Wood Johnson University Hospital in New Brunswick, New Jersey, and did an adult reconstruction fellowship at Anderson Orthopaedic Clinic in Mount Vernon, Virginia.

Congress Cutting Specialists’ Pay? An orthopedic surgeon who has his ear to the ground on Capitol Hill tells OTW, “MedPAC just released a new SGR (Sus-tained Growth Rate) ‘fix’ that will sig-nificantly impact orthopedic surgeons. Included are calls for substantial cuts to specialists’ reimbursement, while hold-ing primary care physicians reimburse-ment at current levels. I had a private conversation with someone on ‘the Hill’ who told me that Democrats and Republicans alike recognize the failure of the SGR, but a fix of any type is chal-lenging, especially in the current eco-

Wikimedia Commons


VOLUME 7, ISSUE 33 | OCTOBER 18, 201118nomic climate. Historically, the Med-PAC recommendations have not widely been enacted, largely due to political struggles. This is one of the impetus-es for creation of the widely unpopu-lar Independent Payment Advisory Board—however, many providers fear arbitrary cuts with minimal Congres-sional oversight will have detrimental impact on patient care. Furthermore, MedPAC’s SGR fix has potentially severe negative impact on access to orthopedic care and may further divide the physi-cian community—theirs is the only fix that preferentially cuts specialist reim-bursement. Aren’t we already divided enough? Competing interests often are represented by one powerful lobby on the Hill, while there are over 200 medi-cal and patient advocacy groups!”

Health Affairs Brouhaha. It’s a bee-hive of anger and angst, says an ortho-pedic insider about a recent Health

Affairs story stating that the salaries of orthopedic surgeons and family doctors are more than any other physicians in the country. This individual tells OTW, “Orthopedists are naturally concerned about their image…not to mention that this could be used as another excuse to cut reimbursements. “Ridiculous” and “unfair” and “grossly inaccurate” are some of the things I’ve heard about the study. People are concerned about the validity of the study…for example, it didn’t take into consideration the amount of hours doctors work or the volume of procedures done (which is usually more than in other countries).”

Greg Sasso Joins Biotronic. And the new president and CEO is…Greg Sasso. Sasso was most recently the senior vice president and president of Biomet International, Biomet Sports Medicine and Biomet Microfixation. In his 26 years at Biomet Sasso was one

of the key members of the M&A team that led Biomet’s going-private trans-action by a private equity consortium that consisted of Blackstone, Goldman Sachs, TPG and KKR for $11.7 Billion in 2007.

A World First. Kaye Wilkins, M.D., tells OTW, “I recently returned from the first-ever pediatric orthopedic meeting in Nepal. The specialty is just starting out there, and they have yet to separate pediatric orthopedics into a separate discipline. At present there is no train-ing for pediatric orthopedists there, so they have to train abroad. The major issues? Chronic, untreated fractures and infections…they are where the U.S. was 50 years ago, so progress will be slow. I hope to help out by facilitating a POSNA [Pediatric Orthopaedic Soci-ety of North America] scholarship for at least one orthopedic surgeon—that way they can come here and learn use-ful techniques for use at home.”

Novel Test for Infection. Carl Deir-mengian, M.D., an orthopedic surgeon at the Rothman Institute in Philadel-phia, has developed a unique test for infected hip and knee replacements. Dr. Deirmengian tells OTW, “I ran several clinical studies on the cloudy fluid that is generated when a joint gets inflamed. There have never been any FDA approved tests for synovial fluid...we have only had subjective lab tests (like someone counting cells or running a culture). So I looked at the genetics of the cells in the fluid, and found that the body responds uniquely to different joint diseases. Our key discovery is that the synovial fluid has unique biomark-ers, which are a result of the specific white blood cell response to infection. What is critical, of course, is that the biomarkers in the joint fluid have a higher accuracy than blood tests. We published this work in Clinical Ortho-Advertisement

http://www.afcellmedical.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 201119paedics and Related Research last year and we were also honored to win the Coventry Award from the Knee Soci-ety for this research in the past. CD Diagnostics was formed to develop the point-of-care rapid immunoassay for infection, and our CEO Rick Birk-meyer has been quite successful in advancing toward our goals. We have already secured $1.5 million in angel funding. Currently, we are exploring partnerships with different companies and anticipate significant growth in the near future.”

ORS Increasing Clinical Focus. Ted Miclau, M.D., the next president of the Orthopaedic Research Society (ORS), tells OTW, “Scientific technology has become so much more sophisticated in a relatively short period of time. In the ORS Annual Meetings, the growth of the biological and engineering fields

has been clearly apparent, although there has not been as much expansion in the translational clinical research presented…so, we are trying to more fully develop clinical research in the ORS. Last year we held the first Clini-cal Research Forum, which was a first step in developing a home for clini-cal research, and provided a venue for clinical researchers, basic researchers, industry members, and individuals from funding and regulatory agen-cies to interact with each other. This year, the event will provide for a simi-lar opportunity. The goal will be to provide an overview of key types of research involved in bringing products to market, and through the evaluation of controversial areas such as metal-on-metal, bisphosphonate-related femur fractures, and BMP usage, determine how we might do things better in the future.”

Closer to “Holy Grail” of Articular Cartilage. Dr. Paul Saluan, an ortho-pedic surgeon at Cleveland Clinic, is the Principal Investigator on a novel study involving articular cartilage reconstruction. He tells OTW, “We are just starting out on this three-four year investigation, and we are getting closer to the ‘Holy Grail’ of being able to get type two collagen where it belongs…trying to get back the articular cartilage instead of scar tissue. This is one of the most common issues that sports medi-cine specialists deal with—everything we do is geared toward maintaining normal joint function. To do that you must have normal load bearing. Once the patient loses articular cartilage and gets advanced arthritis then you are out of the realm of sports medicine and into total joint surgery. Our work involves articular cartilage allograft, and the early results are very promising. What we’re doing involves a one stage process as opposed to a two stage process (as it is now). Also positive is that there is ample allograft. The tissue engineering issue is such that there will be wide-spread availability.”

$2.6 Million for Rick Wright, M.D. Rick Wright, M.D., co-chief of Wash-ington University’s Sports Medicine Service, has just been awarded a $2.6 million grant from the National Insti-tute of Arthritis and Musculoskeletal and Skin Diseases of the National Insti-tutes of Health. He is heading up the MARS study (Mutlicenter ACL Revision Study), which is comparing surgical techniques and analyzing outcomes for patients undergoing ACL surgery. The goal? To learn why a subsequent recon-struction is more likely to fail than an initial ACL repair. ◆® ®

Low Back Pain’s Missing Piece

Visit us at NASS booths 2128 and 2638 to learn more about iFuse.

42.9% of post-lumbar fusion patients were symptomatic for SIJ dysfunction

•Rigid titanium constructs provide enhanced stability

•Minimally invasive (MIS) surgical approach

•No preparation of the SI joint or bone graft required

•Designed to minimize rotation and micromotion

A new treatment for your patients with SI Joint Dysfunction

DePalma MJ, et al, Pain Medicine 2011; Volume 12, Issue 5, 732-739

Visit www.si-bone.com to learn more about new consensus diagnostic guidelines and watch SI Joint Diagnosis: A Comprehensive Approach

© 2011. SI-BONE, Inc. All rights reserved. SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. 8167.090911

Advertisement

http://www.si-bone.com



Ortho Surgeons’ In-comes Near Top

How do orthopedic surgeons’ incomes compare to those of other

surgical specialities? As it turns out, not too bad.

According to the September 2011 released Physician Compensation and Production Survey: 2011 Report Based on 2010 Data, only a few surgical spe-cialties received more compensation than general orthopedists. On average, general orthopedic surgeons received $539,345 last year, compared to gen-eral surgeons who received $368,108.

General orthopedic surgeons received significantly more than breast surgeons, oncology surgeons and primary vascu-lar and thoracic surgeons, according to the survey. Cardiovascular surgeons received slightly more, at $560,659, while paediatric cardiac surgeons received compensation comparable to spine surgeons, at $762,846. The high-est compensated surgical specialist was neurological surgeons, who received $767,627.

General orthopedic surgeons who are hospital employees earned more, $526,398, than their counterparts in private practice. General surgeons also received slightly more, $343,999, when employed by a hospital. The compen-sation of general orthopedic surgeons employed at hospitals exceeded that of bariatric surgeons, colon and rectal surgeons and oncology surgeons. Car-diovascular surgeons received slightly more, at $567,171, with pediatric car-diovascular surgeons exceeding that amount by $100,000. Neurosurgeons received the highest compensation—an average of $701,927.

Female general orthopedic surgeons continued to receive lower compensa-tion than men, earning approximately $434,000 last year, which is $63,000 less than male general orthopedic surgeons. However, female orthope-dic surgeons’ compensation exceeded female general surgeons by more than $100,000. Female neurosurgeons received the highest compensation, $654,149, among female surgeons last year.

—BY (October 14, 2011)

Israeli Back Pain Technology Moves to Ohio

Israeli-based Nervomatrix Ltd, is get-ting $3.5 million from Akron, Ohio-

based Everett Partners in series A fund-ing to set up its North American sales and marketing headquarters in Akron.

Nervomatrix has received 510(k) clear-ance from the FDA to begin marketing its neurostimulation back-pain device. It has sold two devices to an uniden-tified customer in California, and the same customer plans to buy four more, according to an October 12 story on medcitynews.com.

Nervomatrix’s technology is a propri-etary imaging function that identifies electrical activity, and in turn pain points, in the back. The device then delivers electrical stimulation on the surface of a patient’s skin to those pain points.

Auto-Targeting Neurostimulation

According to the company’s website, the technology, called Auto-Targeting

company

Wikimedia Commons and Ameth/RRY Photo Creation

Image Credit: Photo courtesy of Nervomatrix Ltd


VOLUME 7, ISSUE 33 | OCTOBER 18, 201121Neurostimulation (ATN), combines proprietary imaging and sensing tech-nologies for localizing pain targets with a neurostimulation technology to treat only the specific area identified to be the most effective for pain relief. The com-pany claims that for the first time, ATN overcomes the limitations of products currently on the market. “ATN offers a superior solution for lower back pain as it provides targeted, high-stimulation pinpoint treatment that is highly effec-tive, non-invasive and drug free.”

Nervomatrix sprang from an Israeli incubator called Targetech. The city of Akron, Summit County and several local private investors formed Greater Akron Investment Partners to invest in Targetech about five years ago. The Targetech partnership was conceived as a vehicle for importing Israeli med-tech companies to Northeast Ohio. The move represents the first time that has happened.

The establishment of the Akron office is expected to happen early next year.

The Akron office is expected to consist of just one or two employees in the early going, but could expand to “dozens” of workers in the coming years if Nervom-atrix’s sales grow as its investors project. The company plans to initially sell the device to back pain centers and chiro-practic centers and eventually expand the device’s application to other areas of the body, such as the knee, shoulder and the upper back.

—WE (October 12, 2011)

Alphatec Back in FDA Good GracesAlphatec Spine, Inc., a medical device company that designs, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine has resolved its prob-lem with the FDA. The regulatory agency had issued a Warning Letter to Alphatec Spine in June 2010 in connection with deficiencies in the response sent by the company in connection with an FDA inspection that took place in February 2010.

Now, subsequent to a follow-up audit of the company’s facility, Alphatec Holding, Inc, the parent company of Alphatec Spine, announced that it has received a close-out letter from the FDA dated September 29, 2011, inform-ing the company that it has resolved all of the deficiencies contained in the Warning Letter.

“The successful resolution of the Warning Letter demonstrates our firm com-mitment to maintaining a robust quality system throughout our organiza-tion,” said Dirk Kuyper Alphatec Spine’s president and CEO.

In addition to its U.S. operations, Alphatec Spine markets its products in more than 50 international markets through its subsidiary, Scient’x S.A.S., via a direct sales force in France, Italy and the United Kingdom and via independent distributors in the rest of Europe, the Middle East and Africa, and Latin America. In Asia, the company markets its products through its subsidiary, Alphatec Pacific, Inc. and through distributors in the rest of the Asia Pacific region.


U.S. Food and Drug Administration



AAOS Inaugurates Orthopaedic Quality Institute

Mindful of rising costs in healthcare, the American Academy of Ortho-

paedic Surgeons (AAOS) recently held its Inaugural Orthopaedic Quality Insti-tute (OQI) in Washington, D.C. Payors, purchasers, government officials, rep-resentatives from industry, and other healthcare stakeholders came together to foster communication and collabora-tion on this topic.

“There is no doubt that innovation is critical to improving care, but just because a device is new does not mean it’s necessarily better,” said Kristy Weber, M.D., OQI co-chair and chair of the AAOS Council on Research and Quality, in the October 10, 2011 news release. “Evidence aggregated through quality tools and measures such as registries, clinical practice guidelines, appropriate use criteria, electronic health records

and the like, will give physicians more definitive answers and enable them to make the behavioral changes needed to improve the care they deliver while simultaneously reducing costs.”

“OQI is not just a consensus meeting where everyone leaves feeling good but nothing changes,” added Kevin Bozic, M.D., MBA, OQI co-chair and chair of the AAOS Health Systems Commit-tee. “AAOS has integrated OQI into its yearly agenda so that we can bring everyone who has a stake in the care of our patients together into one room and come up with actionable items that will improve the quality and efficiency of the care we deliver.”

As for promising results of the meeting, Dr. Weber told OTW, “A wide range of stakeholders invested in quality care for patients with musculoskeletal concerns were in the room together to listen to each other and identify ways to collabo-rate. We are still formulating our spe-cific action plan, but we plan to solicit a wider range of input as to the relevant questions to ask when developing our

evidence-based guidelines on various areas of orthopaedic diagnoses/diseas-es. This may include patients as well as purchasers or payors of health care.”

Dr. Weber added, “Know that the AAOS is committed to working collab-oratively with multiple stakeholders to improve the quality of patient care. This will continue to be an invitation-only yearly event to focus on relevant, timely issues.”

—EH (October 14, 2011)

FDA and CMS Offer Concurrent Review

In a move that holds promise for greater efficiency, the Food and Drug

Administration (FDA) and the Cen-ters for Medicare & Medicaid Services (CMS) have established a pilot pro-

gram for concurrent review of certain FDA premarket review submissions for medical devices and CMS national cov-erage determinations.

Officials believe that reducing the inter-val between FDA marketing approval and Medicare coverage will help facili-tate the development of innovative products and shorten the time it takes to bring the products to patients

legal

Wikimedia Commons

Image creation by RRY Publications, LLC.


VOLUME 7, ISSUE 33 | OCTOBER 18, 201123During its pilot phase, the agencies will offer to parallel review for up to five innovative devices per year. Appropri-ate candidates for the parallel review pilot are medical devices that meet one of the following criteria:

1. New technologies for which the sponsor/requester has a pre-inves-tigational device exemption or an approved application designation.

2. New technologies that would require an original or supplemental application for premarket approval or a petition for de novo review.

3. New technologies that fall with-in the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision.

The pilot program will not change the existing review standards for FDA device approval and CMS coverage

determination. The program is only available for medical device technolo-gies that meet the above criteria.

CMS and FDA encourage any interested sponsors who believe their devices are appropriate candidates and would like to explore the use of the pilot program to contact the FDA via email at [email protected].


Streamlining the 510(k)/De Novo Pro-cess

Earlier this year, the FDA promised to improve the predictability, con-

sistency and transparency of the agen-cy’s premarket review programs.

On October 3, the agency tried to make good on that promise by issuing a draft guidance to cut the red tape of the de novo review process.

The draft outlines a pathway for a con-current 510(k) and de novo petition without duplicative data requirements and, according to the agency, trimming up to 90 days from the process and fos-tering more efficient, early interaction between manufacturers and the FDA. The draft also provides clarity for man-ufacturers on the suitability of a device for the de novo process.

Before manufacturers may market most low- to moderate-risk medical devices, they must obtain FDA “clearance” of a premarket notification or 510(k). Gen-erally, 510(k) submissions must dem-onstrate that the new device is substan-tially equivalent to another, legally mar-keted medical device that is also low to moderate risk.

However, some low- to moderate-risk medical devices are novel and not com-parable to an already legally marketed device. Legislation passed by Congress in 1997 created the de novo process for these types of devices.

Image creation by RRY Publications, LLC. Source: Morguefile and FDA

Satisfy your need for speed.

Introducing

TRIPLE-LEAD THREAD PEDICLE SCREW

www.amedicacorp.com

Unique triple-lead thread design accelerates insertion and reduces user fatigue.

Advertisement

http://www.amedicacorp.com


VOLUME 7, ISSUE 33 | OCTOBER 18, 201124Currently, devices are only considered for the de novo program after the agen-cy rejects a 510(k), establishing that the device is not substantially equivalent to another legally marketed device.

Although FDA has reviewed and grant-ed a number of de novo petitions since the 1997 legislation, the program has been under-utilized because of process inefficiencies.

“Right now, the de novo process is cum-bersome and requires extra work and effort from manufacturers and the agen-cy,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radio-logical Health. “Creating a pathway for a concurrent 510(k) and de novo peti-tion streamlines the de novo program, helping speed safe and effective devices to patients.”

The draft guidance is one of 25 action items listed in the FDA’s Plan of Action for Implementation of 510(k) and Sci-ence Recommendations.

You’ve got until the beginning of Janu-ary to comment on the draft.

Submit written comments to the Divi-sion of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rock-ville, MD 20852. Submit electronic comments to http://www.regulations.gov.

To read the draft guidance, click here.

Draft Guidance for Industry and Food and Drug Administration Staff: De Novo Classification Process (Evaluation of Automatic Class III Designation)

Examples of recent de novo devices, click here.


Medical Device Makers Shun U.S.

If it has seemed that more and more medical device makers are launch-

ing their new products overseas before introducing them to the U.S. market, it turns out that they are.

A Northwestern University study reveals that more than three-quarters of medical device makers go overseas first when launching new products. In the largest yet undertaken survey on the 510(k) review process manufacturers blamed high costs, long review times and unpredictability on the part of U.S. officials for their difficulties.

According to the report by Northwest-ern University researchers, of the 350 medical device company officials inter-viewed, 22% said the high costs of FDA review sent them overseas and 14% blamed a lengthy and complicated U.S. review process. The remaining 63% of the respondents cited unpredictability as the main reason for their decision to go abroad before applying for FDA clearance.

The study, which was paid for by the Institute for Health Technology Stud-ies, a non-profit funded by the medical device industry, drew responses from employees of small, medium and large med-tech companies recently involved in 510(k) submissions.

The Institute of Medicine, in a report issued this summer, recommended that the FDA scrap the 510(k) program altogether and design a new “integrated pre-market and post-market regulatory framework.”

The New England Journal of Medicine wrote that the 510(k) process was out-dated. “As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness,” wrote executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. “The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now out-dated.”


Wikimedia Commons, Mendimsum and photo manipulation by RRY Publications.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm232269.htm



UK Opens Stem Cell Research Center

Scientists at Newcastle University and Arthritis Research, in the Unit-

ed Kingdom, are joining the interna-tional campaign to successfully regen-erate bone and cartilage, damaged by degenerative joint disease, through the use of a patient’s own stem cells.

The research, if successful, could rev-olutionize the treatment of osteoar-thritis. Researchers say that within five years they hope to treat early osteoar-thritis by introducing adult stem cells and other types of cells into damaged joints and repair damage through less invasive operations—which will ultimately delay the need for joint replacement.

Professor Andrew McCaskie, centre director and professor of orthopae-dic surgery at Newcastle University’s

Institute of Cellular Medicine and the Freeman Hospital, is leading the stud-ies in the region.

“This is an exciting new development,” said McCaskie. “We hope and aim that elements of this approach will go from the bench to the bedside within the first five years. Osteoarthritis affects eight million people in the UK and our study is bringing together groups from all around the UK, including doctors and researchers, to look at a different way and process of treating the illness. By using stem cells we’re trying to treat osteoarthri-tis at an earlier stage and assist the human body to repair itself.”

In an October 6 press release, Professor Alan Silman, medical director of Arthritis Research UK, said, “This early experi-mental work is the

first step on a journey that could sig-nificantly reduce the need for joint replacement operations. Although joint replacement can be spectacularly successful, finding an injectable cell-based answer that could be used ear-lier would be a major breakthrough, reducing pain and disability and minimizing health service costs. We believe our new centre will lead the way in this exciting field of research.”


biologics

Wikimedia Commons and TubularWorld/Entrance to Newcastle Univer-sity Medical School

Sclerosis Risk With Polyethylene UKA

Women with a high body mass index (BMI) who have all-

polyethylene unicompartmental knee arthroplasty (UKA) are at increased risk for sclerosis. This is according to a study of the factors influencing sub-chondral sclerosis in 98 patients who underwent medial unicompartmental knee arthroplasty between 2004 and 2007.

The women’s mean age was 67.7 years and mean body mass index was

28.8. Following surgery, investigators observed nine revisions in the group. Three revisions were subchondral—

under the tibial component—which researchers used as the basis for failure in the study.

large joints

Wikimedia Commons and Couri CE, da Silva GA, Martinez JA, Pereira Fda A, De Paula FJ/Pelvic and lower extremity radiograph shows extensive calcification (sclerosis) of the femoral arteries


VOLUME 7, ISSUE 33 | OCTOBER 18, 201126In addition to taking radiographs at 55 months follow-up in 77 patients (89 UKAs), principal investigator Chloe Scott, M.D. and her team used the Oxford Knee score and questionnaires as outcome measures. Results showed subchondral sclerosis in 25.8% of patients, which was quantified by an increasing grayscale ratio that was significantly associated with the pres-ence of sclerosis. Using the grayscale ratio, researchers also identified BMI, gender, and age as prognosticators for sclerosis. Older women with BMI of 35 were deemed most at risk, according to the findings.

Surgeons should be cautious when performing unicompartmental knee arthroplasty with all-polyethylene non-congruent tibial components in women with a body mass index greater than 35 because that practice may put them at increased risk for sclerosis, said Dr. Scott in a presentation on the study at the 12th EFORT Congress 2011 meeting .

“We think that subchondral sclerosis does occur under an all-polyethylene tibial component,” she said. “Adaptive remodeling is occurring in the proximal tibia due to the increased strain you get with an all-poly component compared to a metal-backed one.”

Scott and her team recommended using metal-backed rather than poly-ethylene UKA components in those most at risk, but said in her presen-tation that finite element and image analysis are needed to determine the efficacy of that implant type.


Faster Hospital Dis-charge, Better Out-comes?

How soon is too soon to be dis-charged from the hospital follow-

ing primary hip or knee replacement surgery? Patients at an Ontario hospi-tal are being discharged two days after their operations.

Physicians at the Kingston General Hospital associated with Queen’s Uni-versity implemented the fast-track arthroplasty program in 2009 at Hotel Dieu Hospital. When they compared patients’ discharge times and outcomes before and after implementation of the program, they found that patients’ aver-age length of stay was reduced from 116 to 47 hours.

Key components of the fast track pro-gram include early patient education and discharge planning and intraopera-tive local infiltrative analgesia and phys-iotherapy starting four to six hours after surgery. The clinicians select patients for the fast-track program based on cri-

teria that are associated with improved outcomes following lower-limb total joint arthroplasty.

“Our fast-track model is easily adopt-able, requiring little investment in addi-tional resources or the mastery of new technical skills,” said lead investigator Michael Raphael, fourth-year medical student at Queen’s University.

The eligibility criteria for the fast-track program include:•ageupto85years•an American Society of Anesthe-

siologists score no greater than 3 with no functional limitation due to cardiac or respiratory disease

•abodymassindexof45kg/m2orless

•independentmobility•anormalhematocrit•nohistoryofrheumatoidarthritis•nohistoryofpulmonaryembolism

or deep vein thrombosis within the previous six months

•an absence of warfarin therapyunless atrial fibrillation is present

•functional strength in the upperextremities.

Wikimedia Commons and Jeffery Russell


VOLUME 7, ISSUE 33 | OCTOBER 18, 201127Patients also need to have stairs-free access to their home bedroom and bathroom, and have adult assistance available on return from the hospital.

The first postoperative night patients receive IV patient-controlled anesthesia and then are transitioned to oral medi-cations. They are started on physiother-apy within four to six hours of surgery.

Raphael and two physicians compared data from 100 patients treated at Hotel Dieu Hospital before implementing the program with 100 patients treated with the fast-track program. The fast-track patients experienced significantly lower median rest and active pain scores and used significantly lower amounts of opioids.

The groups also had a similar number of postoperative emergency depart-ment visits (14 and 13, respectively). In the fast-track group, there was one readmission for postoperative hema-toma and another for infection. In the standard-discharge group, there was one readmission for inadequate pain control.


Pedicle Screw Study Launched

Expanding Orthopedics Inc. (EOI), based in Israel, has launched a

post-market study in Europe of its XPED Expanding Pedicle Screw Sys-tem for spinal fusion. Up to 50 patients will be enrolled in the multi-center study which will be led by the spine team of Stauferklinikum in Germany. Participants will be followed for up to

24 months using quality-of-life ques-tionnaires and radiographic assess-ments. The study is designed to assess the performance and usability of EOI’s Expanding Pedicle Screw System.

According to the company announce-ment, the XPED Pedicle Screw System is a complete spinal implant system including both standard and expand-able pedicle screws along with the nec-essary instrumentation. The system is designed to provide greater fixation in various bone conditions as an adjunct to spinal fusion of the thoracic, lumbar, and sacral spine.

The XPED screw has an expandable 4-wing design that company officials believe increases the contact area with the bone, thus facilitating improved bone anchoring and natural bone in-growth. The XPED Pedicle Screw Sys-tem is CE marked and commercially available across Europe.

“Initial anchoring and long-term fixa-tion of the pedicle screw within the vertebral body are crucial for successful spinal fusion”, said Ronald Rissel, M.D., Head of Spine Center, Stauferklinikum, and Mutlangen, Germany, the October 3 press release. “A growing number of our patients undergoing spine fusion

surgery suffer from an impaired bone condition as a result of chronic dis-eases, an unhealthy lifestyle and aging spine. In these patients, standard ped-icle screws are sub-optimal, leading to a higher risk of screw loosening and resulting in a high re-operation rate. I expect the XPED expandable screw’s innovative design to provide enhanced anchoring and potentially improve patient outcomes.”

“We are honored to have one of the leading European centers in the field of orthopedics take part in this study” said Mr. Ofer Bokobza, CEO of Expanding Orthopedics Inc. “Up to 20% of patients undergoing spinal fusion with pedicle screws can benefit from the XPED Ped-icle Screw System, which represents a worldwide market potential of about $1B. We expect the XPED Pedicle Screw System to improve surgery outcomes and significantly increase quality-of-life of treated patients.”

Expanding Orthopedics Inc. is a pri-vately owned company that owns a broad patent portfolio covering the XPED and additional spine and ortho-pedic applications.


spine

Source: Expanding Orthopedics



McMillan Becomes Or-thofix Spine Chief

Back in December, Orthofix Interna-tional N.V. announced an internal

reorganization designed to streamline operations within the company’s three global business units: Spine, Orthope-dics and Sports Medicine. The move was facilitated in part by the recent consolidation of the company’s opera-tions into their new facility in Lewis-ville, Texas.

On October 4, the company announced that Bryan McMillan has been promoted to the position of president of the spine global business Unit. McMillan had been executive vice president-general

manager for the spinal implants divi-sion of the global business Units since February 2011.

“Bryan has proven himself as an excep-tional leader in our spinal implants business,” said Robert Vaters, the com-pany’s president and CEO. “I am cer-tain that as president of the spine glob-al business Unit, he can further drive growth while creating synergies and cross-selling opportunities between our best in class spinal implants, biologics, and our market leading spinal stimula-tion products.”

McMillan has been with Orthofix since March 2010 in various roles of increas-ing responsibilities, including vice pres-ident of global Development for spinal implants. He will be responsible for overseeing all activities of the compa-

ny’s spinal implants and spinal stimula-tion businesses, which were previously managed separately.

Prior to joining Orthofix, McMillan held several leadership roles at Stryker Cor-poration including the position of vice president, Stryker Finance. In addition to his medical device industry experi-ence, McMillan spent nine years in investment management/banking with the firms of Rauscher Pierce, Everen Securities and CIBC Oppenheimer. He received his degree in Political Science and Business from Arizona State Uni-versity, and has successfully completed the Harvard Executive Leadership pro-gram and Strategic Marketing Curricu-lum at the University of Texas, Austin.


Advertisement

people

Bryan McMillan/Orthofix International N.V.

http://www.pearldiverinc.com



Orthopedics This Week | RRY Publications LLCMain Contact Information:

RRY Publications LLC116 Ivywood Lane • Wayne, PA 19087

TOLL FREE: 1-888-749-2153Fax: 610-260-6451

Robin R. Young, CFA Editor and Publisher [email protected]

Elizabeth Hofheinz, M.P.H., M.Ed.Senior Writer

[email protected]

Walter Eisner Senior Writer

[email protected]

Tom Bishow Vice President of Sales

[email protected]

Biloine W. YoungWriter

[email protected]

Suzanne KirchnerProduction Manager

[email protected]

Jayme JohnsonProduction Coordinator

[email protected]

Dana BaderGraphic Designer

[email protected]

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

Don’t miss your chance!Advertise with Orthopedics This Week

http://www.ryortho.com/advertise.php

week in review 4 Carragee’s Mismeasure of rhBMP2 and...

Documents

Transcript of week in review 4 Carragee’s Mismeasure of rhBMP2 and...