week in review 4 Medtronic and Carragee on Collision ...ryortho.com/wp-content/uploads/2012/11/10_25_11_Newsletter.pdf · 1-888-749-2153 | 2 VOLUME 7, ISSUE 34 | OCTOBER 25, 2011

VOLUME 7, ISSUE 34 | OCTOBER 25, 2011

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

week in review

breaking news

4 Medtronic and Carragee on Collision Course in Court? ◆ Medtronic side

stepped a direct confrontation with Eugene Carragee, M.D., and The Spine Journal over allegations of “biased and corrupted” Infuse research. But a lawsuit filed in Florida against Medtronic citing Carragee may set up a confrontation in a courtroom. Read what English v Medtronic is all about.

8 Kiyoshi Kaneda to Receive NASS’ Wiltse Award ◆ The 2011 NASS Wiltse Award winner

may best be known for something that does not appear on any plaque, award or patent filing. Professor Kiyoshi Kaneda’s legacy may well be his promotion of education and training interchanges between Japan and the rest of the world.

12 Orthopaedic Crossfire® Tackles Squeaking Hips ◆ A Current Concepts

in Joint Replacement™ debate between Steven J. MacDonald, M.D., F.R.C.S.(C) and Stephen B. Murphy, M.D. Hear what each party has to say about hip squeaking.

17 Reporter’s Notebook ◆ Brian Parsley, M.D. touts joys of returning to private prac-

tice…NASS to recognize Kiyoshi Kane-da, M.D., Gunnar Andersson, M.D., and Joel Press, M.D., AAOS and the OTA team up with SOMOS to organize disaster response…read on…

21 TranS1 Subpoenaed; No Accusations Made..........................................

Patients Catching Fire in OR?............................................................Spine Stem Cell Trials Underway............................................................Stapling – A New Scoliosis Fix ............................................................Surgeon’s Dilemma – Staple or Suture?............................................................Children’s Knee Injury Rate Up............................................................DePuy’s 3Q11: Steady, Waiting for Synthes............................................................Stryker Gains in 3rd Quarter

For all news that is ortho, read on.


VOLUME 7, ISSUE 34 | OCTOBER 25, 20112Orthopedic Power RankingsRobin Young’s Entirely Subjective Ordering of Public Orthopedic Companies

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

This Week: Nice bounce last week as worries over the sovereign debt crises in Europe eased somewhat and orthopedic sales and earnings reports were slightly better than expected. Stryker, our #1 ranked company, is using these historically low valuations for orthopedic technologies to build strategically.

1 1 Stryker 25.23% 4.49%11% income growth; 4 acquisitions in the last

11months. Beat estimates. Solid #1.

2 2 Zimmer 27.75 (1.48)Stryker’s strong report, Biomet’s better-than-expected

results hint at decent numbers this week from Big Blue.

3 4 Kensey Nash 34.24 4.02 140% leap in sales of orthopedic biologic products

fueled a strong Q3 report. UP one spot.

4 3 Medtronic 28.63 2.01 Still the lowest PE stock in ortho, but price-to-sales is in middle of the pack. Means MDT lacks earnings

growth.

5 5Johnson &

Johnson26.33 1.03

Pretty much once a week someone writes that JNJ is the place to park money in these uncertain times.

Waiting for Synthes deal to close.

6 6Smith & Nephew

22.8 2.33 Most analysts still think that SNN can maintain sales growth of around 9% YOY. And deliver roughly 10%

EPS growth.

7 9 Conmed 9.65 20.47 Stock price surged in front of this week’s earnings release. Consensus is that EPS will be flat on just

3.7% sales growth.

8 8 Orthofix 14.72 (7.92)Consensus is that OFIX will report $0.65 vs. $0.48 from a year ago. But sales growth is only expected

to be 3%.

9 7 Integra 15.38 2.30 Citigroup upgrades IART to BUY. Most investors view

IART as a growth company—but primarilyvia acquisition.

10 10Wright Medical

8.76 (1.00)Profit taking this last week has brought WMGI back

down to earth.



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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 Bacterin Intl Holdings BONE $2.48 $98 27.18%2 Conmed CNMD $25.90 $740 20.47%3 Symmetry Medical SMA $8.61 $313 16.04%4 Exactech EXAC $15.00 $197 9.81%5 Tornier N.V. TRNX $22.95 $899 7.85%6 RTI Biologics Inc RTIX $3.82 $211 7.00%7 Stryker SYK $49.17 $19,094 4.49%8 Kensey Nash KNSY $25.64 $221 4.02%9 Smith & Nephew SNN $46.12 $8,236 2.33%

10 TiGenix TIG.BR $0.97 $88 2.30%

1 TranS1 TSON $1.85 $52 -37.50%2 Alphatec Holdings ATEC $2.21 $197 -9.43%3 Orthofix OFIX $32.34 $595 -7.92%4 NuVasive NUVA $17.33 $691 -7.08%5 Zimmer Holdings ZMH $54.64 $10,408 -1.48%6 Wright Medical WMGI $17.82 $702 -1.00%7 Johnson & Johnson JNJ $63.78 174,780 1.03%8 CryoLife CRY $4.65 $131 1.53%9 Synthes SYST.VX $167.91 $19,944 1.60%

10 ArthroCare ARTC $30.06 $825 1.66%

1 Medtronic MDT $34.29 $36,210 10.422 Zimmer Holdings ZMH $54.64 $10,408 11.783 Johnson & Johnson JNJ $63.78 $174,780 13.024 Smith & Nephew SNN $46.12 $8,236 13.395 Orthofix OFIX $32.34 $595 13.42

1 Wright Medical WMGI $17.82 $702 25.462 NuVasive NUVA $17.33 $691 21.663 Synthes SYST.VX $167.91 $19,944 21.254 ArthroCare ARTC $30.06 $825 21.025 Exactech EXAC $15.00 $197 19.74

1 Orthofix OFIX $32.34 $595 0.782 Integra LifeSciences IART $37.40 $1,029 0.843 Kensey Nash KNSY $25.64 $221 1.214 Zimmer Holdings ZMH $54.64 $10,408 1.245 Stryker SYK $49.17 $19,094 1.28

1 ArthroCare ARTC $30.06 $825 3.502 NuVasive NUVA $17.33 $691 3.333 Johnson & Johnson JNJ $63.78 174,780 2.224 Wright Medical WMGI $17.82 $702 2.125 Smith & Nephew SNN $46.12 $8,236 2.09

1 Symmetry Medical SMA $8.61 $313 0.872 Exactech EXAC $15.00 $197 1.033 Conmed CNMD $25.90 $740 1.044 Orthofix OFIX $32.34 $595 1.055 CryoLife CRY $4.65 $131 1.12

1 TiGenix TIG.BR $0.97 $88 142.322 MAKO Surgical MAKO $39.55 $1,639 37.003 Bacterin Intl Holdings BONE $2.48 $98 6.384 Synthes SYST.VX $167.91 $19,944 5.415 Tornier N.V. TRNX $22.95 $899 3.95

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



It didn’t take long for the plaintiff’s bar to seize on the June Spine Journal’s

Carragee Infuse study and find a patient to file a personal injury lawsuit against Medtronic, Inc.

On September 19, 2011, the San Fran-cisco law firm of Lieff Cabraser Hei-mann & Bernstein, LLP, issued a press release announcing that a lawsuit (Jen-nifer English v Medtronic, Inc., Case No. 9:11-cv-81054) was filed in the U.S. District Court of the Southern Dis-trict of Florida on September 16.

The suit states: “According to articles in the June 2011 issue of The Spine Jour-nal (an international medical journal that publishes peer-reviewed research articles related to evidence-based spine

care), earlier Medtronic-sponsored studies and articles inaccurately report-ed the safety of rhBMP-2 (the active fusion ingredient in Infuse) by under-estimating its risks.”

“Biased and Corrupted Research”

Their press release stated that the Jour-nal criticized research by Medtronic-funded physicians, “encouraging the widespread off-label use of Infuse as ‘biased and corrupted research.’ The articles in The Spine Journal charge that the prior studies in support of Infuse were authored by researchers with sig-nificant financial ties to Medtronic, and that this prior research vastly under-stated or failed to disclose Infuse’s side effects and risks.”

Medtronic chose not to publicly defend the studies, but asked Yale University to conduct an independent evaluation of all evidence and data collected about Infuse to date and make as unbiased and objective report as possible. The company has been able to avoid a direct clash with Eugene Carragee, M.D., but may now find itself having to address his allegations in a federal court.

Jennifer English’s Pain

The lawsuit was filed on behalf of Jen-nifer English, a physical therapist of Lake Worth, Florida. English received Medtronic’s Infuse Bone Graft (Infuse) as part of a posterior-approach lumbar

Medtronic and Carragee on Collision Course in Court?By Walter Eisner

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spine surgery performed by Amos Dare, M.D., at the Wellington Regional Medi-cal Center in Wellington, Florida, on August 8, 2007.

The surgery was conducted to address disk herniation and stenosis. During the surgery, according to the suit, Dr. Dare used Infuse in an off-label manner by implanting the product posteriorly into the lumbar region of English’s spine in order to attempt to fuse vertebrae S1 to L5. The FDA’s original approval for Infuse was for an anterior approach.

Infuse was approved by the FDA on July 2, 2002, for anterior use in the lower, or lumbar, region of the spine (at levels L4 through S1) to treat degenerative disc disease.

After the surgery, the suit says English experienced “increasingly severe pain and weakness on her left leg.”

Eight weeks after the surgery, English underwent an emergency revision sur-gery to remove ectopic bone growth that was compressing her nerve. Dur-ing this surgery, according to the suit,

her L5-S1 nerve was nicked and the dura sac surrounding her spinal cord was punctured, “creating a cerebral spinal fluid leak...which caused a four-

centimeter-wide cyst to form.” The cyst caused additional sever pain.

In March 2010, English underwent a third surgery, this time to remove hard-ware such as pins and screws inserted in her first surgery. The suit says her sur-geon noticed excess bone that required removal, but could not be removed at that time. English continued to expe-rience significant pain, cramping and spasms going up her back, as well as weakness in her left leg.

An MRI done on August 4, 2011 showed, according to the suit, that English continued to experience ecto-pic bone growth in her lumbar region. “Comparing this region to a June 11, 2010 MRI study, the August 4, 2011 MRI study reported ‘more bony bridg-ing posteriorly along the lateral mar-

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VOLUME 7, ISSUE 34 | OCTOBER 25, 20116gin of the interbody fusion.’ This bony bridging had lead to ‘more encroach-ment upon the left L5 nerve root,’” claims the suit.

Blaming Medtronic

English claims that Medtronic is responsible for her situation because the company “misrepresented the safety of Infuse to physicians and patients...and recklessly, willfully, or intentionally failed to alert English or her physicians of the extreme danger to patients of the off-label use of Infuse through a poste-rior approach.”

The suit says English would not have chosen to be treated with Infuse “had she known of or been informed by Defendants of the true risks of the off-label use of Infuse.”

Insufficient Warnings

Any warnings Medtronic may have issued concerning the dangers of off-label use of Infuse through a posterior approach were, according to the suit, “insufficient in light of Medtronic’s contradictory prior, contemporaneous and continuing promotional efforts and overpromotion of Infuse for off-label posterior-approach use in the lumbar spine.”

We called English’s lawyers and asked them why her surgeon chose to perform an off-label procedure and why their client wasn’t suing him?

They said that English’s physicians could not have discovered any defect in the Infuse product through the exercise of due care.

Dr. Amos Dare

At issue, no doubt, will be what Dr. Dare would have known about Infuse in August 2008, when English’s surgery took place.

According to Dr. Dare’s website dra-mosdare.com, he received his doctor-ate in Medicine from the Yale School of Medicine in 1997. He performed his internship in General Surgery at the New York University (Lennox Hill Hos-pital) in 1997 and was a neurosurgical resident at the State University of New York in Buffalo. From 2003 – 2004 he was a neurosurgical oncology Fellow at MD Anderson Cancer Center in Hous-ton, Texas. Since 2004, he has served as President of Palm Beach Brain & Spine, PA in West Palm Beach, Florida.

In 2005 he became the Medical Direc-tor of Palm Beach Brain & Spine, LLC in

Wellington, Florida and is currently the Director of Neurosurgery at Wellington Regional Medical Center.

He authored a book copyrighted in 2009 and titled: How to Take Care of the Pain in Your Back. He follows sev-eral case histories from diagnosis to treatment. “The book sheds light on several of the latest technologies avail-able today for the management of back pain,” states the promotional material for the book.

The lawyers told us, and claim in the suit that English’s physicians, “relied on Medtronic’s misrepresentations” regard-ing the safety and efficacy of Infuse in connection with their decisions to use Infuse off-label. They said English and her physicians did not know of the specific risks, and/or were “misled by Medtronic as to the nature and inci-dence of the true specific risks, and/or knew of the true risks and chose to not inform Plaintiff of those risks.” They claim Medtronic’s improper off-label promotion of Infuse cause her physi-cians to use the product off-label.

“The Evidence”

And this is where The Spine Journal and Carragee come in as part of a long list “evidence” that Medtronic promoted the off-label use of Infuse.

English’s lawyers argue that “these Medtronic-sponsored articles omitted mention of adverse effects seen in the earliest trials of Infuse. They also omit-ted mention of the risks of sterility and cancer associated with rhBMP-2 use, as reported in Food and Drug Admin-istration documents and hearings. The actual rate of incidence of these serious side effects is much greater than the Amos Dare, M.D./dramosdare.com


VOLUME 7, ISSUE 34 | OCTOBER 25, 20117rate disclosed by Medtronic or these Medtronic-sponsored studies to physi-cians or to the public.”

They argue that Medtronic cultivated relationships with opinion leaders, paying them handsome consulting fees, travel expenses for seminars, and other perks, to encourage these physicians to promote the off-label use of Infuse.

“Medtronic…improperly paid doctors to promote, both directly and indirect-ly, the off-label use of Infuse through the posterior and lateral approaches in lumbar spine fusions,” alleges the suit.

Kuklo

The lawsuit cites The Wall Street Jour-nal’s reports of Timothy Kuklo, M.D.’s “fabricated claims of efficacy” and forg-ing of signatures of co-authors for an article in a British medical journal while receiving “over $800,000” as a paid consultant for Medtronic.

Poteet, Grassley and the DOJ

English’s lawyers also reached back to settled whistleblower cases involving a former employee named Jacqueline Poteet.

Those cases alleged that Medtronic paid illegal kickbacks to physicians to pro-moting the off-label use of Infuse in the spine, which resulted in the submission of false or fraudulent claims to federal health care programs.

In July 2006, Medtronic agreed to pay $40 million to the government and enter into a Corporate Integrity Agree-ment with Office of Inspector General to settle the lawsuits in July 2006.

Despite the 2006 settlement, English’s lawyers claim that Medtronic has con-

tinued to “improperly and illegally pro-mote the off-label use of Infuse in non-FDA-approved spine surgeries.

U.S. Senate Investigations

The lawsuit cites letters and ongoing inquiries from U.S. Senators regard-ing payments to physicians related to Infuse.

The Senators, led by Democrat Herb Kohl and Republican Charles Grass-ley, also note The Spine Journal articles to conclude that the Infuse trials and reports “suffered from idiosyncratic trial design, reporting bias, and peer-review/publication shortfalls.”

The lawsuit then quotes the Senators repeating Carragee’s assertion that each Medtronic sponsored study was funded in whole or in part by median payments

between $12 million to $16 million by the company.

Medtronic’s Burden of Proof

Given all this evidence, English’s law-yers say the burden of proof should be on Medtronic to prove that the compa-ny did not cause the harms suffered by their client.

They say English demands a jury trial and will be entitled to damages in an amount to be determined at the trial.

There is no telling how the timing of this lawsuit plays out. But if it reaches a trial, Medtronic may well find itself staring over their defense table at Dr. Carragee on the witness stand. The gov-ernment should sell seats for that. ◆

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VOLUME 7, ISSUE 34 | OCTOBER 25, 20118Kiyoshi Kaneda to Receive NASS’s Wiltse AwardBy Robin Young

Professor Kiyoshi Kaneda, M.D., Ph.D. has won the Wiltse Award

twice—once from the International Society for Study of the Lumbar Spine (ISSLS’s Wiltse Lifetime Achievement Award) in 2004 and now in 2011 from the North American Spine Society (NASS).

NASS’ Leon Wiltse award honors excellence in leadership and/or clinical research in spine care.

Almost exactly one year ago Professor Kaneda was being presented the presti-gious Harrington Award by the Scolio-sis Research Society at the spectacular Kyoto International Conference Cen-

ter. In 2000 he won the Orthopaedic Research Society’s Arthur B. Steindler Award.

Professor Kaneda, who is now in his 50th year of treating patients, has played a pivotal role in the history and development of Japanese and global spine surgery in advancing the care of patients with severe spinal deformities. He is also the inventor of the Kaneda Dual Rod system.

But Professor’s Kaneda’s legacy may well be something that is not on any plaque, award or patent filing. Professor Kane-da’s great and most enduring contribu-tion to spine surgery may well be his

program for promoting the exchange of information and training between sur-geons in Japan and the rest of the world.

Gateway to U.S./Japanese Inter-change

Paul McAfee, M.D., Director of the Scoliosis and Spine Center, St. Joseph Medical Center in Towson, Maryland, is one of the dozens of surgeons who traveled to the northern Japanese island of Hokkaido at Professor Kaneda’s request. McAfee remembers his pro-gram vividly: “Professor Kaneda invited Art Steffee and me to the 50th Anniver-sary of the founding of Hokkaido Uni-versity School of Medicine Department of Orthopedics (founded in 1948) to be keynote speakers. At that meeting I remember that AcroMed gave Dr. Kane-da and the University of Hokkaido the VSP and pedicle screw technology and Dr. Kaneda gave his anterior instrumen-tation technology (later to be named the Kaneda Dual Rod System) to AcroMed.

Instead of keeping the royalties for his personal benefit, Kiyoshi used the funds over the next 20 years to send his brightest and best trainees to the U.S. for Fellowships. I would say that Kaneda’s greatest contribution was that he was the gateway to U.S. and Japa-nese interchange of ideas and training.”

Publication and Research Awards

Recalls Bryan Cunningham, Director of the Orthopedic Spine Research lab at St. Joseph’s Medical Center: “The Japanese Fellows from Hokkaido Uni-

Kiyoshi Kaneda



versity were simply amazing. They each produced numerous publications and received research awards while work-ing with us in Baltimore.”

Indeed, the number of papers stream-ing out of the Cunningham/McAfee lab in Baltimore from Kaneda’s protégées is impressive. Kaneda’s fellows were on 38 published studies emanating from the Baltimore lab.

That was just one teaching institution.

Dr. Kuniyoshi Abumi, for example, did a fellowship with Dr. Manohar Panjabi at Yale (approx. 1986) and Dr. Manabu Ito was a fellow with Dr. Hansen Yuan at Syracuse (1992) so the entire volume of peer reviewed publications coming from Kaneda’s fellows is probably much higher.

At the end of this article we list a few of the spine fellows who, because of Pro-fessor Kaneda, had the opportunity to study in the United States.

Kiyoshi Kaneda, M.D., Ph.D.

Kiyoshi Kaneda was born 75 years ago on September 7, 1936 in a small town in the Fukushima prefecture of Japan. His birth town, by the way, was com-

paratively unaffected by this year’s Tsu-nami and nuclear power plant troubles.

Professor Kaneda graduated from Hok-kaido University School of Medicine, Sapporo, Japan in 1962. In1963 he fin-ished his internship at Kyoto University Hospital where he received his M.D. It was in Kyoto that young Kiyoshi Kane-da met his future wife, a renowned

teacher of social work and leader in her own right.

The newly minted Dr. Kaneda finished his post graduate work in orthope-dics at the Hokkaido University Post-graduate School of Medicine where he received his Ph.D. Dr. Kaneda began his work at the Department of Orthopaedic Surgery, Hokkaido University in 1968.

Kiyoshi Kaneda Partial List of Kaneda’s Spine Research Fellows

Osamu Shirado, M.D., Ph.D.Assistant Professor, Saitama Medical University, Saitama, Japan Received Ph.D., 1990, Hokkaido University.

Yasuhiro Shono, M.D., Ph.D.Lecturer, Hokkaido University School of Medicine, Sapporo, Japan Received Ph.D., 1992, Hokkaido University.

Yoshihisa Kotani, M.D., Ph.D.Assistant Professor, Hokkaido University School of Medicine,Sapporo, Japan Received Ph.D., 1994, Hokkaido University.

Masahiro Kanayama, M.D., Ph.D.Assistant Professor, Hokkaido University School of Medicine, Sapporo, Japan Received Ph.D., 1997, Hokkaido University.

Itaru Oda, M.D., Ph.D.Lecturer, Hokkaido University School of Medicine, Sapporo, Japan Received Ph.D., 1999, Hokkaido University.

Norimichi Shimamoto, M.D., Ph.D.Lecturer, Hokkaido University School of Medicine, Sapporo, Japan Received Ph.D., 2001 Hokkaido University.

Jun Kikkawa, M.D., Ph.D.Lecturer, Saitama University School of Medicine, Saitama, Japan Received Ph.D., 2009, Saitama University.

Hidemasa Umekoji, M.D., Ph.D.Lecturer, Saitama University School of Medicine, Saitama, Japan Received Ph.D., 2011, Saitama University.



Harvard, Twin Cities Scoliosis Cen-ter and Hokkaido University

In 1973 he became a visiting clinical fellow under Professor John E. Hall at The Children Hospital Medical Center, Harvard Medical School, Boston, Mas-sachusetts. In 1974 he was the visiting clinical fellow under Professor John Moe and Dr. Robert B. Winter at The Twin Cities Scoliosis Center, Minneapo-lis, Minnesota.

Upon returning to Sapporo in 1976, Dr. Kaneda was appointed Associate Profes-sor at the Department of Orthopaedic Surgery, Hokkaido University School of Medicine. Ten years later, 1986, Dr. Kaneda was appointed Professor and Chairman of the Department of Ortho-paedic Surgery, Hokkaido University.

We had the honor of interviewing Pro-fessor Kaneda at his home in Sapporo, Japan, just prior to the presentation of NASS’ Leon Wiltse Award. Professor Kaneda will receive his award at 10:55 am, Friday November 4th during the 2011 NASS Annual Meeting in Chicago.

Professor Kaneda Recalls an Extraordinary Career

OTW: Professor Kaneda, congratula-tions on being selected the 2011 winner

of the North American Spine Society’s prestigious Leon Wiltse Award. What were some of the most important influ-ences in your career and development as a Professor and international leader in spine surgery?

Professor Kaneda: Thank you. I am honored and privileged to receive the Leon Wiltse Award from the Society. Looking back I would like to first rec-ognize Harvard University’s Professor

John Hall. He extended an invitation to me to be a spine fellow with him at Har-vard University in the 1970s. I didn’t speak very much English at the time. But I went to Boston. After his lectures, Professor Hall would take the time to explain further his lectures. It was from Professor Hall that I began to learn anterior approaches for treating spinal deformities. I studied the Zielke, Dwyer and Texas Scottish Rite approaches. In 1979 I returned to Japan and brought

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the anterior rod approach with me. But we had problems and difficulties. The single rod system couldn’t handle the loads.

OTW: Can you describe how you devel-oped the Kaneda Dual Rod System?

Professor Kaneda: Biomechanically, the single rod system has weaknesses. It only works in two dimensions. So we started testing a two rod design. With a dual rod, we were able to address spi-nal instability within a three dimension approach. The rods in the dual rod sys-tem were skinnier, but they provided more stability than a single rod. We have found that the dual rod system is effective for stabilization in many indi-cations including deformities and ver-tebral fractures.

OTW: While you have retired from Hokkaido University, you still see patients twice a week and are perform-ing surgery once a week. What is your principal research and clinical practice interests these days?

Professor Kaneda: The Aging Spine! The effects of osteoporosis and com-pression fractures on the spine, back pain, and spinal cord injury is of high importance to me. [Professor Kaneda

published “Comparison of Incidence Rates of Vertebral Fractures in Japanese Patients with Osteoporosis”—in JBJS 2004]. The preferred treatment plan that we use begins with prevention—walking and drug therapy. Then we use bracing. Kyphoplasty, which was recently approved for reimbursement in Japan, is also helpful at the beginning

stages, but it is not for every patient. Eventually, for some patients, we per-form surgery and try to decompress where there has been vertebral collapse.

OTW: Thank you Professor Kaneda. We wish we had more time and we look forward to seeing you at NASS. ◆

* 2009 Whitecloud Award for Best Basic Science Paper. 16th Annual Meeting of the International Meeting of Advanced Spine Techniques (IMAST).

* 2002 Best Paper of the Society Award – Japanese Scoliosis Research Society.

* 2002 North American Spine Society (NASS) Award for Basic Science Spinal Research

* 2001 North American Spine Society (NASS) Award for Basic Science Spinal Research

• 2001 Moe Exhibit Award, Scoliosis Research Society• 1998 Moe Exhibit Award, Scoliosis Research Society

• 1998 Japanese Spine Research Society Award for Basic Science

• 1992 Cervical Spine Research Society (CSRS) Basic Science Research Award

• 1991 North American Spine Society (NASS) Award for Spinal Research

• 1991 American Orthopaedic Association (AOA) Award for Orthopaedic Spinal Research

• 1991 Cervical Spine Research Society (CSRS) Residents Award for Cervical Spine Research

Research Awards Presented to Kaneda’s Fellows

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VOLUME 7, ISSUE 34 | OCTOBER 25, 201112Orthopaedic Crossfire® Tackles Hip SqueakingBy Elizabeth Hofheinz, M.P.H., M.Ed.

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

TopicCeramic-Ceramic: For the Hard of

Hearing & Lives Alone

For the Proposition:Steven J. MacDonald, M.D., F.R.C.S.(C)University of Western OntarioLondon, Ontario, Canada

Against the Proposition:Stephen B. Murphy, M.D.Tufts University School of MedicineBoston, Massachusetts

Moderator: Thomas S. Thornhill, M.D. Harvard Medical SchoolBoston, Massachusetts

This debate was held in December 2008 in an Orthopaedic Crossfire® session at the 25th Annual Current Concepts in Joint Replacement™ (CCJR) Winter meeting in Orlando, Florida. The CCJR meetings are organized by A. Seth Gre-enwald, D.Phil. (Oxon) and the Ortho-paedic Crossfire® debates serve to frame contemporary controversies and con-tribute information in a uniquely com-pelling format within the very popular CCJR meetings (www.CCJR.com).

Dr. MacDonald: (A video starts which shows a mock physician’s office—Dr. Murphy’s office—where a patient calls with a ridiculously squeaky hip.) “I’m sorry, Mrs. Jones. I don’t hear anything,”

says the assistant. “Dr. Murphy? He’s in audiology getting fitted with some spe-cial earplugs.”

“There is no perfect bearing surface. Here is a 24-year-old woman who had recovered from acute lymphocytic lym-phoma and had bilateral hip avascular necrosis. This is the ideal indication for ceramic-on-ceramic (and I did this sur-gery for her). The biggest challenge on the squeaking is not being sure of the incidence and not understanding the etiology…and if we don’t understand the etiology then it’s hard to solve. We have several series from well respected authors; one shows less than 1% inci-dence and up to 21%. What percentage do you quote your patients?”


VOLUME 7, ISSUE 34 | OCTOBER 25, 201113“I took an informal survey at a closed Hip Society meeting…almost everyone indicated that they had seen squeak-ing in ceramic-on-ceramic. This isn’t a new bearing…why all of a sudden are we getting these increased incidents of squeaking? We have two well-docu-mented FDA IDE [investigational device exemption] studies with no squeaking. One explanation is if the incidence of something is only 1 or 2% then you could miss that in an FDA trial or in a few hundred patients because it is underpowered. But it’s not like we had a plethora of case reports either in the 70s, 80s, or 90s about this problem.”

“There are a number of possible causes. There is rim impingement leading to microseparation, with subsequent edge loading and stripe wear. There are papers saying cup position matters and others saying it doesn’t matter. Maybe it is metal particulate debris getting into the bearing. Is it head size? And there is neck length…again, there are authors saying ‘yes’ and others saying ‘no.’ Or, is it the ceramic material? There’s alumina versus a delta material.”

“What has changed in the last 20 to 30 years? For one thing…design. There are two groups: metal backed and non-metal backed. The latter design has the ceramic acetabular liner and metal shell level, is used in several current designs, and has a successful clinical history. Another more contemporary design has a metal backing on the ceramic acetabular liner and can be designed such that there is a prominent metal rim above the metal shell. This design has not been used historically and is really focused to one device.”

“The level mount one really has very rare squeaking reports and the promi-nent one does have a high report of Advertisement



squeaking; all series with very high squeakers are in that one design—it’s that simple. Rodriguez recently pub-lished a series looking at this exact shell with two different stems; one stem had a less than 1% rate of squeaking with that design. Another stem had a 5-10% [rate] so it’s probably a combination of things such that a different stem allows amplification of the vibration (so you hear squeaking). The design is critical, the way we do it is important…but we should avoid minimizing the complica-tions and we shouldn’t vilify an entire class of devices.”

Dr. Murphy: “It is true that I don’t hear very well. It’s also true that I’ve always used flush mounted non-metal backed ceramic liners without an elevated rim for the past 11 years. So Steve has made half of the argument for me and I’d like to make the other half. Appropriately

designed alumina ceramic-on-ceramic bearings have been used in our institu-tion over 1,100 times for more than a decade by nine surgeons, none of whom has ever had a patient with a squeak. Our experience is that the loud, clini-cally reproducible common squeak-ing is associated with one specific hip implant combination. This is an issue of metal material and design around the bearings—not an issue of the bearings themselves.”

“Overall, alumina ceramic-on-ceramic bearings have had superb outcomes in ten year studies. All of the reported problems seem to have happened after the FDA clearance when any femoral component was able to be used with them—before that they were restricted. The first report of common loud squeaking was made by the Lenox Hill group; this report was 36

years after the first alumina ceramic-on-ceramic hip, ten years after we started the FDA studies, but only three years after people were allowed to do more or less anything they wanted.”

Wagging a finger at his colleague, Dr. Murphy noted, “I’m disappointed with my friends from New York. They implied that the squeaking happened common-ly with all ceramics even though they had only used one design…and they didn’t have the scientific justification to make that statement. Also, they never said what implants they were using; and they never mentioned that they had changed the design or the bioma-terials. Lastly, they didn’t seek or heed the experience and knowledge of peo-ple that had much more experience and knowledge than they had.”

“My team and I examined all of our revi-sions over five years; we had five revi-sions for squeaking. All had an elevated metal rim, impingement, and metallo-sis. This is consistent with Ian Clarke’s finding that was published several years ago. In a recent Mayo Clinic study they deliberately injured the bearings and caused squeaking. With lubrication a worn bearing doesn’t squeak and with lubrication but with metal staining a worn bearing does squeak. We also examined the influence of design and we found two groups, one with flush mounted liners and one with elevated metal rims. We subdivided the latter group into those with stems made of a conventional titanium alloy and those with stems made of a beta titanium alloy. Those with the beta titanium alloy and the elevated metal rim were by far statistically significantly problematic as far as squeaking.”

“We looked back at the Lenox Hill study and sure enough they used a

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VOLUME 7, ISSUE 34 | OCTOBER 25, 201115recessed liner and a beta titanium alloy. Another recent study focused on neck length and found shorter necks to be associated with squeaking. What did they use? A recessed liner and a differ-ent stem with the same beta titanium alloy. A recent study by Dr. Restrepo of the Rothman Institute focused on cup position; they used more than one stem but they didn’t say how many of which. I checked with the authors and found that four retrievals had squeaking…and guess what…all had a recessed liner and a stem made of beta titanium alloy.”

“This has become like the fable of the blind men and the elephant. The one touching the tusk thinks it’s a spear…this is like the people who focus on cup or implant position. The blind man who touches the trunk thinks it’s a snake…that is like the group focused

on neck length who never mentioned in their article that they were using a different biomaterial. The man who thought the elephant’s ear was a fan…like those focused on acoustics. Acous-tics are the effect of squeaking—not the cause. And there was the blind man who felt the elephant’s tail and thought it was a rope…this is the group study-ing retrievals. They cannot determine what is going on if surgeons don’t tell them what the stems were that the retrievals were attached to. In fact, the big elephant is this beta titanium alloy. Occasional squeaking is multifactorial, but loud, frequent squeaking requiring revision is specifically associated with this biomaterial.”

Moderator Dr. Thornhill: “Steve, we surgeons are trying not to be the blind man walking behind the elephant and

stepping in something warm! Steve, what actually causes the squeaking? Is it a multiplicity of factors?”

Dr. MacDonald: “There is not just one factor. I think you need to have some type of metal debris at the level of the joint. If that is present you may get an increased rate of squeaking. All ceramic-on-ceramic has the potential to squeak.”

Moderator Dr. Thornhill: “Do you agree?”

Dr. Murphy: “You can get a squeak out of any hard bearing…it’s not very com-mon and it’s multifactorial. Metal stain-ing is certainly one of the causes. Con-ventional titanium stems hardly ever squeak with an elevated liner; we found that in order for a conventional titanium

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stem associated hip to get a squeak it had to be very malpositioned and have severe metallosis. We found that with a beta titanium you don’t need malpo-sitioning and you only need a little bit of metallosis. When we investigate fur-ther I think we’ll find that it’s just small amounts of a particular adverse mate-rial that is causing the problem.”

Moderator Dr. Thornhill: “If it’s my hip then it doesn’t matter whether it’s ‘hardly ever!’ Have you had a squeak in a ceramic-on-ceramic bearing?”

Dr. Murphy: “I have had 0.5 incidents where patients say that their hip has squeaked. That could be once a year, it could have happened once and gone away, or it could be once a month…it doesn’t happen to anybody more than once a day. What I want people to understand is there is a difference

between people who squeak with every step and having it happen occasion-ally—like people who complain that their kneecap clicks after a total knee. I don’t have any patients in my practice that have a relevant squeaking issue; these are not people who are having reoperations.”

Moderator Dr. Thornhill: “You could use a different stem so if we take out that combination are you OK with the very low incidence of squeaking?”

Dr. MacDonald: “Three publications have reported incidents of squeak-ing, all about half of one percent. It’s the same shell design and same elevat-ed rim, but a different stem—so you haven’t eliminated the problem. I don’t consider that exceedingly rare; I think Steve has outlined the major driver but we need to study other things.”

Moderator Dr. Thornhill: “Steve, the beta titanium stem…is the problem that it actually increases titanium wear debris? Is it harmonics?”

Dr. Murphy: “There’s fact and there’s opinion. The fact is that this implant combination is associated with loud squeaking. My opinion is that the metal is getting into the joint, affecting the bearing, and creating the squeak-ing energy. The fact that the stem is also flexible and thin and amplifies the acoustics is a totally separate issue, which I also think is true.”

Moderator Dr. Thornhill: “So you think it’s the material properties rather than the stem design?”

Dr. Murphy: “I don’t think design of the stem and the shape has anything to do with it.”

Moderator Dr. Thornhill: “Will the delta ceramics make this problem go away?”

Dr. MacDonald: “There is not enough data to support or refute this.”

Moderator Dr. Thornhill: Ten second response?

Dr. Murphy: “Delta will be similar to alumina. If you contaminate the joint and cause a problem then you’ll have a problem; if you design things so that you don’t contaminate the joint then you won’t have a problem.”

Moderator Dr. Thornhill: “Thank you gentleman…nice debate.” ◆

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Dear OTW Reader:

Brian Parsley, M.D. touts joys of return-ing to private practice…NASS to rec-ognize Kiyoshi Kaneda, M.D., Gun-nar Andersson, M.D., and Joel Press, M.D., AAOS and the OTA team up with SOMOS to organize disaster response…read on…

U.S. Sidelining Itself. A frustrated orthopedist tells OTW, “Our govern-ment is stepping back and letting other countries take the lead. Politicians and wildly unreasonable regulations are hampering our future…we used to be a country with a ‘we can do anything’ attitude…now we’re on the sidelines watching the action abroad. We should look closely at what the Europeans are doing along the lines of new product development. Insurers are a big part of the problem…truly, who is getting the money with these premiums going up? We are becoming a Scandinavian country…and I can’t remember the last time an innovative product came out of Scandinavia. I mean, to hear the CEO of Coca-Cola saying that the environment in China is more business friendly than that in the U.S. is such a shift. I’ve just never felt like this in my life…it makes me think about all of those books about the downfall of the Roman Empire.”

NASS: Awards for Spine Surgeons. Kiyoshi Kaneda, M.D., will receive the 2011 Leon Wiltse Award, which honors excellence in leadership and/or clinical research in spine care. Dr. Kaneda is the former Chair of the Department of Orthopaedic Surgery at the Hokkaido

University School of Medicine, Sap-poro, Japan. A respected leader in the field, Dr. Kaneda is best known for his work in spinal stabilization and instru-mentation. He also has received the Wiltse Lifetime Achievement Award from the International Society for the Study of the Lumbar Spine. Gunnar Andersson, M.D., Ph.D., will receive the Henry Farfan Basic Science Award, which recognizes outstanding con-tributions in spine related basic sci-ence research. Dr. Andersson is Pro-fessor Emeritus at Rush University School of Medicine, Chicago. He also was the Chair of Orthopaedic Surgery and Senior Vice President of Medical Affairs at Rush. Dr. Andersson is Past President of the International Society for the Study of the Lumbar Spine and the Orthopaedic Research Society. Joel

Press, M.D., is the recipient of the David Selby Key Service Award, which honors a NASS member who has con-tributed greatly to the art and science of spinal disorder management through service to NASS. Dr. Press is Professor of Physical Medicine and Rehabilita-tion at Northwestern University School of Medicine, Chicago. Dr. Press is past President of the North American Spine Society (NASS) and the former Chief of Staff at the Rehabilitation Institute of Chicago.

New Senior VP at Orthofix. Michael Finegan, who joined Orthofix as Vice President of Corporate Development in 2006, has moved into the role of Senior Vice President of Business Develop-ment and President of Biologics at that company. From 2009 he served

Reporter’s NotebookBy Elizabeth Hofheinz

Wikimedia Commons


VOLUME 7, ISSUE 34 | OCTOBER 25, 201118as the President of Biologics. Mr. Fin-egan came to Orthofix from the Boston Scientific Corporation, where he held several positions, with the most recent being Vice President of Corporate Sales. He graduated from Wake Forest Uni-versity in 1985 with a B.A. in Econom-ics.

Rothman Continues Expansion. Joseph A. Abboud, M.D., a shoul-der and elbow surgeon who received his medical degree from the George-town University School of Medicine, has joined the Rothman Institute. Dr. Abboud completed his orthopedic resi-dency as well as his shoulder and elbow fellowship at the University of Pennsyl-vania School of Medicine. Dr. Abboud was previously a Clinical Assistant Pro-fessor of Orthopaedic Surgery at the University of Pennsylvania.

Biologics Out of Asia. An avid ortho-pedic researcher tells OTW, “I think one of the exciting new frontiers in orthope-dic research is the application of plate-let-rich plasma for tendon and muscle healing in the field of sports medicine. More clinical studies still need to be done, and certainly this can be daunt-ing process in the United States. This has spurred international collabora-tions that I think will ultimately be as fruitful for orthopedics as it has been for other scientific domains. Our insti-tution has recently sent someone to Asia for research purposes, and it is apparent that the historic boundaries to such col-laborations are quickly evaporating.”

DJO Loses Executive VP. Andrew Holman, executive vice president, U.S. commercial operations, is leaving DJO to pursue other opportunities. In con-nection with this transition and for the immediate future, DJO President and Chief Executive Officer Mike Mogul

will assume direct responsibility for DJO’s commercial activities in the Unit-ed States. Mogul formerly served as Stryker Corporation’s Group President, Orthopaedics.

Returning to Private Practice. Brian Parsley, M.D., who is in the presiden-tial line for the American Academy of Hip and Knee Surgeons, has recently returned to private practice…and is he thrilled! Dr. Parsley tells OTW, “One of the biggest joys has been regaining control of my practice. This way, I can take care of patients the way I feel they should be treated; in other environ-ments patients are rushed through an office for the sake of volume—and the personal touch is lost. Also, I am happy to not have to deal with the economic headaches of an academic practice. The academic model is just more inefficient; and while they have to be more eco-nomically driven now, they are not as nimble as a private practice in control-ling costs and caring for patients. I’m happy to be back in practice at a physi-cian owned hospital.”

New Leadership for Ascendx Spine. Romano Ferrari is the new chairman of Florida-based Ascendx Spine. Since 2009 Mr. Ferrari has been president of Healthcare Industry Consultants, based in Paris. Earlier in his career, he served as president of Medtronic AVE Europe; vice president/Europe for Bax-ter Healthcare (Edwards Lifesciences); global vice president of Marketing & Sales for Sorin Group; and, president of Critical Care for Ohmeda.

Learning the Lessons From Haiti. Dr. Christopher Born, Chief of Orthopedic Trauma at Rhode Island Hospital within the Department of Orthopaedic Sur-gery of Brown University, is celebrating progress. He tells OTW, “AAOS and the

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VOLUME 7, ISSUE 34 | OCTOBER 25, 201120Orthopaedic Trauma Association have teamed up with the Society of Mili-tary Orthopaedic Surgeons (SOMOS) to develop a database for orthopedists who want to respond to disasters. In Haiti we found that a lot of doctors didn’t know what they were getting into. Some of the issues that need to be addressed are safety and security and the ethics of people doing things they are not trained to do. The plan calls for developing three types of respond-ers: trauma trained physicians who are available on an immediate basis, non-trauma trained doctors who are also able to leave on short notice, and those who are able to be available for recovery or sustaining situations weeks after an event. If people want to be included in the AAOS database they must undergo an educational training process. The highlight here is that SOMOS has taken its combat extremities course and refor-

matted it for civilians who are going to be acute responders. This coordinated effort will go a long way toward stream-lining disaster management.”

Keeping Golfers in Shape. DePuy Mitek has announced that it is donat-ing $60,000 to charity as part of an ongoing effort with the PGA TOUR to promote joint health. As part of the first ORTHOVISC PGA TOUR Player Char-ity Program, thousands of fans voted via computer kiosks at various PGA TOUR tournaments for their favorite play-ers, who will be receiving donations for their charities. The top four play-ers were John Daly, Jim Furyk, Stewart Cink and Jonathan Byrd.

No Postop Narcotics? A seasoned orthopedist tells OTW, “There is a new movement in hospitals to move away from using narcotics to relieve pain.

There are issues with these drugs, namely that the patients are either total-ly knocked out or not very responsive, they have more pulmonary complica-tions, and they often have urinary com-plications. Our hospital is one of the many now using IV Toradol, an anti-inflammatory that is great for pain. But there is even an issue with this drug; in lab animals it has been shown to slow down bone healing. So, like many hospitals, ours is also advocating the use of IV Tylenol—which seems to be working well. The problem is that for years nurses have been drilled to offer the appropriate levels of pain control meds, i.e, ‘make the pain stop.’ So you have a lot of nurses who are still in the old mindset of being accustomed to patients who are knocked out. This ‘no narcotics’ movement is a real pendulum swing…but it is quite overdue.” ◆

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Stryker Gains in 3rd Quarter

Despite “continued challenges pre-sented in today’s difficult eco-

nomic environment,” Stephen Mac-Millan, Stryker Corp.’s CPCEO (chair-man, president and CEO), announced “another quarter of consistent and solid sales and earnings growth.”

The company reported a 14.9% increase in total sales for the third quarter to $2.03 billion. Reconstructive sales of $901 million increased 8%, MedSurg sales rose 12% to $767 million and Neuro/Spine sales of $363 million

increased by 48.8%. The large increase in Neuro/Spine sales was due to the acquisition of Boston Scientific’s neuro business. Excluding the impact of the acquisition and the impact of a posi-tive currency exchange, Neuro/Spine sales only rose 0.5%. Overall, a positive foreign currency exchange contributed 3.2% to sales.

On a reported basis, hips climbed 9.9%, knees rose 2.6% and trauma was up 16.8%. On a reported basis, spine sales rose 7.8%

MacMillan attributed Reconstructive product sales to higher shipments of hip and trauma and extremities implant systems. Sales growth through acquisitions, were offset by lower ship-ments of knee and other implant sys-tems. Excluding the impact of acquisi-tions, sales of Reconstructive products increased 2.3% in constant currency over the prior year.

Outlook

The company announced that excluding an expected impact of foreign currency

and acquisitions, sales growth is expect-ed to be 4-5% for the full year 2011 compared to its prior forecast of 5-7%.

The Reconstructive Market

Mizuho Securities analyst Mike Matson said it was a solid quarter in a tough environment and he expects growth to improve somewhat in 2012.

Matson estimates that the recon mar-ket grew by 1% on a constant currency basis during the third quarter based on actual results from Biomet, DePuy and Stryker as well as estimates for the other orthopedic companies. On a con-stant currency basis, he estimates that global knee growth was 0% and global hip growth was 3%. He thinks Stryker’s hip growth indicates market share gains while its knee growth indicates market share losses. Overall, he says Stryker gained recon market share overall.

—WE (August 30, 2011)

company

Source: Stryker Corporation

Stryker 3Q11Sales

($ in millions)%

Change

Total Reported Sales $2,031 14.9%

Reconstructive $901 8.0%

Hips $300 9.9%

Knees $311 2.6%

Trauma/Extremities $236 16.8%

Med Surg $767 12.0%

Neurotech/Spine $363 45.8%

Spine $179 7.8%

Stryker Board and RRY Photo Creation


VOLUME 7, ISSUE 34 | OCTOBER 25, 201122DePuy’s 3Q11: Steady, Waiting for Synthes

DePuy Orthopaedic’s reported sales were up 5.7% to $1.38 billion for

the third quarter of 2011. A positive foreign currency impact contributed 4.4% to those sales.

BMO Capital Markets analyst Joanne Wuensch noted that orthopedic sales looked a little better than the second quarter. On a constant currency basis, hip sales were up 1% (down 4% in the U.S. and up 8% outside the U.S.), given metal-on-metal concerns and the recall of its ASR hip. Knee sales, on a constant currency basis, were down 4% world-wide (down 7% in the U.S. and down 1% outside the U.S.). Spine sales were

up 1% worldwide (down 3% in the U.S. and up 10% outside the U.S).

During the quarter, the FDA cleared the company’s Trumatch Personalized Solutions System for use with the Sigma Fixed-Knee bearing system. This adds another competitor to the customized knee market, including Biomet, Smith & Nephew, Stryker, and Zimmer.

On a call with analysts on October 18, management noted that hospital/sur-gical procedures continue to be nega-tively affected, following six quarters of year-over-year declines in procedures. Management also commented on phy-sician office visits falling dramatically, including nine consecutive quarters of declines, noting “obviously nowhere

near pre-recession levels of volumes.”

Management estimates that the orthopedic market declined 2% during the sec-ond quarter in the U.S. and was down 1% worldwide. The company expected that softness to have continued into the third quarter.

The Johnson & Johnson (DePuy’s parent) acquisi-tion of Synthes is proceed-ing according to plan and Synthes shareholders will have their vote on the deal in mid-December. Man-agement anticipates clos-ing the transaction in first half of 2012. The company submitted its EU merger regulation filing in mid-September.

—WE (October 21, 2011)

Patients Catching Fire in OR?

The last concern of a patient about to undergo surgery is a fire in the

operating room. Unfortunately, it is more common than most patients or physicians realize. Experts estimate that approximately 600 surgical fires, defined as fires that occur in, on or around a patient who is undergoing a medical or surgical procedure, occur in operating rooms each year in the U.S. Some of these have caused serious inju-ry, disfigurement or death.

To reduce this number, the FDA is launching a “Preventing Surgical Fires” initiative to increase awareness of the factors that contribute to surgical fires, disseminate surgical fire prevention tools and to promote risk reduction practices in the OR.

Surgical fires can occur any time three critical elements are present. These are an ignition source such as

•electrosurgicalunits,lasers,orfiberoptic light sources;

•afuelsourcesuchassurgicaldrapesand alcohol-based skin preparation agents;

Image creation by RRY Publications, LLC. Source: Wikimedia and DePuy

US Food and Drug Administration


VOLUME 7, ISSUE 34 | OCTOBER 25, 201123•an oxidizer such as oxygen or

nitrous oxide.

Materials that may not burn in room air can ignite easily and burn fiercely in an oxygen-enriched environment. In fact, most surgical fires occur in an oxygen-enriched environment. Alcohol-based skin preparation agents are very flam-mable when still wet. The placement of surgical drapes (such as when they are placed in a way that allows oxygen to pool under them), and the handling of ignition sources (such as resting hot ignition sources on the drapes) may also increase the chance that a surgical fire will occur.

The FDA initiative recommends that surgeons deliver the minimum concen-tration of oxygen needed to maintain adequate oxygen saturation for their patients and use a closed oxygen deliv-ery system such as an endotracheal tube or laryngeal mask whenever possible. If using an open delivery system they should take additional precautions to exclude oxygen from the field.

These precautions include draping techniques that avoid accumulation of oxygen in the surgical field, the use of incise or fenestrated drapes which may help isolate oxygen from the surgical site, blowing air to wash out excess oxy-gen, or alternatively, scavenging oxygen from the field.

Ignition sources, such as electrosurgical units and electrocautery devices, when not in use, should be placed in a holster and not on the patient or drapes. Surgi-cal drapes can ignite easily and burn in an oxygen-enriched environment, even if the products are described as “flame-resistant.”

—BY (October 18, 2011)

TranS1 Subpoenaed; No Accusations Made

TranS1, Inc. has received a subpoena from the Office of Inspector Gen-

eral (OIG) of the Department of Health and Human Services (HHS). The sub-poena was issued under the authority of the federal healthcare fraud and false claims statutes.

In an 8-K October 17 filing with the Securities and Exchange Commission, the company stated the OIG was seeking documents for the period of January 1, 2008 through October 6, 2011. TranS1 is cooperating with the government’s request and is in the process of respond-ing to the subpoena. Company officials are unable to predict what action, if any, might be taken in the future by HHS as a result of the subpoena or what impact, if any, the outcome might have on its con-solidated financial position, results of operations, or cash flows. The company said no claims have been made against TranS1 at this time.

There was some speculation on Wall Street about the nature of these subpoe-nas and whether other spine companies had received similar requests. Nothing else had been reported as of this writ-ing. The company has been struggling with reimbursement issues, but has recently been successful in convincing some large insurance carriers to cover their AxiaLIF procedure.

The False Claims Act, 31 U.S.C. §§ 3729-3733, deals with those who knowingly submit, or cause another person or entity to submit, false claims for payment of government funds. The inquiries are often related to a sealed whistleblower lawsuit.

It bears noting that no accusations have been made against the company. As we saw with bone stimulation manufactur-ers in 2009, the government sometimes uses subpoenas to gather information to settle reimbursement issues.


Image Credit: RRY Publications Photo Manipulation


VOLUME 7, ISSUE 34 | OCTOBER 25, 201124ISTO Spine Fusion Graft Cleared for Europe

ISTO Technologies, Inc. has received the Conformite Europeenne (CE)

Mark approval for its InQu product line. InQu is a bone graft substitute and extender currently sold through a network of independent distributors in the U.S. Receipt of the CE Mark allows ISTO to start selling the product in Europe.

Mitchell Seyedin, Ph.D., ISTO’s presi-dent and CEO stated, “The product has proven to be an innovative and cost effective bone grafting alternative for spinal fusion and other orthope-dic surgeries in the United States and we believe that distribution in Europe will augment our domestic revenue growth.”

On October 13, the company stated that InQu is a “differentiated biomate-rial scaffold of synthetic and biologic

polymers used mainly in spinal fusion applications.” The product is currently manufactured in four different forms (granules, paste, putty, and a three-dimensional scaffold).

“The versatility of the product configu-rations provides surgeons with more options and allows for broader prod-uct applications. The company believes InQu represents a new approach to optimizing bone healing, based on its combination of structural and biologi-cal attributes inherent to two uniquely combined biomaterials, polylactide-co-glycolide (PLGA) and unmodified hyal-uronic acid (HyA). Both biomaterials have a long history of safe and effective clinical use,” continued the statement.

PGLA, according to the company, is a structural component that creates an osteoconductive scaffold. HyA provides improved handling and exhibits unique biophysical and biological properties, which play an important role during embryonic development, tissue regen-eration and bone repair.

InQu is intended to fill bony gaps or voids that are not intrinsic to the stabili-ty of the bony structure. InQu is intend-ed for use as a bone graft substitute in the skeletal system (extremities and pel-vis), and as a bone graft extender in the spine when combined with bone auto-graft. These defects may be surgically created or result from traumatic injury to the bone.

ISTO is a St. Louis, Missouri, privately held company with products intended for the repair and regeneration of dam-aged or injured cartilage and bone. The company’s product derived from its car-tilage regeneration platform is DeNovo ET, a scaffold-free engineered cartilage tissue, intended for the repair of dam-aged articular cartilage in the knee. DeNovo ET is developed in partnership with Zimmer Holdings, Inc.


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Augment Cleared for Australia

BioMimetic Therapeutics, Inc. has announced that the Therapeu-

tic Goods Administration (TGA) has approved the company’s medical device application for Augment Bone Graft clearing the way for commercialization of the product in Australia and its list-ing on the Australian Register of Thera-peutic Goods (ARTG). Based on the clinical data from the North American pivotal trial and Canadian registration trial evaluating Augment Bone Graft, the product has been approved in Aus-tralia for use as an alternative to auto-graft, the current gold standard in bone

grafting, in hindfoot and ankle fusion procedures.

“Approval of Augment Bone Graft by another major regulatory agency, such as the TGA, marks a significant achieve-ment in BioMimetic’s global product development program and further vali-dates our technology, clinical data and ability to gain regulatory approvals,” said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics, in the October 19, 2011 news release. “Given that obtaining autograft often requires a second surgical procedure, increasing the pain and potential for complica-tions for the patient, and that Augment will be the first alternative approved in foot and ankle fusion surgery with large, randomized controlled clinical data, we are optimistic that Augment

will find broad support from Australian hospitals, surgeons and patients alike. We are completing the final steps for pricing and reimbursement and expect a full launch of the product in the first quarter of 2012.”

When asked if there was anything par-ticularly different or interesting about working in Australia versus the U.S., Russ Pagano, VP of Clinical and Regu-latory Affairs, told OTW, “The TGA is structured very similarly to the FDA, and thus we underwent a rigorous approval process. Although Augment Bone Graft is considered a device, like the U.S., both the TGA drug and device teams are required to spend considerable time reviewing the entire data package. We were not required to enroll additional patients in a clinical study in Australia; instead our product was approved based on clinical data from the North American and Canadi-an trials that also evaluated Augment. The TGA holds a meeting analogous to an FDA panel meeting; however, in Australia, this meeting is closed to the public and sponsor. Therefore, we didn’t have an opportunity to present our case for approval of Augment as we did in the U.S., which could make receiving an Australian approval even more difficult.”

Regarding highlights of the upcom-ing product launch, Hans Kestler, VP, Orthopedics and Sports Medicine, told OTW, “The full launch of the product this spring will be the first utilizing our new brand elements, which were designed to communicate the compa-ny’s mission to reject the ordinary when developing products for surgeons who aren’t satisfied with the status quo. Aug-ment will be delivered to hospitals in updated packaging that features our new colors, logo and messaging.”

—EH (October 21, 2011)

biologics

Image Credit: BioMimetic


VOLUME 7, ISSUE 34 | OCTOBER 25, 201126Spine Stem Cell Trials Underway

Dr. Hyun Bae, co-director of the spine fellowship program at

Cedars-Sinai Spine Center, Los Ange-les, was among the first surgeons to use growth factor tissue engineering for intervertebral discs and multilevel artificial disc replacements for both the lumbar and cervical spine.

Now he is deeply involved in stem cell research and believes that the appropri-ate patients could benefit greatly from stem cell use. “I think stem cells will make a big impact on spine care,” says Bae. “I don’t think this is some mythical soundscape that won’t work. I think in the next 10 years, stem cells will make a significant impact on our medical field.”

Bae is participating in several clinical trials for spine surgery. One involves

the injection of stem cells into the disc to promote disc regeneration. The goal is to relieve the patient’s pain without resorting to fusion procedures. Accord-ing to Bae, this has been successful in

animal models and is now being used in a human trial.

In patients with an annular tear, the sur-geons are using a fibrin glue to close the

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VOLUME 7, ISSUE 34 | OCTOBER 25, 201127disc and promote healing instead of fus-ing it or removing it. They are injecting fibrin glue in half of the patients and a placebo in the other half to measure the glue’s efficacy. Bae is surprised with the success some patients are exhibiting. “Some of the patients have had amazing results,” he says. “I’m surprised because initially I was sceptical, but I’ve been amazed.”

A third trial is investigating the use of stem cells for treating vertebral compres-sion fractures in patients with osteopo-rosis. Surgeons transport allograft stem cells to the surgical site where the cells are manipulated by non viral meth-ods to produce a bone morphogenic protein-type molecule, which, they believe, should promote healing.

“We want the stem cells to produce a growth factor that can also stimulate healing,” says Bae. “We’ve shown in ani-mal models that we can insert a gene into the cells that will be able to pro-duce bone. We can heal a radial, verte-bral body or long bone defect by inject-ing stem cells into the surgical site that have been modified to produce bone.”

Bae hopes to research this method with patients who have osteoporosis. While these patients have global bone loss, there are certain sites where the loss is more significant. “If we are able to inject stem cells into a damaged site like the hip joint, we may be able to prevent the major fracture morbidity associated with osteoporosis,” he says.

Cedars-Sinai is one of eight centers where surgeons are examining the use of stem cell injections for disc regenera-tion. Most devices and procedures uti-lizing stem cell technology have not yet been approved by the Food and Drug Administration.


Children’s Knee Injury Rate Up

Children are banging up their knees—experiencing tears of the

anterior cruciate ligament (ACL) and meniscus—at a dramatically faster rate than in the past. This is according to a study conducted by The Children’s Hospital of Philadelphia and presented at the American Academy of Pediatrics annual meeting October 15-18 in Bos-ton.

“Knee injuries are an ever-growing problem for children and adolescents involved in sports,” said J. Todd Law-rence, M.D., Ph.D., orthopedic surgeon at the hospital.

The study team reviewed the records for all patients under 18 with ACL and meniscus tears treated at The Children’s Hospital from January 1999 through January 2011 and compared them to patients who sustained tibial spine fractures during that same time period. A total of 155 tibial spine fractures, 914 ACL tears and 996 meniscus tears were identified. Tibial spine fractures increased by only 1 per year, whereas ACL tears increased by more than 11 per year and meniscus tears increased by almost 14 per year.

“Since tibial spine fractures were once thought to be the pediatric equivalent of an ACL tear,” said Lawrence, “this continued rise in ACL tears in children suggests that injury patterns are chang-ing and that the true incidence of these injuries is increasing.”

The study’s authors hope their research will high-light the importance of identifying pediatric and adolescent athletes who may be at risk for ACL and meniscus injuries and encourage coaches, parents and athletes to consider incorporating injury prevention pro-grams into their work-outs. The Center has developed a sports inju-ry prevention program called Ready, Set, Prevent which is designed to be performed as part of the traditional sports warm-up. The free video is available at: http://www.chop.edu/video/sports-medicine-performance/ready-set-prevent/home.html


large joints

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Surgeon’s Dilemma – Staple or Suture?

To staple or to suture—that is the question. How the wound is closed goes a long way in determining surgi-

cal success. The effect of the staple-or-suture-choice may be magnified in elective procedures such as total knee arthroplasty. Up to the present, the literature has been divided on the subject.

Now comes another study. Researchers reviewed two cohorts of patients at a level one trauma and referral cen-ter: 181 patients qualified for inclusion in the study. Surgeons employed staples in 82 cases (45.3% of total) and sutures in 99 cases (54.7%). The staples group had no complications while the sutures group had nine (9.1%).

These nine complications consisted of four infections, two of which were super-ficial, one was deep and one was clas-sified as “organ/space.” Three patients required re-suturing for dehiscence; one experienced allergic type reaction to suture material; and one experienced gout flare resulting in dehiscence. The

mean surgical time with sutures was 122.3 minutes and with staples was 114 minutes.

Outcome variables included time of surgery, wound dehis-cence, surgical site infection per the Center for Disease Control criteria and repeat procedures for debridement and re-closure. The conclusion was that the study dem-onstrated significantly fewer complications with staple use than with suture use. This study was first reported by BioMed Central, an open access publisher.


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Study: Omega-3 Helps Osteoarthritis

A study from the University of Bris-tol has shown for the first time that

omega-3 in fish oil could “substantial-ly and significantly” reduce the signs and symptoms of osteoarthritis (OA). In the study, published in the journal Osteoarthritis and Cartilage, omega-3-rich diets were fed to guinea pigs, and reduced OA by 50% compared to a standard diet.

Lead researcher Dr. John Tarlton, from the Matrix Biology Research group at the University of Bristol’s School of Vet- Wikimedia Commons William Merritt Chase



erinary Sciences, said classic early signs of the condition, such as the degrada-tion of collagen in cartilage and the loss

of molecules that give it shock-absorb-ing properties, were both reduced with omega-3.

“Furthermore, there was strong evi-dence that omega-3 influences the bio-chemistry of the disease, and therefore not only helps prevent disease, but also slows its progression, potentially con-trolling established osteoarthritis,” Dr. Tarlton said in the October 17, 2011 news release.

Dr Tarlton added: “The only way of being certain that the effects of omega-3 are as applicable to humans as demon-strated in guinea pigs is to apply omega-3 to humans. However, osteoarthritis in guinea pigs is perhaps the most appro-priate model for spontaneous, naturally occurring osteoarthritis, and all of the evidence supports the use of omega-3 in human disease.”

Medical research director of Arthritis Research UK, Professor Alan Silman, added. “The possibility that omega-3 fatty acids could prevent osteoarthritis from developing has been a tantalizing one. Some limited, previous research in dogs has suggested that we were a long way away from understanding the potential use in humans. However, this current research in guinea pigs is excit-ing as it brings us closer to understand-ing how omega-3 might fundamentally interfere with the osteoarthritis process, and that it could potentially be taken as a treatment.”

“Most diets in the developed world are lacking in omega-3, with modern diets having up to 30 times too much omega-6 and too little omega-3. Taking omega-3 will help redress this imbalance and may positively contribute to a range of other health problems such as heart dis-ease and colitis.”


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Stapling – A New Sco-liosis Fix

A four-year-old California girl, named Grace, is romping about much

like any other child her age, thanks to pioneering surgery by University of California-San Francisco orthopedic surgeon Dr. Mohammad Diab. Grace has severe scoliosis and instead of pro-scribing a heavy torso-covering plastic brace that she would have to wear for 20 hours a day, Diab stapled together several vertebrae in her spine.

As reported in the San Francisco Chron-icle, while stapling is a temporary fix, it saves the girl from years of wearing a brace. Also, it is hoped that the stapling will correct the curve and prevent it from getting worse.

Spinal stapling, a surgery designed at a children’s hospital in Philadelphia, is considered both experimental and controversial among scoliosis experts. Some doctors see it as an alternative to the standard treatments, which can be difficult to endure and aren’t always successful.

“I don’t want people lining up for this,” said Diab. “I’m inherently cautious, and it’s not for everyone. But I want people to pay attention, because there may be alternatives” to the traditional treat-ments.

The most common treatment is the unpleasant bracing procedure which children routinely resist. If bracing fails and the curvature worsens, children often need surgery to implant rods along their spine that force it to grow straight. But that surgery isn’t always successful either, and children need

frequent follow-up operations to adjust the rods as they grow.

“It would be nice to have better treat-ments. Asking a 12-year-old girl to wear this big piece of plastic 20 hours a day is a particular kind of torture,” said Dr. Jim Policy, director of the scoliosis center at Oakland Children’s Hospital. He is waiting for more research on the stapling procedure before he considers using it.

Scoliosis, for which there is no known cause, affects about 1% to 2% of Ameri-cans—the majority of them women. A normal spine will have a curve of 10 degrees or less, whereas the spine of scoliosis patients can curve 45 degrees or more.


spine

Children’s Hospital of Boston


VOLUME 7, ISSUE 34 | OCTOBER 25, 201131Vexim: SpineJack in India

Vexim, the French company known for the MI treatment of vertebral

compression fractures, has announced that it has obtained the registration cer-tificate for SpineJack in India. The com-pany will market the SpineJack in India as soon it receives the import license from the Indian authorities.

“This registration certificate shows, once again, SpineJack’s conformity to the requirements of the worldwide market. Even if the deployment of SpineJack in Europe is our first prior-ity, and that deployment is progress-ing with increasing success given the

interest that SpineJack is generating in the global market, we will continue to reply favorably to demand for this product coming from other markets. This is the case for India today and this registration certificate, completed by a pending import license, will soon enable Vexim to start commercializing SpineJack in that market thanks to our local distributor,” emphasized Vexim’s President and CEO Bruce de la Grange in the October 3, 2011 news release.

de la Grange told OTW, “During the time it took to register the SpineJack and its associated products in India, we realized a number of milestones with regard to this market. First, we have signed an exclusive distribution contract with our distributor, followed

by product training for the personnel of the distributor and his key opinion leaders in India. During this process, we came to the following conclusions: there are quite a number of highly trained and accomplished orthopedic surgeons operating in India. There are also a large number of excellent clinics in India offering state of the art care in India. The Indian regulatory authorities have shown that they are dedicated to insuring that the highest level of care and innovative technologies in medical devices be available to Indian patients, and we are very pleased to be classified in that category by the Indian regula-tory authorities.”


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