week in review 4 The 23 Top Foot & Ankle Surgeons in the U...

VOLUME 8, ISSUE 17 | MAY 22, 2012

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

week in review

breaking news

21 “Fear and Medical Tour-ism” in Vegas..........................................

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For all news that is ortho, read on.

4 The 23 Top Foot & Ankle Surgeons in the U.S. ♦ Who better to pick the top foot

and ankle surgeons than their own col-leagues? OTW has asked leading foot and ankle specialists to select the best of their peers. Here is what we heard.

8New Policy Would Cut Some Spine Surgery Funding ♦ The Blues of Illinois

say there is a lack of evidence to justify spinal fusion for DDD and other indi-cations. Spine’s best minds fire back in this OTW exclusive story by accusing the insurer of shoddy literature work and using unscientific guidelines. Read it here.

13 Orthopedics in the Amazon Basin ♦ Or-thopedists just want to fix

things. Dr. Peter Cole decided to make a semi-annual trip to the jungle to fix some especially needy patients. He and his team could write a text book in pa-thology with what they see in a week. Dr. Cole’s labor of love and faith is sim-ply wonderful and uplifting. We hope it inspires you too.

17 Vince v. Hungerford on Correcting Extra-Articular Deformity ♦

Extra-articular deformity? Go intra-articular for the correction, says Kelly Vince. David Hungerford: There are many kinds and sources of deformity: congenital, metabolic, etc. And what is the magnitude of the deformity, and the location from the knee, etc.?



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

THIS WEEK: How fast the wind turns. Last week it was at our back as several companies pleasantly surprised with sales (NuVasive beats estimates, Biomet and SNN stand out) or earnings (Globus had huge earnings numbers). This week the wind is blowing hard from across the Atlantic. Bank runs in Greece. Spain and Italy teetering. And the threat of new global credit contraction.

RANKLAST WEEK

COMPANYTTM OPMARGIN

30-DAYPRICE CHANGE

COMMENT

1 1 Orthofix 16.23% 4.89%If ever there was a time to appreciate headquarters in

the Netherlands Antilles, this may be it.

2 3 NuVasive 6.63 15.98NUVA so completely beat expectations that the glow has yet to wear off. Time for another look at spine!

3 6Symmetry Medical

5.29 20.41Up 20% in the last month. SMA is being run by a

comparatively young, strategic management team.

4 NR ArthroCare (0.67) (1.04)It had to happen eventually—ARTC is finally bottoming

out. Also is the 2nd lowest PE to Growth in Ortho.

5 2 Conmed 10.09 (7.99)Can’t fight the tape. CNMD deserves better valuation

than this but will require more strong quarters.

6 4Integra

LifeSciences13.34 2.30

Recent run up in IART’s price just triggered a profit taking sell-off. 2nd lowest overall valuation in ortho.

7 5Johnson & Johnson

24.93 0.14In a stormy world, JNJ looks like an investor’s version of the London Fog Trench coat. Time-tested wind and

rain protection.

8 7 Zimmer 24.95 (8.45)Nearly un-noticed is the fact that 4 analysts have

raised their estimates in the past 30 days.

9 8 Stryker 23.68 (9.38)As we see in ZMH, the market is just not enamored right now with big ortho—regardless of demographic

argument.

10 9 Medtronic 28.24 (2.79)In advance of this week’s release, most analysts are forecasting declining sales but higher margins for the

quarter.



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Robin Young’s Orthopedic Universe

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

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)

LOWEST PRICE TO SALES RATIO (TTM) HIGHEST PRICE TO SALES RATIO (TTM)

COMPANY SYMBOL PRICE MKT CAP 30-DAY CHG

1 Kensey Nash KNSY $38.39 $334 34.80%2 Symmetry Medical SMA $8.32 $305 20.41%3 NuVasive NUVA $18.73 $809 15.98%4 Wright Medical WMGI $19.71 $775 6.08%5 Orthofix OFIX $39.03 $731 4.89%6 Exactech EXAC $16.52 $218 3.96%7 Integra LifeSciences IART $32.96 $890 2.30%8 RTI Biologics Inc RTIX $3.56 $199 0.56%9 Johnson & Johnson JNJ $63.35 $173,983 0.14%

10 ArthroCare ARTC $24.80 $686 -1.04%

COMPANY SYMBOL PRICE MKT CAP P/E

1 Medtronic MDT $36.96 $38,460 11.512 Zimmer Holdings ZMH $58.86 $10,367 11.943 Johnson & Johnson JNJ $63.35 $173,983 12.624 Stryker SYK $50.26 $19,146 13.195 Orthofix OFIX $39.03 $731 13.99

COMPANY SYMBOL PRICE MKT CAP PEG

1 Orthofix OFIX $39.03 $731 0.812 ArthroCare ARTC $24.80 $686 0.983 Stryker SYK $50.26 $19,146 1.224 Zimmer Holdings ZMH $58.86 $10,367 1.285 Integra LifeSciences IART $32.96 $890 1.34

COMPANY SYMBOL PRICE MKT CAP PSR

1 Alphatec Holdings ATEC $1.65 $148 0.752 Symmetry Medical SMA $8.32 $305 0.853 Conmed CNMD $26.96 $763 1.054 Exactech EXAC $16.52 $218 1.065 CryoLife CRY $4.69 $129 1.08

COMPANY SYMBOL PRICE MKT CAP 30-DAY CHG

1 MAKO Surgical MAKO $22.17 $944 -46.31%2 Bacterin Intl Holdings BONE $1.59 $67 -28.70%3 TiGenix TIG.BR $0.60 $55 -23.97%4 Alphatec Holdings ATEC $1.65 $148 -23.61%5 Tornier N.V. TRNX $20.68 $818 -12.93%6 TranS1 TSON $2.94 $80 -12.82%7 CryoLife CRY $4.69 $129 -9.98%8 Stryker SYK $50.26 $19,146 -9.38%9 Zimmer Holdings ZMH $58.86 $10,367 -8.45%

10 Conmed CNMD $26.96 $763 -7.99%

COMPANY SYMBOL PRICE MKT CAP P/E

1 Wright Medical WMGI $19.71 $775 50.542 NuVasive NUVA $18.73 $809 43.563 Symmetry Medical SMA $8.32 $305 33.284 Kensey Nash KNSY $38.39 $334 26.855 Exactech EXAC $16.52 $218 23.27

COMPANY SYMBOL PRICE MKT CAP PEG

1 Wright Medical WMGI $19.71 $775 6.002 NuVasive NUVA $18.73 $809 4.503 CryoLife CRY $4.69 $129 4.194 Symmetry Medical SMA $8.32 $305 2.775 Johnson & Johnson JNJ $63.35 $173,983 2.15

COMPANY SYMBOL PRICE MKT CAP PSR

1 TiGenix TIG.BR $0.60 $55 47.582 MAKO Surgical MAKO $22.17 $944 11.173 Synthes SYST.VX $165.78 $19,691 4.964 Kensey Nash KNSY $38.39 $334 4.665 TranS1 TSON $2.94 $80 4.18

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VOLUME 8, ISSUE 17 | MAY 22, 20124The 23 Top Foot & Ankle Surgeons in the U.S.By OTW Staff

Who do other orthopedists want treating their feet? We asked!

Leaders in the foot and ankle realm let us know their thoughts on the top orthopedic surgeons in their subspe-cialty.

Here is that list. We don’t have “the mar-ket” on lists…this isn’t the be-all and end-all list—but it is a list of who are arguably the finest foot and ankle physi-cians, teachers, investigators or admin-istrators in the country. This informa-tion was obtained via a telephone survey of thought leaders in the field. The infor-mation in quotes is what we heard about these surgeons.

In alphabetical order, here are the top 23 foot and ankle surgeons in America.

Ned Amendola, M.D. is professor and director of the University of Iowa (UI) Sports Medicine Center. Dr. Amen-dola was named recipient of the Kim and John Callaghan Endowed Chair in Sports Medicine by the UI in June 2009. “He is a superb team physician with a good perspective on the field. He has a very practical way of managing the injured athlete.”

Robert B. Anderson, M.D. is an ortho-pedic surgeon with OrthoCarolina, and is a past president of the American Orthopaedic Foot & Ankle Society

(AOFAS). He is also a founding mem-ber of the Foot & Ankle Institute at OrthoCarolina. “He is the ‘go to guy’ for professional athletes with foot and ankle problems. And he is just a very nice guy.”

Donald E. Baxter, M.D. is an orthope-dic surgeon with Athletic Orthopedics & Knee Center in Houston, Texas. He is also a past president of AOFAS. “He has made significant contributions to foot and ankle, and in particular, he is known for innovations in understand-ing problems related to runners.”

James W. Brodsky, M.D. is an ortho-pedic surgeon with Orthopedic Associ-

Source: Wikimedia Commons and Pavlov by Repin


VOLUME 8, ISSUE 17 | MAY 22, 20125ates of Dallas, and is clinical professor of orthopaedic surgery at the University of Texas (UT) Southwestern Medical School. He is also director of the Foot and Ankle Surgery Fellowship Training Program at Baylor University Medical Center and UT Southwestern Medical Center. Dr. Brodsky is a past president of the AOFAS. “He is a specialist in total ankle replacement, bunion surgery, and diabetic foot problems; he does great work in his gait lab.”

Thomas O. Clanton, M.D. is chief of the Foot and Ankle section at the Stead-man Clinic in Vail, Colorado, and is a past president of the AOFAS. Dr. Clan-ton is an affiliated clinical professor at the University of Texas Health Science Center at Houston. “He is highly expe-

rienced, and is known for his work with elite athletes.”

J. Chris Coetzee, M.D., Mb ChB is an orthopedic surgeon with Twin Cities Orthopedics in Minneapolis and clini-cal associate professor at the University of Minnesota Department of Orthopae-dic Surgery. Dr. Coetzee is also an asso-ciate editor for Foot & Ankle Interna-tional. “What a bright guy and a great researcher.”

Mike J. Coughlin, M.D. is in indepen-dent practice in Boise, Idaho, and is a former president of the AOFAS. He was also president of the International Fed-eration of Foot & Ankle Surgeons from 2002-2005. “He is extremely innova-tive, is a co-author of two major text-

books, and helped develop the STAR ankle. He probably knows more about the forefoot than anyone else in the U.S.”

Jonathan T. Deland, M.D. is an asso-ciate attending orthopedic surgeon and chief of the Foot and Ankle Service at Hospital for Special Surgery. Dr. Deland is also associate professor of surgery (orthopaedics) at Weill Cornell Medi-cal College. “He is the world expert on posterior tibial tendon dysfunction, one of most controversial topics in our spe-cialty.”

James K. DeOrio, M.D. is associate professor of orthopedics at Duke Uni-versity Medical Center who was for-merly chair of Mayo Clinic Orthopae-

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VOLUME 8, ISSUE 17 | MAY 22, 20126dics in Florida. At present, Dr. DeOrio also holds appointments at Mayo Clinic College of Medicine, F. Edward Hebert School of Medicine, and Uniformed Service University of the Health Sci-ences. “He is a real talent, and is very experienced with total ankle replace-ment.”

Rick D. Ferkel, M.D. is an orthopedic surgeon with the Southern California Orthopedic Institute, and is director of the Sports Medicine Fellowship Pro-gram at the same facility. Dr. Ferkel is also a clinical instructor of orthopedic surgery at the University of California Los Angeles. “He is an acknowledged expert in arthroscopic ankle techniques who has tremendous experience.”

John S. Gould, M.D. is professor and section head of foot and ankle at the University of Alabama in Birmingham. He is the lead author of ‘Operative Foot Surgery,’ and is a past president of the AOFAS. “He is a superb clinician who has written an impressive book on foot and ankle surgery. His technique is very subtle and his understanding of pathol-ogy is so thorough that he picks up things you don’t think about.”

Steven L. Haddad, M.D. is an ortho-pedic surgeon with the Illinois Bone & Joint Institute in Chicago. He is also Associate Professor of Clinical Ortho-paedic Surgery at the University of Chicago Pritzker School of Medicine. In addition, Dr. Haddad is section head of Foot and Ankle Surgery at NorthShore University Health Systems. “He is very innovative, especially with the ankle arthroscopy. He is creative and has the best PowerPoint presentations of any-one in the country.”

William G. Hamilton, M.D. is clinical professor of orthopedic surgery at the College of Physicians and Surgeons of

Columbia University, senior attending Orthopedic Surgeon at St. Luke’s-Roo-sevelt Hospital, and assistant attending surgeon at the Hospital for Special Sur-gery. Dr. Hamilton is a past president of the AOFAS and is the official orthopedic surgeon of The New York City Ballet. “He is THE guru of the management of orthopedic problems in dancers.”

Sigvard T. Hansen, Jr., M.D. is Profes-sor Emeritus at the University of Wash-ington in Seattle. He is also director of the Sigvard T. Hansen Foot & Ankle Insti-tute, and was a founding member of the Orthopaedic Trauma Association. “He is IT as far as traumatology. And there is no type of case that he turns away.”

Jeffrey E. Johnson, M.D. is professor of orthopedic surgery at Washington University School of Medicine in St. Louis. He is also chief of the Foot and Ankle Service and director of the Foot

and Ankle Fellowship program at that institution. “He is a very clear thinking, top notch clinician who is also a highly sought after speaker. He is an expert on the management of diabetic ankle frac-tures and flatfoot deformities.”

Thomas H. Lee, M.D. is an orthope-dic surgeon with the Orthopedic Foot & Ankle Center in Westerville, Ohio. Additionally, Dr. Lee was a design sur-geon on the INBONE II Total Ankle System. “He is a very creative, dynamic, high volume surgeon.”

Roger A. Mann, M.D. is an ortho-pedic surgeon with Oakland Bone & Joint Specialists, and is a past president of the AOFAS. He is co-author of the most widely used orthopedic textbook on foot and ankle surgery, entitled, ‘Surgery of the Foot and Ankle.’ Dr. Mann was lead investigator on the FDA study evaluating the STAR ankle. “He

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VOLUME 8, ISSUE 17 | MAY 22, 20127is a leader in the field who has made an enormous contribution in bringing foot and ankle to the consciousness of orthopedic surgeons.”

Mark S. Myerson, M.D. is director of the Institute for Foot and Ankle Recon-struction at Mercy Medical Center in Baltimore, Maryland. Dr. Myerson is a past president of the AOFAS. “He is a prolific researcher and clinician and is a founder of a website that helps sur-geons advance their clinical knowl-edge—FOOTinnovate.com.”

John S. Reach, Jr., M.Sc., M.D. is assis-tant professor of Yale Orthopaedics and is director of the Yale Foot and Ankle Service. He has pioneered and advocat-ed for the use of handheld ultrasound visualization to detect and treat mus-culoskeletal conditions—both in the consultation room and in the operat-ing room. “He does any and all types of foot and ankle surgery, including trauma, forefoot and hindfoot surgery. The fact that he does trauma is impres-sive because most surgeons who have been in practice for years leave trauma to the younger guys.”

Mark A. Reiley, M.D. is the chief medi-cal officer, inventor and founder of SI-BONE, Inc. He is also the creator of the INBONE Total Ankle System. Dr. Reiley developed and patented kypho-

plasty; he is the co-founder of Kyphon. Before retiring from practice in 2009, Dr. Reiley practiced at Berkeley Ortho-pedics Surgical group. A founder of the group, Dr. Reiley practiced there for over 20 years. “He is a flexible thinker who has really changed how orthope-dists practice worldwide.”

Charles L. Saltzman, M.D. is profes-sor and chair of orthopaedic surgery

at the University of Utah in Salt Lake City. He also holds an adjunct profes-sorship in the Department of Bioengi-neering. Dr. Saltzman is a past presi-dent of the AOFAS. “He has been criti-cal of the science in our field, and has been extremely involved with the NIH [National Institutes of Health] to bring the highest level of academics to foot and ankle.”

Lew C. Schon, M.D. is an orthope-dic surgeon with Greater Chesapeake Orthopaedic Associates, LLC at Union Memorial Hospital in Baltimore. He holds academic appointments at Georgetown University Medical Cen-ter and Johns Hopkins School of Medi-cine. “He is a bright thinker, a good surgeon, and the most forward-think-ing clinical researcher we have. He is experienced with orthobiologics trials, and has done a lot of work on nerves in the foot and ankle.”

David B. Thordarson, M.D. is profes-sor of orthopaedic surgery at the Uni-versity of Southern California; he is also vice chair for education and residency program director. In addition, Dr. Thor-darson serves as editor-in-chief of Foot & Ankle International. “He has good hands, is smart, and is very facile in the OR. He also possesses a wide depth of knowledge.” ♦

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VOLUME 8, ISSUE 17 | MAY 22, 20128New Policy Would Cut Some Spine Surgery FundingBy Walter Eisner

“Spinal fusion is considered not medically necessary when the

sole indication is disc herniation, DDD, facet syndrome, or initial discectomy and/or laminectomy for neural struc-ture decompression.”

So says Blue Cross Blue Shield of Illi-nois (BCBSI) in a May 14, draft medi-cal policy summary. The reason? “Lack of evidence of improved outcomes.” Within hours, spine surgeons were online alerting colleagues.

“This is a new draft policy for public comments. It is by no means a final pol-icy,” BCBSI’s media and public affairs manager told us in an email on May 17.

Health Care Service Corporation (HCSC) operates the Blue Cross and Blue Shield plans in Illinois, New Mex-ico, Oklahoma, and Texas, employing

more than 16,000 people and serving more than 13 million members. It is the fourth largest health insurance compa-ny in the country.

Death by a Thousand Increments

Illinois’ BCBSI is just the latest. Blues in North Carolina, Florida and Minnesota have placed new restrictions on backs of policyholders whose physicians have recommended spine fusion surgery. The insurers have responded to the ensuing outcry from physician societies by walk-ing back the more onerous portions of the proposed restrictions, but not back to where the original policy started. Call it death by a thousand increments.

Milliman Care Guidelines

The Blues in North Carolina made the same proposal in 2010 and, in June

2011, a Local Coverage Determination (LCD) in Florida, citing Milliman Care Guidelines said that Medicare will no longer cover multi-level lumbar fusion for symptomatic degenerative disc dis-ease (DDD).

Milliman Company develops and pro-duces “evidence-based clinical guide-lines used by more than 1,800 clients, including more than 1,000 hospitals and 7 of the 8 largest U.S. health plans.” The guidelines are not peer reviewed and are developed internally.

In both cases, physician societies were able to convince the insurers to modify their proposals, slightly.

The Blues Proposal

In Illinois, BCBSI lists 11 conditions for which surgery may be considered nec-essary, in addition to the four “non-nec-essary” conditions noted above. They also listed three conservative non-sur-gical therapies which must be included before surgery will be considered.

The insurer listed a number of studies (see OTW Summary of the Proposed BCBSI Policy on page 12) to justify their proposal of limiting surgery and requir-ing additional non-surgical treatments.

Surgeon’s Push Back

Gunnar Andersson, M.D., Ph.D., and Frank Phillips, M.D. of Midwest Ortho-paedics at Rush (Rush University Medi-cal Center in Chicago) are deeply con-cerned.

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VOLUME 8, ISSUE 17 | MAY 22, 20129Disappointing Literature Review by Insurers

“There is a tendency to select those studies that support your opinion and deselect others” noted Dr. Andersson. “There is also a tendency to lump all patients together and make sweeping decisions regarding groups of patients some of who would respond very well to fusion treatments and others who probably would not. So while we need to make a better job in selecting the appropriate patient as surgeons the insurers should refrain from using sweeping decisions. By doing so a num-ber of patients who would have signifi-cant clinical benefit will be excluded from that opportunity.”

Of course, added Dr. Andersson, the scientific community is struggling with how to best treat chronic back pain and degenerative disc disease.

“There are several reasons for this,” said Andersson. “One is pain itself, which when it becomes chronic does not always have a specific anatomic cause. Another is the fact that many of our patients are different and there-fore unlikely to all respond to the same treatment. I’m not surprised that the insurers are challenging the use of spi-

nal fusions for treatment of chronic back pain. The numbers of fusions are increasing and the costs are increasing even faster making a legitimate target for the insurance companies when they are trying to reduce their costs.”

However, he said he is disappointed at how insurers are reviewing the litera-ture.

“Non-Transparent, Non-Validated Guidelines”

Dr. Phillips said there is no doubt that everyone should strive towards more efficient delivery of health care. “How-ever the use of non-transparent, non-validated guidelines to direct treatment decisions is not in our patients best interests.”

“The insistence that surgical treatments be compared to non-surgical therapies

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represents the wrong paradigm. These should not be viewed as competitive treatments as they are typically applied in series rather than in parallel. For most conditions, and in particularly the treatment of low back pain, surgery should only be considered after failure of appropriate non-surgical interven-tions.”

Considerable Evidence Supporting Fusion

Phillips said there is a considerable body of literature supporting the prem-

ise that fusion can reduce pain and dis-ability in the treatment of low back pain from DDD in carefully selected patients. He added, “In addition to the surgical versus non-surgical trials mentioned in the BCBSI statement, data from Level 1 studies comparing various surgi-cal strategies (including the U.S. IDE TDR FDA Trials) have been published supporting effectiveness. Furthermore numerous high quality non-random-ized trials should be considered as part of the evidence base.”

Societies Respond

Chicago is also home to the largest spine surgery societies: North American Spine Society (NASS), American Acad-emy of Orthopaedic Surgeons (AAOS) and The International Society for the Advancement of Spine Surgery (ISASS).

ISASS President Steven Garfin, M.D., provided OTW with a statement that BCBSI was basically cherry picking evidence that supports their view and ignores evidence that recommends that fusion surgery be considered as treat-

ment options for carefully selected patients with disabling low back pain due to degenerative disease at one or two levels.

NASS is reviewing the BCBSI policy and will submit its comments by the May 31st deadline.

See ISASS Rebuttal (Next Page)

Frank Phillips, M.D. and http://www.rushortho.com/frank_phillips.cfm

Steven Garfin, M.D.

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NuVasive’s Lukianov – “A New Reality”

Alex Lukianov, chairman and CEO of NuVasive, Inc. said he believes that what we are seeing in Illinois is an unintend-

ed consequence of “Obamacare” [The Affordable Care Act], whereby payers are deeply concerned about their future bottom line and taking steps to improve it now.

“Given the forthcoming changes asso-ciated with Obamacare, [resulting] in higher costs to payers as well as their subscribers, the payers are playing a financially driven game of reduc-ing access to needed spine surgery,” observed Lukianov.

Lukianov says that this is unfortunately the new reality in terms of what it will take to get appropriate surgical spine care in the U.S.

Un-vetted Milliman Guidelines

“Despite overwhelming evidence in the form of the HTA [Health Technology Assessment] and various other scien-tific publications (SPORT, et al.), which clearly support the need for spine sur-gery for specific indications. The BCBSI requirements are more closely linked to the Milliman style guidelines, neither of which are grounded in scientific litera-ture or vetted by surgeons,” continues Lukianov

Lastly, Lukianov feels the spine market has bottomed out versus growing in the U.S. “The ongoing attacks by pay-ers have created a surgery lag effect.

ISASS Rebuttal (Steven Garfin, M.D., President)

BCBSI’s draft policy is moderately onerous in the sense that most indications for a spinal fusion are still covered. The areas where lumbar spinal fusions procedures “are not considered medically necessary” include patients where the sole indication is a disc herniation or neuro structure compression (initial discectomy/laminectomy) “as well as” degenerative disc disease and facet syndrome.

This is the area where the primary controversy exists.

While many patients with degenerative disc disease or facet syndrome will not have that diagnosis as their sole indication, there are patients with chronic low back pain who have not responded to appropriate non-operative treatment and who will benefit from a surgical procedure. Those patients may now lose the opportunity of a clinically meaning-ful improvement. Given that all patients are different, sweeping policy statements can exclude appropriate patients from appropriate clinical care.

BCBSI bases their decision on the “lack of evidence of improved out-comes for spinal fusions.”

There are six randomized controlled trials of fusion surgery versus non-surgical therapy of which BCBSI reviews. In addition there are at least 15 publications comparing prospectively in randomized trials fusion surgery versus a different fusion technique or lumbar arthroplasty. There are also retrospective controlled trials, prospective non-comparative cohort studies and studies of surgery only cohorts.

Except for one retrospective cohort study, these other studies are not considered. Instead BCBSI quotes a study from 1992 which states that there were no randomized trials of fusion which is correct and another study from 1999 which also did not find any randomized controlled trial which is also correct.

They also quote a guideline for the performance of fusion procedures published by the American Association of Neurological Surgeons and the Congress of Neurological Surgeons in 2005 which concluded that the evidence at that time was weak and recommend the need for the neurosurgical community to design and complete prospective random-ized trials to answer the many lingering questions with rigorous scientific power.

What they did not quote was the recommendation from the guideline that fusion surgery be considered as treatment options for carefully se-lected patients with disabling low back pain due to degenerative disease at one or two levels. They also quote a technology assessment by the Agency for Healthcare Research and Quality in 2006 which correctly concluded that are no randomized controlled trial evidence that directly compares lumbar spinal fusion with nonsurgical conservative treat-ments in populations older than 65 years of age for any indication. It is unlikely that randomized controlled trials for this particular purpose will be specifically performed in populations older than 65 years. AHRQ also concluded that “lumbar fusion may result in some benefit compared with conservative treatment in middle age patients with axial back pain who have severe disability or pain from disc disease”. This statement was not included in the reviews. In aggregate all the studies show that there are patients who clearly benefit from spinal fusion surgery. It is also true that not all patients require surgery.

Alex Lukianov, chairman and CEO of NuVasive, Inc


VOLUME 8, ISSUE 17 | MAY 22, 201212Patients still get treated albeit later rath-er than sooner. This lag effect is largely factored into spine market growth pro-jections.”

End Game

If history is a guide, the surgical soci-eties, physicians and their patients will hammer at Blue Cross Blue Shield until May 31. Then the insurer will announce modifications to their proposal based on evidence of their choosing and declare themselves reasonable and flexible.

In the meantime, more patients will have to endure non-surgical treatments until they meet the new guidelines. That is the new reality as the science of spine care continues to search for the elusive pain generator of lower back pain. ♦

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OTW Summary of the Proposed Blue Cross Blue Shield of Illinois Policy

Intervertebral disc pain is a potential cause of low back pain [LBP]…There is a lack of consensus in the medical litera-ture as to what extent the intervertebral disc is innervated.

The vast majority of cases of chronic LBP do not require surgery, and conservative non-surgical treatment will nearly always be tried first.

National survey data indicate that the number of spinal fusion operations rose 77% between 1996 and 2001, in contrast with hip replacement and knee arthro-plasty, which increased 13-14% during the same period (UW Med Report 2004).

Treatment for lumbar disc disorders is controversial. The relationship between an abnormal disc and neural dysfunc-tion does not correlate statistically with the imaged pathology. Biochemical and inflammatory factors play primary roles.

Biological influence of a disc herniation is expected to change over time and to be altered by passive and active non-surgi-cal interventions (Wheeler et al. 2011).

A 1992 review by Turner et al. could find no randomized trials of fusion. Combin-ing many studies of fusion performed for many different clinical indications, they found an average of 68% of patients reported a satisfactory outcome. A 1999 Cochrane review (Gibson et al.) conclud-ed that at that time there was no accept-able evidence of any form of fusion for degenerative lumbar spondylosis, back pain, or “instability.” The authors could find no randomized clinical trials (RCTs) comparing fusion to a nonsurgical alter-native, only trials which compared surgi-

cal techniques of fusion to each other.

In a 2004 article, Deyo and Mirza state that it is not clear whether some patients really benefit from spinal fusion com-pared to rehabilitative approaches, and the complication rate is relatively high compared to other types of back surgery and to non-surgical treatment.

In 2005, two spine surgeon societies (AANS/CNS [American Association of Neurological Surgeons/Congress of Neu-rological Surgeons]) found that many of the published studies had flawed results due to poorly defined outcome mea-sures, inadequate numbers of patients, and comparison of dissimilar treatment groups (Heary 2005).

In 2005, Fairbank et al. conducted a multicenter randomized controlled trial to assess the clinical effectiveness of surgi-cal stabilization (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain. Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.

In 2006, Maghout et al. concluded that increased use of intervertebral fusion de-vices after their introduction in 1996 was associated with an increased complica-tion risk, without improving disability or reoperation rates.

In 2006, the Agency for Healthcare Research and Quality (AHRQ) con-cluded that there is no RCT evidence that directly compares lumbar spinal fusion with non-surgical conservative treatments in populations older than 65 years of age for any indication.

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VOLUME 8, ISSUE 17 | MAY 22, 201213Orthopedics in the Amazon BasinBy Biloine Young

When the little girl, who lived in a village on a tributary of the Ama-

zon River in Peru, was bitten on the leg by a poisonous snake, she developed a serious condition called a “compart-ment syndrome.” It took her frightened parents a couple of days to get her to a rudimentary government jungle hospi-tal where doctors found that the pres-sure on the child’s blood vessels had caused the muscle tissue to die. To save her life they amputated her leg above the knee.

A decade and a half later, the girl, now grown and the mother of an infant, learned through jungle missionaries, that an American orthopedic surgeon was visiting a riverfront hospital of a

nearby region, in an Amazon frontier city called Pucallpa. With her infant in a sling over her back, and supporting her walking with the help of a pole, she trekked over muddy rainforest trails and floated by dugout canoe for an 18 hour journey to get to the hospital.

Here she met Peter Cole, Chief of Orthopaedic Surgery at Regions Hospi-tal, Saint Paul, Minnesota. Cole made

a plaster cast mold of the stump of her leg, took it with him on his return to the U.S., and left it with the Tillges Cer-tified Orthotic & Prosthetic Company in Maplewood, Minnesota. When Cole returned to Pucallpa six months later, he had with him a new leg for the young woman. “The first time anyone had seen her smile,” said Cole, “was when she was taking her first steps with the

Caption: Dr. Peter Cole’s at Work in Pucallpa, Peru/Source: Scalpel at the Cross. www.scalpelatthecross.org

Alejandra Before Prosthesis

BIG Smile After Prosthesis


VOLUME 8, ISSUE 17 | MAY 22, 201214prosthetic. Everyone was clapping and crying.”

Peter Cole’s journey from Saint Paul to the jungle village of Pucallpa on the Ucayali River, a major tributary of the Amazon, began, in one respect, as a boy of 10. He moved with his parents to Caracas, Venezuela, where his father and grandfather were involved in the oil business, and lived there for almost four years where he learned Spanish. “It was a very impressionable time of my life,” he says. Furthermore, though Cole did his undergraduate work at Emory University in Atlanta, he went to medical school at the University of Miami in South Florida. “Half of our staff and patients were Latin,” he remembers. “I had a lot of close Cuban friends. I’ve always had an affinity for the Latin culture.”

A meeting with Craig and Heather Gahagen, while Cole was in medical school, was providential. Gahagen was an aviation missionary, operating an aviation program that had been found-ed by his father in the 1960s and which connected missionary settlements in the Amazon basin. His base was about 40 miles west of the Brazilian border. Cole remembers Gahagen challenging him and his wife Nancy. “When med school is done, you won’t have any excuses,” he told them, “You have to come down and visit us.” The day after his gradu-ation from medical school, in 1991, Peter and Nancy Cole flew to Peru. During the three weeks they spent in the village of Pucallpa the two Christian couples dreamed about “how we could marry our two professions. And that is when it started,” Cole said.

It began with the Coles making semi-annual trips to the jungle village. “We believed that if we waited until the

‘right time’, until our kids were ready, we would never have gone,” Cole said. Their youngest son, Channing, was six months old on his first trip. In Pucallpa, Cole walked into the rundown govern-ment hospital, introduced himself, and said that he just wanted to check out what sort of facility they had. To his delight he was welcomed with “com-plete open arms. They latched onto me,” he said. “They wanted to take me on rounds, scrub for surgery, and show them how to do things. To this day I have never even shown them proof that I am a doctor.”

By 2004 Cole had established sufficient-ly strong relationships with the hospi-tal, local government officials, and the outlying missionary settlements that he and Nancy decided to buy some land

and establish a permanent base. They purchased 25 acres and, in 2005, built a guest house that would sleep 15. They affectionately called it “Jungle Bunks.” The guest lodge is built on pilings fif-teen feet above ground, because, in the rainy season, the Amazon rises 32 feet. A 50 meter long board walk leads up to the door to traverse the water during the monsoons.

In the initial years, beginning in 2004, the project was completely financed by the Coles. Over the past seven years, as the scale of the project has grown, they have added to their payroll a mission director and secretary, as well as a full time Peruvian surgeon. Cole explained that, with the growing number of trips, the fiscal health of the mission depends on weaning the organization off their

Dr. Peter Cole with Leyla and Betty


VOLUME 8, ISSUE 17 | MAY 22, 201215majority support. The mission current-ly runs on about $120,000 a year.

The Mission Director, Lisa K. Schroder, was hired in 2006. Cole describes Sch-roder as being “a talented and fearless worker” who lives in Rochester, Indi-ana, and travels to the Twin Cities once a month to meet with Cole “She is a wife and mother of two boys, who left a high-powered career as an engineer for Zimmer Inc. and committed to an out-of-home job helping the fledgling project,” he said. In addition to her background in orthopedic engineering, Schroder has an MBA from Purdue.

Twice a year, Cole and Schroder take from 12 to 20 team members to Pucall-pa for a week-long marathon visit. Word goes out months in advance when a medical trip is taking place. On the day the medical team arrives at the jungle city, patients begin lining up at 4:00 in the morning at the hospital. If the visit is for a week, the team will see about 100 people on Monday, and iden-tify the 25 they will operate on the rest of the week.

Cole is proud of the fact that all of the surgery is performed at the local hos-pital. As he explained, “We are not just

building a hospital and running it with our own people, or going down with our team and taking over a hospital. Rather, we work with the hospital per-sonnel, rub elbows, teach, and dem-onstrate how we treat patients by our actions.

They are so grateful for what we do, that they open up clinic space, staff operating rooms with their anesthe-tists, their OR nurses, their floor nurs-es. Even the Chief Hospital Director welcomes us with a ceremonial greet-ing. This approach really helps us to disseminate information, to spread a culture of care in a place where life is very cheap,” he said.

Cole’s team members counter the rac-ist attitudes that exist in Peru toward the indigenous people. “The Amazon Indians are not seen in the same regard

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Team Member Sarah Molitor with Patient Yanndo

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VOLUME 8, ISSUE 17 | MAY 22, 201216as people of Spanish descent,” he said. “Just the fact that we would talk to these patients, look them in the eye, hold their hands, is unusual for them, and I believe makes a difference.”

Cole notes that an orthopedic team at work is not like a primary care situa-tion. “There is a lot of complicated tech-nology involved in orthopedics. We use more tools, implants, and instrumenta-tion than any other specialty,” he said. Because these are not available at the government hospital, every member of his team takes with them from the States, a trunk of implants and instru-ments that are stockpiled for use with patients.

About 60% of Cole’s patients are indi-viduals who have deformed bones. He says that bones that did not heal prop-erly are all over the Amazon because there are no orthopedic surgeons there. “If you are hurt there you do not get treated.” He emphasizes that this is not “slam-bam surgery.” A single sur-gery can take up to five hours. But the results transform lives. “Take a young girl with a thigh bone that has not healed,” he said. “She lives on crutch-es, will never get married, will be an outcast in her village, and will be com-pletely marginalized in this culture. Some infants with deformities, such as clubfoot, are even killed by their Indi-an parents because they are believed to be possessed,” he said.

Cole says he could write a text book in pathology with what he sees in a week at Pucallpa. “If you have a tumor in the U.S. it will manifest so early and be treated so early, that you never see what it is like when it is taking over an entire leg and is growing through the skin,”

he says. “Not so at the far reaches of the Amazon!”

The mission has recently added anoth-er dimension to his work in Peru. As he explains, “In my U.S. life I am an investigative researcher who promotes and publishes functional outcomes in orthopedic surgery, in a genre of research termed, evidence-based medi-cine. I felt that it was disingenuous of me to be a champion of outcomes in orthopedic surgery, which emphasizes close follow-up of patients, and then go down to the Amazon and never know what happened to my patients.”

As a result, a couple of years ago, the organization hired the Peruvian general surgeon Rosa Escudero, M.D., to work full time following up on the patients. “She goes into the villages, into the Indian tribes, even the barrios, to get follow up. That is gold to me! As a phy-sician I am just not comfortable render-ing a treatment and not knowing what happens.” Cole said that Escudero also

runs the mission at the local organiza-tional level, particularly as it relates to gearing up for trips and patient care.

Cole explains that his Peruvian col-leagues at the government hospital have a hard time understanding his desire to follow up on his patients. (Cole confess-es that, in this case, he may be impos-ing his American culture on the local medical system.) They wonder why the Americans want to set up a clinic to see all of the patients he had operated on in the past—who they believe are doing just fine. “They do not understand that I want to know the good as well as the bad outcomes. It helps us prognosticate for other patients. It helps us see what we could do even better,” he says.

So what drives Cole? Part of the appeal is that he finds orthopedics to be a won-derful field. Orthopedists, he says, “are all guilty of wanting to fix things. I like to take something broken and fix it, and see the result the next day,” he said. “It is not like managing diabetes or hyper-tension. It is a very ‘immediate gratifica-tion’ kind of field.”

“What is often left unspoken”, Cole explains, “is that his work in Pucallpa is a Christian ministry”. He is quick to add that it is not a Bible distribution network and certainly not a proselytiz-ing ministry. “We are there to demon-strate our love for God by loving oth-ers through our work.” The ministry is named, Scalpel At The Cross. “The scalpel represents the surgeon’s profes-sion. I lay that at the foot of the cross to be used by God however He wants. I put my talents there. I am an instru-ment of His,” he said. Cole invites people to visit the website at www.scalpelatthecross.org. ♦

Chavez Diaz Elmer x-ray of patient needing Ex-Fix

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VOLUME 8, ISSUE 17 | MAY 22, 201217Vince v. Hungerford on Correcting Extra-Articular DeformityBy Elizabeth Hofheinz, M.P.H., M.Ed.

Extra-articular deformity? Go intra-articular for the correction, says

Kelly Vince. Not so fast, counters David Hungerford…there are many kinds and sources of deformity: congenital, meta-bolic, traumatic, and surgical, and what is the magnitude of the deformity, and the location from the knee, etc. There are multiple considerations.

This week’s Orthopaedic Crossfire® debate is “Extra-Articular Deformity: Always Correctable Intra-Articularly.” For the proposition was Kelly G. Vince, M.D., F.R.C.S.(C) from the University of Auckland in New Zealand. Against the proposition was David S. Hungerford, M.D. of the Johns Hopkins University in Baltimore; moderating was Steven J. MacDonald, M.D., F.R.C.S.(C) of the University of Western Ontario.

Dr. Vince: “I like to correct these defor-mities inside the joint. Extra-articular deformity is a limb deformity with implications for the joint; it should be easy to solve. When it comes to varus-valgus alignment issues it’s the mechanical axes that we must examine. When it comes to flexion-extension problems, we can ignore most of them. The mechanical axis: center of knee, center of hip, center of ankle. And the anatomic axis just drifts and melts away because it is distorted.”

“Sagittal deformities: you get an impos-ing looking X-ray and you’re not sure what to do. The secret is that this patient bends well and extends well, and we should probably just ignore it—

like fracture work, it’s in the plane of the joint. For the next phase of planning, you need full length X-rays.”

“We only need that femur film. We draw the mechanical axis, the bone cut should be at right angles to it, and you can set your IM [intramedullary] guide accordingly. If you have navigation it makes everything simple. It requires a bit more attention to the soft tissue surgery, but results in a postoperative result with a restoration of the angle that you would like.”

“Some of them look intimidating—until you draw that simple angle that goes from the center of the head to the distal femur, and at right angles. When it comes to tibial extra-articular defor-mities these are straightforward because

our extramedullary cutting guides span the joint and tibia, and correspond to the mechanical axis.”

“Surgical technique: the alignment of the new arthroplasty comes simply from the component position and the bone cuts. Then things get a little challeng-ing in that we must do ligament releases and possible constraint…and in very few cases I have done ligament advanc-es and even ligament reconstructions. Consider a gentleman with a midshaft femur fracture. There’s a little more valgus in the distal cut…and requires having to do a little more release of the medial collateral ligament.”

“Another patient with bilateral femur fractures…really impressive malunion that nobody wants to revisit. She was

Wikimedia - KaihsuTai and Current Concepts in Joint Replacement/RRY Photo Creation

Kelly G. Vince, M.D., F.R.C.S.(C)University of Auckland

New Zealand

VS

David S. Hungerford, M.D. Johns Hopkins University

Baltimore, Maryland

Moderator: Steven J. MacDonald, M.D., F.R.C.S.(C)University of Western Ontario


VOLUME 8, ISSUE 17 | MAY 22, 201218unable to accept blood transfusions, and I didn’t want to do two opera-tions—four because it’s bilateral—and I didn’t want her to have blood loss at one surgery. So we did it all intraop-eratively with aggressive releases, and supplemented things with a non-linked constrained device.”

“At times I’ve done ligament advanc-es—Ken Krackow’s technique—which I’ve modified very slightly. At times I’ve done ligament allografts including an Achilles tendon that’s anchored below the tibial component, and goes through a drill hole in the femur.”

“When it comes to the limits of cor-rection, there is a paper from Taiwan which was inspired by John Insall. They say that they can’t do a distal femoral cut if it goes through the attachments in the collaterals—and that makes sense. What I would do is cut a little more dis-

tal, and carry on. And then they said they won’t do the correction if it doesn’t correspond to the tibial axis. It wouldn’t bother me to make that cut—center of knee to center of ankle—and then do a rebuilding of the bone.”

“A case I did in Australia: because I wanted to have the options of con-straint and fixation, I actually did an osteotomy along with the case so that the stem could go up the canal, and I’d have those options. How simple can it be with intra-articular correction? But if you correct the osteotomy the hip has to get accustomed to a whole new range of motion—and you’re going to have to do some pretty daunting sur-gery at the knee as a result. In conclu-sion: keep it simple.”

Dr. Hungerford: “I think the opera-tive word in this discussion is ‘always.’ Kelly already proved my point in that

he showed a case in which he did an extra-articular correction. So if we come to the conclusion that there will be cases where an extra-articular defor-mity should be corrected extra-articu-larly, the question is, ‘How do you make that decision?’”

“The question is, ‘When do you do intra-articular and when do you do extra-articular?’ In most deformities, the deformity is because of intra-artic-ular bone loss, and it doesn’t make any difference how much that is, it can always be corrected intra-articularly. When you get to extra-articular defor-mity you have lots of kinds and sources of deformity: congenital, metabolic, traumatic, surgical.”

“The issues: the magnitude of the defor-mity, the location from the knee—a deformity that is close to the knee has almost a 1-to-1 degree deformity of the

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VOLUME 8, ISSUE 17 | MAY 22, 201219knee itself, whereas an extra-articular deformity near the hip or ankle has very little impact. Also, is it medial or lat-eral? Is the femur involved, or the tibia? The malalignment on the knee when it’s supracondylar is about 20 degrees, whereas when it’s subtrochanteric it’s almost zero. Same with the ankle. If you have a big deformity at the ankle you might want to do something, but it has very low impact on the knee unless it’s close to the knee.”

“The varus deformity requires a lateral resection, so in this case you have a lat-erally based wedge…and this becomes an issue in making this decision. With a valgus deformity you’ll have a medial based wedge intra-articularly to correct the deformity.”

“Femoral and tibial intra-articular corrections are not equal. The femur

affects stability only in extension, meaning that you produce instability on the medial side in extension, but not in flexion, therefore the ligamen-tous alignment that you need to do becomes quite a bit more complex. The tibia deformity that you create intra-articularly to correct an extra-articular deformity affects stability in both flexion and extension, and in those cases ligamentous releases and ligamentous reconstructions are more straightforward.”

“All you really need to do is to tem-plate…you’re going to determine the cut that is required, so this automati-cally takes in account the level of defor-mity. Lateral over-resection is better tolerated by the simple fact that the lateral side of the joint is dynamically stabilized. So you can tolerate, func-tionally, lateral instability of a mod-

est degree…where the same degree of instability on the medial side is not well tolerated.”

“Some deformities which are multifac-torial—lateral translation, anterior rota-tion, and severe deformity—are much better taken care of by an osteotomy. In one patient who had a high tibial oste-otomy for varus disease, where it’s vast-ly overcorrected, had good joint space. I decided to do an extra-articular cor-rection back to neutral as the first step. After 15 years she has not yet had a total knee replacement.”

“So you have a decision tree of whether to correct intra-articularly or extra-articularly, and whether it’s a separate procedure or a combined procedure…and then, whether residual deformity is acceptable (and I think that’s not).”

Moderator MacDonald: “Kelly, not everyone is set up with navigation, so you can’t use an IM alignment rod for your femoral resection…take us through how you do that in the OR…an extra-medullary referencing for a standard femoral cut.”

Dr. Vince: “Whether you decide to do an intra-articular correction or the kinds of osteotomies that David has described, get a long film. From that, draw the mechanical axis from the cen-ter of the femoral head to the center of the femur (if the deformity is in the femur), and then draw the right angle at the distal part of it. Before naviga-tion, I would draw that line, and if the malunion or deformity was proxi-mal to where the IM guide would go, you would also draw the IM guide on the X-ray and measure that angle. If the deformity precludes the use of IM guides then I’ve gone to intraoperative X-rays to confirm the cut.”

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VOLUME 8, ISSUE 17 | MAY 22, 201220Moderator MacDonald: “Any of you used a technique where you are looking under fluoro with the femoral head and marking the femoral head using that as your guide with a long rod intraopera-tively?”

Dr. Vince: “That would be a variation of an intraoperative X-ray.”

Dr. Hungerford: “I would agree with what he said about if you’re going to do this correction and you’ve done your templating and made your mark you can put your distal femoral cutting guide on as to where you think that line ends up, take an intraoperative X-ray and it’s the equivalent of a postoperative X-ray. Most instrumentation systems have the ability to make small correc-tions if you wanted to.”

Dr. Vince: “Add a spacer block that the alignment rod goes through and stick it in the joint parallel to your new cut on the femur, and look at where that rod hits the femoral head.”

Moderator MacDonald: “David, if you must do a corrective osteotomy, how do you determine when you’re able to incorporate that into your total knee construct or when you’re going to have to do a separate procedure? Or do you get a custom stem?”

Dr. Hungerford: “You don’t have to make a corrective osteotomy at the site of the deformity. You could have a 45-degree malunion of the femur in the midshaft and you could make about a 22-degree supracondylar oste-otomy that you could do at the same time as a total knee replacement. In most cases I would like to not subject the patient to two separate surgeries, but I’ve done four or five in which I thought that the patient might well get a significant improvement functionally

by having their malalignment corrected to neutral. In all but one of those cases that proved to be true. I had a patient with a segmental fracture with about a 20-degree varus deformity of her tibia at several levels and she looked like she’d be a good candidate for a valgus oste-otomy…and that worked for almost 10 years. Ten years later it was a neutral total knee replacement.”

Moderator MacDonald: “Sometimes when you plan these cuts out the soft tissue balancing is a little wonky—not so predictable. Any tips there?”

Dr. Vince: “Look at the patient with a big varus bow in the femur, so you may not be tuned into the fact that they have a big deformity. If you correct that appropriately you’re going to have to do a large medial release or leave them malaligned, overloading the medial side. We want to get the cuts where they should be, do the releases and not be fearful of over-releasing in these cases because we should have planned to have constraint available (or some other plan).” ♦

Please visit www.CCJR.com to register for the 2012 CCJR Winter Meeting, December 12 - 15 in Orlando, Florida.

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Feds Give “All Clear Signal” on Infuse Investigation

The government has closed its inves-tigation of Medtronic, Inc.’s activi-

ties surrounding its Infuse bone graft.

The company announced on May 16 that it has been notified by the U.S. Department of Justice and the Office of the United States Attorney for the Dis-trict of Massachusetts that federal pros-ecutors have closed their investigation.

Chris O’Connell, Medtronic’s executive vice president and head of the group which includes the spine business, said, “We are pleased.”

This ends federal civil and criminal investigations of the company that began on October 6, 2008, when Medtronic received a subpoena from the U.S. Attorney’s Office for the Dis-

trict of Massachusetts pursuant to HIPAA requesting production of docu-ments relating to Infuse. Medtronic then received supplemental subpoe-nas or document requests, including a December 18, 2008 civil investigative demand from the Massachusetts Attor-ney General’s Office, an October 14, 2011 subpoena issued by the California Attorney General’s office, and several inquiries from the United States Senate Finance Committee.

The investigation apparently widened last year after researchers involved in Medtronic’s clinical trials were criticized by The Spine Journal and U.S. sena-tors. They claimed Infuse isn’t as safe as Medtronic says and that Medtronic’s paid trials led to biased results. Yale University is currently reviewing the safety of the spine product. Medtronic is paying the school $2.5 million for an independent review.

Given the duration of the investigation, Wells Fargo Analyst Larry Biegelsen said he was surprised that the govern-

ment walked away empty handed. He believes this news removes a significant overhang to Medtronic and its spine business because there was a concern that Medtronic would have to settle this case for a significant amount of money. Such a settlement would have acceler-ated the decline in Infuse because sur-geons would have grown increasingly concerned about being sued for using the bone graft off-label.

“This news could represent a turn-ing point for the beleaguered product because it could be a signal to sur-geons that Infuse may be okay. This is important to Medtronic and the spine industry in general because Infuse is considered a very effective product that helps increase fusion rates,” concluded Biegelsen.

Medtronic will report quarterly spine sales on May 22.

—WE (May 17, 2012)

company

Morguefile and RRY Publications LLC photo creation


VOLUME 8, ISSUE 17 | MAY 22, 201222“Fear and Medical Tourism” in Vegas

Medical tourism is usually associ-ated with foreign exotic places

like India, Thailand and Costa Rica.

But Vegas? The metaphors are beyond tempting. One-armed bandits; what happens in Vegas...; gambling with your health; Fear and Healing in Vegas. Our gonzo-journalism hero, Hunter Thompson, would be inspired.

According to a story by Richard Velotta on May 16 in VEGASINC, a group called the Southern Nevada Medical Industry Coalition is in the process of drafting an asset analysis and a quality algorithm before writing a feasibility study on how to grow Southern Nevada’s $50 billion medical tourism industry as well as its $106 billion medical wellness industry.

Velotta writes that at a recent sympo-sium an all-star panel of doctors agreed

that “building on quality health care” and excelling at specialties and treat-ments people can’t get anywhere else are the most important elements in developing a thriving medical tourism industry.

Yevgeniy Khavkin, M.D., is a neuro-surgeon at the Nevada Spine Institute, which markets in Russia, China and Middle East. Khavkin said Russian patients are convinced that the best medical care in the world is offered in the U.S. and he and his physician wife are more than willing to see their for-mer countrymen as patients.

The asset analysis reported by Velotta would be an inventory of the medical specialties available in Southern Nevada while the quality algorithm would compare quality of care and treatment outcomes achieved in the area against peers nationwide.

The Las Vegas Convention and Visitors Authority embraced the concept, hiring

Cheryl Smith as a medical tourism sales manager. Smith told physician attend-ees at the symposium that they are now “brand ambassadors.” Smith, wrote Velotta, told the group, “You can man-age their experiences when they’re here, and we want to give people a healthy reason to choose Las Vegas.”

Velotta cited the example of an exist-ing specialty at the Gastric Band Insti-tute, which offers surgical remedies for obesity. Such a specialty has what many consider to be a perfect medical tour-ism operation. Surgeries are short and relatively painless, but patients need to stay in the area for several days for post-surgical follow-ups.

Perhaps to have a walletectomy per-formed at one of the family friendly casinos. They could also save the stem cells from the gastric procedure and prepare them for regenerative thera-pies. Your fat stays in Vegas, but you take the stem cells home.

Panelists agreed that as the reputation of medical professionals in Las Vegas becomes more widely known, more specialists will consider moving to the city. But they bet-ter sharpen up their skills as brand man-agers.

We’d love to hear from our readers which specialty med-ical services they’d suggest to the coali-tion.

—WE (June 16, 2012)

Steve Marcus and Las Vegas Sun/Cleveland Clinic Lou Ruvo Center for Brain Health, designed by Frank Gehry


VOLUME 8, ISSUE 17 | MAY 22, 201223OrthoSensor Builds Cash Stash

OrthoSensor, Inc., developer of an orthopedic device that provides

real-time data to surgeons during sur-gery, announced in early May that the company has raised an additional $15 million in financing. The additional capital raised the company’s total Series B investment to $36 million.

Jay Pierce, the company’s CEO, said the Ft. Lauderdale, Florida-based company will use the cash to expand the com-mercialization of its first product, the OrthoSensor Knee Balancer, as well as bringing new products to the market. The company announced a partnership with Stryker Corporation last August to use the device with the Stryker Triath-lon knee implant. Pierce reportedly said the “intelligent” device has the potential to be compatible with any implant.

“The strong interest in our latest round of funding demonstrates the continued

investor confidence in OrthoSensor and the tremendous market opportunity for intelligent orthopedics,” said Pierce in the May 7 press release. “Since the start of our limited release in September, the OrthoSensor Knee Balancer has been adopted in some of the most prestigious orthopedic facilities in the United States and is providing a wealth of data asso-ciated with soft tissue tensioning and knee kinematics. We will utilize these funds to expand the commercial launch of the Knee Balancer and to bring to market the next products in our port-folio of intelligent orthopedic devices. Our cutting edge technology is poised to transform the treatment of musculo-skeletal disease by facilitating evidence-based orthopedics.”

Intelligent Orthopedics

The Knee Balancer is embedded with sensors that provide sur-geons with actionable data on implant fit and knee kinematics. The sensors wirelessly transmit

key information to a graphic display, enabling surgeons to make informed adjustments to the soft tissues to opti-mize implant placement. The company says that accurate implant placement and soft tissue balance have been shown to extend the life of implants, reduce the incidence of revision surgeries and improve patient function.

The company has three product plat-forms: OrthoSensor Surgical, Ortho-Sensor Implantables and OrthoSensor Analytics.

—WE (May 15, 2012)

OrthoSensor, Inc./OrthoSensor Knee Balancer



Save That Cord!

Ashton Arbuckle had barely been born at City Hospital in Dubai

before a doctor was collecting blood from his umbilical cord and preparing it for shipment. Within hours the refrig-erated blood was on its way to the UK to be placed in a cryogenic storage unit for the next 25 years. As reported by Alice Haine for the UAE The National on May 10, the Arbuckles arranged for the procedure because of the possibility that the stem cells in baby Ashton’s cord blood could save his life and the lives of any siblings he may have in the future.

Umbilical cord blood is a rich source of stem cells which have the ability to self-renew almost indefinitely. They also can develop into cells with specialized char-acteristics that researchers believe may, in the future, be useful in the treatment of scores of illnesses.

The first suc-cessful cord blood trans-plant to regen-erate blood and immune cells took place in France in 1988 on a six-year-old American boy suffering from Fanconi’s ane-mia. According to Haine, since then more than 30,000 cord blood stem-cell transplants have taken place on patients suffer-

ing from a variety of ailments.

“It’s a growing concept,” says Darryn Keast, the regional manager for Med-Cells, the company responsible for col-lecting Ashton’s blood. “Since 2010, cord blood has surpassed bone marrow as the transplant of choice because there is no pain or risk. Because more people are storing, more of these samples are available,” he said.

There are now more than 200 cord blood banks operating in the U.S. and internationally. In the U.S. the FDA now regulates cord blood banking nationally. Twenty-seven states have enacted cord blood education bills that cover 81 % of U.S. births. Of those four states only require education about cord blood donation while the other 23 follow the federal Institute of Medicine guidelines that call for parent education about all options for their child’s cord blood.

—BY (May 17, 2012)

Nevada Doc Builds Own Hospital, Rehab Unit

It is many orthopedists dream to own their own surgery facility—to con-

trol outcomes with their own clinic and staff. One who has done that is Michael Crovetti, M.D. who practices out of the Coronado Medical Center, Las Vegas, Nevada. Ignoring the fact that reim-bursements for surgical procedures were being cut, three years ago Crovetti

invested $2.5 million in a surgery site and $1.2 million in a recovery suite concept to help rehabilitate patients following their procedures.

While Crovetti admitted to a reporter for the Las Vegas Review Journal that he might be a “control freak” he notes that his hip and knee replacement patients are walking a few hours following their surgery. His staff nurses, anesthesiolo-gists and assistants have been with him for years and provide the team effort that, he maintains, controls the out-come he wants.

“Repetition is the secret to success in my business because that’s what pre-vents mistakes being made. It’s about not skipping steps, making sure every box is checked. Repetition equals safe-ty for the patients,” Crovetti said in the

biologics

Wikimedia Commons and Jeremy Kemp

large joints

Courtesy of Dr. Michael Crovetti and Coronado Medi-cal Center


VOLUME 8, ISSUE 17 | MAY 22, 201225May 13 press release. The second criti-cal criteria for him is that his patients see an upbeat and positive staff that is driven by the desire to provide the best patient outcomes. “It comes down to patient satisfaction and that comes from working well together. The biggest feedback I get is how pleasant and won-derful everyone is,” he said.

According to the Review Journal, Nevada is one of 22 states that require national accreditation from a regula-tory body in order for an office-based surgery center to exist. The three pri-mary accrediting organizations that are recognized by states that require accreditation are the Joint Commission on Accreditation of Healthcare Organi-zations, the Accreditation Association for Ambulatory Health Care (AAAHC) and the American Association for Accreditation of Ambulatory Surgery Facilities.

Crovetti received his accreditation from AAAHC and has a transfer agreement with a nearby hospital in case he runs into surgery complications. He has also received accreditation for his recovery suite model, a concept he is pitching to other surgeons around the country. His belief is that, while he, himself, follows best practices when it comes to surgery, a patient’s ultimate benefit comes when he or she start moving that replaced knee or hip as soon as possible after surgery.

So far Crovetti’s enterprise is succeed-ing, despite tough economic times. Besides the quality of the service, the key appears to be volume. Crovetti, who primarily replaces knees and hips, does about 600 surgeries a year. He has partners who share the facility with him. Altogether, they do about 2,000 surgeries annually at the site.

While Crovetti admits that his timing could not have been worse when he opened a surgery center in 2009 and the recovery suites in 2010, there is one image he sees almost daily that convinc-es him that he made the right decision.

“Nothing is going to replace watching a guy who just had his hip replaced walk-ing down the hall three hours later,” he said.

—BY (May 18, 2012)

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VOLUME 8, ISSUE 17 | MAY 22, 201226Nanoparticles Reduce Joint Damage

Researchers from the Georgia Health Sciences University (GHSU) have

discovered that a DNA-covered sub-microscopic bead used to deliver genes or drugs directly into cells to treat dis-ease appears to have therapeutic value just by showing up. Indeed, within a few hours of injecting empty-handed DNA nanoparticles, the team found an increased expression of an enzyme that calms the immune response—indoleo-mine 2,3 dioxygenase, or IDO.

“It’s like pouring water on a fire,” said Dr. Andrew L. Mellor, Director of the GHSU’s Medical College of Georgia Immunotherapy Center and the study’s corresponding author, in the May 15, 2012 news release. “The fire is burning down the house, which in this case is the tissue normally required for your joints to work smoothly,” Mellor said of the immune system’s inexplicable attack on bone-cushioning cartilage. “When IDO levels are high, there is more water to control the fire.”

Follow-up studies include document-ing all cells that respond by producing more IDO. GHSU researchers already are working with biopolymer experts at the Massachusetts Institute of Technol-ogy, the University of California, Berke-ley and the Georgia Institute of Tech-nology to identify the optimal polymer. The polymer used in the study is not biodegradable so the researchers need one that will eventually safely degrade in the body. Ideally, they’d also like it to target specific cells, such as those near inflamed joints, to minimize any poten-tial ill effects.

Dr. Mellor told OTW, “The most important point to emerge from our study is that DNA nanoparticles were

effective in reducing joint damage in a mouse model of rheumatoid arthritis. This point is important because DNA nanoparticles are versatile and can be readily adapted for clinical applications such as arthritis treatment. For exam-ple, polymer scientists have developed biodegradable polymers with lower immune toxicity, both highly desirable features for clinical reagents to treat arthritis. In our study, we also report-ed a simple but novel way to reduce

immune toxicity substantially by incor-porating non-immune stimulatory DNA into nanoparticles. Thus, DNA nanoparticles protect healthy tissues from immune-mediated destruction, and may alleviate damage to joints in patients with arthritis.”

As for when might this work result in a treatment, Dr. Mellor commented to OTW, “This study, and related work in other centers, has created a completely new perspective on how to manipulate the immune system to prevent, slow or reverse immune-mediated destruc-tion of healthy tissues in several mouse models of human autoimmune diseas-es. It is difficult to estimate how long it will take these new scientific insights to work their way into new clinical treat-ments and procedures, but these new developments could lead to initial clini-cal trials in the next 5-10 years.”

—EH (May 18, 2012)

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Predict Arthritis Before Symptoms Arrive!

Now, a research team from the University of Missouri’s (MU)

Comparative Orthopaedic Laboratory has found a way to detect and predict arthritis before patients begin suffering from symptoms. The study, published in the Journal of Knee Surgery, involved analyzing the joints of dogs that suffer from arthritis.

James Cook, a researcher from the MU College of Veterinary Medicine and the William C. and Kathryn E. Allen Distin-guished Professor in Orthopaedic Sur-gery, along with MU researchers Bridget Garner, Aaron Stoker, Keiichi Kuroki, Cristi Cook, and Prakash Jayabalan, have developed a test using specific bio-markers that can accurately determine

if a patient is developing arthritis as well as predict the potential severity of the disease. The test can be run off of a sin-

gle drop of fluid from a patient’s joint, which is obtained with a small needle similar to drawing blood.

Practice Makes TKRs Shorter, Fewer and Better

Where total knee replacements (TKR) are concerned, practice appears to speed everything up. According

to a study in Health Affairs, reported May 10 by Becker’s Spine Review writer Sabrina Rodak, the patients of sur-geons who performed more total knee replacements tended to have shorter lengths of hospital stay, shorter operating times and fewer complications than those operated on by surgeons who performed fewer such surgeries.

Five hospitals that are organized under the High Value Healthcare Collaborative, a consortium of health systems, examined differences in their mode of delivery of care to primary total knee replacement patients. They found that there was significant variation among the five institutions in how they related to their patients.

For example, the hospitals with the lowest in-hospital com-plication rate had a preoperative approach to outpatients that used a multispecialty evaluation of the patient. When the patient was in the hospital the staff used a multidis-

ciplinary inpatient co-management approach. The hospital with the shortest operating time was equipped with a dedi-cated operating room team that was reserved for total knee replacement surgery.

—BY (May 17, 2012)

Andrew Huth Photography and RRY Publications

University of Missouri


VOLUME 8, ISSUE 17 | MAY 22, 201228“With this biomarker test, we can study the levels of specific proteins that we now know are associated with osteoar-thritis,” Cook said in the May 15, 2012 news release. “Not only does the test have the potential to help predict future arthritis, but it also tells us about the early mechanisms of arthritis, which will lead to better treatments in the future.”

“This test has already shown early use-fulness for allowing us to monitor how different treatments affect the arthritic joints in people,” Cook said. “With fur-ther validation, this test will allow doc-tors to adjust and fine tune treatments to individual patients. Also, being able to tell patients when they are at a high risk for developing arthritis will give doctors a strong motivational tool to convince patients to take preventive measures including appropriate exer-cise and diet change.”

Asked to describe the process of how the test is being adapted to humans, Dr. Cook told OTW, “It is actually already adapted to humans in terms of the methodology—meaning, we use the exact same technique (1-2 drops of fluid from the joint) and the exact same panel of proteins for humans as we do in dogs—we just have not obtained nearly as much data in peo-ple yet as we have in dogs—so we need to keep doing studies to make sure that we validate the test for all the applications in people, i.e., screening for early arthritis, determining sever-ity of arthritis, and assessing response to various treatments—these valida-tion studies will take several years and are part of the process for gaining FDA approval for clinical use of this as a diagnostic test in people.”

—EH (May 18, 2012)

Arthritis: Manipulate Cilia, Reduce Inflammation?

Scientists from Queen Mary, Univer-sity of London have found a new

therapeutic target to combat inflamma-tion: primary cilia. They took cartilage cells and exposed them to a group of inflammatory proteins called cytokines, specifically interleukin-1 (IL-1), to see whether there were any changes to the primary cilia. There were…

The research, published in the journal Cellular and Molecular Life Sciences, revealed tiny organelles called pri-mary cilia are important for regulating inflammation. Dr. Martin Knight who led the research at Queen Mary’s School of Engineering and Materials Science said in the May 9, 2012 news release: “Although primary cilia were discov-ered more than a century ago, we’re only beginning to realise the impor-tance they play in different diseases and conditions, and the potential therapeu-tic benefits that could be developed from manipulating cilia structure and function.”

“When we exposed the cells to IL-1, in just three hours the primary cilia showed a 50% increase in length. But what was most interesting was when we treated cells to prevent this elongation of the cilium. The cartilage cells had a greatly reduced response to the inflam-matory proteins and were therefore not as inflamed. This suggests a brand new therapeutic target for inflammation.”

Co-author Dr. Angus Wann, said this is the first time primary cilia have been suggested as a target for novel thera-pies to reduce the effects of inflamma-tion. “If we can work out how to bet-

ter manipulate the primary cilium, we could potentially attenuate or even pre-vent inflammation,” he said.

As for where they go from here, Dr. Knight told OTW, “Ongoing research in my group, funded by Arthritis Research UK and the BBSRC [Biotechnology and Biological Sciences Research Council], is investigating the role of a specific primary cilia signalling path-way, known as hedgehog signalling. This pathway is aberrantly activated in osteoarthritis and drives the degradation of the cartilage and yet nobody knows why. We hypothesize that mechanical injury and subsequent inflammation alters the structure of primary cilia leading to changes in cell function and the development of arthritis. The next critical phase of our cartilage research at Queen Mary University of London, is to identify pharmaceutical agents in the form of small molecules which reg-ulate cilia structure. This will allow us to manipulate the complex structure-function relationship for primary cilia thereby controlling the cellular signal-ling pathways that lead to joint inflam-mation and arthritis. We are in the pro-cess of applying for grant funding for this ambitious proposal which we hope will lead to a totally novel treatment for arthritis and an improved understand-ing of this complex disease.”

—EH (May 16, 2012)

Wikimedia Commons and Katherine Connolly-Dart-mouth Electron Microscope Facility



CBS Featured Sealant for Low Back Pain

On May 6 a national TV program (CBS Sunday Morning) focused

attention on the Phase III clinical study being conducted by Biostat System for the treatment of discogenic low back pain. The Biostat System, as described by its manufacturer, Spinal Restoraton, Inc., is a new drug limited by federal law to investigational use only. The system consists of BIOSTAT BIOLOGX Fibrin Sealant, a human derived, resorbable biologic tissue sealant, and a proprietary application system designed to safely deliver the biologic to the intervertebral disc. Proponents assert that application of the sealant to the disc may alleviate

discogenic pain by sealing the painful disc disruptions, reducing inflamma-tion, and enhancing tissue repair.

The company completed a 15-patient, Phase II clinical trial with a two-year fol-low up in January 2011. The Phase III trial, which is randomized and placebo controlled, will involve 260 subjects in 20 centers across the U.S. Enrollment is more than 85% complete, according to Gary Sabins, president and CEO of Spi-nal Restoration, who said, “Spinal Res-toration is excited about the progress that has been made toward developing the rigorous scientific evidence neces-sary to obtain regulatory approval for the Biostat System.”

Investigators are studying the Biostat System in subjects who suffer from chronic discogenic low back pain but

do not have large disc herniations or a history of lumbar spine surgery. While surgery is an appropriate option for many patients, company officials believe that there is a great need for an interventional treatment for patients with early disc degeneration when sur-gery is the least desirable option. They maintain that, currently, there is no conservative or interventional therapy with unequivocal efficacy for treating chronic discogenic pain in this patient population.

The Biostat System study is the first intradiscal biologic therapy for dis-cogenic pain to enter into a Phase III clinical trial. An estimated four million adults in the United States suffer from low back pain.

—BY (May 18, 2012)

spine

Biostat System


VOLUME 8, ISSUE 17 | MAY 22, 201230OIC Launches Pedicle Screw System

The Orthopaedic Implant Company (OIC) has announced the launch

of its Pedicle Screw System. The new product line is used for stabilization and fixation during posterior spinal fusion procedures.

“Our pedicle screw product line repre-sents a simple, intuitive system that can save hospitals and surgery centers up to $3,000 per fusion level,” said OIC’s V.P. of Business Development Mark Medi-

na in the May 14, 2012 news release. “This is another demonstration of how we deliver high quality implants at cost-effective levels while strengthening our position in the marketplace.”

The new system provides surgeons with a full range of implants with reli-able and reproducible results. The sys-tem includes poly-axial pedicle screws, rods and cross connectors for posterior lumbar fusions. The system’s unique set screw design prevents cross threading, and components are color-coded by size for easy identification.

OIC entered the medical device market in 2010, pledging to save more than a billion dollars in health care costs by 2015. The company will be exhibiting at the 10th Annual Orthopedic, Spine and Pain Management-Driven ASC Conference June 14 – 16 in Chicago. President Itai Nemovicher will be pre-senting the company’s new product line and will be available to discuss OIC’s cost-effective approach to working with hospitals and insurers.

According to OIC, its implants are 50 to 60% of the average market price of premium implants, potentially saving

health care systems millions of dol-lars a year. High-quality, low-cost implants and products can be used for a variety of procedures, including treatment of broken bones, lumbar fusions and joint replacements. All OIC products are FDA approved and manufactured in ISO 13485 facilities.

Asked how they save $3,000 per fusion, Itai Nemovicher told OTW, There are a number of ways we are able to drive down the cost. We’ve created a system that is simplistic and includes instrumentation that surgeons/OR staff are very familiar with. This offers surgeons/OR staff a level of comfort that provides OIC the ability to reduce our costs by elimi-nating the need for representation on a case by case basis. In addition and staying true to OIC’s vision of fiscal responsibility, we don’t over inflate our implant pricing to what the cur-rent market tolerates. Even though OIC could apply a larger premium on our pricing to align them with hospi-tal dictated formulary/matrix pricing, we choose not to.

—EH (May 16, 2012)The Orthopaedic Implant Company


VOLUME 8, ISSUE 17 | MAY 22, 201231HSS, Boachie, Open Orthopedic Hospital in Ghana

Ghana…where the dreams of one orthopedist converge with the

hopes of those needing care. Hospital for Special Surgery (HSS) and Oheneba Boachie-Adjei, M.D., chief of the scolio-sis service at Hospital for Special Sur-gery and founder and president of the Foundation of Orthopedics and Com-plex Spine (FOCOS), have announced the opening of a 50-bed specialty hos-pital providing comprehensive muscu-loskeletal care for adults and children in Ghana, Africa.

“FOCOS’s mission is to provide afford-able orthopedic care to those who would not otherwise have access to such treat-ment,” explained Dr. Boachie-Adjei in the April 26, 2012 news release. Dr. Boachie-Adjei was born in Kumasi, Ghana, and immigrated to the United States in 1972. “The patients we treat both surgically and nonsurgi-cally have disabling muscu-loskeletal disorders includ-ing complex spine deformi-ties and pediatric orthopedic problems.”

The FOCOS Orthopaedic Hospital—located on 10 acres—will also serve those in need of emergency medicine, ambulance services, diag-nostics (including MRI, CT, echocardiogram, catheteriza-tion lab, complete labora-tory services and radiology), pharmacy and physiotherapy. Since its inception in 1998, Dr. Boachie-Adjei—through FOCOS—has treated more than 17,000 local and inter-national patients.

“The medical outreach program has been sustained by more than 1,800 donors who have contributed in excess of $10 million and a $1.5 mil-lion Ghanaian government grant,” said Dr. Boachie-Adjie in the April 26, 2012 news release. “FOCOS aspires to become the premier orthopedic teach-ing hospital in sub-Saharan Africa. I have worked with a pioneering team of international volunteers, including col-leagues at Special Surgery, to make this Hospital a reality.”

“As a world leader in musculoskeletal medicine, Hospital for Special Surgery is committed to national as well as international outreach,” said Louis A. Shapiro, FACHE, president and CEO, Hospital for Special Surgery. “We are proud to have supported Dr. Boachie in his efforts to make the FOCOS Ortho-paedic Hospital a reality.”

Asked what had to happen in the last six months for this to come to comple-

tion, Dr. Boachie-Adjei told OTW, “Six months ago we were completing the furnishing and equipment installation while holding outpatient clinics for patients who were coming to our old clinic. A lot of sophisticated equipment needed expert installers for the U.S. and Germany working with local engineers. New hospital accreditation applica-tion had been submitted to the Ghana Health service and staff was recruited and policies and procedures were put in place and all inspection programs were arranged and completed by the admin-istrative staff.”

Looking to the future, Dr. Boachie-Adjei commented to OTW, “A year from now we hope to be fully operational with a regular surgical schedule beside the quarterly mission trips. We want the local surgeons to use the facility to treat orthopedic patients.”

—EH (May 14, 2012)

Hospital for Special Surgery



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