VOLUME 7, ISSUE 17 | MAY 24, 2011

week in review

Ankle Surgery Biologics Drama at FDA Panel ◆ Biologics for an- 4kle fusion got a shot in the arm when the FDA’s Orthopedic Panel vot- ed to recommend approval for BioMi- metic’s Augment. It wasn’t pretty. It was dramatic, close and contentious. We were there when CEO Lynch made his “Hail Mary” pitch.

The Restless Orthopedic Sur- geon ◆ Creativity and orthope- 8 dic surgery are usually incom- patible concepts – except in oncology. There we find a restless class of sur- geons who scramble onto the surgical high wire and perform remarkable feats of anatomical reconstruction. picture of success breaking news

Dr. Taylor Smith ◆ Dr. Biotech Firms Histogenics Taylor Smith, winner of the and ProChon Merge 272011 Humanitarian Award 17...... from AAOS, has worked with Chinese Terumo Buys Harvest Technologies refugees in Hong Kong, contributed ...... first hand to musculoskeletal care in Stryker Snaps Up Orthovita for $316 Fiji, and has made a number of trips to Million Haiti since the earthquake...... Anesthetic Change Boon for Patients ...... FDA “522s” Metal-on-Metal Hips Scalpel…Now or Later? ◆ ...... What does the latest evi- U.S. Senate Looking at PODs 13dence-based literature say ...... regarding the surgical timing of injured Quick to Dough PMMA From extremities? Are there guidelines for Medtronic acute versus staged care? What if there are pulmonary problems or a chest in- jury…read on. For all news that is ortho, read on.

1-877-817-6450 | www.ryortho.com 2 VOLUME 7, ISSUE 17 | MAY 24, 2011 Orthopedic Power Rankings Robin Young’s Entirely Subjective Ordering of Public Orthopedic Companies

This Week: Macro factors such as regulatory, reimbursement and the general economic funk (high unemployment rates and budget cuts at state and federal levels) create conditions for low sales growth rates, but building pent-up demand. Low single-digit sales growth generally is the new normal.

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

According to Wall Street’s analysts, ATEC is 1 1 Alphatec 1.11 13.55% expected to have the highest rate of earnings growth of any orthopedic stock in 2011. With the lowest P/E to growth ratio and the 3rd 2 2 Orthofix 14.49 17.19 lowest future P/E, OFIX still best value.

NUVA is now the bellwether spine surgery implant 3 3 NuVasive 6.69 11.73 supplier. It will pull up the industry.

The key to ZMH is that operating margin. It forms 4 4 Zimmer 26.64 10.01 the basis for investor interest. Any investor.

Johnson & Now comes the long, slow process of merging 5 5 26.33% 2.02 Johnson two armies—Synthes and DePuy.

Valuation is actually pretty attractive at these 6 7 Stryker 25.61 2.34 levels—8th best in ortho.

New CEO should give MDT a sense of direction 7 8 Medtronic 31.23 8.58 and renewed purpose. IART’s collection of small to mid-sized Integra 8 6 15.18 3.76 companies a strategic conundrum in a period of LifeSciences health care reform. Smith & Is wound care the new hot product category? 9 9 23.22 2.54 Nephew Biohealing’s sale to Shire colors SNN.

2nd best PSR and very low P/E to growth rate is 10 10 Symmetry 8.08 (3.50) the only reason SMA makes the Power Rankings.

1-877-817-6450 | www.ryortho.com 3 VOLUME 7, ISSUE 17 | MAY 24, 2011 Robin Young’s Orthopedic Universe

Top Performers Last 30 Days Worst Performers Last 30 Days Company Symbol Price Mkt Cap 30-Day Chg Company Symbol Price Mkt Cap 30-Day Chg

1 Orthovita VITA $3.83 $295 76.50% 1 TranS1 TSON $4.25 $89 -20.56% 2 Tornier N.V. TRNX $26.98 $1,053 34.90% 2 TiGenix TIG.BR $1.65 $51 -8.00% 3 Mako Surgical MAKO $31.98 $1,310 21.14% 3 Symmetry Medical SMA $9.64 $351 -3.50% 4 Orthofix OFIX $39.00 $704 17.19% 4 CryoLife CRY $5.30 $148 -3.11% 5 Alphatec Holdings ATEC $3.52 $314 13.55% 5 ArthroCare ARTC $33.25 $908 -2.72% 6 NuVasive NUVA $30.85 $1,224 11.73% 6 Wright Medical WMGI $15.40 $601 -2.28% 7 Zimmer Holdings ZMH $67.70 $12,996 10.01% 7 Kensey Nash KNSY $24.50 $209 0.45% 8 Stryker SYK $63.42 $24,607 8.58% 8 Exactech EXAC $17.77 $232 0.97% 9 Medtronic MDT $42.21 $45,138 3.76% 9 RTI Biologics Inc RTIX $2.84 $157 1.07% 10 ConMed CNMD $28.82 $816 3.56% 10 Bacterin Intl Holdings $3.35 $128 1.52%

Lowest Price / Earnings Ratio (TTM) Highest Price / Earnings Ratio (TTM) Company Symbol Price Mkt Cap P/E Company Symbol Price Mkt Cap P/E

1 Medtronic MDT $42.21 $45,138 12.79 1 NuVasive NUVA $30.85 $1,224 36.73 2 Johnson & Johnson JNJ $65.69 180,066 13.63 2 ArthroCare ARTC $33.25 $908 27.94 3 Kensey Nash KNSY $24.50 $209 13.92 3 Wright Medical WMGI $15.40 $601 23.69 4 CryoLife CRY $5.30 $148 14.32 4 Synthes SYST.V X $169.72 $20,159 22.19 5 Zimmer Holdings ZMH $67.70 $12,996 14.94 5 ConMed CNMD $28.82 $816 22.00

Lowest P/E to Growth Ratio (Earnings Estimates) Highest P/E to Growth Ratio (Earnings Estimates) Company Symbol Price Mkt Cap PEG Company Symbol Price Mkt Cap PEG

1 Orthofix OFIX $39.00 $704 0.87 1 Alphatec Holdings ATEC $3.52 $314 4.46 2 Kensey Nash KNSY $24.50 $209 0.98 2 CryoLife CRY $5.30 $148 2.86 3 Exactech EXAC $17.77 $232 1.13 3 ConMed CNMD $28.82 $816 2.43 4 NuVasive NUVA $30.85 $1,224 1.15 4 Johnson & Johnson JNJ $65.69 180,066 2.06 5 Symmetry Medical SMA $9.64 $351 1.38 5 Integra LifeSciences IART $51.01 $1,457 1.81

Lowest Price to Sales Ratio (TTM) Highest Price to Sales Ratio (TTM) Company Symbol Price Mkt Cap PSR Company Symbol Price Mkt Cap PSR

1 RTI Biologics Inc RTIX $2.84 $157 0.94 1 Mako Surgical MAKO $31.98 $1,310 29.57 2 Symmetry Medical SMA $9.64 $351 0.97 2 TiGenix TIG.BR $1.65 $51 21.35 3 ConMed CNMD $28.82 $816 1.14 3 Synthes SYST.V X $169.72 $20,159 5.47 4 Wright Medical WMGI $15.40 $601 1.16 4 Tornier N.V. TRNX $26.98 $1,053 4.63 5 Exactech EXAC $17.77 $232 1.22 5 TranS1 TSON $4.25 $89 3.40

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

Advertise with Orthopedics This Week Click Here for more details or email [email protected] Tom Bishow: 410.356.2455 (office) or 410.608.1697 (cell)

1-877-817-6450 | www.ryortho.com 4 VOLUME 7, ISSUE 17 | MAY 24, 2011 Ankle Surgery Biologics Drama at FDA Panel By Walter Eisner

questions about the way adverse events were defined and reported in the study, shifting primary study endpoints, the appropriateness of CT scans and the effectiveness of itself.

Lynch’s “Hail Mary”

The panel was about to vote when Lynch made an unscheduled and impassion- ate presentation to the panel.

“Please,” he pleaded, “judge our prod- uct by our clinical evidence, not some other product.” Lynch told the panelists that the company’s recombinant human

Photo manipulation by RRY/ Walter Eisner

am Lynch, founder, president and More on the specifics of Augment and SCEO of BioMimetic Therapeutics, the clinical study later. Inc., had heard enough. Trial Questioned Lynch, D.M.D., D.M.Sc., had been in the audience all day on May 12 as FDA “The trial has no meaning,” said Brent staffers and some members of the FDA Blumenstein, Ph.D., a statistical con- Orthopedic and Rehabilitation Devices sultant and long serving member of the Panel tried to rip apart his company’s Panel. Lynch had also listened to the Augment Bone Graft clinical study. FDA point out the risk for “potential” for formation in patients receiving Augment is designed to be used by Augment based on a Black Box warning orthopedic surgeons during ankle sur- for a Johnson & Johnson product called gery, specifically hindfoot and ankle Regranex. Augment contains the same fusion procedures, as a replacement for PDGF molecule as Regranex. Regranex autograft bone harvesting. BioMimet- is FDA approved for use as a foot ulcer ic is seeking a premarket application treatment. In addition, Lynch’s team (PMA) approval. had to spend the day responding to Advertisement

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Sam Lynch, D.M.D., D.M.Sc./BioMimetic platelet-derived growth factor (rh- PDGF) had been in clinical use for over five years, in 250,000 patients as a dental product (sold under the brand name GEM 21S). Furthermore, Lynch pointed out, 600 patients in the U.S., Canada and Europe had already been treated with Augment and not one significant adverse event was ever reported.

Lynch felt compelled to speak directly to the panel to address items brought up during the meeting. As the leader of the team and given how the day had gone, Lynch thought it was his responsibility to make the final argu- ment, and if necessary, “take the bul- let” if the panel voted against approv- al. Considering how the day had gone, that outcome would not have been surprising.

Biologic FDA Woes Advertisement The FDA has not been a friendly place for biologic products intended for surgery. Recently the agency denied surgery and before that the FDA panel The financial markets, in anticipation Medtronic’s application to have its failed to recommend Stryker’s bone of yet another panel biologics rejection, bone morphogenic protein product, morphogenic protein, OP-1, also for had sold BioMimetic’s stock off – driving Amplify, approved for spine fusion spine surgery. it down to 40% to $8.00 from $14.00 –

1-877-817-6450 | www.ryortho.com 6 VOLUME 7, ISSUE 17 | MAY 24, 2011 when word of the FDA’s concerns with the company’s PMA was made public.

It was under those circumstances that Dr. Sam Lynch stood up and made his speech at the end of a brutal day in front of the panel.

Safe, Effective and Beneficial

The final vote was 12-6 in favor of approving Augment as a safe treatment for ankle surgery. The panel members spoke publicly about their votes. Panel- ists and clinicians Glenn Johnson, M.D., and Sam Nasser, M.D., Ph.D, both said Walter Eisner they were swayed by Lynch’s summa- tion by the company and was followed rior to autologous bone graft in promot- tion and were openly critical of the FDA by a full bore attack by the FDA. In fair- ing fusion. Its primary benefit is that the for not presenting the safety record of ness, the FDA staff is required to play use of the product spared patients from the company’s dental product. When “devil’s advocate” and give panel mem- undergoing a second ankle surgery to the panel was discussing adverse reac- bers reasons to find shortcomings with harvest bone. tion definitions, Nassar said he thought the company’s PMA and clinical trial the agency came in to the meeting with data. The panel is made up of clinicians, In Rohr’s view, Augment was being rec- an agenda. Mark Malkerson, the agen- academicians and statisticians who are ommended by BioMimetic for a ques- cy’s representative on the panel, gamely charged with reading and considering tionable procedure (bone graft fusion), told the panel that the agency would the voluminous materials, testimony which could open up new potential endeaver to do better in the future. and then to openly debate the merits of risks (cancer) for little or no benefit the application and criticisms. (bone graft harvest site pain). The panel went on to vote 10-8 that Augment for surgery was In our experience with panels, statisti- It was left to the other surgeons on the effective and, finally, voted 10-8 that cians almost always find enough faults panel to forcefully argue that while this PDGF biologic product when used with the applicant’s clinical trials to using bone graft to promote fusion in by surgeons in hindfoot and ankle sur- deem the study “meaningless.” It’s usu- the ankle was not a preferred choice, gery, delivered benefits that outweighed ally left to the clinicians who have the for patients with various comorbities the risks. responsibility of treating patients, to such as diabetes, obesity and aging provide the “real” world perspective for , using bone grafts was the gold A contentious and long day had come the FDA. standard. Several panelists even argued dramatically to an end. that the absence of pain by not having And so it was with Augment. a second operation to harvest their graft Lynch and the BioMimetic’s team had was irrelevent. swayed a particularly large panel with The Challenge 18 voting and three non-voting mem- Due to the relatively low number of bers. Ironically, it was a clinician, William ankle surgery patients in the study Rohr, M.D., an orthopedic surgeon (434), the dropping of 37 patients for Panel Deliberations from California who took the panel on major protocol violations or not treated an early tangent over the effectiveness at all, caused the statisticians to declare As is customary, the day of the FDA of bone graft in general. BioMimetic set the study underpowered. Again, the Panel meeting began with a presenta- out to prove that Augment was not infe- clinicians spoke up and said they

1-877-817-6450 | www.ryortho.com 7 VOLUME 7, ISSUE 17 | MAY 24, 2011 found the reasons for excluding the 37 that the matrix plus the biologic accel- confidence the material could be used patients as reasonable. erated fracture healing and enhanced for other orthopedic indications. fusion with no evidence of ectopic Clinical Trial bone formation (a plus over Infuse) and If approved by the FDA, Augment Bone no evidence of toxicity. Graft would be the first, new recombi- BioMimetic’s clinical trial for using Aug- nant protein technology for orthopedics ment in ankle surgery was approved Augment’s PDGF is created using introduced to the market in nearly a by the FDA in 2007. The company recombinant DNA technology which decade and the first and only cost effec- enrolled 434 patients for treatment in is more than two decades old and has tive fully synthetic bone growth factor a Pivotal Randomized Controlled Trial been used by spine surgeons and other replacement for autograft with Level 1 (RCT) at 37 centers in the U.S. and physicians in hundreds of thousands of data supporting its safety and efficacy. Canada. It was the largest RCT ever patients globally. for the foot and ankle. The company’s Since we started with Dr. Lynch, we’ll PMA was accepted for review by the Platelet-Derived Growth Factor (PDGF) let him finish. FDA in 2010. is a naturally occurring protein and one of the primary growth factors released “Many years ago, my colleagues and I The primary endpoint was the percent when platelets activate and degranulate in first imagined the possibilities of using of patients whose ankles successfully response to injury. PDGF is responsible PDGF as a broad multi-factorial stimu- fused at six months (a 50% osseous for triggering a number of cellular events lator of musculoskeletal tissue repair. bridging via CT). Secondary endpoints critical to bone growth and healing. It is exciting to see that our hypothesis were clinical, functional, radiologic, culminated today with a favorable advi- quality of life, and safety outcomes. Treatment for Arthritis, Ankle Pain sory panel recommendation.” or Fracture The data was not perfect. While six- Lynch should thank the clinicians. ◆ month data showed that Augment Surgeons often recommend a fusion of was non-inferior to autografts, Aug- the foot or ankle when a patient pres- ment failed to show non-inferiority at ents with debilitating end stage arthritis the 36-week and 52-week follow-up of the ankle, hindfoot and midfoot. For points. The results were close and hurt patients with diabetes or osteoporosis by the unavailability of some patients or fracture, there is a high risk that the for follow-up. The long term follow-up bones following surgery will not heal points caused the spine surgeon on the completely. That is known as a non- panel, Raj Rao, M.D., to comment that union. Typically, surgeons have relied biologics may not stay as robust over on a second ankle surgery, an autograft time and degradation of the bone qual- procedure to harvest chips of healthy ity is possible. bone, to then implant into the surgery site and, hopefully, improve healing. Augment Bone Graft Often surgeons harvest this bone from the patient’s hip, tibia or heel. When Augment is a blend of calcium phos- that happened, patients can experience phate (beta-TCP), bovine collagen and a number of post surgery complications human platelet derived growth factor. and, according to the eight published Augment’s beta tri-calcium phosphate studies, 27% will complain of chronic is the scaffold upon which bone is donor site pain. expected to grow after surgery. The human platelet derived growth factor BioMimetic’s success with GEM 21S, (rhPDGF-BB) is the signaling protein indicated for periodontal bone defects that triggers new bone growth in the and gum tissue recession, and approved ankle. The conclusion of the study was by the FDA in 2005, gave the company Advertisement

1-877-817-6450 | www.ryortho.com 8 VOLUME 7, ISSUE 17 | MAY 24, 2011 The Restless Orthopedic Surgeon By Biloine Young

ne of the things about ortho- “Opedic oncology is that every patient is different. If you do total joint replacements you take care of the same problem, with only a little different fla- vor. If you do sports medicine you take care of the same problems, with slightly different flavors, in each person. But in oncology you work with people from the very young to the very old and everyone in between. The young- est patient I have taken care of was a couple of months old. The oldest was in his high 90’s.” — Dr. Joel Mayerson, Associate Professor of Orthopaedics; Director, Division of Musculoskeletal Oncology; Ohio State University Medi- cal Center.

Creativity and are usually incompatible concepts—except Dr. Joel Mayerson in oncology where the ability to think creatively in five dimensions (3D spa- distinction in life came from becoming From a young age Mayerson wanted tially + biomechanically + biologically) one of the 2% of Boy Scouts to attain to be a doctor. “I enjoyed science and has forged a restless class of surgeons the rank of Eagle. “In scouting I got to I wanted to help people. Medicine was who scramble onto the surgical high do outdoor activities that I never would a good way to mesh the two together. wire and perform remarkable feats of have done otherwise,” he said. “My My parents tell me that I wanted to be anatomical reconstruction. Formulary? parents were not outdoor type people. a doctor from the time I was in elemen- Text books? These guys don’t need no With scouting I got to do camping and tary school.” An offensive tackle on his stinkin’ formulary. activities that they would not have got- high school football team (“I was a big ten me involved in.” guy,” he says), as well as a runner and a Mayerson, whose surgical legerdemain wrestler, he wanted to become a sports OTW has featured a couple of times, On his lengthy list of professional and medicine doctor and take care of ath- is the orthopedic oncologist who rein- academic awards, Mayerson’s Eagle letic teams. forced his patient’s pelvis with bones Scout rating tops the list. He credits from his amputated leg. Where do these scouting with teaching him how to be a Mayerson graduated from the Universi- restless orthopedic surgeons come leader and a member of a team. “Being ty of Toledo in 1990, summa cum laude from? part of a team is another part of being a in biology, and received his M.D. degree good surgeon,” he says. “Learning how from John’s Hopkins in 1994. His In Mayerson’s case, the industrial rust to be the captain of a team was devel- course was set when, as a fourth year belt town of Lima, Ohio, a pharmacist oped in me during those early years in medical student on an elective rotation father and stay-at-home mom. His first scouting.” he was, totally by accident, assigned to

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in life. Somebody who is 80 years old has different needs to ambulate and get around in life than if they were 15.

A recent patient was a ten-year-old fourth grader who, when he broke his femur, doctors discovered that he had a softball size malignant tumor just above his knee. The standard of care in the United States would have been to fill the void with a cadaver bone and a metal knee.

In talking with his patient, Mayerson discovered that what his young patient wanted most to do in life was play base- ball. “That was his goal and all that he wanted. He wanted to be a major league baseball player.” The most important consideration was the boy’s activity level now and into the future. Mayer- son knew that with a cadaver bone or Rotationplasty/Source: Dr. Joe Mayerson a metal bone in his leg the boy would not be able to play sports. The cadaver work with Dr. Frank Frassica , chair of sons I love my job—it is different all of the orthopedic oncology service. “From the time. I would have a hard job doing that day,” Mayerson says, “I fell in love the same thing over and over again. with orthopedic oncology.” With this career I do not have to.”

Mayerson continued. “Everyone who Mayerson finds that anatomy is pretty has a tumor, has it in a different loca- much all the same. “The important part tion in the body. Some people have of oncology is not only anatomy. You it in their bones, some people have it have to work at the six cardinal direc- in their muscles, sometime the tumor tions, figuring out where you can get starts in that area, and sometimes it around the tumor, make sure you can starts in another place and spreads to remove it with appropriate margins, their bones and muscles. Every patient top and bottom, left side and right side, is different, every problem is different. front and back. And we have to look When I graduated from my fellowship I at the imaging, know where the pitfalls had done over 500 oncology cases and are and how we are going to get around several hundred as a resident. I thought them.” I was really well trained and there was not a whole lot more that I was going The reconstructive side, he says, should to see. be decided by the patient’s expectations and what they want to do in their life. “I was pretty naïve. I have been in prac- “You have to get to know the patient,” he tice now for 11 years and I still see new says. “People have different reconstruc- stuff every day. That is one of the rea- tive needs and varying levels of desires Advertisement

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bone is fragile and the metal and plas- around, and the foot is attached to that could be lengthened as the girl tic parts wear out—usually between 10 where the knee joint used to be. The grew. Since the implant had not yet been and 15 years. “Like the transmission on foot’s heel is in front with the toes point- approved by the FDA, he had to get a your car,” Mayerson notes, “they have ed back so that the ankle joint functions “compassionate use” approval before a certain number of miles in them and as a knee joint. The surgery was a suc- he could proceed with the surgery. The then they wear out and you have to do cess and the boy is playing baseball. implant consisted of a hollow titanium a revision and fix it. Every time you fix tube inside a plastic tube housing a com- it, it gets harder. After a while you run In another rare surgery Mayerson pressed steel spring. When warmed by out of opportunities to redo it.” implanted a device called the Repiph- heat, generated by an electromagnetic ysis, by Wright Medical Technology, field, the device lengthens. “Because of Taking into consideration the patient’s in the arm of a five-year-old girl with this device, Elizabeth was able to keep young age and his fervent desire to cancer. Mayerson removed most of the her arm, which will help her lead a nor- play baseball, Mayerson performed a cancerous upper arm bone to treat the mal healthy life,” said Mayerson. rare procedure, called rotationplasty, cancer and filled the gap with donated in which the leg is amputated, turned living bone and the high-tech implant In the first surgery of its kind performed in the United States ( or, perhaps any- where) Mayerson and his team removed the left leg, hip and part of the pelvis of a cancer patient and used the healthy bone, blood vessels and muscles from the amputated leg to rebuildthe hip and pelvis so it would be strong enough to support a prosthetic leg.

The surgery was performed by the entire sarcoma surgery team that May- erson had put together and heads. Working together in the operating the- ater was a surgical oncologist to make sure that the bowel and blood vessels were moved out of the way; there was a neurosurgeon to do the spine part of the surgery; there was a plastic surgeon who was able to dissect out small blood vessels so they could save the parts that were not being amputated and could be used in the reconstruction and an anesthetist who could deal with major blood loss.

“As a team, we all sat down for seven to eight hours in advance and went through each step of the surgery,” said Mayerson. “ The first day the patient had surgery for twelve hours—with two shifts of doctors. The second sur- gery lasted for 25 hours with three or four shifts of people.” Mayerson esti- Source: Dr. Joe Mayerson

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an entire team that is able to do these things. Our goal is to continue to build the program and let people who have terrible problems know that there are various ways to take tumors out. Other places may not have the team and so they tell their patients that their tumors When you need are not removable and that they can- a cover which not help them. We want these people to would you know that this institution is a place that choose? may be able to help them.” Allograft Membrane Synthetic Barriers Does Mayerson and his team celebrate their successes? “Absolutely,” he said. “We are always a little bit anxious when the surgery is done because there are Allograft Membrane a whole host of complications that can Transplants for occur. Our celebration may not be that FROM day. But when Mr. P ( the pelvis recon- Surgical Coverings struction patient) left the hospital in three weeks, off pain medication, we The Change is Natural. celebrated. It was one of the most amaz- afcellmedical.com ing things I have ever seen.” Advertisement Indeed, chronicling the surgical artful- mates that, altogether, counting nurses, Mayerson says, “One of the things we ness of not only Dr. Mayerson, but also technicians and staff in the blood bank, have worked very hard to do is develop his team and other orthopedic oncolo- from 400 to 500 people were involved a multi-disciplinary team. There are gists are some of the most amazing sto- in this surgery. very few centers in the country that have ries we cover in OTW. ◆

1-877-817-6450 | www.ryortho.com 13 VOLUME 7, ISSUE 17 | MAY 24, 2011 Scalpel…Now or Later? By Elizabeth Hofheinz, M.P.H., M.Ed.

t’s 2am and a patient rolls into the ER Iwith several fractures. What should be addressed acutely? What if you sus- pect a bleeding problem? What are the issues associated with waiting? Along with Drs. Mark Lee, Yvonne Murtha, and Philip Wolinsky, Dr. Brett Crist, Co-Chief of Orthopaedic Trauma at the University of Missouri, reviewed the lat- est evidence-based literature regarding the surgical timing of injured extremi- ties. The researchers then presented their findings at the 2011 meeting of the American Academy of Orthopaedic Surgeons.

Dr. Crist states, “For several years there has been a debate over the merits of early total care versus staged injury management. Fortunately, there is a lot of good work in the literature to help us identify patients who would ben- Source: Dr. Crist efit from what we call damage control their study subjects, those who had all ies have shown that fixing high ener- orthopedics, i.e., the staged approach.” these or two out of three of these were gy pilon fractures acutely leads to an at high risk for the ‘second hit phenom- increased risk of infection and wound Going in and fixing everything during ena’ where the inflammatory response problems. Due to literature in the late one, long surgery, says Dr. Crist, is just causes significant problems potentially 1990s showing decreased risk of infec- not appropriate for every patient. But leading to multisystem organ failure. ” tion and wound problems with the there are few hard and fast rules for sur- staged approach, today these injuries geons to follow. Dr. Crist: “The key is to Black and white…easy to identify. undergo staged management at most try to identify the patients who would Other colors…not so much. “There are centers.” be harmed by early total care. Several extremes at each end of the spectrum, years ago Dr. Hans-Christoph Pape with, for example, an isolated femur A large swath of the gray zone, states worked with colleagues in Germany fracture identifiable as something that Dr. Crist, involves those patients with to establish guidelines for acute versus can be fixed acutely. Then there are multiple orthopedic injuries. “Let’s say staged care. Their research determined patients with head, chest, extremity, that someone comes in with a frac- several situations in which a patient and abdominal injuries who clearly tured femur and tibia, and is awake should receive staged treatment: if there cannot and should not receive total and alert, but has a pulmonary injury are bleeding problems, if someone is acute care. It’s the ones in the gray zone that is evolving. The decision making under-resuscitated, if they are hypo- that can be challenging to identify. We process would be to determine if this thermic, have a significant chest injury, can fall back on the literature, however, patient is adequately resuscitated and or if they have multisystem injuries. Of for guidance. For example, most stud- how extensive his pulmonary injury is.

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Let’s say that someone comes in with a fractured femur and tibia, and is awake and alert, but has a pulmonary injury that is evolving. The decision“ making process would be to determine if this patient is adequately resuscitated and how extensive his pulmonary injury is. Using the Hanover Criteria—the aforementioned work from Dr. Pape and his colleagues—is helpful. In addition, one should also look at lactate levels, urine output, fluid and blood requirements.

Using the Hanover Criteria—the afore- is not trending toward having pulmo- increased risk of avascular necrosis. The mentioned work from Dr. Pape and his nary problems that might be worsened barrier to such acute treatment is typi- colleagues—is helpful. In addition, one ”by a prolonged orthopedic surgery. So cally being able to reach a facility that should also look at lactate levels, urine to avoid problems, adequate evaluation has the appropriate abilities to manage output, fluid and blood requirements. with published guidelines should be these injuries (most likely an issue in a This is mainly determined by allowing used and insure adequate fluid resus- rural area).” a complete evaluation by the general citation.” surgeons and orthopedists before rush- But, says Dr. Crist, the literature needs ing to the OR from the ER to nail the So when do you stand up and pay more work. “Dislocations are either long bone fractures. Problems can be very close attention? Dr. Crist states, urgent or emergent, depending on the avoided by making sure that the patient “The literature shows us that the treat- joint. While we have good data for the ment of joint dislocations should not hip, unfortunately, the literature is not be delayed because this may result in as good when it comes to other .” avascular necrosis or neurovascular compromise. Studies show that hip And if you see blood vessels in distress, dislocations should be treated in less advises Dr. Crist, get moving. “The lit- than 12 hours and others indicate that erature has concluded that a patient less than 24 hours can help avoid an with vascular issues is indeed emergent

Advertisement Source: Dr. Crist

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As a subspecialty we are leaning more towards staging things. The downside of a staged approach is that there is a longer hospital stay and more“ exposure to anesthesia. The downside of treating too acutely is that the patient may need additional surgery later, may be on a ventilator too long, or may develop a bodywide infection.

and litigation for compart- femoral neck fractures in young peo- ment syndrome at Massachu- ple. The general thinking has been that setts General Hospital” claims they should be done in the middle of over a period of 20 years. The the night if that is when the patient situations that resulted in arrives. But with an increasing num- the highest payouts/awards ber of trauma rooms available, a recent against the physicians were survey of OTA [Orthopaedic Trauma those where there was a delay Association] members revealed that if in treatment (a delay in see- someone comes in at midnight or later ing the patient or a delay get- then a significant number of trauma- ting to the OR).” tologists are starting to put them on as a first case the next morning due to Dr. Crist says that the review resource availability.” process helped them chal- lenge what is considered to “When we examined literature from be dogma. “For example, other countries we found that there are take the urgency of fixing instances of people showing up a cou- Advertisement

given the risk of significant blood loss, as well as limb loss. In this case, the liberal use of a tourniquet is appropri- ate, while clamping off the blood ves- sels would be done as a last resort. A tourniquet should only be on a couple of hours…otherwise ischemia will kick in. The literature says that these situations need to be addressed within six hours; the problem is that if you’re dealing with a large main artery there is no way that someone is going to last six hours.”

Things are also unequivocal when the nerves, blood vessels, and muscles are being compressed and starved of oxygen. “Compartment syndrome is a true emergency, and needs to be fully addressed in an acute fashion. Researchers reviewed insurance claims Source: Dr. Crist

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ple of months after their injuries and they still didn’t have avascular necrosis. It appears to boil down to fracture pat- terns and surgical technique—if you get an anatomical reduction and use inter- nal fixation then chances are that the patient will fare better (risk of avascu- lar necrosis and nonunion) than those

who had malreductions. Patients with BIOLOGICS 1 Year CT Scan significant displacement and commi- nution tend to do worse. In summary, the literature indicates that you should treat femoral neck fractures as soon as you feel you can do them well. If that is 3am and you have the team and the For distribution interests, contact: resources, then do it.” 800-557-9909 www.pioneersurgical.com “With regard to talus fractures,” says Dr. Crist, “they have traditionally been thought of as an emergency where you need to immediately reduce the joint and fix it anatomically. The problem, however, is that the soft tissues will Play Time is Over. ® Indicates USPTO Registration often swell and you could have poten- tial difficulties with wound closure or Advertisement later wound breakdown. We found two can wait, Dr. Crist says, “Orthopedic states you should address it as soon as studies that looked at risk of avascular surgeons who find themselves strug- possible.” necrosis; they concluded that the timing gling with these situations often have of the repair wasn’t the main factor…it resource issues such as OR access or So perhaps this is why orthopedic sur- was fracture type. Open fractures had adequate ancillary support. Something geons are holding back a bit on the scal- a higher rate of avascular necrosis and else that can be an problem is the sur- pel. Dr. Crist: “As a subspecialty we are nonunion. In these cases, one should geon’s expertise or comfort level with leaning more towards staging things. debride the open fracture and stabilize treating things such as a complex talus The downside of a staged approach it with or a splint— or femoral neck fracture.” is that there is a longer hospital stay and only address it definitively when and more exposure to anesthesia. The the soft tissues allow. Closed fractures Ethics…can’t live without ‘em…but it’s downside of treating too acutely is that should be immediately reduced and hard to get the full picture because we the patient may need additional surgery undergo definitive fixation when the must abide by them. “We would ideally later, may be on a ventilator too long, soft tissues allow as well.” have better literature going forward. or may develop a bodywide infection.” But you cannot do a prospective double As for what might prevent an orthope- blind trial on an injury that is rare, and When in doubt, advises Dr. Crist…stage dist from making the best decision as then intentionally delay care to see if those injuries that can be staged. ◆ far as what is an emergency and what it makes a difference when the dogma

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Spine, Orthopaedics and Biosurgery lio includes Vitagel Surgical Hemostat, a company markets...We believe the collective tal- proprietary, collagen-based matrix that ent of our sizable sales forces across controls bleeding and facilitates heal- Stryker Snaps Up multiple franchises positions us to ing, and Vitasure Absorbable Hemostat, Orthovita for $316 build on Orthovita’s success and accel- a plant-based product. Million erate sales growth.” With 2010 revenue of $95 million and tryker Corporation announced Tony Koblish, Orthovita’s president expected 2011 revenue of $99 mil- Stoday that it is buying Orthovita, and CEO said, “This transaction deliv- lion (based on consensus estimates), Inc. for around $316 million in cash, ers significant value to our shareholders Stryker is paying 3.3x Orthovita’s 2010 or $3.85 per share. and allows us to combine our portfolio sales, which, says Mizuho Securities of orthobiologic and biosurgery prod- analyst Mike Matson, is above Ortho- Joanne Wuensch, BMO Capital Mar- ucts as well as our novel and unique vita’s small-cap orthopedic peers that ket analyst, notes that this is Stryk- proprietary biomaterials pipeline with are trading at 1.6x 2010 sales, an 80% er’s fourth acquisition in the last 12 Stryker’s industry-leading sales and premium to Orthovita’s stock price 30 months and further reshapes the com- marketing teams. days ago. pany’s orthobiologics franchise, (after selling off OP-1 in February). It cer- Orthovita’s orthobiologic platform The stock started moving up early tainly looks like Stryker continues to offers products for the fusion, regen- April and jumped from around $2.30 put the snake-bitten OP-1 era in the eration and fixation of human bone. per share to over $2.80 per share with rearview mirror and replaces it with Its biosurgery platform offers products the May 5 announcement that Noridian more basic synthetic bone cement and for controlling intra-operative bleeding. Administrative Services, LLC published surgical products. Current fusion and regeneration prod- a Part B Future Local Coverage Deter- ucts are based on the Vitoss Bone Graft mination (LCD) revisions providing Orthovita is a manufacturer of synthet- Substitute technology and address the for continued reimbursement of physi- ic bone grafts, , non-structural bone graft market with cian fees for vertebroplasty and verte- and hemostasis products. synthetic, bioactive alternatives to bral augmentation procedures related patient- and cadaver-derived bone tis- to vertebral compression fractures. Stryker’s CPCEO (Chairman, President, sue. Cortoss Bone Augmentation Mate- Cortoss Bone Augmentation Material, CEO) Stephen McMillan said, “With rial, an injectable, polymer composite approved and launched in the U.S. in this acquisition we are meaningfully that mimics the mechanical properties 2009, is indicated for use in vertebro- expanding our orthobiologics product of weight-bearing human cortical bone, plasty and vertebral augmentation. portfolio and strengthening our com- provides the basis for the company’s fix- petitive position in key segments of the ation portfolio. The hemostasis portfo- Matson pointed out that Orthovita’s revenue growth had slowed from over 25% in early 2009 to the low single- digits. He thinks Orthovita’s main prob- lems were its lack of scale and product breadth and sales should be significantly higher in the hands of Stryker’s numer- ous sales forces. Matson also noted that with the biologics market becoming increasingly price sensitive, he thinks that lower-cost synthetic products such as Vitoss are positioned to gain market share from higher cost alternatives.

—WE (May 16, 2011) Stryker / Orthovita

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The study was conducted in 2006 and FDA “522s” Metal-on- legal left many questions unanswered. For example, the study does not indicate Metal Hips where rural residents suffering from More Hip Surgery in he FDA was very visible at the Feb- hip or knee arthritis or debilitating back Rural America ruary 2011 AAOS (American Acad- pain went for their surgery, how quickly T emy of Orthopaedic Surgeons) annual they recovered, or whether rural resi- o much for popular wisdom. The meeting and telegraphed that the agen- dents were in worse overall health than assumption that rural areas in the cy was going to take a closer look at S their urban counterparts. The study did United States lack medical care was metal-on-metal (MoM) hips. On May reveal that rural residents underwent dealt a blow by a study of almost 46 6, the agency sent out letters ordering both emergency surgery and elective million Medicare patients conducted 21 makers of the hips to submit plans surgery more frequently than did city by researchers at Texas Tech Univer- within 30 days for conducting post- dwellers. sity Health Sciences Center in El Paso, market studies on patients who have Texas. Published May 2011 in the received the device. The agency wants The authors of the study say their find- Archives of Surgery, researchers found to know whether or not the implants ings could mean that rural residents that older residents in rural areas are are shedding high levels of metallic are sicker, getting treatment they don’t more likely to undergo any of nine com- debris into patients. mon surgeries—including back surgery need, or are more likely to delay treat- ment until they worsen and require and hip and knee replacements—than In the “522” letter the agency outlined spine or hip surgery. “When I first saw are residents of cities. four major areas for the study: the result, I looked at it and said maybe I got it backwards,” said lead author Dr. The researchers used ZIP codes and a 1. Adverse events observed Mark Francis, a researcher at Texas Tech government classification system that 2. Levels of serum and whole blood University Health Sciences Center in El ranks regions on a 10-point scale, 1 levels of chromium Paso. Though the cases are five years being the most urban and 10 being 3. Patient selection criteria associated old, Francis believes the results likely the most rural. They compared sur- with higher metal concentrations reflect current practice as he had found gery rates among residents in regions 4. Modes and causes of failure 7-10 (most rural) with residents in similar trends going back to the 1990s. regions 1-3 (most urban). According to He said it’s unlikely the recession had the study results, rural residents were much impact because these patients are 20% more likely to undergo heart valve covered by Medicare. replacement and 15% more likely to undergo knee or . —BY (May 20, 2011)

Photo manipulation by RRY Publications LLC/Wiki- media Commons

MoM hips, in which the ball-and-socket components are made from metals like cobalt and chromium, used to account for almost one-third of the estimated 250,000 hip replacements performed Source: Jvoll/Wikimedia Commons in the U.S. annually.

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However, over the last two years as • Med-Tek Corp./Synergy Ortho- distributorships some time ago. The reports surfaced that the implants were paedics Intl. Inc. Committees are now renewing a review prone to early failure and that some • Orthopaedic Device Corp. in a bipartisan manner. Sources in the patients had developed serious health • Orthopedic Manufacturing Co. Senate tell us they would like the HHS problems related to particles of metallic • Osteo Technology, Inc. OIG (Department of Health and Human debris, their use has declined. • Pfizer Inc. Services/Office of Investigator General) • Stryker Howmedica Osteonics to provide regulatory clarification to In March we wrote that the British • Techmedic Inc. what is a rather muddled picture con- Orthopaedic Association reported that • Turnkey Intergration USA Inc. cerning what these proliferating entities DePuy’s ASR implant might fail in up • Wright Medical Technology may or may not be doing. to one-half of the patients who received • Zimmer the device within six years after implan- John Steinmann, D.O., the founder tation. DePuy pulled the device from the —WE (May 18, 2011) of one of the first PODs in the indus- market last year. Other major produc- try, Inland Spine and Orthopedics in ers of the hip implants include Zimmer, California, told OTW that he would Stryker, Biomet and Wright Medical. U.S. Senate Looking like the opportunity to testify before at PODs the committees to tell his distributor- Among other things, the FDA is recom- ship story and paint the model in a fair mending a cross-sectional study design rthopedics This Week has learned light. Steinmann and his colleagues at which captures patients with or with- Othat the United State Senate Spe- AASD, the trade association formed by out revision to their original MoM THR cial Committee on Aging and the Sen- PODs, want to encourage policymak- (total hip replacement) at time periods ate Finance Committee are taking a ers in Washington to find favor with between initial implant and eight years renewed look at Physician-Owned Dis- the model, provided appropriate safe- after implantation. tributorships (PODs). guards are in place.

Biomet responded to an OTW inquiry We’ve also learned that some letters of —WE (May 16, 2011) with a written statement that the com- inquiry went out to a half a dozen such pany was “supportive” of the FDA request. Biomet has collected clinical data on approximately 23,000 hips and noted that, “Careful review of current- ly available evidence indicate that our products are safe and effective.”

The list of companies receiving the FDA 522 letter included:

• Advanced Bioresearch Association • American Ortomed Corp. • Biomet • C.R. Bard Inc. • Downs Surgical Ltd. • Encore Medical • Endomedics Inc. • Implantology Corp. • Johnson & Johnson (DePuy) • Joint Medical Products Corp. • Link America Inc. Morguefile

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every 450 bone marrow cells appears the management of wound healing,” biologics to have the capacity to transform into McGrath said. skin cells. Bone Marrow Signal- McGrath hopes to harness the key parts ing Secrets Revealed “This work is tremendously exciting of HMGB1 to create a drug treatment for the field of regenerative medicine,” that can augment tissue repair. The esearchers have long been aware said Professor John McGrath, head of developed treatment will be tested in Rthat cells in bone marrow play a the genetic skin disease group at King’s. animal models within a year and enter role in the healing of wounds on the “The key achievement has been to clinical trials shortly afterwards. skin. What had not been understood find out which bone marrow cells can is which specific bone marrow cells transform into skin cells and repair and —BY (May 20, 2011) are involved, what starts the healing maintain the skin as healthy tissue, and process and how the appropriate cells to learn how the process happens.” are lured to the affected skin. Now, Biotech Firms Histo- researchers at King’s College, London, The researchers also discovered that, genics and ProChon and Osaka University in Japan believe when injured, skin releases a distress Merge they have answered those questions. hormone called HMGB1 which mobi- lizes cells from bone marrow and n a stock-for-stock exchange— directs them to where they’re needed. Working with mice, some of which had the dollar value of which has not Mice with skin grafts had high levels of I skin grafts and some did not, they dis- been released—Waltham, Massachu- HMGB1 in their blood. covered that certain specific bone mar- setts-based Histogenics Corporation row-derived cells migrated to the skin acquired ProChon Biotech Ltd., a pri- “Understanding how the protein graft to heal the skin much more quick- vately held biotechnology company ly than did others. They found that very HMGB1 works as a distress signal to few bone marrow cells traveled to the summon these particular bone mar- un-grafted wound sites and those that row cells is expected to have signifi- did contributed little to the repair of the cant implications for clinical medicine, skin. The researchers found that one in and could potentially revolutionize

Histogenics Corporation originally founded in Israel. Histogen- ic’s new management team will be led by Patrick O’Donnell, former CEO of ProChon. O’Donnell will also serve on the Board of Directors.

Histogenics develops and manufactures products to improve the body’s ability to regenerate healthy , improve joint function and prevent degenerative disease. Formed in 2000, the company is developing new treatments for sports injuries and other orthopedic condi- Source: bobjgalindo/Wikimedia Commons tions where demand is growing for

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long-term alternatives to joint replace- tion technology. Other promising clini- the U.S. subsidiary of Japan’s Terumo ment. Histogenics has successfully cal data is on products that augment Corporation, one of the world’s lead- completed Phase I and Phase II clinical cartilage repair in microfracture pro- ing medical device manufacturers with trials in which the NeoCart autologous cedures and in soft-tissue regeneration $3.4 billion in sales and operations in tissue implant’s effectiveness is com- based on a combination of proprietary more than 160 nations. pared to that of standard microfracture growth factor, stem cell, scaffold, and surgery. bioadhesive technologies. The initial Harvest Technologies Corporation focus of the company will be to com- developed two medical device thera- ProChon’s research has been focused plete the NeoCart Phase III clinical pies that show promise in optimizing on modulating the fibroblast growth study. the body’s natural healing process. The factor system in humans (an innova- first is theSmartPReP®2 APC+ system tive pathway to tissue growth) which Histogenics is privately held. Investors which allows physicians to rapidly pre- have allowed ProChon to create inno- include Altima Partners, Boston Mil- pare highly concentrated, autologous vative and, the company hopes, more lennia Partners, Foundation Medical platelet rich plasma (PRP) enriched effective solutions for tissue regenera- Partners, Stryker Corporation, Inflec- with growth factors to naturally stimu- tion. Specifically, ProChon’s technolo- tion Point Partners and Takagi Sangyo. late the body’s healing process for bone gies allow for the combination of cell Boston Equity Advisors, LLC served as and soft tissue wounds. The second is regeneration technologies with propri- the investment bank and was respon- the SmartPReP 2 BMAC technology etary growth factors and biocompat- sible for identifying and arranging the platform, a point-of-care device that ible scaffolds. As a result, ProChon’s transaction. requires just 15 minutes to process technologies can potentially deliver to and concentrate adult stem cells from a patients the ability to restore injured or —BY (May 18, 2011) small aspirate of autologous bone mar- chronically damaged tissues to a more row. (Other concentration techniques normal state. ProChon has an exten- require hours, or in some cases days, sive patent estate with issued patents Terumo Buys Harvest to prepare.) Both applications have from the United States, Europe, Israel Technologies shown promising results in the treat- and Australia. ment of cardiovascular and peripheral erumo Americas Holding, Inc. is artery disease. “This acquisition positions the new Tacquiring Harvest Technologies Histogenics as a leading regenerative Corporation, an innovative biotechnol- SmartPReP 2 BMAC is considered a medicine company with products ogy company that invented the tech- breakthrough technology. The concen- in the clinic, with solid intellectual nology that allows physicians to derive trate produced by this system has been property, and with experienced com- highly concentrated autologous adult documented to generate more total mercial and technical management,” stem cells from their patients in 15 min- nucleated cells with enhanced viability O’Donnell said. “Merging these two utes. Terumo Americas Holding, Inc. is that affect a desired outcome in animal companies will have a significant posi- tive impact on the adoption of regen- erative medicine, beginning with car- tilage regeneration. We will leverage each company’s distinctive capabilities to develop a broad regenerative medi- cine pipeline that will address surgical applications in orthopedics, vascular, and neurosurgery.”

O’Donnell indicated that the company has positive Phase II clinical data on its NeoCart autologous cartilage regenera- Image manipulation RRY Publications LLC/Terumo/Harvest/morgueFile.com

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models compared to concentrations According to the company, “Trabecular obtained by using the more common large joints Metal Tibial and Femoral Cone Aug- laboratory methods. The system is ments have the potential to provide easy to implement and requires half Zimmer Launches reliable structural replacement of bone the amount of aspirate of bone marrow Cavity Fillers for Knee and stable fixation for femoral and tib- from the patient. ial articulating components in even the Revisions most challenging knee revision cases. Harvest Technologies Corporation is Designed to treat deficiencies in the new range of trabecular material focusing its initial commercialization knee independent of the final implant augment shapes and cones in knee efforts in Europe to support clinical A position, the tapered shape of the aug- revision surgeries was launched by research for the treatment of end-stage ments fits the patient’s anatomy without Zimmer Holdings, Inc., on May 17. critical limb ischemia (CLI), a result of dictating implant alignment.” peripheral artery disease, which often Jeffery McCaulley, the president of Zim- leads to lower-limb amputation and The augments are made from Zimmer’s mer Reconstructive, said these new ana- increased patient morbidity and mor- trabecular metal material, “a highly tomic sizing options allows surgeons to tality rates. The company is also con- porous biomaterial that resembles the put in implants and fill defects in all ducting a 42-patient pilot, random- structure, function and physiology of kinds of knee revision cases with the ized, controlled, safety cardiac study of trabecular bone.” The company says, NexGen Knee system. its BMAC system in three U.S. medical “No other porous metal material is sup- centers. The BMAC product is injected ported by the amount of peer-reviewed, into the patient’s heart muscle during The new augments are, “designed to published clinical data of Trabecular bypass surgery to study its safety and fill these defects, provide a structural Metal Technology and its history of clini- effectiveness in this patient popula- foundation to the existing bone and cal success in orthopaedic applications. tion. Previous studies have shown help support revision knee implants,” This novel material supports bone for- clinical promise. according to a company statement. Sur- mation, enabling biologic fixation and a geons are often faced with a range of stiffness similar to cancellous bone. The Per the May 11 press release: “Harvest small to large cavitary defects. elasticity of Trabecular Metal Technol- Technologies Corporation is at the technological forefront of developing point-of-care systems that allow physi- cians to apply non-surgical approach- es for difficult-to-treat diseases such as CLI,” said Gary Tureski, President and CEO of Harvest Technologies Corporation. “Terumo Corporation has long been a global leader in medi- cal device technology to treat vascular and peripheral disease. We are excited about the expanded opportunities this partnership will provide to both com- panies and look forward to advancing the standard of care for patients world- wide who suffer from these debilitat- ing diseases.”

—BY (May 17, 2011)

Zimmer Augments/Zimmer Holdings, Inc.

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ogy provides more normal physiologi- and shown patients explanatory videos. The patients later filled out three mul- cal loading which has the potential to So which method is the most effec- tiple choice questionnaires that asked decrease stress shielding and improve tive in helping patients grasp the risks them about their surgery. They filled long-term implant fixation.” and benefits of the surgery before they out the first at the time they consented undergo it? to it. They filled out the second on the More than three million NexGen Knees morning of the surgery and completed have been implanted worldwide, As Dr. James H. Lubowitz, who heads the third about six weeks later. according to the company, with more the Taos Orthopaedic Institute in Taos, than 1.45 million implanted in the U.S. New Mexico, noted, an artificial knee Overall, the patients scored 75% to since the system’s introduction in 1994. does not work the same as a normal 80% correct answers on knowledge The company claims that each year, knee. “It is metal and plastic and bone about the procedure, and there was no nearly 1 in every 4 knee replacements cement. Patients expecting ‘normal’ difference among the three groups. “We in the U.S. uses a NexGen product. may be disappointed, thus emphasizing expected that the more intense educa- the importance of preoperative patient tion (printed hand out plus video plus That’s going to be a lot of cones and education.” nurse) would yield higher scores,” said augments. Dr. Terence Gioe of the Minneapolis Vet- In an attempt to determine the best erans Affairs Medical Center, who led —WE (May 20, 2011) means of communication, researchers the work. “We may be able to do more divided 151 patients about to have a with simple handouts that patients can total at the Minne- review and refer back to after the initial Paper Triumphs In Pa- apolis Veterans Affairs Medical Center consultation.” tient Ed into three groups. One group filled out a computer-based informed consent Lubowitz remains ambivalent. “I would atients are not very good at absorb- form called iMedConsent and received not say that video aids or nurse educa- Ping or remembering information a printed handout about the risks and about the surger- benefits of the surgery. The second ies they are about to undergo. In an group received the hand-out and also Satisfy your need for speed. attempt to prepare their patients, doc- watched a video. A nurse spoke with tors have used a simple printed hand- the third group after they had received out, had nurses explain the procedure, both the handout and seen the video.

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tion are unnecessary, nor would I insist that they are necessary,” he said. “In non-VA, high-volume practices, or set- tings where orthopedic resident ‘train- ing knees’ (to show to patients) are not available, the use of video or nurse edu- cators could be extremely valuable.” The findings appear in theJournal Arthritis Care and Research.

—BY (May 17, 2011)

Anesthetic Change Boon for Patients

arry Oldham, a 68-year-old Bgrandfather, was doing leg raises 20 minutes after leaving the operat- ing room where he had had his right knee joint replaced. A few hours later he was walking around his room on crutches. In. 48 hours he was home. What was going on? Oldham was par- Photo by Andrew Huth for RRY Publications LLC ticipating in a new approach to knee joint replacement surgery known as joint before, during and at the end of and the next morning I was up and “rapid rehabilitation.” surgery. Patients are also given mild shaving. By 11am I was on crutches sedation and a spinal anesthesia, simi- walking around the ward. I passed the The usual procedure was for a doctor lar to an epidural, which wears off in a beds of men who had conventional to administer nerve blocks (injections couple of hours, enabling them to start knee surgery and got chatting. They of local anesthetic at the top of the leg) moving their legs. couldn’t believe I had my op the pre- followed by a general anesthetic. With vious night. This made me realize how this procedure the patient is pain free Tony Smith, who is based at Robert lucky I was to have been on the rapid following surgery but he cannot move Jones and Agnes Hunt Orthopaedic recovery program.” his leg muscles until the effects of the Hospital in Oswestry, Shropshire, Eng- drugs wear off—usually in 36 hours. land, explains: “While the anesthetist Twelve days following his surgery, Many patients feel nauseous for a time takes care of the patient’s sedation, I Oldham dumped his crutches and was afterwards and—being immobile for so inject the anesthetic solution. The same driving his car. On the 17th day he long—are at risk of developing deep day as their op, they’re encouraged to walked a mile to a favorite tea room vein thrombosis. get up and walk around their beds and and back. With conventional knee sur- do weight-bearing exercises. It’s really gery, patients are on crutches for four With rapid rehabilitation neither a gen- good for their mental well-being to get to six weeks. Surgeons in the UK per- eral anesthetic nor nerve blocks are mobile the same day as their surgery. form about 70,000 knee replacement used. Instead, in a technique called We always explain that they’ll be up and procedures annually. local infiltration anesthesia developed dressed the day after surgery.” in Sydney, Australia, a large dose of —BY (May 15, 2011) anesthetic solution is injected directly Oldham described his experience. into the tissue surrounding the knee “I had the op on the Friday evening

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people Ishrak Named Medtronic Leader

uring a time of industry consolida- Dtion, Medtronic, Inc. finally has a new CEO and chairman.

The company announced on May 11 that Omar Ishrak, Ph.D., will take over for departing Chairman and CEO Bill Hawkins on June 13. Hawkins announced his retirement at the end of last year and the search for his replace- ment took longer than expected, sparking rumors of some disagreement among board members.

GE Track Record

Ishrak is leaving as president and CEO of GE Healthcare Systems, a $12 billion division of GE Healthcare supported by approximately 20,000 employees in 120 countries. Ishrak was also a senior Omar Ishrak, Ph.D./Medtronic, Inc. vice president of GE Corporation and a member of the GE Corporate Executive Before joining GE Healthcare in 1995, of the orthopedic market. Ishrak is join- Council. the company said Ishrak spent more ing Medtronic just as a major competi- than 13 years in senior technology tor in spine, Johnson & Johnson, is tak- A Medtronic statement said Ishrak development and business manage- ing over Synthes. Johnson & Johnson’s brings, “exceptional experience and a ment roles at Philips Ultrasound, Dia- worldwide chairman of the company’s strong track record to Medtronic. Dur- sonics Inc. and Elbit Ultrasound Group. Medical Devices and Diagnostics Group ing his 16-year tenure at GE Healthcare, He earned a Bachelor of Science degree is another GE Healthcare System alum- he consistently drove top and bottom and Ph.D. in electrical engineering from nus, Michael Mahoney. line growth in a number of leadership the University of London, King’s Col- positions. He also helped to transform lege. Ishrak is a member of the board Will Ishrak follow Mahoney’s example the way in which GE Healthcare inno- at The Blood Center of Wisconsin and and move to further consolidate the vates, manufactures and sells products, is on the Health Leadership Council of orthopedic industry by looking to add a particularly in emerging markets. Under the Save the Children Foundation. major hip and knee maker to Medtron- his guidance, the Clinical Systems Divi- ic’s portfolio? We’ll ask him after he sion almost doubled in revenues to Industry Consolidation warms up his new chair. approximately $5 billion from 2004 to 2009. In addition, he transformed Medtronic is the largest medical device —WE (May 18, 2011) GE Healthcare’s Ultrasound business, manufacturer in the world and controls growing revenues from $400 million in well over 40% of the spine market. The 1998 to $1.8 billion in 2010.” company does not compete in the rest

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spine Quick to Dough PMMA From Medtronic

edtronic, Inc.’s latest offering for Mthe treatment of spinal fractures with minimally invasive Kyphon bal- loon kyphoplasty, is the mouthful “poly- methylethacrylate (PMMA),” a new ver- sion that is “quick-to-dough.” Labeled Kyphon Xpede, the PMMA reaches a doughy state more than twice as fast as its predecessors, Lyphone HV-R Bone Cement and Kyphon ActivOs10 Bone Cement. According to Medtronic, the new cement helps streamline the Kyphon balloon kyphoplasty proce- dure, while providing sufficient time for careful surgical introduction and controlled delivery.

Alex DiNello, general manager and vice Advertisement president of the Kyphon Products Divi- which pioneered balloon kyphoplasty. streamlines the balloon kyphoplasty sion, said, “Xpede Bone Cement pro- These include a long working time and procedure,” said Dr. Wade Wong, pro- vides all of the handling characteristics radiopacity for easy visualization dur- fessor of clinical radiology and anesthe- that physicians have grown to expect ing minimally invasive and image guid- siology at the University of California, from the Kyphon Products Division, ed procedures.” San Diego and chief of neurointerven- tional spine. “It is quick to dough, has Medtronic esti- a long working time which provides mates that since me with increased control and ease of it began market- handling.” ing this treatment in 2000, an esti- Xpede Bone Cement expands Medtron- mated 900,000 ic’s portfolio of bone cements for treat- fractures have ment of patients with vertebral com- been treated pression fractures caused by osteopo- worldwide with rosis or cancer. The company expects Kyphon balloon Xpede Bone Cement to be available in kyphoplasty by Europe in the near future. approximately 14,000 trained —BY (May 18, 2011) spine specialists.

I find that Xpede Bone Cement Wikimedia Commons

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THE PICTURE OF SUCCESS Dr. Taylor Smith By Elizabeth Hofheinz, M.P.H., M.Ed.

e has treated refugees with tuber- Hculosis and received patients by oxcart. Dr. Taylor Smith, winner of the 2011 Humanitarian Award from the American Academy of Orthopaedic Surgeons (AAOS), has devoted much of his life to serving those in greatest Dr. Taylor Smith need…even though, says Dr. Smith, it and time away of family. My mom was a can break your heart. teacher…I fought her on certain things Source: Dr. Taylor Smith all the way through high school. In the The founder of the orthopedic divi- patients in insane asylums and worked end, however, I didn’t want to disap- sion of Operation Rainbow, Dr. Smith on Indian reservations. I was greatly point my parents—so I settled down says, “There is so much need that I influenced by them both…and I never and got to studying.” just can’t feel fulfilled if all I do is treat thought of becoming anything other patients with ‘regular’ aches and pains. than an orthopedic surgeon.” Book learning has its place…but, as If a patient is complaining of shoulder Taylor Smith soon discovered, life has pain after a round of tennis, I may find Now Clinical Professor of Orthopaedic other lessons. “While doing my intern- that my mind wanders to the young boy Surgery at the University of California ship at Hermann Hospital in Houston, I treated recently in Haiti who had to in San Francisco, Dr. Smith had the I was drafted. It was a sensitive time, have his leg cut off.” early advantage of being prepared for namely, the Cuban missile crisis. The the lifestyle of an orthopedist. “My dad, advice I got was, ‘If you don’t sign up for The son of an orthopedic surgeon, and the team physician for the Rice Uni- the Air Force or the Navy then you’re the grandson of a general practitioner, versity football team, took me along to going to receive a letter welcoming you Dr. Smith has long been witness to games, where I had a great chance to into the Army.’ I opted for the Air Force, the daily challenges of living of those learn about the injuries and how they went through their flight surgeon pro- who suffer. He says, “My dad was the were handled. I grew accustomed to gram, and went to the Philippines with chief of surgery at Shriners’ Hospital in the family ‘rhythm’ of my dad’s long only one year of orthopedic training. I Houston, while my grandfather treated hours, calls in the middle of the night, was soon reclassified (left the flight sur-

If a patient is complaining of shoulder pain after a round of tennis, I may find that my mind wanders to the young boy I treated recently in Haiti who “had to have his leg cut off. ” 1-877-817-6450 | www.ryortho.com 28 VOLUME 7, ISSUE 17 | MAY 24, 2011

geon program) and joined the orthope- dic department.”

There were planeloads of patients at Clark Air Base in the Philippines, says Dr. Smith, but not a lot of surgeon egos. “We got all of the air evacuations from Vietnam, and would receive an average of eight planeloads of injured a night. I spent over two years training with a superb orthopedist named Dr. Ralph Peterson, who not only taught me how to operate expeditiously, but how to avoid any hint of the prima donna. You just could not demand or expect things that weren’t available. This time was valuable in many ways, and when I did complete my residency I had more experience than most of my peers. That Dr. Smith, staff and patient in Ecador meant that at an early stage in my career I enjoyed more responsibility.” No one had ever seen this before Dr. nia. It was a different kind of drama/ Hodgson put it on the map.” trauma that I encountered there, as this While Dr. Smith was in the Philippines was the era of the Black Panthers and he took time out to travel to Hong Dr. Smith’s life course was forever the Symbionese Liberation Army. I was Kong and study with a spine master. altered by what he experienced in Asia later asked to come to the University of Politically, it was the time of the Cul- those early years. “This was a turning Texas in Houston—the program started tural Revolution in China—clinically, point for me…from then on my eyes by my father—to head up the orthope- it was a revolutionary time for those were open as to the value of interna- dics department. It was very humbling who walked for the first time. “I brief- tional work. I was inspired to see how to work alongside my dad; his were big ly rounded with Dr. Arthur Hodgson, well the local medical personnel could shoes to fill. I was the first full time pro- a guru who was famous for using an do with the little they had—and they fessor of orthopedics there, so I estab- anterior approach for tuberculosis were treating serious conditions such as lished the department and then after and scoliosis. When I asked if I could polio and chronic infections.” seven years returned to California to return to study with him, he invited join a private practice.” me to be one of his first fellows. We After his fellowship in Hong Kong, Dr. treated a flood of refugees coming in Smith found a place for himself in aca- Although his Houston years involved from China, many of whom had a par- demia…then he had to share a place budgets and staff meetings, Dr. Smith tial or total paralysis. When we did an in the sun with his dad. “I accepted a did make time for aiding others abroad. anterior approach to the spine, lo and position as the chief of orthopedics at “I was sent to Taiwan by the U.S. State behold these patients were walking. County Hospital in Oakland, Califor- Department to do spine surgery; while

Working abroad is a wonderful way to expand your—and your family’s—horizons. Many people feel trapped in a routine where they are taking“ call, paying the mortgage, etc. ” 1-877-817-6450 | www.ryortho.com 29 VOLUME 7, ISSUE 17 | MAY 24, 2011

there I met several Australian doctors to get a substantial amount of equip- together to fascinating places—we who had done orthopedic work in Fiji ment transferred down there.” spent three months in Taiwan, and a and they asked me to join them on total of two months in Fiji. Instead of their next trip. The difference between Never a prima donna, Dr. Smith states, being involved with Little League they the two locales was striking. Whereas “We don’t count on having regular came to the OR when I was traveling Taiwan was well advanced in orthope- electricity or water, and in fact have and learned quite a lot from watching dic care, musculoskeletal care in Fiji gotten used to operating without it. I the procedures. Other than my practice, was adrift because of politics. The gov- concentrate on keeping the team small, my children are my biggest accomplish- ernment (largely comprised of native usually including three orthopedists, a ment. It has been wonderful to have my Fijians) had passed a law saying that senior resident, a pediatric orthopedic son go into orthopedics, and have my native Indians could not work in the surgeon, two anesthetists, an anesthesia daughter become a nurse. I have three government. Given that all of the doc- tech and four nurses. Because the island other children who are still in school.” tors were Indians, this left the patients lost a third of its orthopedic surgeons at a real loss.” there is much that must be done in the Dr. Taylor Smith has the last word: “I am way of rebuilding their infrastructure. amazed that people compliment me on “Because of my experience treating To that end we do some teaching when my work. Frankly, I’m embarrassed…I polio patients, my colleague in Hous- we are there; it is usually one on one, just direct traffic.” ◆ ton asked me to accompany him to with our anesthesia people working work in China on an Operation Rain- directly with their anesthesia people, bow project. We made four trips, but etc. My dream is that we could make ILIFTM – The new prescription for lumbar spinal stenosis could see that it was really too far and St. Marc’s a center of excellence and innovation counts. too expensive to continue. We decid- other hospitals in Haiti could emulate ed to focus on Central and South this work.” America after that; in 2010 Operation Rainbow took 13 trips to Haiti and The exuberant Dr. Smith is also practi- Latin America.” cal. He says, “Working abroad is a won- derful way to expand your—and your Dr. Smith says that his secret of success family’s—horizons. Many people feel is pretty simple…he loves his work. trapped in a routine where they are tak- And he has found it especially reward- ing call, paying the mortgage, etc. We ing to contribute to Haiti’s efforts to care get a lot of inquiries from orthopedists for its orthopedic patients. “Two weeks who want to work abroad. More often after the earthquake I was in Haiti than not, it doesn’t work out. So our leading a team put together by Sutter strategy is to find good people and keep Health, a large California medical plan. asking them to return.” We went to a small hospital north of Port au Prince in the town of St. Marc. Reflecting on the intersection of his Experience it for yourself at Along with the team from Mass Gen- work and personal lives, Dr. Smith www.nuvasive.com/experience eral, we worked as a well oiled machine notes, “It was a great sacrifice not being and performed a lot of surgeries. Over able to spend a lot of time with my fam- ©2010. NuVasive, Inc. All rights reserved. the next few months we were also able ily. The upside is that we got to travel Advertisement

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