week in review 4 8 - orthopedics this...

VOLUME 7, ISSUE 18 | JUNE 7, 2011

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picture of success

week in review

breaking news

16 Kyphon Drags on Medtron-ic’s Quarter............................................

Integra Gobbles up Spine Surgery Supplier SeaSpine..................................................................Two Knee Surgery Approaches Compared............................................................Lobo in at Stryker Ortho, Mogul to DJO Global..................................................................Arm Surgery: Inconsistent Outcome Reporting............................................................ReGen Sues FDA Over Knee Surgery Device..................................................................Small City Surgeons Earn More

For all news that is ortho, read on.

4 Zimmer Bites Personal Injury Lawyers ◆ Usually personal injury lawyers sue device

companies on behalf of clients. This time, “Man Bites Dog,” as Zimmer sues lawyers fishing for clients by making false claims about the NexGen Knee System. Zimmer bit back and forced retractions. Read what it was all about.

8 The InFuse Retrograde Ejaculation Controversy ◆ Tomislav Smoljanovic, M.D.,

thought he spotted an inconsistency in a recent rhBMP-2 study. He wrote the study’s authors about it. They ignored him. Now that The Spine Journal has confirmed Smoljanovic’s discovery, the question is why was he rebuffed. We have the story here.

12 The Work of the Musculoskeletal Tumor Society ◆ To a great extent,

because of the MSTS, a diagnosis of bone cancer does not mean that a patient will die or lose his limb. Dr. Richard Lackman, President of the MSTS, discusses the organization and the specialty.

26 One Ortho Entrepre-neur’s China Venture, Part I ◆ Peter Slate, CEO

of Bonovo Orthopedics, has built an unusual company…one that has strong R&D capabilities “on the ground” in China, an impressive distribution net-work, and, a “special sauce.”

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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: Since the first of the year there have been about 10 announced orthopedic acquisitions—the most significant being JNJ’s bid for Synthes, of course. M&A activity has clearly accelerated. Stryker, Kensey Nash and Integra are the most active buyers. With ortho valuations this low, the M&A pick up is not surprising.

1 1 Alphatec 1.11% 19.32%Analysts have increased their earnings estimates by

50% in the last 30 days.

2 2 Orthofix 14.49 19.68No company in orthopedics has OFIX’s unique combination of global distribution, technologies

and low valuation.

3 3 NuVasive 6.69 8.53Off 36% from its all time high. Analyst

expectations are extremely modest for the remainder of this year.

4 6 Stryker 25.61 1.23As of last quarter, SYK reported that cash balances

were roughly $2.8 billion. Still plenty of dry powder left for M&A.

5 4 Zimmer 26.64 (0.53)We loved ZMH’s turning the tables on the

plaintiff’s bar. Go team go!

6 5Johnson &

Johnson26.33 1.51

This whole JNJ Synthes combination continues to shift the frame of reference in orthopedics.

7 8Integra

LifeSciences15.18 (8.33)

IART’s stock has not traded well for a while. But SeaSpine bolt-on is a move in the right direction.

8 9Smith & Nephew

23.22 0.51SNN’s lawyers have been among the most

effective in orthopedics protecting IP. Now Arthrex is the target.

9 7 Medtronic 31.23 (7.19)Seriously rough patch for MDT with Infuse

hit again and lay-offs in Memphis. Time to do something creative and dramatic.

10 10 Symmetry 8.08 (2.69)Current quarter’s sales are actually expected to be

very decent—like 8.50% growth YOY.



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

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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 Orthovita VITA $3.82 $294 68.28%2 MAKO Surgical MAKO $33.06 $1,354 31.45%3 Tornier N.V. TRNX $26.95 $1,052 22.00%4 Orthofix OFIX $40.50 $731 19.68%5 Alphatec Holdings ATEC $3.52 $314 19.32%6 RTI Biologics Inc RTIX $2.90 $160 9.85%7 NuVasive NUVA $33.21 $1,318 8.53%8 Synthes SYST.VX $177.17 $21,044 2.44%9 Exactech EXAC $17.59 $230 2.27%

10 Kensey Nash KNSY $24.62 $210 1.53%

1 TiGenix TIG.BR $1.52 $47 -17.01%2 Integra LifeSciences IART $47.52 $1,357 -8.33%3 Medtronic MDT $39.27 $41,994 -7.19%4 Wright Medical WMGI $15.20 $593 -6.92%5 ConMed CNMD $26.67 $755 -4.92%6 TranS1 TSON $4.46 $93 -3.25%7 Symmetry Medical SMA $9.41 $342 -2.69%8 Bacterin Intl Holdings BONE $3.42 $130 -2.29%9 CryoLife CRY $5.31 $148 -1.48%

10 Zimmer Holdings ZMH $65.82 $12,635 -0.53%

1 Medtronic MDT $39.27 $41,994 11.972 Johnson & Johnson JNJ $66.09 $181,162 13.713 Kensey Nash KNSY $24.62 $210 13.994 CryoLife CRY $5.31 $148 14.355 Zimmer Holdings ZMH $65.82 $12,635 14.53

1 NuVasive NUVA $33.21 $1,318 39.542 ArthroCare ARTC $33.00 $901 27.733 Wright Medical WMGI $15.20 $593 23.384 Synthes SYST.VX $177.17 $21,044 23.165 Exactech EXAC $17.59 $230 20.45

1 Orthofix OFIX $40.50 $731 0.932 Kensey Nash KNSY $24.62 $210 1.083 Exactech EXAC $17.59 $230 1.134 NuVasive NUVA $33.21 $1,318 1.225 Symmetry Medical SMA $9.41 $342 1.37

1 Alphatec Holdings ATEC $3.52 $314 3.002 CryoLife CRY $5.31 $148 2.783 ConMed CNMD $26.67 $755 2.314 Johnson & Johnson JNJ $66.09 181,162 2.065 ArthroCare ARTC $33.00 $901 1.74

1 Symmetry Medical SMA $9.41 $342 0.952 RTI Biologics Inc RTIX $2.90 $160 0.963 ConMed CNMD $26.67 $755 1.064 Wright Medical WMGI $15.20 $593 1.145 Exactech EXAC $17.59 $230 1.21

1 MAKO Surgical MAKO $33.06 $1,354 30.572 TiGenix TIG.BR $1.52 $47 19.733 Bacterin Intl Holdings BONE $3.42 $130 8.454 Synthes SYST.VX $177.17 $21,044 5.715 Tornier N.V. TRNX $26.95 $1,052 4.63

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 18 | JUNE 7, 20114Zimmer Bites Personal Injury LawyersBy Walter Eisner

When Zimmer consultant Richard Berger, M.D. first reported revi-

sions of the NexGen CR-Flex Porous Femoral Component to the company back in October 2006, no one could have anticipated that one of the unin-tended consequences of that action would be the taming of personal injury lawyers.

Berger followed up with a study pre-sented at the 2010 American Academy of Orthopedic Surgeons (AAOS) annual meeting where he reportedly said the NexGen CR-Flex Knee Replacement failure rate may possibly be as high as 9% and, “unacceptably high.”

This was followed by a very public divorce between Zimmer and Berg-er that made national news and was detailed in OTW in June 2010.

A month later, Senator Charles Grass-ley sent a letter to Zimmer saying he

was “troubled” by accounts of the com-pany’s response to allegations of safety concerns raised by Berger and asked for further information. Nothing has been heard from the Grassley’s office since.

Send in the Lawyers

After Grassley’s letter, personal injury lawyers swooped in with websites, let-ters and television ads seeking patients who had received the NexGen Knee System. The lawyers made claims about the device that Zimmer found objec-tionable.

So Zimmer went after the lawyers, made them blink and got them remove the objectionable claims. Call this a “Man Bites Dog” story since it’s usually the company that gets sued.

Zimmer filed a lawsuit in the U.S. Dis-trict Court for the Northern District of Indiana on February 16, 2011 against

three personal injury law firms the company says were, “making inaccu-rate and misleading statements about the Zimmer NexGen Knee System through letter writing, Internet and television advertisements, and websites that incorporate Zimmer’s name and brand.”

The firms in Michigan and Texas includ-ed: Kresch Legal Services; Pulaski & Middleman, and Weller, Green, Toups & Terrell. Three more firms were added to the suit during March and April: Gordon Edelstein Krepack, Rottenstein Law Group, The Moody Law Firm, and Elk & Elk.

The company says it recognizes that it is unusual to take this kind of action

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VOLUME 7, ISSUE 18 | JUNE 7, 20115against law firms, but believes it is nec-essary to protect the interests of the company, patients and surgeons who rely on their products. In addition to the lawsuit, Zimmer continue to send “cease-and-desist” letters and will pur-sue other avenues available to them.

Settlements

Zimmer recently reached settlements with three of those law firms. As part of these settlements, the firms are required to post corrective statements on their websites for the next six months. Addi-tionally, the firm Weller, Green, Toups & Terrell LLP sent a letter of retraction to all of the members of the American Association of Hip and Knee Surgeons (AAHKS) whom they had previously solicited.

What exactly was it that the law firms said that sent Zimmer’s lawyers after them?

Weller: “Defective Knee Implants”

In the Weller case, it was a letter sent to AAHKS members across the country regarding the NexGen system.

According to Zimmer’s Complaint, the first sentence of the Weller letter reads: “As you may be aware, numerous com-plaints have been asserted concerning, and Congress is investigating the safety of Zimmer NexGen Knee Implants.” The letter refers to Zimmer as the man-ufacturer of “defective knee implants.”

The company says the implants are neither “defective” nor the subject of “numerous complaints [and] Congress is not “investigating the safety of” these devices.

Here’s what the AAHKS retraction let-ter said:

We recently sent you a letter con-cerning the Zimmer NexGen Knee System, seeking referrals of patients for possible legal action against Zim-mer. We have determined that the sources we previously relied upon to make claims about the Zimmer Nex-Gen Knee System do not support the statements or implications that sig-nificant numbers of patients receiv-ing the NexGen Knee System as a whole experienced pain or loosening or require additional surgery or that the NexGen Knee System as a whole is otherwise defective.

We apologize for any confusion our prior letter may have caused.

Sincerely,Mitchell A. Toups

Kresch: “Pain, Failure and Revision Surgery!”

Another defendant, the Kresch firm, said this on their www.1800lawfirm.com website:

(a) “Research shows that 36% of patients who received NexGen

knee replacements experienced joint loosening.”

(b) “Patients who received the Nex-Gen joints may experience joint failure at a higher rate than other joint types.”

(c) Physicians presenting at the American Academy of Orthopedic Surgeons (“AAOS”) “argued that 36% of patients who received the NexGen joint experienced pain in their joint.”

(d) “9% of patients who received the NexGen joint had to undergo a sec-ond surgery after experiencing pain associated with the loosening of the joint.”

(e) “In March of 2010 the FDA issued a class 2 recall of the Zimmer Nex-Gen Knee.”

Zimmer claims Kresch made the fol-lowing similar “false, misleading and defamatory statements” on their www.zimmernexgenkneereplacement.com website:

(a) “The FDA has issued a class 2 recall of the Zimmer NexGen knee.”

(b) “March 2010: Data was presented

Zimmer, Inc. vs. Kresch court documens



VOLUME 7, ISSUE 18 | JUNE 7, 20116by a group of knee surgeons that indicated almost 9% of patients examined after 2 years required revision surgery and 36% showed signs of a loose knee replacement.”

(c) (In large letters): “Zimmer Nex-Gen Knee Replacement Lawsuit” and “the Zimmer NexGen knee replacement has been linked to pain, failure and revision surgery!”

Pulaski: “1-800-Bad-Drug”

Pulaski ran television ads throughout the U.S. that solicited potential clients by making statements about Zimmer and the NexGen Knee System.

The Pulaski Spot has flashing red bold-faced letters in front of a knee X-ray stating “Zimmer NexGen Knee Implant WARNING.” It goes on to say “Reports show the ZIMMER NEXGEN KNEE IMPLANT may have a failure rate of 9%.” It tells listeners they may be enti-tled to compensation and advises them to call 1-800-Bad-Drug for a free con-sultation.

Zimmer Rebuts

Garry Clark, Zimmer’s director of pub-lic relations told OTW the law firms, “Have a right to advertise truthfully. They don’t have the right to lie about our products.”

According to the Complaint, the sci-entific evidence is that NexGen joints “perform better, not worse, than ‘other joint types’.”

“No doctors ‘argued that 36% of patients who received’ the NexGen Knee System experienced pain, and 9% of patients who received the joint did not undergo a second surgery. The physician presen-tation mentioned in the Kresch web-sites was a non-peer reviewed account of two doctors’ experience with 108 patients—accounting for a tiny fraction of the many thousands of patients who received NexGen Knee System compo-nents.”

Continued the Complaint: “The loosen-ing reported in those 108 patients was exclusively of a single type of NexGen Knee System component: the NexGen CR-Flex Porous Femoral Component.

“The advertisements falsely extrapolate the reported result from the 108-case AAOS presen-tation not only to all NexGen CR-Flex Porous Femoral Components but further to the over three mil-lion total NexGen Knee System components sold, all contrary to the published data. The publicly-available data on the NexGen CR-Flex Porous Femoral Component demonstrate that it (like the Nex-Gen Knee System as a whole) has among the lowest revision rates for that product type.”

The company says there has never been any recall of the entire NexGen Knee System, which includes more than 40 different components. Moreover, there has never been any recall of the NexGen CR-Flex porous femoral component.

“These false, misleading and defamato-ry statements are clearly and intention-ally designed to mislead patients into reaching the false conclusion that the Zimmer NexGen Knee System is dan-gerous and defective. They have fright-ened patients and have injured Zim-mer’s reputation and other interests.”

Clark told us the company is pressing forward with the litigation against the remaining defendants.

Zimmer first learned of these claims by the law firms when some of their sur-geon customers alerted their sales rep

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VOLUME 7, ISSUE 18 | JUNE 7, 20117or the company. “We have established a team to respond quickly to information we hear from our customers, and also monitor advertising ourselves to try to address problems before they impact our customers or unnecessarily alarm patients,” added Clark.

Correcting the Record

Other than the corrective statements and retraction letter, we asked if there were any kind of financial penalties involved or if the company was count-ing on promises to “be good?”

Clark said that while the company was not in a position to disclose all the terms of past or possible future settlements, the primary goal has been to correct the record about “the most widely used and trusted knee system in the world.” He added the settlements contain strong

financial and other terms designed to deter plaintiffs’ firms from resuming their false and misleading advertising. “We have retained the right to bring each back to Court should they resume problematic activity.”

Maybe it’s just a coincidence, but Zim-mer’s leader Dave Dvorak was the com-pany’s top lawyer before becoming CEO. The message to personal injury lawyers looking for clients is simple. Be careful who you bite and be accurate with your claims because this dog bit back. Hard. ◆

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Tomislav Smoljanovic, M.D., Ph.D., thought he spotted an inconsisten-

cy in the 2002 multicenter, prospec-tive, randomized, non-blinded FDA-approved study of Infuse for spine fusion surgery. In the study, 279 patients with degenerative lumbar disc disease were treated with an anterior lumbar inter-body fusion (ALIF) approach and two tapered threaded cages (Medtronic’s LT-Cage) were implanted in each patient.

One hundred forty-three of the patients received Infuse (rhBMP-2) and the remaining patients (n=136) received autogenous iliac crest bone grafts.

Smoljanovic’s Challenge

But Dr. Smoljanovic, a young 30-some-thing physician just two years out of residency, thought that the study’s results were “irregular.” Said Dr. Smol-janovic: “Although results were gener-ally compared item for item between the rhBMP-2 groups and controls, there were two outcome measure-ments that were not: adverse events related to harvesting of the iliac crest graft and RE (retrograde ejaculation). Although the first one is logical as no bone graft was harvested from the rhBMP-2 patients, the lack of docu-mented comparison of RE between the control and rhBMP-2 others drew our attention. Apparently, six male patients (4.1% of 146 male subjects) complained of RE after surgery.”

So Dr. Smoljanovic asked the study’s authors for clarification.

Dr. Smoljanovic is Croatian and prac-tices at the University Hospital Center in Zagreb, Croatia. In 2000, Dr. Smoli-janovic represented Croatia in the Olympic games as a rower. He asked some of his rowing friends in the U.S. to help him translate his letters to the study authors.

At first Dr. Smoljanovic’s letters to the study’s authors (all of them) were ignored. Said Dr. Smoljanovic in explaining the causes for his letter to go unanswered: “We are orthopedic surgeons who, working in Croatia, have been described as coming from differ-ent ‘ethnic, demographic or training’ backgrounds. As such, perhaps we have

had a unique approach to the critical analysis of reports related to the clinical use of recombinant human bone mor-phogenic protein-2.”

Eventually, Dr. Smoljanovic did manage to get a letter published in the Journal of Bone and Joint Surgery.

In his letter, Dr. Smoljanovic questioned the conclusions from a study conduct-ed by Burkus JK, Gornet MF, Dickman CA and Zdeblick TA and published in the Journal of Spinal Disorders Tech in 2002.

“During the ALIF procedure described in the study by Burkus et al., there

The Infuse Retrograde Ejaculation ControversyBy Robin Young

Steve Fareham /Wikimedia Commons

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VOLUME 7, ISSUE 18 | JUNE 7, 20119was no barrier used to protect supe-rior hypograstric plexus from rhBMP-2 exposure. This sympathetic plexus crosses the lumbosacral junction in retroperitoneal space immeddiately ventral to the interbody cages contain-ing rhBMP-2. Damage or inflammation of the plexus at the point may result in RE.”

Burkus et al., responded to Dr. Smolja-novic’s letter and told the young surgeon that in their study 6.4% of the rhBMP-2 exposed male patients in the study developed retrograde ejaculation. The control group of non-rhBMP-2 treated male patients reported just a 1.5% rate of retrograde ejaculation problems.

Still, said Smoljanovic, “Despite report-ing the higher rate of RE in the rhBMP-2 group, the authors nonetheless categor-ically denied any relationship between the rhBMP-2 use and the onset of RE. In our opinion, this categorical denial was not credible.”

Carragee Joins Fray

Apparently Dr. Smoljanovic wasn’t alone. The higher rate of RE caught the attention of Stanford Univeristy’s Eugene J. Carragee, M.D., Professor at Stanford’s School of Medicine and Divi-sion Chief of Spinal Surgery. “While we have always known there is a risk of male infertility with some spine surger-ies, the risk when performing a spinal fusion with a particular biologic bone growth factor appears to be greater than originally reported in industry spon-sored publications [emphasis added],” said Carregee.

Industry sponsered publications? (the Burkus et al. study was published in the Journal of Spinal Disorders & Tech-niques, editer-in-chief Thomas Zdeblick

M.D. and published by Wolters Klu-wer). The Journal of Spinal Disorders website (http://journals.lww.com/jspin-aldisorders/pages/default.aspx ) doesn’t indicate any industry sponsorship but it does list a large group of editors and reviewers from major institutions in the U.S. and abroad. Perhaps Carragee was thinking of another publication—maybe Orthopedics This Week?

Anyway, Dr. Carragee embarked on a review of past studies of the use of rhBMP-2 in spinal fusion surgery and reported that he and his fellow inves-tigators (Kyle A. Mitsunaga, M.D. with the Stanford University School of Medi-cine, Eric L. Hurwitz, D.C., Ph.D. with the University of Hawaii’s John Burns School of Medicine and Gaetano J. Scu-deri M.D. with Stanford University’s School of Medicine) had found that indeed there is a higher incidence of RE

in male patients undergoing one or two level ALIF spinal fusion surgeries with rhBMP-2 (7.2%) when compared with those without rhBMP-2 (0.6%). In the single-level ALIF surgeries the restro-spective study conducted by Carragee et al., found the rate of RE was 6.7% of all male patients treated with rhBMP-2 versus 0% in the untreated group.

Furthermore, Carragee et al., stated that the data in their retrospective review closely matched the data regarding RE found in the FDA-approved trial of rhBMP-2.

Conflict of Issue Subtext

The prevailing subtext of Carragee’s study is that the risk of RE associated with using rhBMP-2 was minimized if not altogether ignored by the clini-cal investigators who’d conducted the

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VOLUME 7, ISSUE 18 | JUNE 7, 201110original rhBMP-2 studies. And that it was a young surgeon in Croatia who noticed the inconsistencies in prvevi-ous studies and when he brought his concerns to the attention of the orginal study’s authors—was rebuffed.

The issue is conflict of interest. Did the fact that these original studies that were sponsored by Medtronic play a role in keeping information about rhBMP-2’s RE risk from physicians and therefore patients?

James Kang, M.D. a member of the University of Pittsburgh’s Department of Orthopaedic Surgery, provided the best answer, we think, to that question in a commentary he wrote for The Spine Journal:

“In this era of public scrutiny over surgeon’s conflicts of interest, it would seem prudent to carefully assess studies that may strongly influence how surgeons practice their art. Although corporate-

sponsered research is absolutely needed to help advance innovation and patient care, we must come to the hard realization that the data analysis and interpretation in such studies can be biased in favor of the funding sources. After all, it is against our nature to publish a negative result or an adverse event that condemns a product that is being studied if we are being funded by the sponsors of the product. [emphasis added] Therefore, it is of critical importance that independent studies (such as by Carrage et al.) be published so that the practicing surgeon gets a balanced view of the ‘truth’.”

Public Media

The public media has not been so kind. The Madison, Wisconsin newspaper (where Thomas Zdeblick M.D.—the editor-in-chief of the Journal of Spinal Disorders—practices) jumped on this story and listed all of the consulting revenues that Zdeblick received from Medtronic (none of which, by the way, were for rhBMP-2) and made him the villian of this story—in his own home town. It was rough. In cases like this, there is no balance for the surgeon. Zde-blick has been at the forefront of clini-cal research and making spine surgery safer and more consistenty successful for decades. Thousands of patients have their lives back because of Dr. Zdeblick.

The Study Itself

Carragee, in choosing to study rhBMP-2, selected one of the most popular and successful biologic products ever intro-duced for clinical use. Since its FDA approval and with broad adoption, a number of adverse reactions, including inflammatory reactions in soft tissue,

heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence have been reported in the literature.

In terms of one potential adverse event, RE, the original FDA study of rhBMP-2 in anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejacula-tion (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. But the study didn’t establish whether these RE events were due to rhBMP-2 or something else.

So Carragee et al., decided to conduct a retrospective analysis of prospectively gathered outcomes data on consecutive subjects having an ALIF spine surgery procedure with and without rhBMP-2 use. The purpose of the study was to compare the incidence of RE after ALIF in patients with and without rhBMP-2 use.

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Carragee et al., chose male patients with the diagnosis of lumbar spondylo-sis or spondylolisthesis and for whom

the treatment of choice was to receive an ALIF spine surgery of the lowest one or two lumbar levels with and without rhBMP-2.

Carragee and his colleagues then dove into Stanford’s high-volume spine sur-gery practice and selected data for male subjects having ALIF for one- (L5/S1) or two-level (L4/L5, L5/S1) lumbar fusion. In particular, they looked for any record of a retrograde ejaculation diagnosis.

Carragee et al., also tried to match the two groups of male subjects in terms of age and additional procedures per-formed. When they had finished com-piling the data, the investigators found that they had data on 69 male patients who’d received an L5/S1ALIF with rhBMP-2 and 174 male patients who’d received ALIFs performed without rhBMP-2.

Of those male patients uncovered in their data search, 24 and 64 were two-level ALIFs performed with and with-out rhBMP-2, respectively.

In the data, Carragee et al., found five RE events (7.2%) reported in the rhBMP-2 group and 1 (0.6%) in the control group. Looking at single-level L5/S1ALIF procedures, the investiga-tors found that there was a 6.7%and 0% rate of RE in the rhBMP-2 versus control groups, respectively.

At one year after surgery, three of six affected subjects reported resolution of the RE.

Carragee’s conclusion was that the pre-vious reports of higher rates of RE in patients receiving rhBMP-2 as part of an ALIF spine surgery were consistent with the clinical data assembled at Stanford.

For Dr. Smoljanovic, no one is ignoring him now. Based on his ability to critical-ly read these studies, he’s probably an ideal candidate for editorship of one of the peer review journals. Just a thought.◆

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VOLUME 7, ISSUE 18 | JUNE 7, 201112The Work of the Musculoskeletal Tumor SocietyBy Elizabeth Hofheinz, M.P.H., M.Ed.

If you were diagnosed with bone can-cer in the 1970s or earlier, it was a

foregone conclusion that you would lose your limb and you probably would not live long past the amputation. Because of a dedicated cadre of orthopedists, however, things have changed substan-tially in the last 40 years for those who don’t hear the word “benign.”

One of those steadfast orthopedic sur-geons is Dr. Richard Lackman, President of the Musculoskeletal Tumor Society. He states, “Prior to the 1970s almost all patients diagnosed with a bone sarcoma had to undergo an amputation…it was all we could do for patients. In addi-tion, 90% of those patients who were told they had osteosarcoma or Ewing’s sarcoma—the two most common high grade bone sarcomas—died from their disease. In the early 1980s things were looking up, with more treatment options becoming available. The effi-cacy of chemotherapy was improv-ing, and new drugs such as doxoru-bicin, methotrexate, and cis-platinum changed things radically. These drugs allowed us to pre-treat high grade bone sarcomas which then facilitated limb sparing surgery.”

Pushing for these and other develop-ments were 16 orthopedists who got

together in the 1970s to change the then status quo for bone cancer patients. Dr. Lackman recalls those early days: “Nota-ble orthopedic surgeons from major academic institutions joined forces and crafted what would become the Mus-culoskeletal Tumor Society. Because of these and other devoted orthopedists, over the years we began to have more options other than just amputation or watching our patients die.”

It wasn’t until the 1980s that surgeons had something concrete (actually, metal

or bone) to offer patients for recon-struction. Dr. Lackman: “Even though we were able to pretreat patients with these sarcomas, we still lacked good prostheses…those did not emerge for another couple of years. It was also at that time that bone and tissue banking gave us a good supply of allograft bone, meaning that we had another recon-structive option.”

Not a perfect option, but an option. “In the U.S., prostheses became the stan-dard of care because we found that the

Notable orthopedic surgeons from major academic institutions joined forces and crafted what would become the Musculoskeletal Tumor Society. Because of these and other devoted orthopedists, over the years we began to have more options other than just amputation or watching our patients die.

“ ”

Source: Navy News Service/Photographer’s Mate 2nd Class Chad McNeeley/Wikimedia Commons


VOLUME 7, ISSUE 18 | JUNE 7, 201113complication rate for allografts was too high,” recalls Dr. Lackman. “Interesting-ly, in South America, because prostheses are too expensive, they have refined the techniques of allograft reconstruction and have lowered the complication rate associated with this technique. Over time, things have shifted in this coun-try, and reconstruction, rather than amputation, has become the standard of care because we can do it with a rea-sonable expectation for durable func-tion and a local recurrence rate of less than 10%. At ten years follow-up 80% of patients who underwent proximal femoral reconstruction have required no further surgery in most series. This drops to 70% for the distal femur and 60% for the proximal tibia. This is not as good as regular reconstructive sur-gery, but these are large operations with substantial stress on the joints.”

The MSTS, a coterie of super specialists, contains roughly 200 members. They struggle against sarcomas and for fund-ing. Sarcomas are only about 2% of all cancers…but if you’re in that number, it is 110% traumatic. “Those patients with the most severe tumors are going to have to endure a cancer that will spread elsewhere in their bodies. We still lose about a third of patients with primary bone sarcomas. They die from disease in the lungs—we really need better drugs to kill the tumors that we can’t remove in the lungs. There is just not enough funding.”

Despite this, says Dr. Lackman, there is progress. “Chemotherapy has evolved to the point where the cure rate for osteocarcoma is 70%; for Ewing’s sar-coma it is 60%. If patients come in and they already have a tumor in the lung we can still cure them but the prognosis is not as good—about 15% of patients come in with disease in the lung…for them the cure rate is only 30%.”

“With regard to soft tissue sarcomas, over the years we have learned that a combination of surgery and radiation can control the local tumor in 90% of patients. The total cure rate is 70% or better even without chemotherapy

though most large centers are currently pursuing chemotherapy for large, high grade lesions in an attempt to increase the cure rate for these patients at high-est risk. Also, radiation has become more sophisticated, with 3D conformal

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treatment that spares the adjacent tissue such that complications from radiation are less frequent than they used to be.”

So where are the signs of hope for tumor patients in the orthopedic labs? Dr. Lackman states, “I believe that some of the most promising research in the field of sarcoma treatment has to do with non-surgical advances. For exam-ple, targeted drug therapies aimed at a

specific tumor metabolic pathway will hopefully over time replace our current drugs that have a lot of associated tox-icity. Also, developments in the tech-nology of radiation therapy (Intensity-Modulated Radiation Therapy, proton beam radiation, stereotactic radiation) allow for more selective treatment of the tumor with a smaller dose going to normal tissues. Percutaneous treat-ments such as radiofrequency ablation

to heat kill tumors and cryotherapy to freeze kill tumors will also continue to develop. Finally, 3D imaging and sur-gical navigation currently play a small role in tumor surgery but hopefully this will increase as these systems become more sophisticated and user friendly. All of these will help us take better care of our tumor patients.”

For those who take up the challenge of caring for these very ill patients, this is good news. But who are these orthopedists and why do they choose this path? “As an orthopedic oncolo-gist you can have a very stimulating practice,” notes Dr. Lackman. “The surgeries are extremely interesting and diverse, something that is especially enjoyable because orthopedics has become so subspecialized. We treat children, adults, men, and women; we treat all areas of the human body. Perhaps the biggest ‘draw’ for those of us who enter this profession is that if someone has cancer and you can save both a limb and a life, then you are hav-ing a major impact.”

Treating tumors also means that your career ends up with a sort of cross fer-tilization. “Orthopedic oncology is a multidisciplinary pursuit that requires a large, dedicated team of orthope-dic oncologists, pathologists, medi-cal oncologists, radiation oncologists, diagnostic radiologists, interventional radiologists, reconstructive plastic sur-geons, vascular surgeons, and general

I believe that some of the most promising research in the field of sarcoma treatment has to do with non-surgical advances. For example, targeted drug therapies aimed at a specific tumor metabolic pathway will hopefully over time replace our current drugs that have a lot of associated toxicity.

“ ”

Source: National Cancer Institute/Unknown photographer/artist/Wikimedia Commons


VOLUME 7, ISSUE 18 | JUNE 7, 201115surgeons who specialize in oncology. This is a reflection of the fact that the best care for tumor patients is usually done at a major teaching hospital...it is difficult to find all of these resources in a small hospital.”

The Musculoskeletal Tumor Society works hard to get everyone on the same page. Dr. Lackman says, “We have numerous activities, all of which are focused on our goal of continuing the dissemination of knowledge and the evolution of treatment. We do this via society meetings, research studies, publications, specific tumor sessions at AAOS, etc. An example of one of these sessions is, ‘Are our attempts to improve surveillance in high grade soft tissue sarcomas working and are they safe?’ The issue is that we want to opti-mize treatment without harming our patients…but these are rare tumors and no one institution has a tremen-dous volume of data. We are working towards doing more multi institutional studies in an effort to get a larger study population.”

“Fellowship training began in the late ‘70s and has grown to 12 programs (almost too much). We struggled with reimbursement issues for years, and until recently had the worst reimburse-ment rate in orthopedics. It was only a year ago that spine was reimbursed at one dollar per unit (based on the

Intraoperative Work per Unit Time measure), while tumor surgery was reimbursed at 34 cents. Things have improved somewhat and this may fur-ther motivate people to consider ortho-pedic oncology.”

These vital specialists are needed by patients, and they are needed by their colleagues. The fact is that an orthope-dist or a general surgeon may have a tumor patient in front of them and not know how to proceed. Enter the MSTS. “We teach surgeons how to ‘keep out of trouble’ when it comes to tumors as there are lots of pitfalls where it is easy to do the wrong thing. Our annual courses attract hundreds of non tumor surgeons and teach them about the issues involved in, for example, how to approach a patient with no cancer his-tory who reports a painful lytic bone lesion. Another example that we cover deals with soft tissue tumors, making surgeons aware that if a patient has a deep mass, you should not biopsy the mass before obtaining an MRI scan and you should not excise it until you know that it is benign.”

“We serve as regional resources and get calls from local doctors asking help for particular situations. They may just say, ‘Can I email you a picture and can you tell me if it’s something to worry about?’ I’m really pleased that more and more orthopedic surgeons have been sen-

sitized to the fact that improper treat-ment can harm the patient. That means they more frequently tend to seek out advice.”

From the 1940s to the 2010s, the prac-tice of treating the oncology patient has been transformed—and at the center of that remarkable history is the dynamic and ever forward looking Musculoskel-etal Tumor Society. ◆

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Lobo In at Stryker Ortho, Mogul to DJO Global

Kevin Lobo’s job as Group Presi-dent of Stryker Corporation’s new

Neurotechnology and Spine business didn’t last long. In fact, it ended before it began.

Lobo was scheduled to assume his new role on June 10. However, it was announced by Stryker on May 31 that Lobo would, instead, take over as Group President of the company’s Orthopae-dics business. The company said, Mike Mogul, the current Group President, informed them on May 24 of his inten-tion to resign from his position, effec-tive June 10, in order to accept the job of CEO of DJO Global, Inc.

Lobo joined Stryker after nearly a decade at Johnson & Johnson, where he held a number of senior level leadership roles. In his new role, he will have respon-sibilities for the company’s Recon-structive, Trauma, Craniomaxillofacial (CMF), Joint Preservation, Extremities and Orthobiologics business units and will be based in Mahwah, New Jersey.

Mike Mogul

There was no comment from Mogul as to why he was leaving Stryker to join DJO. He will succeed Les Cross, DJO’s current President and CEO, who will assume the role of Chairman.

Mogul joined Stryker in 1989 and took over orthopedics in 2005. He was named Group President, Orthopaedics in 2009.

DJO Global

DJO Global is a provider of orthopedic devices, with products used for rehabil-itation, pain management and physical therapy. The company also develops, manufactures and distributes surgical reconstructive implant products and claims to be the largest non-surgical orthopedic rehabilitation device com-pany in the U.S. and among the largest globally, as measured by revenues.

DJO Global was created in 2007 as the result of combining ReAble Therapeu-tics, Inc. with DJO Opco Holdings, Inc.

ReAble was a manufacturer and dis-tributor of electrotherapy products for pain therapy and rehabilitation, clini-cal devices for the treatment of patients in physical therapy clinics, and knee, hip and shoulder implant products. In 2006, ReAble was acquired by an affili-

ate of Blackstone Capital Partners V L.P. DJO Opco Holdings, Inc., formerly named DJO Incorporated, was a manu-facturer and distributor of orthopedic rehabilitation products, including rigid knee bracing, orthopedic soft goods, cold therapy systems, vascular systems and bone growth stimulation devic-es. On November 20, 2007, ReAble acquired DJO Opco through a merger transaction. ReAble then changed its name to DJO Incorporated and contin-ues to be owned primarily by affiliates of Blackstone.

Blackstone is also responsible for lead-ing a group of private investment banks that took Biomet private in 2007. That now puts Mike Mogul and Biomet’s CEO, Jeff Binder under the same Black-stone family of orthopedic investments.

—WE (June 1, 2011)

company

Mr. Mike Mogul and Mr. Kevin Lobo


VOLUME 7, ISSUE 18 | JUNE 7, 201117OIC Pledges to Save Billion

Move over, big boys…there’s a new, cost-conscious player in town…

The Orthopaedic Implant Company (OIC) has entered the medical device market with its president pledging to save more than a billion dollars in health care costs by 2015. OIC Presi-dent Itai Nemovicher contends that large medical device manufacturers have too much control over the ortho-pedic device industry, causing medical implants and equipment costs to sky-rocket beyond all reason.

“The co-dependent relationship between health care providers and medical device sales reps leads to up-selling and dra-matically increased implant costs,” Nemovicher said in the May 18, 2011 news release. “This relationship removes objectivity from the device selection pro-cess and makes the hospital and doctor dependent on the device rep. The inevi-table result is that patients, hospitals and managed care organizations wind up paying unreasonably inflated amounts for medical implants.”

Timothy Bray, M.D., ortho-pedic traumatologist and a Director of the Board at OIC added, “As a surgeon dedi-cated to the care of ortho-pedic trauma patients, I am pleased that OIC will help provide quality outcomes in a cost-effective manner. In this period of global cost containment we believe our business model is well positioned for the future of orthopedic trauma. We are committed to cost-effective, comparative research and working with hospitals and insurers to deliver a national, reproducible program.”

Nemovicher indicates that OIC’s implants are 50 to 60% of the aver-age market cost of premium implants, potentially saving millions of dol-lars a year. All OIC products are FDA approved and manufactured in ISO 13485 facilities. The company antici-pates that new products and markets will be added to the OIC product line in the coming months.

Nemovicher told OTW, “It is not that we can produce or manufacture implants at a lower cost than our competitors - we simply have elimi-nated the high overhead associated with a direct sales force and reduced our margins to what we feel is more appropriate given the current state of our healthcare system.”

As for where he sees the company in five years, Nemovicher commented to OTW, “In five years, I envision the com-pany being able to offer our customers a full range of products and services that revolve around increasing OR efficien-cies while reducing their supply chain costs. This isn’t simply about providing low cost implants, it’s about promot-ing fiscal responsibility and creating a paradigm shift in the way implants are currently sold and used.”

Finally, OIC has pledged to donate por-tions of its profits to non-profit founda-tions that share the company’s values.

—EH (May 31, 2011)

Heidi Fuller/Wikimedia Commons

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VOLUME 7, ISSUE 18 | JUNE 7, 201118Kyphon Drags on Medtronic’s Quarter

“Dropped,” “Missed,” “Falls,” “Dis-appoints” and “Fell Short,” were

the words used by analysts to describe Medtronic, Inc.’s latest quarter’s sales results.

The company’s total reported sales of $4.295 billion for the quarter were up 2% over the previous year’s fourth quarter.

Spine Down/Kyphon Dragging

Reported spine sales of $875 million however were down 1%. Worse yet, Kyphon sales were down 9%.

Macroeconomics and Group Pur-chasing Impact

During a conference call with analysts on May 24, the company blamed, “the continued macroeconomic downturn, decreased utilization and increased payer pushback” for the results. Com-pany speakers told analysts that they estimated markets in spine were only growing in the low single digits versus 6% to 7% a little over a year ago. The company also noted fewer bulk pur-chase deals with customers during the quarter as well as a decision to take a much firmer stance on discounting new products. Company CFO Gary Ellis told analyst the lowering of bulk purchases was not related to dropping Novation as a group purchasing vendor.

New Products

“Although the U.S. market continues to be challenged, our new products drove solid 6% growth in our international business. In Core Spinal which includes Core Metal Constructs, IPDs [interspi-nous process decompressions systems] and BKP [balloon kyphoplasty] prod-ucts, revenue of $648 million declined 4% as this business continues to feel the impact of its exposure to the BCF and IPD markets. Core Metal Construct products declined 1%. While Solera account showed strong double-digit growth and Solera is starting to drive the overall posterior fixation category, it is in less than 30% of the U.S. accounts that have our legacy system. We con-tinue to ramp the launch of Solera and expect to penetrate nearly all of our U.S. account by the end of FY 2012,” Ellis told analysts.

In DLIF [direct lateral interbody fusion], the company saw growth in the high-teens and expects the procedure to be navigation enabled this summer.

Spine Market Share

BMO Capital Markets analyst Joanne Wuensch estimates the worldwide spine market increased 1.6% in the first quarter of 2011, while Medtronic’s sales declined. She estimates that Medtronic’s market share will decline to 35.2% in 2011, from 36.1% in 2010, and 38.1% in 2009.

Mike Matson, Mizuho Securities’ ana-lyst, said NuVasive gained 0.6% in spine market share for the quarter, while Medtronic lost 2.1%. Orthofix gained 0.2% of share, Stryker held share, and Zimmer lost 0.2%. Going forward, Mat-son expects Orthofix and NuVasive to continue to gain market share.

—WE (May 25, 2011)

Source: Larry Biegelsen/Wells Fargo

Medtronic Spine 4Q11Sales

($ in millions)% Change

Total Reported Sales 875 down 1%

Spine Hardware 543 3%

Kyphon 105 down 9%

Biologics 227 5.0%

Wikimedia Commons



ReGen Sues FDA Over Knee Surgery Device

ReGen Biologics, Inc. is suing the FDA.

The company filed suit on May 31 over the agency’s rescission of the com-pany’s 510(k) cleared Menaflex device. The company says the rescission was “arbitrary, capricious, and abuse of dis-cretion and not in accordance to law, and in excess of statutory jurisdiction, authority and limitations.” The compa-ny also claims the rescission is “unlaw-ful and a nullity.”

Road to Bankruptcy

The FDA classified Menaflex as a Class II device in December 2008. On March 30, 2011, the FDA rescinded the clas-sification telling the company it did not warrant Class II classification because it did not meet the predicate requirements and would therefore require a premarket approval application (PMA) for Class III classification. ReGen filed for Chapter 11 Bankruptcy on April 8, 2011.

Statutory Authority Questioned

ReGen argues that the FDA does not possess the statutory authority to reclas-sify a lawfully classified device through a rescission process and should instead follow-up classification procedures. The agency has never questioned the safety of the device.

Gerald Bisbee, Jr., Ph.D., ReGen’s chair-man and CEO said: “Our company’s experiences with the FDA over the last six years, including the FDA’s unprec-edented decisions to re-review the 510(k) and ultimate rescission, have

forced ReGen to unnecessarily expend an inordinate amount of time and incur significant expenses.”

“The agency rigorously reviewed the company’s 510(k) submission, obtained independent expert guidance from an Advisory Panel of experts, whom they selected, and ultimately determined the device to be substantially equivalent (SE) to its surgical mesh predicates. We dis-pute FDA’s authority to change the clas-sification of the Menaflex device through rescission of the marketing author-ity conferred by the SE determination legally granted in 2008. ReGen believes that the Menaflex device provides a very valuable option for appropriate patients in the U.S. as it has for patients in the EU for more than a decade. This action has forced a small public U.S. company, committed to improving patients’ lives, into bankruptcy.”

The legal basis for rescinding a previ-ously cleared device is murky as the agency itself has recommended that Congress clarify that authority. The ReGen saga played out during a very public rebellion by anonymous agency scientists who accused agency leaders of ignoring their scientific recommen-dations. Two FDA orthopedic panels

told the agency that they considered the device safe and an internal agency report sided with the company’s claims that agency scientists were applying the wrong predicate standards for their device. Dan Schultz, M.D., the agency’s former device director, ultimately over-ruled the scientists and cleared the device. He was replaced by Jeff Shuren, M.D., JD. Shuren said the FDA’s internal processes were compromised by out-side influences and therefore required the agency to review and ultimately rescind ReGen’s clearance.

Industry Silence

AdvaMed and the MDMA, the two medical device trade associations, have sat on the sidelines as ReGen takes on the FDA. We emailed the two groups to ask if they were planning on filing briefs in support of ReGen’s complaint. We’ve not received a reply as of this writing.

Bisbee concluded, “I believe this action by the FDA will adversely affect other companies’ ability to plan and bud-get for expansion after receiving the agency’s final 510(k) decision and stifle innovation.”

—WE (June 2, 2011)

legal

Photo manipulation by RRY Publications. Source: MorgueFile



Zimmer Introduces Hip Replacement Sys-tem in Europe

Zimmer Holdings, Inc. introduced the CLS Brevius Stem with Kinec-

tiv Technology and the Maxera Cup, a new ceramic-on-ceramic hip designed for younger patients at the 12th annual European Federation of National Asso-ciations of Orthopaedics and Trauma-tology (EFORT) meeting in Copenha-gen, Denmark on June 1.

CLS Brevius Stem

The Brevius Stem adds the Kinectiv technology to the CLS Spotorno Stem which has been used in more than 560,000 total hip arthroplasty proce-dures around the world since being introduced in the 1980s.

The company says the Kinectiv technol-ogy offers a wide array of head center locations allowing for an independent, intra-operative control of leg length, offset and version for a more accurate restoration of the patient’s natural anat-omy. The Brevius Stem is shorter than conventional stems, providing greater bone conservation compared with the original Spotorno Stem.

Maxera Cup

The Maxera Cup features a large diam-eter femoral head that, according to the company, provides, an increased range of motion and enhanced stabil-ity. The full hemispherical design of the new cup provides stable fixation. The cup incorporates Biolox delta Ceramic Technology which the company claims provides low wear, high fracture resis-tance and excellent bio-compatibility, making the cup an appropriate choice for the treatment of younger and more active patients.

The cup is a ceramic-on-ceramic sys-tem based on the Biolox delta Alumina Matrix Composite. The company says the ceramic surface has been proven to reduce friction and lower wear, while its favorable wetting character-istics contribute to better lubrication. A ceramic-on-ceramic system offers an alternative to metal-on-metal articula-tion for patients who may be sensitive to specific metal ions and/or metal wear.

The Maxera Cup is not yet available for commercial distribution in the U.S.

EFORT 2011

EFORT is the umbrella organization of Europe‘s national orthopedic asso-ciations. Its mission is to promote the exchange of scientific knowledge and experience in the field of prevention and both the conservative and surgical treatment of diseases and injuries con-cerning the musculo-skeletal system. To this end, particular emphasis is placed upon activities focusing on education and research.

EFORT was established by the national associations for orthopedics and trau-matology from 20 European countries.

The Federation was founded in Mar-entino, Italy, in 1991, and today has 42 national member societies from 40 member countries, as well as six associ-ate scientific members.

—WE (June 3, 2011)

Skier Technique Cause of ACL Tears

What mistake do expert skiers make that leads to anterior cruci-

ate ligament (ACL) tears in their knees? Most people assume that they happen as the skier is crashing, tumbling, falling

head over heels down a course. A study by the Norwegian School of Sports Sci-ences revealed a different story; that the ligament is torn while the skier is still skiing and it is the torn ligament that is the cause of the crash. “Prior to this study, we really had no idea how these potentially devastating injuries, like ACL injuries, actually happened in World Cup skiers,” according to Roald Bahr, one of the study’s authors.

The study, by a panel from the Norwe-gian School of Sports Sciences, pub-lished in the American Journal of Sports Medicine found that a turning, off-bal-

large joints

Zimmer Holdings, Inc.

Source: Wikimedia Commons and Didier Defago


VOLUME 7, ISSUE 18 | JUNE 7, 201121ance skier leaning backwards is a recipe for knee disaster.

The group examined videos of 20 World Cup skiers who had suffered an anterior cruciate ligament tear, an inju-ry that wipes the skier out for a year and can have health consequences in the future. They reviewed videos of the runs that led to the injuries to deter-mine the exact moment of the ACL tear, recording all the details of the moment of injury, the skier’s behavior and situa-tion, as well as the angles of joints and the position of the skiers’ limbs. Bahr and his colleagues observed the inju-ries to skiers in the downhill, slalom, giant slalom, and super-G events.

They found that the toughest situation is when a skier is trying to make a turn on the course, but leaning too far back-wards and inwards into the turn while off-balance. That causes the outer ski to lift off the snow—and when the skier tries to reach out with his leg to get the ski back on the ground, the very back of the ski hits the snow, pulling the leg with it and rotating the lower leg. The force on the knee caused by that rota-tion is too much for the ACL, one of four ligaments connecting the thigh-bone to the shinbone.

ACL tears also happened when skiers were forced into a split, when their inner ski hooked on to a gate during a turn, and when they landed on the back of their skis after a jump.

Bahr noted that while most ACL inju-ries heal up within a year, people who have suffered ACL tears have a much higher risk of getting arthritis in the future.

—BY (May 28, 2011)

Two Knee Surgery Ap-proaches Compared

Blame advancing age for many of the degenerative changes that take

place in cartilage. With the passage of time cartilage loses its cushioning properties and its ability to mend itself. That is why most studies of surgical procedures on cartilage focus on young patients, because they are perceived to have the most to gain from successful interventions.

A group of researchers in Italy decid-ed to compare the outcomes from two procedures which are used to treat knee cartilage lesions in older patients – defined as patients who are 40 years of age or older and show no signs of osteoarthritis. The investiga-tors tested second-generation autolo-gous chondrocyte implantation (ACI) techniques and hoped to learn more about such treatment’s potential for older patients, its failure rate and pos-sible complications.

The investigators treated sixty-one patients who were 40 years of age or older and who were diagnosed with grade III to IV cartilaginous lesions of the condyles but who had no clear signs of osteoarthritis. The treatment that the clinical researchers chose was a second-generation type of ACI procedure.

The patients were prospectively evalu-ated at five years’ follow-up. Twen-ty-two patients were treated with an arthroscopic Hyalograft C implant and 39 were treated with an open Chondro-Gide MACI procedure.

The researchers found that patients who’d been treated with an open Chon-dro-Gide MACI procedure experienced significant improvement as measured by using both subjective (patient’s self-reported outcome) and objective (quantitatively measured) evaluations.

The investigators used the Interna-tional Knee Documentation Committee (IKDC) subjective score scale in their study. Patients treated with an open

Source: Wikimedia Commons and SSgt. Derrick C. Goode, U.S. Air Force


VOLUME 7, ISSUE 18 | JUNE 7, 201122Chondro-Gide MACI procedure report-ed that their IKDC scale improved from 36.8 ± 8.4 pre-knee surgery to 68.1 ± 21.8 post knee surgery. The failure rate, however, was 20%.

Patients who were treated with the arthroscopic Hyalograft C technique improved at a faster rate than the patients undergoing an open procedure (no sur-prise there) and their IKDC scores were similar at the 24-month follow-up and final evaluation.

The researcher’s conclusion was that patients who were older than 40 years benefited in most cases from being treated with an open Chondro-Gide MACI technique and that those patients had good results that were still in evi-dence at the medium-term follow-up. In one important cautionary note, the results for the MACI procedure were inferior when compared to results using the same procedure in younger popula-tions. The failure rate at medium-term follow-up was higher than that experi-enced with younger patient populations – a result that was consistent in both of the two treatment groups. The only dif-ference between the two groups was the faster recovery when the arthroscopic approach was used.

The study was conducted by doc-tors at Rizzoli Orthopaedic Institute, the Orthopaedic Department, Sacro Cuore–Don Calabria Hospital, and the Biomechanics Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy.

—BY (May 26, 2011)

Zimmer’s PSI Makes Better Knee Surgery

Neena Agarwal helped make medi-cal history at her Fortis Hospital

in India, when she had both knees replaced in a knee surgery that had been practiced on a computer using the Zim-mer patient specific instrumentation (PSI) , technology. The revolutionary new technique had been introduced at the hospital only a month before. The doctors who operated on Agarwal had practiced the entire procedure a week earlier on the computer.

Before performing the surgery, doc-tors took a magnetic resonance imag-ing (MRI) scan for a precise 3D mea-surement of Agarwal’s knees. With the information from the MRI, a replica of the patient’s bones was created as a 3D model on the computer. Before he per-formed the actual surgery, the surgeon made the surgical cuts and placement of implants virtually on the computer using specialized software that was part of the system.

“At the time of the actual operation, we had to simply execute the plan using instruments designed exclusively for the patient,” said Dr Kaushal Malhan, the knee and joint replacement surgeon who operated on Agarwal. “This is a new technology, whereby before per-forming the bilateral knee replacement surgery, we operated on the patient vir-tually with the help of software using 3D images of the patient’s knee. This reduced the risk of error in decision-making at the time of operation and makes surgery more objective, faster and safer for the patient.”

Daniel Zanotti, MD, who performed the first PSI knee replacement in Ohio in January, 2010, said, “Zimmer PSI knee replacement is the next generation of computerized technology to help customize total knee replacement for patients.”

—BY (May 17, 2011)

Source: Zimmer, Inc.



Carpal Tunnel Not So Swede

What is going on in Olmsted Coun-ty, Minnesota? A just-released

study in Sweden, when compared to a 2009 study by the Mayo Clinic, uncov-ered the fact that twice as many people in Olmstead County have been diag-nosed with carpal tunnel, compared to the rates discovered in Sweden. Could carpal tunnel syndrome be cultural?

Mayo Clinic researchers have long noted that there are unexplained differences in the populations of people who are diagnosed with specific ailments. They wanted to know why. In their 2009 study they hoped to uncover some of the long-term trends in the diagnoses of carpal tunnel syndrome. Dr. Russell Gelfman, Assistant Professor of Physi-cal Medicine and Rehabilitation of the College of Medicine of the Mayo Clin-ic and a lead researcher, said that the study was conducted on the residents of Olmsted County, which happens to be near the Mayo Clinic, “because they were a sort of captive population.”

The significance of the 2009 Mayo Clin-ic study became apparent when a recent study conducted in Sweden found that fewer than four out of every thou-sand Swedish women are diagnosed with carpal tunnel syndrome. The rates for men in Sweden are half that – at just under two per 1000, accord-ing to the study led by Isam Atroshi at Hassleholm Hospital in Sweden and published in the Archives of Internal Medicine. The Swedish researchers, in comparing their outcomes to those of other researchers, noted the compari-son with the Olmstead County study

and brought it to the attention of their colleagues at Mayo.

Carpal tunnel syndrome is a painful condition caused by a pinched nerve in the wrist. Though it sometimes goes away by itself, it may require treatment, with surgery possible to relieve pressure on the pinched nerve if wrist splints or corticosteroid hormone injections fail. Click here to view a complete diagnos-tic chart on CTS.

“A few studies have estimated the inci-dence of carpal tunnel syndrome (CTS), showing large differences between countries,” wrote Atroshi. Russell Gelf-man, who led the Mayo Clinic study, said, “This study (from Sweden) adds to our observations that there are dif-ferences in the incidence of medically-attended carpal tunnel syndrome and surgical treatment between countries.”

Atroshi suspects that both medical and social factors may be at play. For instance, carpal tunnel syndrome could be related to obesity or to different types of work, he wrote. Gelfman believes that life-style choices, such as the read-iness of a population to seek medical help, or the occurrence of ailments such as diabetes, could also be at work.

—BY (June 3, 2011)

Arm Surgery: Incon-sistent Outcome Re-porting

Two studies from Hospital for Spe-cial Surgery (HSS) highlight the

way that clinicians report outcomes of surgery for a traumatic nerve injury involving the arm. The team found that this reporting is not standardized, and it is thus difficult to compare the effi-cacy of different surgical treatment. In a second HSS study, investigators say they have developed a tool to measure outcomes that they hope can be refined and used worldwide.

“There is a great deal of discrepancy in how the results of brachial plexus sur-gery are reported. This makes it hard to compare and contrast studies and understand outcomes of brachial plex-us surgeries across centers and across continents. From this work, we have determined that there is a need for a standardized outcomes measurement system or tool,” said Steve K. Lee, M.D., in the May 20, 2011 news release.

In a second study, the same investiga-tors describe a first draft of a tool that they hope clinicians can use so that the reporting of outcomes is standardized.

Dr. Wolfe told OTW, “We analyzed over 1,000 published studies to try to

extremities

Source: Wikimedia Commons and Maen K. Housen

Gray’s Anatomy/Wikimedia Commons

http://upload.wikimedia.org/wikipedia/commons/a/a1/Carpal_Tunnel.pdf


VOLUME 7, ISSUE 18 | JUNE 7, 201124draw conclusions concerning treatment options for patients with upper brachial plexus injuries. We were surprised to realize that less than 50 were suitable for inclusion in our study, because so few investigators used standardized measures of reporting. Even within the studies that we selected, less than 50% reported both motion and strength data, and only a few reported outcomes of pain or function. Since plexus inju-ries are relatively uncommon, it is criti-cal that we all use the same outcome parameters so that we can compare and contrast treatments across centers and across oceans.”

As for the challenges involved in get-ting people to use this tool, Dr. Wolfe commented to OTW, “The tool as is can be considered lengthy and com-plex; therefore, it will be a challenge for all centers to adopt it immediately. If a small panel of experts can agree on the essential measurements of outcome, we can streamline the tool and post it to the web for all to download and utilize. Our therapists can actually collect the data; and an online system requires develop-ment to log in de-identified data. There are costs to establishing and maintain-ing a database such as this - we will be working to acquire grant funding to enable this.”

—EH (June 1, 2011)

Small City Surgeons Earn More

Orthopedic surgeons practicing in small cities earned more than their

counterparts in the suburbs or in met-ropolitan areas, according to the just-released Medscape Physician Compen-sation Report 2011. Those practicing

in small cities earned nearly $450,000 in 2011 which is $80,000 to $150,000 more than that earned by surgeons in the suburbs ($300,000) and in metro-politan areas ($321,000.)

Orthopedic surgery is one of the two top earning specialties in medicine. (The other is radiology.) Despite changes in reimbursement throughout the health-care system, compensation for ortho-pedists and orthopedic surgeons has remained stable over the past few years. The median annual income of orthope-dic surgeons in 2011 was $350,000 with 20% of the respondents reporting earnings in excess of $500,000. (For employed orthopedic surgeons, com-pensation refers to salary, bonus, and profit-sharing contributions. For part-ners, compensation includes earnings after tax-deductible business expenses but before income tax.)

Almost half of the orthopedists and orthopedic surgeons surveyed reported that their earnings have remained about the same from year-to-year. The remain-ing 51% of orthopedic surgeons were split nearly equally between reporting declines (26%) or increases (24%) in their earnings since the previous year.

It helps to be male. Male physicians out-earn women by about $86,000, perhaps because women are more like-ly to work fewer hours in exchange for flexible schedules that give them more time for their families.

Median salaries for orthopaedic sur-geons also vary by region of the United States. The North Central region, which reported the highest salary, has the low-est density of orthopedic surgeons, but the South Central region, which also has a low density of orthopedic sur-geons, reported salaries at the median level. Orthopedic surgeons in the Mid-Atlantic region earned the second high-est income. The lowest median salaries ($250,000) are found in the West. The wide disparity in salary between the regions did not, according to the survey, correlate with the density of orthopedic surgeons in any particular region.

Orthopedic surgeons, who are employed by hospitals, reported the highest compensation, at more than $400,000 last year on average. Physi-cians who were in a single specialty group followed close behind. Those who were partners in a private prac-tice or members of a multispecialty group reported earnings of between $350,000 and $400,000 last year while solo practitioners reported an average of around $300,000 over the same period.

To conduct the study, Medscape que-ried 15,794 U.S. physicians across 22 speciality areas from February 2, 2011 to March 30, 2001.

—BY (May 28, 2011) reimbursement

Source: Wikimedia commons and 2bgr8



Integra Gobbles Up Spine Surgery Sup-plier SeaSpine

Integra LifeSciences Holdings Corpo-ration, the sixth largest supplier of

orthopedic implants and instrumenta-tion in the world, has purchased sup-plier of spine surgery implants SeaSpine for $89 million in cash. SeaSpine sells implants and instruments for surgeons to treat patients suffering from debilitat-ing back pain due to instability, stenosis or the effects of aging and degenerative processes in the spine.

Privately held SeaSpine was found-ed in 2002 and is headquartered in Vista, California. Approximately 64 SeaSpine employees will now become IntegraSpine employees and SeaSpine’s

$50 million in annual sales will now be added to Integra’s $60 million in annual spine sales. Since its inception, Sea-Spine has posted double-digit revenue growth and has been profitable every single year.

Integra, which says on its website that it develops, manufactures and markets devices for use in cranial and spinal procedures, peripheral nerve repair, small bone and joint injuries, and the repair and reconstruction of soft tissue,

is actually one of the most diversified suppliers of orthopedic implants in the world and has quietly acquired its way to #6 in the overall orthopedic industry sales rankings.

Those Wall Street analysts who’ve reviewed this transaction have writ-ten that they expect that the purchase of SeaSpine will roughly double the number of distributors and customers in Integra’s existing U.S. spinal product distribution base.

Kirt Stephenson, former president of SeaSpine, will become the president of Integra’s U.S. Spine division. He will report to Brian Larkin, president of global spine & orthobiologics and the head of strategic development. “We are very excited to become a part of Integra,” Stevenson said. “Integra’s broad access to U.S. hospitals and GPO agreements

across its selling organizations repre-sent a tremendous opportunity for us to leverage our collective resources and expertise in the spine market. Integra’s strong balance sheet provides stability and growth capital necessary for us to emerge as a leader in a rapidly consoli-dating market.”

Stuart Essig, CEO of Integra, was equally effusive in his comments say-ing; “SeaSpine is an ideal strategic fit for Integra, as the combination brings together two well-respected innovators in the spinal fusion market. Integra has a track record of successfully executing on and integrating strategic transac-tions, and we expect to realize the ben-efits of this combination in both our top line growth and earnings per share over the long-term.”

—BY (May 25, 2011)

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spine

Source: Integra LifeSciences and SeaSpine

http://www.xiaflex.com/hcp/obtaining_XIAFLEX.jsp?s=XIACOMEDO401



THE PICTURE OF SUCCESSOne Ortho Entrepreneur’s

China VenturePART ONE

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

Peter Slate knows a lot…he knows that if he picks up his chop sticks

before his Chinese host then he—and his business deal—will be frowned upon. And Slate, the Chief Executive Officer of Bonovo Orthopedics, Inc., knows that in the increasingly power-ful Chinese economy success for those from outside the country lies in local team building and—most of all, says Slate—a “special sauce.”

Slate and his team at Bonovo don’t just have a sales rep in a high rise in Shang-hai. They have a 17 year-deep history in the Chinese orthopedic industry. Peter Slate: “We have two ISO-certified man-ufacturing facilities, strong R&D capa-bilities and one of the leading distribu-tion networks in the Chinese orthope-dics industry. Our overarching goal is to be the first China-based orthopedics company known for globally competi-tive quality products and surgeon sup-port.”

Enter…the special sauce. Accord-ing to Slate, who has spent years put-

ting together international ventures, “Because we are successfully connect-ing surgeons from the East and West, in a short time we have created a unique bridge between these two worlds. As a result we are able to offer the Chinese surgeon community the latest qual-ity products along with connections to Western thought leaders and training. We have assembled a creative team and we are all passionate about our mission. And our senior team has the flexibility to adapt and compete in the dynamic Chinese market.”

Slate, an avid triathlete who grew up surfing on the New Jersey shore, pre-pared for a life of international adven-ture by obtaining a JD/MBA. “This joint degree served me well as I have had to wear the CFO/General Counsel/CEO hats all at once. It has been good for Bonovo because it has helped us with speed to market and cost controls.”

As a young attorney, Slate was busy doing acquisitions and the like…but he couldn’t shake the entrepreneurial

bug that kept landing on his shoulder. “When I was 24, I co-founded a bever-age company, sold it, and then joined the founding team of a physician prac-tice management company to head up mergers and acquisitions. I later worked for LG Electronics—which had invested in Zenith Electronics—to assist with the financial and operational restructuring of Zenith. It was at Zenith that I got to peer into the Chinese busi-ness world.”

A corporate officer at the age of 31, Peter Slate—along with his team—fig-ured out how to make Zenith profitable enough to obtain sufficient financing to endure bankruptcy. In the process, Slate figured out his future. “We moved Zenith’s manufacturing from Mexico

Peter Slate and Bonovo Orthopedics

The Bonovo Academic Alliance has been developed under the leadership and guidance of Dr. Hansen Yuan, who has trained over 60 of the top orthopedic surgeons in China. Through our fellowship programs, international symposia, summits and surgeon training opportunities, surgeons from China have access to both our network of key opinion leaders and western technology.

“

”


VOLUME 7, ISSUE 18 | JUNE 7, 201127and Illinois to suppliers in China and Japan, something that whet my appetite for doing business in Asia. I had always enjoyed learning about other cultures. Early in my career I thought, ‘Working with a focus in Asia would be a special experience…one that would give me unique perspective and a competitive advantage.”

One hundred and fifty employees and 200 independent distributors later…Slate was right. His openness to learn-ing about the East, combined with his business acumen, meant that he could successfully grow a company 6,000 miles from familiar territory. Slate, who currently splits his time between Beijing and Arizona, states, “One of the things I am most proud of is The Bonovo Aca-demic Alliance, an entity that serves as our hub for enhancing the connection between Eastern and Western surgeons. The Bonovo Academic Alliance has been developed under the leadership and guidance of Dr. Hansen Yuan, who has trained over 60 of the top orthopedic surgeons in China. Through our fellow-ship programs, international symposia, summits and surgeon training opportu-nities, surgeons from China have access to both our network of key opinion lead-ers and western technology.”

Bridge-building, he calls it…with sur-geons from the U.S. on one side and surgeons from China on the other.

And, to make connections you need to stretch yourself. Slate and his surgeon-recruits have done this and asked the same from those on the Eastern side of the bridge. “My Mandarin is not great, but I have made an effort to learn the language to show respect for my sur-geon partners and my team. I have also become a student of China’s art, histo-ry, and business environment. Under-standing these things—which are not just cultural nuances—can mean the difference between our company sink-ing or swimming. There is a cultural dichotomy between the old guard and the entrepreneurial community that has fueled China’s growth over the last 20 years. It is important that we build this appreciation into our planning and cor-porate strategy.”

Elaborating, Slate notes, “The entrepre-neurial environment created through economic zones and other regulations favorable to business is evidence that China is committed to fostering signifi-cant and rapid growth. The country is wrestling with significant challenges. China spends about 5% of their GDP on healthcare while the U.S. outlays 17% of its GDP on the same...even though the Chinese population is almost five times the size of the U.S. They have a massive aging population that needs better access to healthcare; there is little healthcare available to the rural population. The big challenge at the

government level is to try and deter-mine how to overlay onto the existing system a healthcare infrastructure that is able to address all of these dynamic changes. These are challenges we have been addressing in the U.S. for over 40 years. While the U.S. system is far from perfect, Western thought leaders have much to contribute in helping China address these challenges.”

From the ancient Xia Dynasty to today…from Beijing to Warsaw, Indi-ana…there have always been short term thinkers seeking get rich quick schemes. Not Peter Slate, however. He wants Bonovo to grow and endure. He knows how to make that happen and has the track record to prove it. Before starting Bonovo, Slate launched a tech-nology transfer company named Ari-zona Technology Enterprises. “Using a model developed along with the Presi-dent of Arizona State University, in four years’ time we created and funded 22 companies. My technology transfer experience taught me many lessons about early-stage company develop-ment. For one thing…..every inven-tion isn’t an innovation. You may have a patent for a novel spine therapy but it takes a lot to turn it into a multi-mil-lion dollar company. It requires great people and execution. Nine times out of ten, a good technology with a great team trumps a great technology with a mediocre team. And, when the smoke

The big challenge at the government level is to try and determine how to overlay onto the existing system a healthcare infrastructure that is able to address all of these dynamic changes. These are challenges we have been addressing in the U.S. for over 40 years. While the U.S. system is far from perfect, Western thought leaders have much to contribute in helping China address these challenges.

“ ”


VOLUME 7, ISSUE 18 | JUNE 7, 201128(excitement) clears you want to have a team that can stand the test of time.”

“It is rare to have such research and development capabilities ‘on the ground’ in China. We are developing products that are every bit as good as Western technologies…products that eventually will make their way to other markets around the globe. We are also working with surgeons in China to co-develop products based on technologies originating in China. Being able to offer quality products, access to technology development and world-class training has been helpful as we go about recruit-ing Chinese surgeons because we are able to show them that working with Bonovo can provide a long-term part-nership that will further their practice.”

Peter Slate: “We are making good prog-ress but we have a long way to go to achieve our goals. I am really thrilled that we have developed such a strong international strategy—and that it is working. For those who wish to swim in international waters, my advice would be to make sure that your busi-ness model is capable of adapting to the complexities presented by the mul-

tiple cultures in which you do business. There are tremendous opportunities for growth overseas. Due to the chal-lenges of working through the FDA, the competitive nature of the U.S. markets, and reimbursement issues, many com-panies are beginning to look further afield for sustainable success. We feel that this bodes well for Bonovo’s busi-ness model and for the infrastructure

we have established in China. ” ◆

Next week: Learn about selling in China and how that relates to the hospital sys-tem there. Also, find out some of the important differences between Chinese and American business culture.

Peter Slate and Bonovo Orthopedics

http://www.pearldiverinc.com



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