week in review 4 10 - Orthopedics This...

VOLUME 6, ISSUE 32 | OCTOBER 12, 2010

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picture of success

week in review

breaking news

4The Best Spine Technolo-gies of 2010 ◆ Which tech-nologies, engineers and inventors

received the BEST SPINE TECHNOL-OGY AWARDS for 2010? Here they are. Congratulations to the inventors and engineers who’ve taken a dream and through extraordinary effort be-come the Best Technology of 2010.

10AAOS/NASS “Unalign” Over Vertebroplasty ◆ Do AAOS and NASS

disagree over the evidence of the effec-tiveness of vertebro- and kyphoplasty? AAOS issued new clinical guidelines for the procedures that don’t match NASS’s guidelines. Where’s truth and is there new evidence on the horizon?

15Fix Knees With Fat? ◆ A new technique from Dr. John A. Szivek of the

University of Arizona is showing that fat tissue might be a treasure trove of stem cells that can be used to re-grow cartilage in damaged knees and offer one more alternative to total knee re-placement surgery.

18Back to the Future? General Orthopedics ◆ Twenty years ago the

future was in specialization. Given the numerous upcoming changes, howev-er, perhaps, say our experts, the future lies to a certain extent in the past…in general orthopedics.

31Dr. Jeffrey A. Gold-stein ◆ Renowned for his work on ProDisc, Dr.

Jeffrey Goldstein, Director of the Spine Service at New York University Hospi-tal for Joint Diseases is now develop-ing a unique surface structure for im-plants…and one that is very precise.

22Wright Settles With DOJ..........................................Surgeon-Owned Distribu-

torships Expanding............................................................Childhood Diabetes and Weak Bones............................................................Breakthrough for Osteoporosis?............................................................Integra Debuts Calf Muscle Device............................................................Meeting Tackles Inequities in Arthri-tis Care ............................................................Isoform Brings Creaspine and Scient’X Together

For all news that is Ortho, read on.


VOLUME 6, ISSUE 32 | OCTOBER 12, 20102Orthopedic Power RankingsRobin Young’s Entirely Subjective Ordering of Public Orthopedic Companies

This Week: Remember the adage, “buy on rumor, sell on news”? Odds makers at Intrade say Republicans have a 73% chance of taking control of the House of Representatives, and a 40% chance to control the Senate. This Cinderella rumor is pushing stock prices up, but it turns into a pumpkin on November 2nd. FYI.

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

1 1 Kensey Nash 38.72% 11.28%Analysts expect KNSY to report flat EPS on down sales this month. Market disagrees. Keeps buying. Likes the cash flow.

2 2 Orthofix 13.51 4.02Zacks puts a “Buy” on OFIX just as new deformity system introduced at NASS. OFIX has consistently surprised on upside.

3 5 Stryker 24.71 9.57Five-year dividend growth rate is a whopping 43.6%. And, looking at SYK’s cash hoard, it is still too low. Should keep rising.

4 6 Alphatec 1.59 5.29New ELA product is coming to market with more data than competition. Saw it at NASS. Impressed. Up 2 spots this week.

5 7 CONMED 8.76 22.74Up nearly 23% in the last 30 days. Reflects the developing rebound in hospital capital purchasing.

6 3Integra

LifeSciences15.37 6.95

Unfortunately, the Street thinks of IART as a deal stock. So investors watch the deal wire and balance sheet. Quiet right now.

7 4Johnson &

Johnson27.1 7.44

JNJ benefiting from election year rally. Won’t last forever. Then earnings and dividend yield take over as investment drivers.

8 9Smith & Nephew

22.83 9.97SNN expected to report 4% sales growth to $953 million in September quarter. That, we think, sets the stage for EPS upside surprise.

9 10 Zimmer 27.69 6.69Fourth cheapest ortho stock there is clearly upside available. Consensus is calling for 9% EPS growth.

10 8 Exactech 11.81 3.1Market looking for down earnings this quarter despite higher sales. Could be higher marketing expenses to maintain share.



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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 TiGenix TIG.BR $2.89 $89 49.9%2 RTI Biologics Inc RTIX $2.63 $144 24.6%3 CONMED CNMD $23.75 $684 22.7%4 Orthovita VITA $2.13 $164 22.4%5 Kensey Nash KNSY $29.98 $267 11.3%6 CryoLife CRY $6.19 $175 11.1%7 Smith & Nephew SNN $45.66 $8,120 10.0%8 Stryker SYK $49.68 $19,720 9.6%9 Symmetry Medical SMA $9.73 $350 8.1%

10 NuVasive NUVA $33.46 $1,320 8.0%

1 Mako Surgical MAKO $10.02 $339 -5.6%2 Osteotech OSTE $6.46 $117 1.1%3 Synthes SYST.VX $118.98 14,120 1.1%4 TranS1 TSON $2.56 $53 1.6%5 Exactech EXAC $14.96 $193 3.1%6 Capstone Therapeutics CAPS $0.92 $38 3.4%7 Medtronic MDT $33.45 $36,120 3.8%8 Orthofix OFIX $30.00 $529 4.0%9 Alphatec Holdings ATEC $2.19 $191 5.3%

10 Zimmer Holdings ZMH $51.96 $10,440 6.7%

1 Medtronic MDT $33.45 $36,120 9.992 Exactech EXAC $14.96 $193 12.093 Zimmer Holdings ZMH $51.96 $10,440 12.374 Wright Medical WMGI $14.55 $571 12.805 Average $11,242 13.20

1 Smith & Nephew SNN $45.66 $8,120 62.882 RTI Biologics Inc RTIX $2.63 $144 34.403 Synthes SYST.VX $118.98 $14,120 33.264 NuVasive NUVA $33.46 $1,320 27.495 Symmetry Medical SMA $9.73 $350 25.41

1 Orthofix OFIX $30.00 $529 0.662 NuVasive NUVA $33.46 $1,320 0.723 Exactech EXAC $14.96 $193 0.734 Medtronic MDT $33.45 $36,120 1.035 Smith & Nephew SNN $45.66 $8,120 1.12

1 CONMED CNMD $23.75 $684 18.182 Alphatec Holdings ATEC $2.19 $191 3.403 Kensey Nash KNSY $29.98 $267 3.234 Johnson & Johnson JNJ $63.23 174,160 2.095 ArthroCare ARTC $28.25 $763 1.97

1 RTI Biologics Inc RTIX $2.63 $144 0.832 CONMED CNMD $23.75 $684 0.933 Orthofix OFIX $30.00 $529 0.964 Symmetry Medical SMA $9.73 $350 1.025 Exactech EXAC $14.96 $193 1.04

1 TiGenix TIG.BR $2.89 $89 318.122 Mako Surgical MAKO $10.02 $339 10.143 Synthes SYST.VX $118.98 $14,120 7.834 Kensey Nash KNSY $29.98 $267 3.325 NuVasive NUVA $33.46 $1,320 3.06



Thousands of lab, machine shop and operating room hours by 210

inventors and engineers resulted in 43 spine technology submissions to the 2nd annual Orthopedics This Week Spine Technology Awards. Those sub-missions were then analyzed by 6 judg-es and the best 19 in 8 categories were selected to receive the crystal Best Spine Technology of 2010 award.

The Orthopedics This Week spine tech-nology awards honor the process, hard work and, most especially, the inven-tors and engineers who take a dream and run the regulatory and organiza-tional gauntlet to market.

Bringing a new technology to the spine arena is hard. It is an honor to celebrate the inventors and engineers who get to the finish line.

As was the case last year, this year’s sub-missions reflected the state of innovation in spine. Last year, motion preservation and dynamic stabilization technologies were predominant. This year a combi-nation of biologics, diagnostics and prac-tical “low-tech” innovations dominated the submissions. Only three companies submitted a motion preserving implant.

Sign of the times.

In 2009, the spine technology awards were held in a gold, gilt covered ball room. This year it was held in a restau-rant surrounded by tanks of sharks. The metaphor was apt. Not since the days of the pedicle screw suits has the process of innovation in spine been subject to so much nay-saying. The regulatory, blogging and financial sharks seem to be circling.

The six judges for this year’s awards were:

• Jim Youssef, M.D. is co-founder of SpineColorado, a multidisciplinary comprehensive facility, which focuses on the treatment of spinal disorders by combining the latest in non-operative and operative tech-niques.

• Alex Vaccaro, M.D., FACS Profes-sor of Orthopedic Surgery, Thomas Jefferson University Hospital, is Co-Director of the Regional Spinal Cord Injury Center of the Delaware Valley, and of the Spine Fellowship Program, both of Thomas Jefferson University Hospital.

The Best Spine Technologies of 2010 By Robin Young

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RRY Publications/MorgueFile


VOLUME 6, ISSUE 32 | OCTOBER 12, 20105• Jeffrey Wang, M.D. Chief of the

UCLA Spine Service, Director of the UCLA Spine Surgery Fellow-ship, and board certified. Dr. Wang is Professor of Orthopaedics and Neurosurgery and Biomechanical Engineering with expertise in the surgical treatment of all neck and back disorders. Dr. Wang is the Executive Director of the UCLA Comprehensive Spine Center.

• Gil Tepper, M.D. F.A.C.S., Medical Director Miracle Mile Medical Cen-ter; Diplomate, American Board of Orthopedic Surgery, QME

• Dilip Sengupta, M.D., Ph.D. is

Professor of Orthopedic Surgery, Dartmouth-Hitchcock Medical Center, Lebanon Spine Center.

• Maryellen Keenan Industry Advi-sor, Special Consultant, Hospi-tal for Special Surgery, New York, New York; Founder, Da Vinci Cen-ter, Miami, Florida, Founder, Latin Angels, Partner, Ariel Savananah Angel Investors; Industry Analyst & Speaker, Bear Stearns, Industry Analyst & Speaker, Piper Jaffray

Each submission was scored on a scale of 1 (worst) to 5 (best) for the follow-ing criteria:

1. Is this technology innovative? (To what extent does the submitted technology represent a creative and innovative technology?)

2. Does this technology have long-term significance? (To what extent does this technology have staying power?)

3. How well does this technology address a clinical problem? (Does this technology solve a current clin-

ical problem or a problem that is inadequately solved today?

4. Does this technology improve the current standard of care?

5. Would I use it?

The judges diligently read and scored all 43 submissions according to the five criteria outlined above. Adding up the scores we found some expected winners but also some unexpected winners!

Applause please for the people who created the BEST SPINE TECHNOLO-GIES for 2010!

The Best Biomaterial Technology of 2010

• Mostvotes–OsteoAMP Antibacte-rialo Inventor(s):

•AmitGovil•ScottCadotte

o Engineer(s): •AmitGovil•NeilThompson

OsteoAMP antibacterial is an allograft biomaterial which has been processed in a way which creates a material with significantly higher levels of growth factors than are available in other putty materials. (BMP-2 concentrations are 100x more than the concentrations found in market-leading DBMs). In addition the material is also extremely anti-bacterial.

• 2ndmostvotes–AOC Technologyo Inventor(s):

•TimFischer•Dr.TadeuszWellisz•JonArmstrong•JohnCambridge

AOC is a carrier system for synthetic, DBM or BMP bone grafts suspended in a matrix to use in spine surgery. It dis-solves and is eliminated from the body unchanged without any metabolic pro-cesses in 24-48 hours or as needed. It is non-inflammatory, does not swell as it dissolves and does not disperse par-ticulate matter. AOC can be formulated to NOT contain water so that it can be a carrier for all manner of compounds including proteins.

•3rdmostvotes–VALEO ALo Inventor: Ashok C. Khandkar, Ph.D.

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VOLUME 6, ISSUE 32 | OCTOBER 12, 20106o Engineer(s): Alan Lakshmina-rayanan, Ph.D.

Valeo AL is a Silicon Nitride ceramic based technology which offers the sur-geon superior strength with bone-like

imaging and hydrophilic characteris-tics. It is cell friendly and presents supe-rior cellular adherence on surface. The material is biologically inert, presents no visual artifacts or interference with CT scans, X-rays or MRI

The Best Cervical Care Technology of 2010

• Mostvotes–VISTA TXo Inventor (s):

•GeofGarth•WayneCalco•ErikZimmer•JoeHorvath

o Engineer(s): •JoeHorvath

Vista TX is a fully adjustable CTO and comes in six sizes in one adjustable

collar. Multiple adjustment points for customized fit. Metal free, MRI compat-ible, NO tools required to fit. Vista TX offers motion restriction without cum-bersome shoulder straps and is the new standard in patient comfort and care.

• 2ndmostvotes–Valeo C o Inventor: Ashok C. Khandkar, Ph.D.o Engineer(s): Alan Lakshmina-rayanan, Ph.D.

Valeo C is a silicon nitride ceramic based technology which offers the sur-geon superior strength with bone-like imaging and hydrophilic characteris-tics. It is cell friendly and presents supe-rior cellular adherence on surface. The material is biologically inert, presents no visual artifacts or interference with CT scans, X-rays or MRI.

• 3rdmostvotes–PERPOS Cervical Systemo Inventor(s):

•BobFlower•BradCulbert•LarryKhoo,M.D.•ChrisWarren

o Engineer(s): •BobFlower•ChrisWarren•FaustoOlmos

PERPOS is a transfacet compression

device which can be placed posteriorly. It is the first and only FDA approved posterior percutaneous device for cervi-cal spine stabilization. PERPOS can be precisely placed and then compressed axially without the need for additional rotation. Design improves compression strength 45% and pullout strength by 24% over typical lag screws.

The Best Diagnostics and Imaging Technology of 2010

•Mostvotes–ScoliScoreo Inventor (s):

•KennethWard,M.D.•AxialBiotech

o Engineer(s): •KennethWard,M.D.

ScoliScore Adolescent Idiopathic Sco-liosis (AIS) Prognostic Test received the most votes of ANY submission to the Spine Technology Awards. It is the first DNA-based prognostic test for a spi-nal disorder. ScoliScore is a clinically validated, multi-gene test with a 99% Negative Predictive Value that accurate-ly determines the likelihood of curve progression into a severe range (spinal fusion surgery indicated) for children

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VOLUME 6, ISSUE 32 | OCTOBER 12, 20107diagnosed with Adolescent Idiopathic Scoliosis (“AIS”). Publication of the test validation is in press (Spine 2010)

• 2nd most votes – Molecular Dis-cography o Inventor(s):

•GaetanoScuderi,M.D.•LewisHanna,Ph.D.•RobertBowser,Ph.D.

Molecular Discography received the second most votes of ANY submis-sion to the Spine Technology Awards. The inventors identified a biomarker that identifies the exact spinal location responsible for low back pain (LBP). They then developed and validated an ELISA assay based on that biomarker. The biomarker is a protein complex of Fibronectin and the G3 fragment of Aggrecan. The inventors found that FACT test accurately predicts the level of LBP in patients with degenerative disc disease (DDD). Molecular Discography is designed to use this protein complex to prospectively identify patients with DDD for future treatments as an alter-native to provocative discography

The Best Lumbar Care Technology of 2010

• Mostvotes–Allen Spine Systemo Inventor (s) and Engineers:

•GeorgeT.Wong•PaulA.Licari•DavidWarburton•EdwardJDaleyII•ThomasK.Skripps

The Allen Spine System is an extension of the OR table that allows surgeons to turn any OR table into a surgical spine table. It costs a FRACTION of the price of a Jackson table and offers intraop-erative lumbar flex and a small storage unit. Advanced accessories adjust to fit the individual patient’s anatomy

• 2ndmostvotes–MicroBlade Shav-er and iOFlex o Inventor(s):

•JefferyBleich•VahidSaadat•RoyLeguidleguid•GregorySchmitz•RobertGarabedian•RonaldLeguidleguid•NestorCantorna•MichaelWallace•ArnieBorgstrom

o Engineer(s): •RobertGarabedian•RoyLeguidleguid•RonLeguidleguid•GregArcenio•PaulMircik•MichaelWallace•MartinaHrncir•GregWelsh

MicroBlade Shaver is a new device for removing bone and soft tissue in the foramen, lateral recess and central canal. It allows the surgeon to decom-press up to four lumbar nerve roots through a single incision. Using the MicroBlade shaver, the surgeon can achieve comprehensive decompres-sion while preserving the facet joints and lamina. MicroBlade’s “inside out” approach maintains biomechanical sta-bility and offers greater bone preserva-tion for other procedures such as fusion fixation. Finally, it directly removes impinging ligament and bone with con-trolled bimanual reciprocations.

iO-Flex is a 3-step surgical technique that consists of access with the Ipsi or Contra Probe, localization of neural tissue using NeruoCheck and decompression with MicroBlade Shaver. Up to four nerve roots can be decompressed through a single point access with the iO-Flex System.

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VOLUME 6, ISSUE 32 | OCTOBER 12, 20108• 3rdmostvotes–Deformity CRICK-

ETo Inventor(s):

•Dr.OhenebaBoachie-Adjei•Dr.PierceNunley•Dr.RaymundWoo•MichaelBarrus•ScottJones•AndrewRock

o Engineer(s): •MichaelBarrus•ScottJones

CRICKET is a threaded anvil instru-

ment that provides up to 27 mm of rod reduction when used with the MESA screw, thereby eliminating the need for reduction screws. When the rod is fully reduced, the anvil is capable of apply-ing a very large force on the rod, such that the rod cannot translate or rotate within the screw housing.

The Best Minimally Invasive Care Technology of 2010

• Most votes – NeuroVision Guid-anceo Inventor (s):

•JosefGorek,M.D.•MartinHerman,M.D.•ThomasScholl

•AlbertKim•EricFinley

o Engineer(s): •RickEis•ShannonWhite

NeuroVision is a system which improves pedicle screw placement. The product uses a unique combination of tech-nique with technology so that surgeons can achieve more precise compound and optimal angle for a given pedicle. NeuroVision delivers real-time dynam-ic EMG guidance

• 2ndmostvotes–HeliFix Interspi-nous o Inventor: James J. Yue, M.D.o Engineer: Danielle Richterkess-ing

HeliFix is a tapered helical tip which is rotated into the interspinous process and self distracts up to the final implant distraction height. The implant seats itself into the interspinous space using a built-in saddle feature which creates “wings” to prevent medial lateral migra-tion. It is made with PEEK material and comes in five different sizes.

• 3rd most votes – INTRABEAM TARGIT Therapy Systemo Inventor(s) and Engineer(s):

•MatthiasBenker•HolgerFuchs•UdoObertacke•FrederickWenz•FrankSchneider

INTRABEAM TARGIT Therapy System miniature X-ray source delivers radia-tion directly into tumor cavities by generating a high dose of LOW energy (50kV) X-rays in a precise, spherical distribution pattern. Penetrates to a depth of 1-2 cm. Better flexibility, ver-satile, single dose treatment alternative, low energy

The Best Motion Preservation Tech-nology of 2010

• Mostvotes–Elaspine Implant Sys-temo Inventor (s):

•Dr.ThomasZehnder•RetoBraunschweiler

o Engineer(s): •RetoBraunschweiler•JonathanClark

Elaspine is a pedicle screw based pos-terior motion preservation system. The key element of the system is an elas-tic polymer rod with a patented form-fit connection to a mono-axial pedicle screw head. Elaspine shares the load within the vertebral tripod and thereby enhances stability mainly of the sagit-tal and frontal planes. By reducing the effects of peak loads, helps protect screw anchorage.

The Best Pain ManagementTechnology of 2010

• Most votes – Biomarker for low back pain patientso Inventor (s):

•GaetanoScuderi,M.D.•LewisHanna,Ph.D.•RobertBowser,Ph.D.

This biomarker identifies the exact location in the spine responsible for low back pain. The inventors developed and validated an ELISA assay based on


VOLUME 6, ISSUE 32 | OCTOBER 12, 20109their discovery that a protein complex of fibronectin and the G3 fragment of Aggrecan is just such a biomarker for pain. This biomarker accurately pre-dicts which LBP patients will respond to epidural steroid treatment (sensitiv-ity of > 90%).

The President’s Award for Best New Spine Technology of 2010

The President’s Award recognizes inno-vative technologies that either don’t fit into a particular category or, for what-ever reason, did not get submitted for consideration. After roughly 25 years as a Wall Street medical technology analyst, I use my own judgment as to which technologies qualify for the President’s Award. Last year I selected a software program that improved billing and receivables management for spine surgery practices. This year I selected

two stem cell technologies one of which I helped to invent and in which I have a financial interest. These selections are not subject to independent review or scoring and reflect my own opinions and biases. Of course, considering all of the successful medical technologies I’ve uncovered over the years, my biases and opinions are not too shabby. The two stem cell technologies that are this year’s President’s Award winners are:

•PureGen ELA Stem Cello Inventors and Engineers:

•KeithCrawford,M.D.•PamelaLayton•SriVishnubhotla

Early Lineage Adult stem cells are a NEW population of adult stem cells which reside throughout the body and are more abundant than MSCs in bone marrow. ELA are pluripotent and have

the capacity to differentiate into fat, cartilage and bone. In rat studies, ELA formed bone earlier and more consis-tently than bone marrow aspirate or bone marrow derived MSCs. ELA deliv-ers consistent numbers and quality of cells to the bone repair site.

• NuCelo Inventor(s):

•BioD•AFCell

NuCel is non-cadaveric human allograft tissue which is derived from living donor birth tissues. It is a combina-tion of amniotic fluid and other birth tissues. It is an HCT/P, multipotential Cellular Matrix. The allograft is cryo-preserved in vials and contains colla-gens, hyaluronic acid, trophic proteins and cells including BMPs and MSCs. ◆


VOLUME 6, ISSUE 32 | OCTOBER 12, 201010AAOS/NASS “Unalign” Over VertebroplastyBy Walter Eisner

The good Sister of Assisi Heights and Dowagers of the world are con-

fused. Just a couple of years after the North American Spine Society (NASS), the world’s largest spine society, told them that vertebroplasty and kypho-plasty were equally effective in treating their pain as a result of a vertebral com-pression fracture, the American Acad-emy of Orthopaedic Surgeons (AAOS) tells them that vertebroplasty isn’t all that effective.

AAOS/NASS Differences

In a stunning move and a seeming break with NASS, AAOS has issued new clinical guidelines recommending against the use of vertebroplasty, “for patients who present with an osteopo-rotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neuro-logically intact.” Osteoporosis is almost universally present in older women. When the bones become weaker, ver-tebrae can collapse, resulting in pain, dysfunction, and sometimes deformity such as “dowager’s hump” or kyphosis.

AAOS Workgroup Guidelines

What evidence did the AAOS work-group that developed the new guide-lines come up with to reach their con-clusion? As stated in the September 24 AAOS guidelines, the workgroup con-cluded:

“The single strong recommenda-tion in the guidelines is based on two Level I studies comparing ver-tebroplasty to a sham procedure,

and three Level II studies compar-ing vertebroplasty to conservative treatment.”

The “sham” procedure refers to the Kallmes/Buchbinder studies published in the New England Journal of Medi-cine (August 2009) which found that

patients receiving cement injections into the vertebral space fared about the same as patients who had a “simulated” procedure that inserted a needle into the space without injecting cement. One of those patients was a Good Sister of Assisi Heights in Minnesota.

NASS Caution of “Sham” Evidence

Shortly after the publication of those studies, NASS issued a statement cau-tioning against relying on the Kallmes/Buchbinder studies due to methodolo-gy shortcomings, including low enroll-ment. NASS, and a coalition of surgi-cal societies, had also taken an official position on the effectiveness of verte-broplasty and kyphoplasty in a letter to CMS (Centers for Medicare and Medic-aid Services) in 2008.

MorgueFile

David Kallmes, M.D.



In that letter the coalition wrote that vertebroplasty and kyphoplasty were equally effective in reducing pain, but that kyphoplasty, with a significantly higher price tag, offered no additional value over vertebroplasty and recom-mended equal reimbursement for the two procedures.

Harmony of Watters

What accounts for these seemingly con-tradictory positions and recommenda-tions from NASS and AAOS?

To find out, we sought out Bill Wat-ters, M.D., a NASS and AAOS member whose name appeared on both organi-zation’s recommendations. Watters is Director of the NASS Research Council and AAOS’s Guidelines and Technol-ogy Oversight Chair. Watters told us the NASS review of vertebroplasty was limited to only assessing the Kallmes

and Buchbinder studies. “We said we found some shortcomings with those studies’ methodologies and suggested additional research was needed before making any formal recommendations about vertebroplasty.”

AAOS performed that additional research, and, according to Watters, used a much larger body of evidence and data to arrive at their conclusions. Watters noted however that a more recent study, Vertos II (Klazen, Lohle, et al.) was published in the August 9, 2010 edition of Lancet. That study was not included in the AAOS analysis because of its publishing date.

Vertos II Results

That study of 202 patients in the Neth-erlands and Belgium concluded:

“In a selected subgroup of patients with acute osteoporotic vertebral fractures and persistent pain, ver-tebroplasty is effective and safe. Pain relief after the procedure is immediate, sustained for one year, and is significantly better than that achieved with conservative treat-ment and at acceptable costs.”

We asked Stephen Esses, M.D., Chair of the AAOS guidelines about the addi-tional evidence considered by the work-group since NASS’s recommendations.

Post-NASS Evidence

Esses cited, among others, three addi-tional studies with moderately reliable data enrolling a total of 210 patients and comparing vertebroplasty to con-servative treatment. Two studies were

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201012of patients with acute injuries, while the other included patients with sub acute injuries (mean time after injury 11.6 weeks).

According to the AAOS guideline document, “In the randomized trial of patients with acute injuries, patients in both groups were offered pain medi-cation and physiotherapy, while only patients in the conservative group were offered brace treatment. In the non-randomized trial of patients with acute injuries, all patients were offered similar analgesia and osteoporosis medications.

“In the randomized trial of patients with sub acute injuries, patients were treat-ed with pain medication according to

individual needs. Pain was significantly reduced for one day in the vertebroplas-ty group, but not for longer durations (the significant result at six weeks is not clinically important). Function was improved for two weeks in one study and six weeks in another, but was no longer significant beyond six months. Quality of life and analgesic-use favored the vertebroplasty group at two weeks. Fracture-related mortality was signifi-cantly reduced in the vertebroplasty group, but overall mortality was not.”

Evidence Moves On

It turns out the apparent disagree-ment between the two medical societ-ies comes down to the simple notion of evidence of science moving on and

making the best judgments that can be made with the data available at the time.

Don’t bury vertebroplasty just yet.

According to an August 2009 Forbes magazine article, patients may still ask for vertebroplasty no matter what the results show. “Sister Rogene Fox, an 81-year-old nun at Assisi Heights con-vent in Minnesota, was in the placebo group of the Mayo Clinic [Kallmes] study after getting a painful vertebra fracture in 2007. The pain went away 10 weeks after getting the placebo sur-gery, she says. This year, when she had a second vertebral fracture, she went back to get the real thing. Her pain went away within 10 days. ‘For me it was better, because within 10 days to

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201013two weeks my pain was considerably relieved. I would go back for another one,’ she says.”

And, according to Eeric Truumees, M.D., NASS board member and editor of SpineLine, Dr. Kallmes would likely perform future vertebroplasty proce-dures. Truumees told us that Kallmes is indeed still performing it.

“Weak” Kyphoplasty Endorsement

AAOS’ workgroup offered a tepid endorsement of kyphoplasty. The workgroup noted that the pair of Level II studies comparing kyphoplasty to conservative treatment found clinically important pain relief at various points but were still flawed. “The three stud-ies comparing kyphoplasty to vertebro-plasty had inconsistent results,” wrote the workgroup in its guideline.

The workgroup guidelines went on to say that while kyphoplasty and verte-broplasty are similar procedures, the evidence supports treating them differ-ently within the recommendations. “In a comparison of kyphoplasty to con-servative treatment, for example, pos-sibly clinically important differences for critical outcomes were seen for up to 12 months; comparing vertebroplasty to conservative treatment showed possi-bly clinically important differences for these outcomes only on the first day after surgery.”

“Additionally, a direct comparison between the two procedures showed a possibly clinically important advantage in critical outcomes for kyphoplasty at up to two years. The fact that these results were not consistent among all studies, however, lowered the confi-dence level that future research will confirm the results of current evidence

and resulted in the ‘weak’ rec-ommendation.”

The Academy also considered other treatments, but found, “High-quality evidence was not available to support many of the treatments currently being used for patients with osteo-porotic spinal compression fractures. As a result, the work group was unable to support or oppose such common treat-ments as bed rest, complemen-tary or alternative medicine, exercise, the use of analgesics or opioids, bracing, or electri-cal stimulation.”

NASS was listed as a participant in the peer review of the clinical practice guideline and gave its explicit consent to allow the Society’s name to be used in the recommendations. NASS, however, did not specifically endorse the guide-lines. As of this writing, NASS leaders told OTW they were preparing com-ments on the guidelines.

The other medical societies listed as peer review participants include: the American Academy of Physical Medi-cine and Rehabilitation (AAPMR); the American Association of Neurological Surgeons/Congress of Neurological Surgeons (AANS/CNS Joint Section); the American College of Radiology (ACR); AO Spine International; the International Spine Intervention Soci-ety (ISIS) and the National Osteoporo-sis Foundation (NOF).

Industry Response

A spokesperson for Medtronic, the largest supplier of kyphoplasty prod-ucts, told OTW that the company was happy to focus on the fact that kypho-

plasty is now the only procedure for the treatment of vertebral compres-sion fractures to be recommended by AAOS guidelines. A spokesperson for Stryker informed us that the compa-ny is encouraged by the results of the Vertos II study recently published by the Lancet.

Vertos IV On Horizon

Maarten Persenaire, M.D., Chief Medi-cal Officer of Orthovita, told us that AAOS did not comment on the criti-cism of the Kallmes study, specifically that it did not require an MRI or bone scan to demonstrate the (sub) acute nature of the fracture seen on plain films, nor did they require pressure pain over the spinous process as part of the physical exam.

“Dr. Lohle, the senior author of Vertos II, told me last week that they are start-ing a new study, Vertos IV, in which they will study the same patients as in Ver-tos II, i.e., the ones with pain proven to be caused by (sub) acute fractures, and randomize them to the two treat-ment arms exactly as done by Kallmes

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201014and Buchbinder. He told me that a similar study is also being planned in Aus-tralia.

“The very public position taken by AAOS is a little surprising given the fact that the proce-dures are tran-sitioning away

from orthopedic surgeons and hospitals to the interventional radiologists and ambulatory centers,” added Persenaire.

The good Sister of Assisi Heights and Dowagers of the world can take heart that NASS and AAOS, while not yet in harmony on this topic, will neverthe-less adjust and update their recommen-dations as science moves forward. ◆

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201015Fix Knees With FatBy Jacqueline Rupp

Fat…we Americans have an interest-ing outlook on it. In one sense it’s

nearly a dirty word, but, at the same time we’ve become marred by an epi-demic of obesity.

Dr. John A. Szivek and his research team at the University of Arizona’s Arthritis Center might give us all a new way to look at fat—as a source of stem cells and a treatment for osteoarthritis pain resulting from cartilage damage.

Osteoarthritis affects nearly 30 million adults reports the CDC (Center for Dis-ease Control), with cartilage breakdown being one of the main reasons for pain. Total knee replacement is the standard of care for treating osteoarthritis in the knee, but there are significant draw-backs, namely that the diseased and, usually, the entire joint is replaced even if only part of it is damaged. How can you target healing in one particular spot of the knee, while leaving the healthy parts well enough alone?

Well, regeneration of the cartilage is the recurring dream. Enter Dr. Szivek who is turning to stem cells in fat as the solu-tion for re-growth.

Why Fat?

The idea of using stem cells from fat for regeneration is actually not new, dating back to the late 1990’s, when investiga-tors studying cardiovascular tissue regen-eration began employing cells from fat tissue. “The more difficult part is extract-ing them and preparing them specifically for orthopaedic applications,” explains Szivek, “and convincing the cells to form the right kind of tissue.” Szivek says that typically if you place the stem cells on

cartilage tissue or with other cartilage cells, they transform into cartilage cells, but getting them to form the right kind of cartilage is the hard part.

Fat cells can only produce fat tissue, but there are other cells in fat tissue because of the number of blood vessels in it, with stem cells being found in the lining of the blood vessels

“Joint cartilage is a highly organized, highly stratified tissue and the cells need to follow that pattern otherwise you end up with a fibrocartilage that is too flexible and weak.” Not good for knees.

But how does this method differ or even outperform current methods, like using autologus cartilage cells collected from the patient? Szivek says that stem cells collected from fat is a lot cheaper and

easier to obtain and prepare. (We all have a little extra hanging around.) “And [with autologus cartilage cells] it’s diffi-cult to get those few cartilage cells that can be collected safely to divide to the point where you have the 10,000,000 cells….” (The quantity needed to grow such complex forms of cartilage tissue.)

So what are the main benefits to using fat tissue to harvest stem cells? Well let’s look at how stem cells are typically col-lected. Bone marrow is the go-to source for mesenchymal stem cells and that requires harvesting from the patient’s living bone (generally the iliac crest). Contrast that to harvesting fat tissue, which can be collected in a similar fashion to cosmetic liposuction (more on the possibilities here later).

“The cells are plentiful in fat even in older patients,” says Szivek. “5 to 10

John A. Szivek, Ph.D. adding cells to the Cell stretching machine/Dr. John Szivek



grams will provide between millions and tens of millions of cells. They can even be harvested from around the kneecap so it could be possible to do everything with one incision during surgery.”

In Szivek’s work standard lab equip-ment is used to extract the cells, but he says more efficient methods are defi-nitely on the development horizon. “There are already a few companies that have developed completely automated enclosed ‘boxes’ that will process tis-sue in the operating room. The advan-tage of using an automated system is that it’s faster and more reproducible.” He adds this method promises a single,

efficient procedure. “Extract the fat, take out the cells and then place them into the knee.” Although Szivek has been in contact with two if these “box” developers, neither is approved for use in the U.S. for orthopedic applications at this time.

From Fat to Cartilage

If you guessed that scaffolding would be the next step in the process after the cells are extracted, you’d be right. Szivek’s team developed a special scaf-fold that was created with the use of 3D CT scans. A patient’s bone struc-ture can be imaged and recreated in the scaffold. “The scaffold we are using has a structure that mimics the shape of the bone adjacent to the cartilage in a particular joint and we have primar-ily developed this type of scaffold so that we can replicate the compliance or springiness of the patient’s bone. This allows us to accurately collect load measurements through the cartilage,” says Szivek.

“Our implantable sensors and radio transmitter systems are the only ones in use to measure loads from tissues in situ,” says Szivek. The device, which looks like a smart phone, consists of a transmitter in the interior of the scaffold and a portable receiver. It measures the types of loads cartilage normally experi-ences when patients exercise, but could also offer clues to the best rehabilitation methods for cartilage tissue growth. Szivek says this is the first time a moni-tor like this is being used to measure loading in living tissue.

At the moment Szivek says this type of “focal defect repair” is currently being targeted to the younger patient demo-graphic, however the long-term goal is to “be able to resurface an entire dam-aged surface,” particularly for those suf-fering from osteoarthritis. If this works out, the result could be fewer total knee replacements.

Get Better Knees and Get Skinny All at Once?

We couldn’t help but wonder, given the connection to fat here, what the pos-sibilities for a procedure like this could be. Obesity affects a large number of Americans each year—around 34% of the population according to Preva-lence and Trends in Obesity Among U.S. Adults, 1999-2008 published this year in the Journal of American Medical Advertisement

Strain Gauged Scaffold/ Dr. John Szivek

The cells are plentiful in fat even in older patients,” says Szivek. “5 to 10 grams will provide between millions and tens of millions of cells. They can even be harvested from around the kneecap so it could be possible to do everything with one incision during surgery.

“ ”



Association. And with those numbers come obesity-related orthopedic issues, particularly in the knees. A Canadian report that looked at 2003-2004 joint replacements found that only 18% of joint replacement patients had what was considered an acceptable weight, with nine out of ten knee replacements patients being either overweight or obese. “That extra weight can be very damaging to an artificial joint since activities such as rising from a chair or climbing stairs can put up to five times your body weight onto your knee joints. As it turns out artificial knees do wear out more quickly if a patient is heavy,” adds Szivek.

So it’s obvious…fat generally isn’t a good thing for joint health. But could we come to the point where the joint and weight problems were solved together? If you are a doctor perform-ing a liposuction procedure to harvest stem cells, why not go further and take away additional fat? A thinner frame will ultimately figure better for the patient’s joints, right? How does the line then become blurred between orthopedic and cosmetic surgeons?

This isn’t the first time the two practices have hybridized and the future should be inter-esting in this field.

“Patients have already been lobbying me to show that more fat removal is better,” adds Szivek, “so that these two procedures could be combined. At the moment we only use 5 to 10 grams of fat (about the size of a golf ball). More tis-sue means more cells and more cells may be useful.”

Outcomes and Outlooks

Szivek says his team has observed no cartilage tissue when no cells are used

with their scaffold and “appropriate cartilage tissue formation on some of our scaffold systems when stem cells are used.” In one case Szivek says the engineered tissue was indistinguishable from the surrounding native tissue. “In addition, we have been able to mea-sure loading during walking, running, jumping, crawling and stair. Although we have taken measurements from patients in other applications we have not yet collected measurements from the knees of human patients.”

The University of Arizona team has just begun processing the human tissues for cell culture using an FDA-approved clean room and chemicals. “Assuming these cells respond as well as the ones we have used in our model we will be able to ask the FDA to allow prelimi-nary testing in a patient model,” adds Szivek. ◆

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Hand-held Computer and Receiver monitor/Dr. John Szivek


VOLUME 6, ISSUE 32 | OCTOBER 12, 201018Back to the Future? General OrthopedicsBy Elizabeth Hofheinz, M.P.H., M.Ed.

What do pterodactyls and general orthopedics have in common?

Well, the fact is that you just don’t hear much about them anymore. With the explosion of specialized training, gen-eral orthopedics strives to maintain its identity in the melee of sub—and super sub—specialty training. While not as compartmentalized as spine or shoulder, general orthopedics still has a substantial role to play in the well being of millions of patients with musculosk-eletal conditions.

Dr. John Callaghan, President of the American Academy of Orthopaedic Surgeons, notes, “General orthopedists will always be a significant compo-nent of our field, especially in the era of healthcare reform when millions of individuals will be joining the insur-ance rolls. The fact is that while the majority of orthopedists are pursuing specialized fellowships, they end up doing a lot of general orthopedics work. For example, someone may do a sports medicine fellowship, but then once in

practice, go on to do trauma and adult reconstructive work. There is no ques-tion, however, that you will find more general orthopedics being done in the least populated the areas.”

And, says Dr. Callaghan, you do not need a fellowship trained foot and ankle surgeon to handle minor tendon inflammation. “There are many muscu-loskeletal conditions that do not require complex treatment/surgery, and can be managed by a general orthopedist or,

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201019depending on the situation, a physi-cian assistant. These are things such as simple hip, ankle, and wrist fractures as well as knee arthroscopy for anterior cruciate ligament and meniscal tears.”

Turning the pages of the calendar, Dr. Callaghan notes, “As we progress with technology and create sub-sub special-ties, things may be harder for general orthopedics. That said, however, we now have more active young people, an increase in active ‘boomers,’ and a rising obesity rate…all of which mean more joint replacement, something that can usually be handled by general orthopedists. Because of these changes, we may see a shift of general orthope-dists back to urban areas. Also, with more and more orthopedists being employed by hospitals, we are seeing a rise in contracts that include provisions that the surgeon will care for all ortho-pedic conditions. There will be fewer instances of orthopedists being able to

pick and choose which cases they want to take on.”

Dr. Robert Stanton, President of the American Orthopaedic Society for Sports Medicine, says that the banner of general orthopedics is held highest by those in the sports medicine arena. “You can’t blame young surgeons for wanting to pursue a fellowship. Not only does it carry a certain cache, but it helps them establish their practices. Indeed, if you take a look at the AAOS job listings it is rare to find an ad for a general ortho-pedist. Those of us who pursue sports medicine, however, are probably doing more general orthopedics than any-one else. Why? Because we handle the gamut of musculoskeletal trauma.”

Taking a step back, Dr. Stanton states, “Patients often seek out specialists, but the fact is that many orthopedic issues do not require such advanced treat-ment. They are often not clear, howev-

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201020er, that all orthopedic surgeons undergo the same basic training and that general orthopedists are equipped to handle their problem if it is not overly complex. General orthopedists are able to order all of the appropriate diagnostic studies and can establish a diagnosis and treat-ment plan. There are certain surgical procedures that are best handled by a subspecialist, however, and the general orthopedist should refer those patients to the appropriate person best able to perform a particular surgery.”

Dr. Thomas Moore, Director of Ortho-paedic Trauma at the Emory School of Medicine, hasn’t had a true general orthopedist depart his program in years. He says, “We have 25 residents a year, all of whom go on to do fellowships; it has been years since we have had a resident who didn’t specialize. Despite this, the majority of the residents end up doing general orthopedics.”

With the healthcare inequity gap clos-ing, Dr. Moore and others are staring across the shrinking divide at about 40 million new patients. Going forward, he says, it will be “all hands on deck.” Dr. Moore: “With the looming chang-es in healthcare, we in the profession must have a focused effort to tackle the manpower needs of the future. We will always have a need for general orthope-dists, especially with our aging popula-tion. By 2020 the cost of hip fractures—something that can be done by general orthopedists—will equal the cost of all other fractures combined.”

The ideal scenario, says Dr. Moore, is having surgeons who are well trained and have flexible attitudes. “Even though the fellowship trend contin-ues, specialists will be doing primar-ily general orthopedics at some point in their careers. The typical scenario

is that before someone develops his or her niche, they do general orthopedics for awhile. I have many friends who are specialists, but still do a significant amount of general orthopedics. And at our level one trauma center we have fel-lowship trained spine surgeons who are happy to put intramedullary nails in a femur—as well as a fellowship trained sports medicine specialist who does hand cases.”

Dr. Moore is fortunate to have such cooperative colleagues. For many insti-tutions all around the U.S., call sched-ules—namely, orthopedists who are willing to take call—represent a signifi-cant problem. “When residents gradu-ate they should be proficient in general orthopedics, and willing to take part in the call duty, something that has always been part of orthopedics. Going for-ward this is where general orthopedists can make a real difference in treating the burgeoning number of patients that are coming down the pike.”

There is a particular area where general orthopedists are at a disadvantage, says Dr. Moore. “As the emphasis on evi-dence based medicine increases, gener-al orthopedists will have to adjust to the best practice guidelines that are being established. Time honored treatment modalities may have to be put aside as we get more data on the viability of vari-ous treatment approaches. This process will be especially challenging for general orthopedists because they tend to have less interaction with their colleagues. Here at Emory we have a conference each morning where all we do is scru-tinize the literature, something that our colleagues in general/rural orthopedics typically don’t have the chance to do.”

“Ideally, I hope to see more situations like they have in Nevada,” says Dr.

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201021Moore. “Dr. Tim Bray, President of the Orthopaedic Trauma Association, has established a system where rural (gen-eral) orthopedists can transfer patients to a tertiary center and get reimbursed. It is a situation that recognizes that sometimes orthopedists reach the lim-its of their training…and it provides a workable solution.”

Brad Henley, M.D., M.B.A. is Professor of orthopedic surgery at the University of Washington in Seattle. A traumatolo-gist, Dr. Henley predicts, “The practice of general orthopedics will persist, but not increase. The relative density of orthopedists to the population varies geographically and you need a certain population density to support a single orthopedist. Where you have a larger population density orthopedists have the opportunity to improve quality by sub specializing and becoming profi-cient in treating diseases within a nar-rower spectrum.”

He continues, “Patient access to ortho-pedic care will be determined by the evolving medical evidence support-ing the need for these services. This means that new technologies and ser-vices will come under more scrutiny.

Certain services offered today will be found by physicians and patients to be of low value and will likely diminish in prevalence. Many simpler services will likely go downstream to non orthope-dists. In fact, general orthopedists are now providing some services that were previously in the domain of orthope-dic specialists.”

Shepard Hurwitz, the Executive Direc-tor of the American Board of Orthopae-dic Surgery, weighs in on some recent statistics regarding general orthopedics. He states, “As it stands now, the current workforce needs call for general ortho-pedists much more so than any subspe-cialists. For the years 2008 and 2009 the percentage of those taking the part II certifying exams in general orthope-dics was 45% and 43%. Looking for-ward, I think that general orthopedics will continue to be a large part of the orthopedic profession, primarily due to the reality of orthopedic practice. It is untenable for surgeons who train in a subspecialty such as sports medicine or spine surgery to have a practice that is mostly patients with subspecialty needs. The most likely reason for the delay in specialized practice is the need to develop a reputation among referring

doctors and people in the community, and possibly the need over time to learn how to practice in the ‘real world.’”

Twenty years ago the future was in spe-cialization…now, perhaps, the future is in the time honored past of general orthopedics. ◆

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201022company

“Biospace med” Now “EOS imaging”

It’s all about image, right? Well, in the case of EOS imaging, yes. The com-

pany has announced that it is retiring the corporate name ‘biospace med’ and will now officially be known as ‘EOS imaging,’ effective immediately.

“Our new corporate name leverages the tremendous goodwill and name recognition that we have achieved in Europe and North America for our EOS orthopedic imaging system,” said Marie Meynadier, Ph.D., CEO of EOS imaging, in the news release. “EOS is clearly changing the way radiologist/orthopedist teams can now diagnose and treat deformative and degenerative pathologies in all age groups, from chil-dren to geriatric patients. Without EOS, radiologists and orthopedists have to

interpret what they’re looking at in a 2D X-ray. Now, with EOS, they can have a complete view of their patient’s skel-etal anatomy: life-sized, standing up, and in 3D from all angles. EOS imaging is working to establish EOS as a new modality in orthopedic imaging, with very low X-ray exposure to the patient and efficient patient workflow for the physician,” added Dr. Meynadier.

“Among radiologists and orthopedists, EOS has now become synonymous with upright, full-body, ultra-low-dose images due to its uniqueness in the medical imaging market,” said Hervé Legrand, Vice President of Marketing for EOS imaging, in the news release. “Orthopedic surgeons are prescribing an EOS exam as they would order an X-ray, a CT scan, or an MRI exam. As a result of this strong branding of EOS, It is logical for us to align our flagship product name with our company name, EOS imaging.”

EOS, developed from a Nobel Prize-winning technology, allows full-body imaging of patients that enables global assessment of balance and posture as well as a 3D bone-envelope image in a weight-bearing position. It also pro-vides over 100 clinical parameters for pre- and post-operative surgical plan-ning. EOS has received FDA 510(k) clearance.

With regard to any potential obstacles for the name change, Hervé Legrand told OTW, “We don’t expect any spe-cific obstacles, since our former cor-porate name, biospace med, was quite unknown whereas our EOS brand has significant recognition among radiolo-gists and orthopedists.”

As for their next areas of growth in the U.S., Legrand commented to OTW, “We

will double the number of EOS instal-lations in North America by year end, with very prestigious sites. We expect strong growth in 2011 due to numerous sales agreements now in place or pend-ing or expected, for a wider coverage of the country.”

—EH (October 6, 2010) ◆

Wright Settles With DOJ

Wright Medical has joined the big guys of orthopedics by announc-

ing on September 30 the company’s very own Deferred Prosecution Agreement and civil settlement with the Depart-ment of Justice.

Wright was not a party to the $311 mil-lion settlements reached by Zimmer, Biomet, DePuy, Smith & Nephew in 2007. Those companies agreed to pay fines and welcome federal monitors for 18 months. Stryker settled with the government in a separate agreement.

The settlement resolved an investiga-tion started in 2007 looking into alle-gations the company paid kickbacks to surgeons in exchange for using Wright products.

The company will make a $7.9 million payment to the government and agree to 12 months of federal monitoring. The company is also entering into a five year Corporate Integrity Agreement with the Office of the Inspector Gen-eral of the Department of Health and Human Services.

Gary Henley, Wright’s President and CEO stated:

legal

Photo manipulation by RRY Publications. Source: Creative Commons



“We are pleased to announce these agreements and look forward to working with the independent moni-tor as we continue our commitment to the highest standards of ethical and legal conduct. This commitment applies to all our dealings with our customers, vendors and business partners, as well as with our sur-geon consultants who are an impor-tant source of innovation in medical technology and integral to the train-ing of their peers. We believe this resolution is in the best interest of our shareholders and that the terms of the resolution reflect our coopera-tion with the government through-out the investigation.”

James B. Tucker, former United States Attorney for the Southern District of Mississippi will be the federal monitor providing oversight. It was not reported how much he will be paid, but it will unlikely reach up to the $52 million former U.S. Attorney General John Ashcroft was reportedly paid to moni-tor Zimmer.

Several Wall Street analysts said the settlement should not impact Wright’s earnings.

—WE (October 1, 2010) ◆

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New Data for RepRegen’s StronBone

RepRegen, which uses patented repair and regeneration technology

platforms designed to mend and regrow hard tissue such as bone and soft tissue such as cartilage, is announcing three- and six-month data from an in vivo study of its CE-marked StronBone Bone Graft Substitute with Strontium. The study demonstrated that StronBone can generate bone quality in, and around, bone defects that is significantly supe-rior to a standard bone void filler (TCP-CaSO4) in the control defect.

Specifically, the study showed that the bone in the defect was significant-ly stiffer (stronger) at three months (69%) in the StronBone bone graft than in the control (it took 6 months for the control to achieve a compa-

rable stiffness); and, the bone in the defect was significantly denser at three months (41%) and six months (62%) in the StronBone bone graft than in the control. Also, the amount of soft tis-sue in the defect at three months was

significantly lower in the StronBone bone graft compared to the control (17% compared to 41%); and, the amount of soft tissue in the defect at six months was significantly lower in the StronBone bone graft compared to the control (12% compared to 40%).

The study was conducted by princi-pal investigator Prof. Allen Goodship along with Prof. Gordon Blunn and col-leagues at the Institute of Orthopaedics and Musculoskeletal Science at Univer-sity College London (UCL).

“Our platform is designed to dramati-cally upgrade the repair and regenera-tion of hard tissue such as bone,” said Ian Brown, RepRegen’s CEO, in the news release. “We intend to begin com-

mercializing the first product from our hard tissue platform this year.”

Earlier this year, an in vitro study pre-sented at the 56th Annual Meeting of the Orthopaedic Research Society (ORS) demonstrated that RepRegen’s patented strontium-based bioactive glass platform enhances cellular attrac-tion of osteoblasts to the matrix.

Ian Brown told OTW, “We aim to be a leading player in our market segment: innovative biomaterial-based products for hard tissue repair and regeneration, and for soft tissue repair and regenera-tion. We are focused, in the short term, on ceramic applications in bone repair and composite applications in cartilage repair. In the long term, we are focused on polymer applications in cardiac and much more.”

As for StronBone going from inves-tigational use only to full approval in the U.S., Brown commented to OTW, “RepRegen is in the process of prepar-ing an FDA submission for StronBone and anticipates completion of that work before year end.”

—EH (October 5, 2010) ◆

Breakthrough for Osteo-porosis?

A single drug that can both prevent further bone loss and encourage

bone formation? Just such a drug may be coming out of Israel…Researchers at the Hebrew University of Jerusalem have discovered a group of substanc-es in the body that play a key role in controlling bone density. Moving on

biologics

Michelle Kwajafa/morgueFile

large joints



their findings, the team has now begun development of a drug for prevention and treatment of osteoporosis and other bone disorders.

The research group working on the project is headed by Prof. Itai Bab, Director of the Bone Laboratory at the Institute of Dental Sciences. The team’s findings have just been published in the American journal PNAS (Proceedings of the National Academy of Sciences).

In their current research, the research-ers found that the bone cells produce a series of substances composed of fatty acids and amino acids called “acyl amides.” They then analyzed their precise chemical composition, created synthetic versions of them, and exam-ined their effect on bone cell cultures.

In experiments on mice, they discov-ered that one of the compounds in the group of synthetic materials, oleoyl

serine (OS), increased bone density in both healthy and osteoporotic mice. They also found that the osteoporotic mice were actually missing the oleoyl serine in their bones. These findings, say the researchers, can serve as the basis for new drugs that can both pre-vent bone loss and boost bone forma-tion and in this way reverse loss of bone tissue in osteoporosis patients.

Development of such a drug has begun in the laboratories of Prof. Raphael Mechoulam (at Hebrew University’s Institute of Drug Research) and Prof. Bab. Yissum, the technology transfer company of the Hebrew University, has submitted a patent application based on their work and is seeking a commercial partner for further devel-opment.

Professor Bab said in the news release that to date, drugs have worked to pre-vent further bone loss or to encourage bone formation, but that none of them are able to accomplish both functions together as this new formula can do.

The researchers noted that research in this field until now has been based pri-marily on proteins and genetics. Now, the Hebrew University researchers say, they have opened a new approach, called “skeletal lipidomics” based on the examination of substances in the skeleton containing fatty acids and amino acids. This has great signifi-cance in understanding the regulation of metabolism in bone and in other body tissues, they say.

As for challenges as they move forward, Dr. Bab told OTW, “It will be challeng-ing to identify the OS receptor and test the OS effect on fracture healing; also, the integration of endosseous implants will be a challenge. As for a commercial

partner, we are searching for a licensee that will also support further research.”

—EH (October 8, 2010) ◆

Arthritis Patients and Employer Support

“Oh, just suck it up, Jim” might be the attitude of many bosses when it

comes to arthritis. The UK-based char-ity—Arthritis Care—is announcing the results of a survey indicating that employer support is a key deciding fac-tor in helping workers with arthritis to keep their jobs.

The UK survey, conducted in prepara-tion for World Arthritis Day on October 12th, found that where bosses fail to offer supports like flexible working and an accessible environment, employees with arthritis too often end up leav-ing their jobs. Of the respondents still working despite having arthritis, 75% said their employer had provided rea-sonable adjustments when requested. But of the respondents not now in work, only 39% said they had received such adjustments.

A full 70% of the survey’s non-work-ing respondents directly blamed leav-

MorguleFile

Kevin Rosseel/morgueFile


VOLUME 6, ISSUE 32 | OCTOBER 12, 201026ing their job on their arthritis. Almost two-thirds of these (64%) said they had requested reasonable adjustments from their employer but only one in three of these (36%) got them.

Arthritis Care is moving forward, and is launching an “Employers’ Pledge” on World Arthritis Day, urging employers across the UK to affirm their commit-ment to improving life at work for peo-ple with arthritis.

Rachel Haynes, Director of Public Relations, said in the news release: “Although times are tough in today’s market, businesses should strive for inclusive workforces that genuinely reflect our society. This Pledge provides an opportunity for them to become bet-ter employers. Many bosses aren’t even aware of government support schemes like Access to Work, or how simple it can be to make adjustments for staff

who need them. For example, giving employees with arthritis a supportive chair, or flexible hours to help them dodge the rush-hour crush, can make all the difference in helping them to stay working.”

—EH (October 7, 2010) ◆

Meeting Tackles Inequi-ties in Arthritis Care

What the real cause is for the cul-tural disparities in seeking treat-

ment and surgery for musculoskeletal problems? Why are women uniquely affected and what are the differences in treatment and outcomes among women who undergo total knee arthroplasty? What are the socio-economic factors currently contributing to the growing disparities in musculoskeletal care? These are just some of the questions

that were recently tackled at a first-of-a-kind national summit: MOVEMENT IS LIFE: A National Dialogue on Arthri-tis, Musculoskeletal Health Disparities and the Health of the Nation, held in Bethesda, Maryland on September 20-21.

“The compound effect of arthritis and chronic medical conditions among women and racial/ethnic minorities is a costly national health crisis,” said Mary O’Connor, M.D., in the news release. Dr. O’Connor, Chair of the Department of Orthopaedics at Mayo Clinic Flori-da, added, “Understanding the effect of arthritis on disability and physical inac-tivity is critical to effective chronic dis-ease management in the United States.”

MOVEMENT IS LIFE, co-chaired by Dr. O’Connor and Dr. Said Ibrahim of the University of Pennsylvania School of Medicine and Philadelphia VA Medi-

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cal Center, included topics such as the role of culture, social/psychological factors and the economic impact of musculoskeletal health disparities. The event was also attended by primary care physicians, orthopedic surgeons, health advocacy organizations, community organizations, academia, faith-based leaders, community advocacy organiza-tions, nurse associations and industry.

One of the specific topics addressed was that the results from a number of stud-ies using varied research methods (e.g., observational surveys, willingness-to-pay measures) have consistently found lower preferences for total joint replace-ment among blacks vs. whites. Possible explanations for this were discussed, including social networks, religiosity, and the different ways that blacks and whites explain arthritis (what they attri-bute it to).

A spokesperson for the event told OTW, “The first success barometer actually was the coordination of the cross-func-tional meeting. It marked the first time that stakeholders from the entire con-tinuum of care came together on a com-mon goal of reducing musculoskeletal disparities, which drew on a variety of perspectives and priorities. There were 120 participants that included entities

such as the National Hispanic Council on Aging, the National Baptist Conven-tion, NIH, the Center For Health Equity Research and Promotion, and Meharry Medical College. The Summit was a ‘call to action’ to end health disparities in arthritis and musculoskeletal health by raising awareness about the issue to slow the progression of arthritis. We will be disseminating a manifesto with fact findings and a three-year strategic plan with actionable, measurable items for addressing this growing issue.”

—EH (October 1, 2010) ◆

Childhood Diabetes and Weak Bones

Do we need yet another reason to keep kids moving? If so, here it

is…Researchers from Medical College of Georgia are reporting that children at risk for diabetes before they reach puberty also may be at risk for weak bones. The study is the first to suggest the association between weaker bones and type 2 diabetes risk in children.

A study of 140 overweight children age 7 to 11 who got little regular exer-cise found that the 30% with signs of poor blood sugar regulation had 4% to 5% less bone mass, a measure of bone strength, said Dr. Norman Pollock, a bone biologist at MCG’s Georgia Pre-vention Institute.

“This finding provides the first clue linking childhood obesity to skeletal fractures,” said Pollock in the news release. Dr. Pollock, first author on the study published in the Journal of Bone and Mineral Research, added, “While

Medical College of Georgia



overweight children may have more bone mass than normal-weight kids, it may not be big or strong enough to compensate for their larger size.”

Dr. Pollock indicated that it is not as simple as saying that everyone who is overweight has weak bones. It may have more to do with how fat is distrib-uted throughout the body. In this study, higher amounts of visceral fat were associated with lower bone mass while more body fat overall was associated with higher bone mass. “Taken togeth-er, it seems that excessive abdominal fat may play a key role linking pre-diabetes to lower bone mass,” Dr. Pollock added.

Dr. Pollock told OTW, “The greatest window of opportunity to enhance bone strength and ultimately reduce the risk of osteoporosis is during child-hood, before the capacity to build bone

mass diminishes. Consequently, our findings should be considered impor-tant for schools too, as physical educa-tion and nutrition programs serve as a means to intervene and improve the health of our children.”

As for taking this data to schools, Dr. Pollock commented to OTW, “Draw-ing conclusions from nonexperimental studies must be considered tentative until confirmed by experimental stud-ies. However, adult data are beginning to surface linking type 2 diabetes and skeletal fractures. Until we better under-stand the cause for our findings and the adult studies, one of the best modifiable factors you can do for skeletal health, child or adult, is to stay active. As for other research, in children, we are cur-rently studying the influence of physi-cal activity, vitamin D, and vitamin K on osteocalcin, a bone-derived hormone,

which has shown in animal studies to have an effect on insulin sensitivity.”

—EH (October 1, 2010) ◆

Integra Debuts Calf Muscle Device

Disposable, articulating and increased control are some of the

benefits being touted for the new Endo-scopic Gastroc Release System.

Cutting the right part of soft tissues makes all the difference to a success-ful surgery. And that’s the basis thought behind Integra LifeSciences Holdings Corporation’s latest release, the Integra Endoscopic Gastroc Release (EGR) Sys-tem. Just introduced to U.S. markets, the EGR system consists of a disposable instrument with an articulating blade. This design is said by the manufacturers to allow surgeons the selectively cutting of soft tissues.

extremities

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VOLUME 6, ISSUE 32 | OCTOBER 12, 201029The EGR system is specifically designed for the surgical procedures treating pos-terior heel cord, or equinus, contracture.

Pete Ligotti, Vice President of Sales and Marketing for Integra Extremity Recon-struction says the device’s retractable blade technology should offer surgeons better control in terms of blade posi-tion which he says should limit the “the uncertainty in determining exactly which tissues to cut.” Ligotti added there are plans to extend this line to include additional sizes.

Surgery for equinus contracture typi-cally involves the recession of specific calf muscle tissue (gastrocnemius) to alleviate the tightness of this muscle and allow for better ankle motion. Although it had traditionally been per-formed as an open surgery, this treat-ment can be done endoscopically, making it minimally invasive with less scarring. Additionally gastrocnemius recession is being used to treat a host of other extremity issues, including poste-rior tibial tendon dysfunction (PTTD), diabetic forefoot ulcers, symptomatic acquired flatfoot, and hallux valgus.

—JR (October 8, 2010)

Isoform Brings Creaspine and Scient’X Together

A licensing distribution between Creaspine SAS and Scient’X ush-

ers in the production of the Isoform fusion device.

Creaspine SAS and Scient’X have come together in a five-year distribu-tion and licensing agreement that sees Bordeaux-based Creaspine’s new inter-body fusion device, Isoform being dis-tributed by Scient’X.

Scient’X, a wholly owned subsidiary of Alphatec Holdings, Inc. will distribute Isoform, a device which has already received CE mark approval. Isoform is planning to be launched to key demo-graphics, namely older spine patients shortly. Scient’X’s press releases calls Isoform “an original fusion solution in the Interbody Devices segment.”

Creaspine’s President Philippe Jenny, M.D., commented in a statement, “We are very happy for CREASPINE to have signed such an agreement with SCIENT’X, as they are the historical leader in Interbody Device solutions. It is a key milestone for our organiza-tion as it demonstrates the effectiveness and value add of our business model to provide innovative solutions to spine surgeons and the industry.”

While Dirk Kuyper, President and Chief Executive Officer of Alphatec Spine said, “I am delighted that Scient’X has estab-lished a partnership with Creaspine to distribute the Isoform interbody fusion spacer globally. I believe this is an extremely exciting technology for our Aging Spine product portfolio that will

be a welcome addition to our interna-tional product offering.”

While Franck Tricot, Creaspine’s Direc-tor of Business Development, pointed to Alphatec’s broad range and scope that he believes will benefit their prod-uct. “I am thrilled that Scient’X chose us as provider of innovation in a well-established market segment. With the global reach of Scient’X and Alphatec Spine, we have confidence in their abil-ity to successfully represent our propri-etary technology in every key interna-tional market.”

Look for other collaborations between the two spine companies as this agree-ment provides for additional develop-ment opportunities.

—JR (October 6, 2010) ◆

Creaspine; Scient’X



Surgeon-Owned Distrib-utorships Expanding

Surgeon-owned distributorships started in California are expanding

to other states.

Alliance Surgical Distributors recently announced that several new medical surgical practices have completed set-ting up their own distributorships.

Two of the new distribution efforts include Alpine Implant Alliance in Stockton, California, and Mesa Sur-gical located in Denver, Colorado. Alpine started in 2010 and is com-prised of seven subspecialty orthope-dic surgeons.

Other Alliance distributors include: Inland Spine and Orthopedics, Vista Orthopedics, Rocky Mountain Trau-ma, Alpine Surgical Technologies, JAB Spinal Systems, North Idaho Surgical Cooperatives and Restorix Technologies.

“Alliance and their surgeon partners are answering the call by our nation to improve efficiencies and provide sav-ings in healthcare. It is our responsi-bility as surgeons to take responsibility for the economic effects of our treat-ment decisions and to do what we can to reduce costs without compromising quality,” said Alliance’s founder John C. Steinmann, D.O.

Alpine Projects $230,000 Savings

“It’s not new that the economy has taken a toll on many hospitals across the U.S. but Stockton, in particular, has suffered significantly as one of the

worst economies in the nation,” said Roland Winter, M.D., Alpine’s manag-ing member. “Our hospital was look-ing for help and we realized it was our duty to do so. Alliance helped us set up Alpine Implant Alliance and we project that we will save our hospi-tal $230,000 within the first year. In the end this savings can translate in to more patient care services.”

According to the Alliance Surgical, Mesa Surgical started as a single sur-geon distributorship in an answer to help its local hospital, Avista, save on its orthopedic procedures. “It proved to be so successful that two more spine surgeons have been added and they continue as a very successful distribu-torship reducing costs,” stated an Alli-ance spokesperson to OTW.

Mesa’s Alternative to Gainsharing

Tom Eickmann, M.D., founder of Mesa Surgical, said, “We started our distribu-torship here in Denver because like many surgeons we saw our hospital struggling to remain profitable. They were considering a gainsharing model which is a short-term solution to a long-term problem. Instead, we introduced our surgeon-owned distributorship and have been instrumental in reducing the costs long term,”

The estab-lishment of s u r g e o n -owned dis-t r i b u t o r -ships has set of a fire-storm in the spinal device sales rep-resentative community. Sales reps question the legality and

ethics of such surgeon/device manufac-turer/hospital relationships. The Attor-ney General of California has declared such distributorships legal.

—WE (October 1, 2010) ◆

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Dr. Jeffrey Goldstein, Director of the Spine Service at New York Uni-

versity Hospital for Joint Diseases, is renowned for his work on the ground-breaking multicenter study on cervical and lumbar disc replacement—AKA, ProDisc. In fact, his work has resulted in some of the first level one data con-cerning patients with low back pain and degenerative disc disease. And although it is Dr. Goldstein who has the limelight when consulting for entities such as ABC, CBS, and FOX, in a heartbeat he credits his success to the talented indi-viduals who surround him.

Born on Long Island, Jeffrey Goldstein had no way of getting around the rig-ors of academia…his father was a high school principal and his mother was a high school teacher. “There were pres-sures, but as long as I achieved the most I could, then my parents were satisfied. Medicine was routinely discussed as being an honorable field, which dove-tailed nicely with my natural bent for science. I was also inspired and intrigued by the opportunity to change people’s lives.”

As Jeffrey Goldstein made his way through Colgate University and SUNY

Downstate Medical School, he came to see that the most concrete way to effect such change was—in the literal sense of the word—to manipulate people. “I was drawn to surgery because of the chance to change someone with my own hands. It is difficult to conceptu-alize what medications do, but when you use your own body as a tool, that is much more tangible.”

Not yet aware of the multiple oppor-tunities available in orthopedics, Dr. Goldstein headed for an internship at Case Western in general and recon-structive surgery. He eventually took a different path, however, after decid-ing that if he was going to be called a “maniac,” it would not be for his ego, but for his passion. “The first time I even considered orthopedics was when the Chair, Dr. Victor Goldberg, said, ‘I’ve heard about you. I have an open position in my residency if you’d like it.’ My initial plan involved general sur-gery because that’s where the big names in reconstructive surgery were. I came to see that my attitude was egotistical, however, and that this was taking me far afield from what I really wanted to do. I had to learn how to follow my pas-sion...helping people by using the full

capabilities of my hands and head.”

Dr. Goldstein then had the good for-tune to work with the legendary Dr. Henry Bohlman at Case Western, who inspired Dr. Goldstein to pursue spine. This was followed by a fellowship with Dr. Paul McAfee in Baltimore. “From Henry I learned why to do spine sur-gery…from Paul I learned how. I was also interested in research, and learned during fellowship how to get the work out of the lab and to the patients.”

Some open their mouths…Dr. Gold-stein opens his ears. Named the Direc-tor of the NYU Hospital for Joint Dis-eases Spine Service in 2007 by Dr. Joe Zuckerman and Dr. Tom Errico, Dr. Goldstein has made listening to his

THE PICTURE OF SUCCESSDr. Jeffrey A. Goldstein

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

Dr. Jeffrey A. Goldstein

In working with the fellows and residents, I am constantly aware of my role as a mentor. If I hurry a patient then they will think that this type of behavior is acceptable; if I take a shortcut on setting up a research project, then they get a negative message there as well.

“ ”



colleagues and trainees a top priority. Why? Because not only does being a leader who listens result in personal and institutional success, but it means top notch care for patients. “Years ago I chose to be open minded when receiv-ing criticism, and to listen thoroughly to the ideas of those around me. I have been fortunate to have walked into situ-ations where I am surrounded by smart innovators. And when I have to pull together a team, I ask myself, ‘Who can I get who knows more than I do?’”

The Associate Director of the Spine Fellowship, Dr. Goldstein extends his open-mindedness to those who are only beginning to learn the rigors of spine. “We treat fellows like junior associates, which is part of our effort to create a strong sense of community. I’m also proud of the fact that we are one of the few accredited spine programs in the country. In working with the fellows and residents, I am constantly aware of my role as a mentor. If I hurry a patient then they will think that this type of behavior is acceptable; if I take a short-cut on setting up a research project, then they get a negative message there as well.”

The diligent Dr. Goldstein has partici-pated in some of the most important research being done for those with back and leg pain, namely the NIH-funded Spine Patient Outcomes Research Trial. “This was one of the first level one stud-ies funded by the NIH. It was pretty challenging to enroll the right patients, and even more difficult to understand

the data. The end result, however, is that for those with no other options, spinal fusion trumps nonsurgical treat-ment in symptom and pain relief.”

But Dr. Goldstein’s magnum opus may be his work in the cervical arena. “I was one of the lead investigators on the cervical and lumbar disc replace-ment trial (ProDisc), which resulted in some of the first level one data available for operating on patients with cervical radiculopathy and low back pain and degenerative disc disease (DDD). It was an enormous amount of work, but gave us the evidence that fusion is indeed a viable option for the right patients. During this time I often thought of a former professor who always asked, ‘Is this what you know or what you believe?’ With the ProDisc study, it was evident that the results were a matter of what we knew and not what we believed.”

And while spine surgeons practice their craft with nerve root retractors as opposed to pastel paints, spine sur-gery is an art, says this vet-eran thought leader. But it is one that must evolve, says Dr. Goldstein. “Spine is an art that is by necessity grow-ing up—and into—a science. As the onus is increasingly on surgeons to develop level one studies, it follows that we will have to be more rigorous in our approach. Something indicative of our current situ-

ation is the fact that when I do weekly case presentations we get eight different opinions from six spine surgeons. Addi-tionally, I am concerned that unless we develop more level one evidence we will be told by people with other agen-das what we can do for patients.”

So where does Dr. Goldstein have the most level of control over levels of evi-dence? In his own lab. “I am currently working on a unique surface structure for implants. If you look at the surface of a total joint you find a random micro-structure, i.e., an amalgamation of pits and pillars that the bone can grow into. When we use a plasma spray process it is rather random. I have created a non-random process where we can antici-pate bony integration of the implant to increase the success of fusion. We are able to dial in the appropriate height

During this time I often thought of a former professor who always asked, ‘Is this what you know or what you believe?’ With the ProDisc study, it was evident that the results were a matter of what we knew and not what we believed.“

”

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and depth, the space in between the pil-lars, and the size and shape of the pil-lars…this is controlled integration and is the next level of care for patients.”

In creating the next generation of those who will care for patients, Dr. Gold-stein is as methodical as he is in the lab. “Because the immediate effects of a mistake in spine surgery can be dis-abling, you must approach fellowship training with an extraordinary atten-tion to each person’s skill level. There’s only so much they learned as residents and in fact they may be temporarily rel-egated to sucking blood in the OR. It is important to bring trainees along at the residency level, however, because you don’t want the first time they’re seeing XYZ surgery to be in their fourth or fifth year. It is a matter of understand-ing what exactly they can do well with the appropriate guidance.”

“Many residents shy away from spine because they don’t understand it. It is easier to understand a fracture and more difficult to comprehend the ratio-nale for performing a cervical disc

operation. But, if in their first year of residency they can understand the anatomy and pathology, then they can understand why you need to put in a lumbar pedicle screw in a particular way. Then in the second year you can teach them how to put the screw in.”

Scientific equations are a routine part of Dr. Goldstein’s days. But perhaps his favorite equation is: orthopedics–passion=a job. “If you do not have pas-sion as the train that drives you then orthopedics is just a job. When guid-ing trainees I always encourage them to look past what is alluring on the sur-face and dig deep to learn what really ‘turns them on.’ Everything gets back to patient care…if you choose spine, but are genuinely intrigued by shoulder, then you can’t be your best for the per-son in the exam room. You won’t know as much and you won’t care as much.”

The “Buddha” in Dr. Goldstein also knows that when it comes to one’s suc-cess, others play an important role. “Not only have I surrounded myself with smart, accomplished people, but

they are also even handed and lack gar-gantuan egos. I tell young surgeons to look around and notice that there are not a lot of ‘jerks’ who are leaders in the specialty societies. People who are successful are those who are willing to learn from those around them.”

And these days, he wants to learn more about the habits and loves of those at home. “My wife and I have an inquisi-tive three-year-old daughter and a son who will soon be two. I try to exercise when I can, but hobbies are generally on the back burner because I really want to be with my children as they discover the world around them. At this age my daughter thinks I make donuts…when I have to leave early for the hospital I tell her, ‘It’s time for daddy to go make the donuts.’”

Dr. Jeffrey Goldstein…using his pas-sion for research and better spine care to inspire those around him and lay the foundation for more and better research studies. ◆

I tell young surgeons to look around and notice that there are not a lot of ‘jerks’ who are leaders in the specialty societies. People who are successful are those who are willing to learn from those around them.“

”

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