Pioneering in the First Century of Hip Replacement: Experiences of a Surgeon-Designer
Charles A. Engh, Sr., MD
Anderson Orthopaedic Institute, Alexandria, VA
Clinical Orthopaedics and Related Research 2003; 407:35-49
Copyright © 2003 Lippincott Williams & Wilkins.
Summary: The current author offers an anecdotal history of the total joint replacement industry in North America that emerged in the 1960s and of the individuals and organizations that shaped it. The author's career as an arthroplasty pioneer, influences that helped him become interested in uncemented fixation techniques, and his impression of the requirements the industry places on emerging orthopaedic leaders also are chronicled.
What an exciting invitation I have received from Dr. Lawrence Dorr and Clinical Orthopaedics and Related Research. I am delighted to be part of this issue in which several of us who were active in the earliest development of total joint replacement have the opportunity to put our memories of those days on paper. This is, in part, the story of my life in orthopaedics and of the industry of total joint replacements told in a way that I hope is enjoyable. Because I have limited my practice and research to hip replacements since 1985, I will mention little on knees or other joints for which total joint replacements now are available.The hip was the first joint to be replaced successfully in great numbers, and other joints have had their own pioneers and their own stories.
I hope you were puzzled by the title of this article. Even laypersons know that total joint replacements only have been around since the late 1960s. That accounts for only approximately 35 years. So what about the other 65 years in the first century? Those 65 years are starting right now. During the coming years, several individuals among the 7000 orthopaedists who have finished one of the 154 North American orthopaedic residency programs in the past 10 years, and those who will be trained by these residents, will pioneer future improvements. Although the earliest pioneering of total joint replacements took place in Europe and America, with today's global economy, some of our future pioneers will have been trained and practiced in other countries. Hopefully, from this article these future surgeons and scientists can gain some insight into the initial causes of failures in this field, and also learn the pathways to success. I will discuss the orthopaedic community I walked into as a young doctor and how it has changed and the people and things that influenced and energized me. Although this review will center on my experiences, I am mindful of the help I received from scores of people and several organizations and of the accomplishments of my contemporaries. This will be roughly a chronological story, and most of the action takes place from the mid1960s through the present. It is a story of the interesting times I have seen and of a career that has been richly rewarding. It also is the story of an industry that has given us what certainly is one of the most profound medical miracles of our time.
If you are an orthopaedist approximately 30 years of age, I imagine that you would like to be an exceptional surgeon. Perhaps you would like to have a large subspecialty practice and be highly regarded by your patients and coworkers. You might want to publish original research and make innovative contributions or have your name recognized within the orthopaedic profession. Finally, you may want all the financial rewards that accompany these things. I can relate to this, because many of my fellow contemporaries and I shared these ambitions when we started in orthopaedics. Unfortunately, for those who would like to be the next pioneers in total hip replacement, it is not possible to follow my pattern. I entered the total joint industry when it had an empty landscape; now it is a sophisticated city. Today, the total joint industry is a different world with an entirely different healthcare marketplace, global economy, patient demographics and expectations, and a much more restrictive regulatory environment. I have tried to identify what I would consider important factors if I were starting my career today.
MY OWN RECOLLECTIONS OF THE PAST 30 YEARS
Becoming an Orthopaedist
My parents owned a family business, a combination orthopaedic hospital and clinic. I think we looked at our business just like families that owned plumbing, electrical, or bricklaying companies. I was the first child born to this family in 1938.
My father trained as an orthopaedist during the 1930s. When he finished, he and my mother, educated as a schoolteacher, looked for a place that needed an orthopaedist. There was a great need for physicians of all specialties all over the United States at the time. My parents chose Arlington, VA, which at the time was a small Southern town. Today, it is a densely populated suburb of Washington, DC. There they built their own proprietary orthopaedic hospital, the Anderson Hospital, named after our ancestral name from Norway.
My parents administrated this hospital themselves for approximately 10 years. Many of the patients in my parents' hospital were children crippled by polio. Other patients had fractures or conditions such as back pain. The beds were filled all the time. During the 1940s, private health insurance was an emerging product, but as I recall, there never was any concern about financing the hospital's operation. The state had established funds for the care of crippled children and workers' compensation for injuries. During and after World War II, the Veterans Administration provided funding for the war wounded, which usually meant amputees. Many of the other patients simply paid their own way.
In the years after World War II, the communities near my parents' hospital grew rapidly, and my parents knew they should modernize and expand the size of the hospital. In the early 1950s, Senator Wayne Morse from Oregon sponsored a bill in Congress to provide funds for a rehabilitation unit in the hospital for a 5-year period. Funds also were available for hospital construction projects under the Hill-Burton Act. 32 This also was the time when hospitals were becoming not-for-profit entities with community involvement and governance, and my parents knew this was the way their hospital must go. Therefore, they donated some land adjacent to the old hospital to a new community not-for-profit entity, while retaining additional land for their practice.
The new hospital organization truly belonged to the local community. When construction of the new facility began, local labor unions sent volunteer workmen. Local building supply companies donated the bricks and mortar. The new hospital was renamed The National Hospital for Orthopaedics and Rehabilitation. The community retained the services of my father as administrative chief of the hospital. His practice next door became the Anderson Clinic, and there still is a clinic at that location. My father hired doctors to staff the hospital and clinics.During the 1950s, my brother, Jerry, and I grew up knowing that we were invited and expected to join the family business.
Even though I came from an affluent family, I worked at several jobs while in medical school. During the summers I worked for a professor of clinical pathology in a urinalysis laboratory and later worked as an operation room assistant. There was no doubt that I was intending to go into orthopaedics, although there was nothing glamorous about it at the time. When I finished medical school in 1963, I matched as an intern at Vanderbilt University Hospital and was offered a second year consisting of a general surgery residency. During this time, interns and residents at Vanderbilt worked 36 hours on and 12 hours off and made approximately $200 per month.
In 1965, I was looking for what many medical students are looking for today, a nationally known orthopaedic residency. There was no formal way of identifying the best programs, and there still is not. However, the most prestigious residencies I looked at then remain the most prestigious today. At the time, I looked for professors with reputations gained from speaking at scientific meetings and writing for the two most important orthopaedic journals of the time, The Journal of Bone and Joint Surgery and Clinical Orthopaedics and Related Research. My mentor at Vanderbilt University was Dr. William Hillman, Chief of Orthopaedics. After 2 years at Vanderbilt University, Vanderbilt University and Johns Hopkins University accepted me for an orthopaedic residency. Dr. Hillman recommended that I go to Johns Hopkins University. I still do not know what that was supposed to mean. I sometimes suspect they overbooked the orthopaedic residency positions at Vanderbilt University, and they were glad to eliminate their problem.
My orthopaedic residency was exciting. The specialty was developing some interesting niches during the early 1960s. There were new hand surgery techniques, and Dr. Raymond Curtis had a large practice in hand surgery at Johns Hopkins University. In Houston, Dr. Paul Harrington developed new techniques that orthopaedics used to straighten scoliotic backs. A Swiss orthopaedist, Dr. Maurice Mueller, was pioneering new techniques and products for internal fracture fixation. Perhaps, Dr. Mueller was perhaps the first great orthopaedic product champion. I define a product champion as someone who develops a better way to do something, teaches it to others, and profits from it professionally and financially. Dr. Mueller's program also was an example of vertical integration. American orthopaedists had to travel to Switzerland to study with Dr. Mueller and be certified by his Association of Osteosynthesis before they were allowed to use his devices. In the late 1960s, Dr. John Charnley developed a hip prosthesis in England. At that time, Dr. Mueller also developed a hip prosthesis.
There were fewer factors present in those days to slow down orthopaedic innovation. We did not think about federal government product approval or product liability. There were no intellectual property issues and no royalties. American orthopaedists went to Europe and learned the technique of total hip replacement. On returning, they often modified the techniques and sometimes developed slightly different prosthetic designs, which were hoped to be improvements.
Meanwhile, I elected to do an optional fourth year of orthopaedic residency at Johns Hopkins University, during which I focused entirely on research. I first spent 6 months with Dr. Robert Robinson, learning to use the electron microscope on a grant from the National Institutes of Health. I then spent another 6 months with Dr. Lent Johnson at the Armed Forces Institute of Pathology facility on the campus of Walter Reed Army Hospital. Dr. Johnson probably was the world's leading authority on orthopaedic pathology at the time. I finished my residency in 1969, after 6 years of postgraduate training.
My Windfall Benefits from Government Service The Vietnam War was in progress during the 1960s and early 1970s, and almost all physicians were obligated to become involved in a government service program called The Berry Plan. This plan helped coordinate the financing, education, and training of physicians with the needs of the government. I had a 2-year obligation to the government under the Berry Plan. My father was a consultant to the United States Public Health Service, and arranged for me to spend 1969 through 1971 at the United States Public Health Service Hospital on the Johns Hopkins University campus. Once a week I wore my United States Public Health Service Lt. Commander uniform, but most of the time I looked like a civilian doctor. I also had a faculty appointment at Johns Hopkins University and taught orthopaedic pathology to medical students and residents. I became board certified during the Berry Plan years.
While I was in the United States Public Health Service, Dr. Nas Eftekhar returned from spending time with Dr. John Charnley at Wrightington Hospital in England. Dr. Eftekhar lectured at Johns Hopkins University, and he convinced the orthopaedic faculty there to use the techniques and products pioneered by Dr. Charnley. Two faculty members, the late Dr. Lee Riley and Dr. Gerald Finerman, went to study with Charnley and Mueller. Because I was there when these men returned with their training and enthusiasm, I was able to learn how to do hip replacement surgery, even though I had little exposure to hip replacement in my residency. As soon as I was introduced to total joint replacement, I knew I wanted a total joint replacement practice.
During the Berry Plan years, I met Bob Kenna who initiated some of my most important professional and business relationships. Kenna was the Howmedica representative who supplied prosthetic components to the orthopaedic department at Johns Hopkins University. In my mind, Bob Kenna pioneered arthroplasty instrumentation for total knee replacements. He sold implants during the day but at night crafted surgical instruments for many of us, including David Hungerford for whom he developed the instruments for the PCA knee (Howmedica, Rutherford, NJ). Development of a Total Joint Replacement Practice
When I completed my training and government service in 1970, I returned to the family practice in Arlington. The late effects of polio were on the wane, there were few patients with amputations, and private health insurance was becoming the rule. Lyndon Johnson had given us Medicare and Medicaid in the middle 1960s, 35 and these programs quickly became the most important healthcare financing programs America has seen.
Just before I joined the practice, my father had hired Dr. Thomas McPherson Brown, formerly the Chief of Internal Medicine at George Washington University. Dr. Brown probably was the most famous rheumatologist in the world at that time. He also was rather infamous, because he thought that rheumatoid arthritis was caused by a bacterium, and he advocated treating it with tetracycline. His contemporary professional peers were not fans of his theories. However, he was one of the most attractive and charming people I have ever met. His adoring patients came from all corners of the world, and his hospital beds always were full. I learned from him that the combination of a charismatic personality and hope can result in powerful stuff in medicine.
The National Hospital for Orthopaedics and Rehabilitation was a closed shop hospital. There was no Institutional Review Board, and there were minimal requirements for hospital privileges at the time, so we were free to practice as we chose. We charged approximately $1200 for a total hip replacement in 1971, and increased the fee each year without any good rationale, except a vague cost of living adjustment. In the 1970s, the hospital recovered 80% of its charge from private payers and Medicare. We routinely ordered respiratory therapy, multiple electrocardiograms, and anything else we wanted for the patients being admitted to the hospital for total joint replacement, and kept the patients in the hospital for 3 weeks. What a contrast to the cost considerations practicing orthopaedists now make on a daily basis.
As mentioned previously, the National Hospital for Orthopaedics and Rehabilitation was built by trade union members, and it always had a high volume of workers' compensation caseloads. It was a challenge to transform the hospital and its image to more of a state-of-the-industry orthopaedic surgical center. In 1981, the hospital still had a closed medical staff, but it also had 50% of the market share of orthopaedic surgery in Northern Virginia, an area of growing affluence. Orthopaedics remained the preeminent specialty at the hospital. My brother and I admitted approximately ˝ of the hospital's patients each year. My father had an orthopaedic residency program with three residents each year. The residents assisted me in surgery and provided 24-hour coverage in the hospital. The American Board of Orthopaedic Surgery discontinued the hospital's residency program in 1980.
Although I was very busy as a general orthopaedist, shortly after joining my father's practice, I desired to develop a subspecialized practice in total joint replacement. My first patients having total hip replacements were affluent and well-educated, and the women outnumbered the men. The majority of patients were referrals from Dr. Brown. As mentioned previously, Dr. Brown attracted patients from all over the country. Frank Stinchfield at Columbia University was Dr. Brown's orthopaedist equivalent for the carriage trade on the Eastern Seaboard. Dr. Brown usually would have referred most of his surgical candidates to Dr. Stinchfield, but after I joined the practice, he referred them to me. To my delight, the patients accepted me.
In 1971, I set a goal to do 80 total hip replacements per year. By 1973, I had met my volume goal, but that was not enough to keep me busy full time. I still practiced general orthopaedics and probably did more spinal fusions and discectomies than any other operation besides total joint replacements.
My younger brother, Dr. Gerard Engh, joined the family practice when his training and Berry Plan responsibilities ended in 1973. He was interested in sports medicine, and also in scoliosis for which he used Harrington rods. He was instrumental in getting local school districts to protect student athletes by adding certified athletic trainers to the school athletic departments. My father, brother, and I worked together until my father retired in 1975.
By the mid1980s, the use of an arthroscope in orthopaedic surgery eliminated the need for many inpatient admissions, and third party payers' use review was preventing or shortening many other inpatient stays. Approximately 1 decade before, President Nixon's administration had sponsored legislation that took the old group health plan concepts and launched a new concept, Health Maintenance Organizations.Medicare introduced the Diagnosis Related Group prospective reimbursement methods for hospitals, giving them the financial incentive to discharge inpatients as soon as possible.The National Hospital began to decline because of its limited service scope in combination with new cost and use control programs. The hospital eventually became part of the Columbia Hospital Corporation of America system, which unsuccessfully tried to reposition it as a general community hospital renamed National Hospital Medical Center Hospital and then the Pentagon City Hospital. The hospital closed in 1999.
Today, because of the present-day healthcare market, even large, successful practices doing total joint replacements face risks when moving to new hospitals or practice facilities in the community. Such moves are most successful if the physician has a loyal team of nurses, therapists, and technicians who are willing to relocate. Currently, the offices for my practice remain in the Anderson Clinic, which has two locations with 12 physicians representing all orthopaedic subspecialties. Five surgeons do 1200 joint replacements per year. I stopped doing total knee replacements in 1985 because my brother already had much experience with them and had begun to limit his practice to knees exclusively. Since 1993, we have operated on patients at the Inova Mount Vernon Hospital (Alexandria, VA) as medical staff of the Inova Center for Joint Replacements.
Development of My Total Joint Replacement Designer Career
I taught myself most of what I know about total joint replacement surgery. Initially, I figured it was basic shop work, just put in the cement and seat the prosthesis. Most of us did not realize that technique, although less important in the short-term, was critically important for durability. Mueller and Charnley's disciples learned some essential techniques that I did not have a chance to learn directly from these men.
When I attended Dr. William Harris' hip courses at Harvard in the early 1970s, I started having my initial internal conflict about the use of cement. Because of what I had learned at the Armed Forces Institute of Pathology about bone physiology and healing, I did not think the use of acrylic cement in patients having joint replacements made for good gardening. This conflict grew stronger after spending a week in 1976 with Dr. Robert Judet, the foremost arthroplasty pioneer in France. Dr. Judet espoused the use of macroporous coating on total joint replacement components for fixation by natural bone ingrowth.By 1975, even though my cement technique had improved, I could tell that something still was not working as it should. Too many of the implants I put in were failing.
When I returned to Arlington, Bob Kenna also moved to the Washington, DC, area and became my Howmedica sales representative. In 1976, Kenna took the lead on getting 510(k) approval from the Food and Drug Administration for porous-coated hip replacements, and helped Dr. Emmett Lunsford (a previous junior partner of Dr. Austin Moore in Columbia, SC) and me find a source from which to buy the implants for our patients. In 1977, Kenna left Howmedica and started his own company, Medishield, with financing from Canadian Oxygen, Inc. Medishield bought the right to make porous-coated femoral components from The Ontario Research Foundation, the organization that owned the North American patent for the porous coating.
Robert Pilliar, PhD, was working with microporous-coated implants in the dental laboratory at the University of Toronto and taught Medishield (and later DePuy) how to sinter the material for joint replacement surfaces. The castings came from numerous sources, and Medishield applied the surface and distributed the end products. Because not many doctors used uncemented hip components routinely, Medishield struggled. Canadian Oxygen, Inc, merged with another firm, and the new company no longer desired the orthopaedic implant business. I became concerned that the sole source of porous-coated implants would disappear.
In 1980, only three implant companies supplied implants, Richards (Memphis, TN), Howmedica (Rutherford, NJ), and Zimmer (Warsaw, IN). Biomet (Warsaw, IN) and DePuy (Warsaw, IN) were small orthopaedic supply companies that distributed other manufacturers' implants. In 1981, Lunsford and I asked DePuy to buy the patent rights to porous-coated hip components. With no implant products of its own, the company was receptive to the idea.
Early in my designer career, other surgeons also were designing bone ingrowth implants. Dr. Gerald Lord, an orthopaedic surgeon in France, independently developed a macroporous-coated stem.I favored his design because it wedged more tightly into the diaphysis. The design helped me develop my analogy of the fence post to the femoral stem, that is, pound the stem in tight at the bottom and the top will not wiggle. Dr. Jorge Galante, the Chief of Orthopaedics at Rush-Presbyterian Medical Center in Chicago, was the first American to develop a microporous surface. Approximately 5 years older than I, he was ahead of me in his work. He studied the basic science associated with fiber mesh porous surfaces with animal research at the University of Chicago in the early 1970s. He subsequently became associated with Zimmer and championed their fiber mesh porous-coated products.
1982 was a significant year. The Hip Society asked Richard Johnston, a disciple of Carroll Larson at the University of Iowa and a fellow of John Charnley, to assemble speakers for the National Institutes of Health Consensus Development Conference on Total Joint Replacements.Naturally, the members of the Hip Society were prominently featured at the conference. I heard about the National Institutes of Health meeting and, in my enthusiasm and naiveté, called to see if I could present my work on microporous-coated hip implants. I was given a chance to speak late in the afternoon of the final day of the conference. Although the members of the Hip Society listened to me and enjoyed my ebullient enthusiasm, I do not think they thought my ideas were feasible. However, when the statement of the Consensus Development Conference pointed to the greatest weakness in total joint replacement, failed acrylic cement fixation, it also casually mentioned that alternative fixation methods deserved additional study.
The method advocated by Dr. Galante, Dr. Lunceford, and myself deserved additional study. By the early 1980s, my first major DePuy product, the AML hip, became available. Just after that, the porous-coated Harris-Galante hip, designed by William Harris and Jorge Galante (Zimmer, Warsaw, IN) was introduced. It was not apparent until later in the decade, after many Harris-Galante hip replacements had failed, that the femoral component of these hips did not have enough porous coating to achieve sufficient bone ingrowth. Because the AML hip had more generous porous coating, its popularity increased, whereas the Harris-Galante stem was discontinued and replaced by one with more porous coating. The Harris-Galante cup was, however, very successful.
In 1983, the seed for my own cup design was sown. Dr. Mike Leinbach, who had a large joint replacement practice in St. Petersburg, FL, introduced me to a West German orthopaedic manufacturer, Emmanuel Anapliotis. Mr. Anapliotis made a product that had become prevalent in Europe, a threaded acetabular component. Before this, Dr. Lunsford and I used porous-coated spiked acetabular components exclusively, and we were satisfied with them. But I converted after seeing the threaded cup. It was a dramatic and satisfying experience to ratchet that cup into the pelvis. I was so impressed that I made a video of the procedure, produced a manual, and had the manual reproduced and sent to Anapliotis. I sent copies to Drs. Benjamin Bierbaum, William Capello, and Thomas Mallory, who all began to use the threaded cups. Having developed connections with the Joint Medical Products Company, I asked the company to design my version of the threaded cup, which I promptly named the Anderson Cup. I am glad I did not name it the Engh Cup. Within the first few years, it was clinically obvious that patients with these cups were having pain and component loosening, whereas patients with the spiked porous-coated cup were not. As soon as I was convinced that the threaded cup was giving bad outcomes, I informed everyone that I was abandoning the product, and I asked Joint Medical Products to do the same. By this time, Anapliotis had sold his small company to Johnson & Johnson and was in retirement. It seemed to me that for the next 5 years Johnson & Johnson saw to it that the video and brochure of the renamed Micron Cup followed me around the Western world.
During that time, Joint Medical Products asked me to develop a design team for them. It included Drs. Benjamin Bierbaum, Thomas Mallory, Hugh Cameron, John Moreland, and biomedical engineer J. Dennis Bobyn. Together with Douglas Noiles, we designed a proximally-coated modular total hip implant. I suppose we thought that modularity was the design of the future. It seemed it would be easier to revise modular hips, and the implant companies probably thought they could charge more if there were more pieces. As part of this arrangement, I became part owner of Joint Medical Products. However, it soon became clear to me that it was not possible to maintain connections to two implant companies, and it became necessary to pick one concept over another. Because I was more comfortable with DePuy's nonmodular fully microporous-coated design, I remained with them. After the death of Dr. Lunsford in 1984, the connection to DePuy became even more important to DePuy and me.
As for the present, I find it somewhat amusing that Joint Medical Products and DePuy have been purchased by Johnson & Johnson, putting all my design work, including my disinherited threaded cup, under the same umbrella.
My Pioneer Contemporaries: Gaining Surgeon-Celebrity Status
In the 1970s, it was considered unethical for medical professionals to do marketing. We did not advertise our practices or lend our professional names to promote other commercial ventures or products. There were fewer orthopaedists at the time, and we were not concerned that we would have to compete with each other, so we did not need to think about marketing. It was a simpler time to be an orthopaedist.
Times changed when total joint replacement showed itself to be a successful technology. There was a profit potential for orthopaedists, hospitals, and manufacturers that none of these parties had experienced. The financial incentives were present, so it was natural for competitive teams to form. Big changes in orthopaedics were inevitable.
The first generation of surgeon-innovators in total hip replacements was composed of individuals such as Charles Bechtol of the University of California at Los Angeles, who worked with Richards to develop a modification of the Charnley hip. Roderick Turner of New England Baptist Medical Center in Boston, MA, worked with Howmedica, whereas William Harris of Massachusetts General Hospital worked first with Howmedica and later with Zimmer.
To promote their products, implant manufacturers were looking for orthopaedists with good surgical skills and a certain "je ne sais quoi" (that certain something) to be product champions. Product champions were gifted with intelligence, charisma, energy, and ambition, but more importantly, they could turn professional education into entertainment. Early examples were Harlan Amstutz from the University of California Los Angeles, Joseph Miller from Montreal General Hospital (who, incidentally, coined the term stress shielding), Michael Freeman from London Hospital, and Mark Coventry from the Mayo Clinic in Rochester, MN. The orthopaedics field now had surgeon-celebrities.
In the middle 1980s, a second generation of surgeon-celebrities appeared. A wonderful example was Anthony Hedley of Phoenix, AZ, who, with a melodic South African accent, added to his charisma. Surgeon-champions, however, had divergent messages. Advocates of cement included Merrill Ritter, a private practitioner from Mooresville, IN, William Capello from the University of Indiana, and Thomas Mallory, a private surgeon from Columbus, OH. However, David Hungerford from the Johns Hopkins University, Lester Borden from the Cleveland Clinic, and Lawrence Dorr, from Los Angeles, CA, tried to preach the truth, that cement was "the enemy." I would like to think that I am included with that last bunch.
It seems to be in the nature of surgeon-champions to be risk takers in most aspects of life. We did not have any longitudinal data on which to base decisions or opinions, so we were guided by our instincts. We each thought we were right, and we had complete confidence in ourselves. I never met one of these who did not think he had something better to offer. I only can speak for myself, but I was so excited and enthusiastic about the products I designed that I was oblivious to naysayers within the profession or industry.
Some of these early surgeon-champions eventually found out they had supported a few "lemons." In the late 1970s, when cemented hip replacements began to show their shortcomings, there was a movement to use resurfaced femoral components led by William Capello, Harlan Amstutz, and Michael Freeman. Within 5 years, many resurfaced hips had bad outcomes, and William Capello deserves credit for being the first product champion to acknowledge that his product had a higher failure rate than conventional hip replacement. Many others since have acknowledged their mistakes, including me with my threaded cup.
While I was incubating my thoughts for this article, I read an article by Stuart Green entitled "The evolution of medical technology: Lessons from the Burgess Shale." He described the initial stages of innovation of a new medical technology as an empty landscape characterized by no preexisting technology with the concomitant production of many unsuccessful models. According to Green, we can expect all the earliest reports of a new design to be glowing and written by the designers and champions. When the longer-term empiric outcomes are less-than-rosy, the next wave of reports is written by individuals who are more objective because they are not directly linked to the design. Little by little, as a range of different features is introduced and enough time passes to assess each of them, the improvements are retained and the other features are abandoned. Soon all the products remaining in the marketplace start looking similar. I note this medical technology life cycle concept because where there are surgeon-champions with stakes in industry, there also is a need for individuals who are independent in their assessments.
Educational meetings became the source for dissemination of these objective outcomes. For instance, the meeting run by Seth Greenwald, Current Concepts of Joint Replacement, hosts several thousand attendees twice each year. Greenwald taught us to how to put all the stakeholders in the same meeting and to finance it logically with all parties' interests laid on the table.
Developing Research to Improve Total Joint Replacements
My father had established a family foundation for medical research in the late 1970s. In 1983, it became a 501 (c)(3) not-for-profit organization named the Anderson Orthopaedic Research Institute. In establishing a research organization, we ran the risks of being termed mercenary and of raising enough money to support the employees. Raising money is difficult and will be one of the biggest risks and headaches for young surgeon innovators. Some medical schools do not have the money to support research, and even surgeons in academia must raise money to do research.
Anderson Orthopaedic Research Institute was modeled after the research organization operated by Dr. Brown in the 1970s. His research institute employed doctoral level bacteriologists. His charismatic personality endeared him to his patients, and his high volume practice endeared him to his hospital, so that both provided funds for his research institute, despite his unconventional research hypothesis. His patients even successfully pressured the National Institutes of Health to let him continue to do his research against the advice of the rheumatology establishment. Brown gave the hospital and patients the opportunity to invest in him and bond to him through the ritual of writing a check. I think Brown was sincere in looking for an organism as a cause and an antibiotic as a cure of rheumatoid arthritis until the day he died. I also think most of his patients felt better simply by believing in Dr. Brown and by owning a stake in his work.
Anderson Orthopaedic Research Institute began to have annual low-key fund raising campaigns, allowing our patients to bond to us as Brown's patients had to him. Even though patient gifts do not constitute a large part of Anderson Orthopaedic Research Institute's operating budget, it always has been important to appreciate these gifts, because they symbolize our patients' appreciation for what we have done for them, their belief in our work, and their own place in total joint replacement research and development. Eventually, the principal funding source for the Anderson Orthopaedic Research Institute came from industry and hospital funds, including supporters, such as DePuy-Johnson & Johnson and Inova Hospital Health System.
In 1983, I decided to hold an educational meeting on uncemented total hip replacement. National Hospital for Orthopaedics and Rehabilitation agreed to sponsor it. I invited all the doctors who had experience using this technique, including Drs. Jorge Galante, Joseph Miller, Thomas Mallory, and Robert Pilliar. Pilliar was not able to attend and sent his doctoral student, J. Dennis Bobyn, who was a remarkable speaker. Because of this meeting, I began an important research alliance with Dr. Bobyn.
Dr. William Harris taught me that to become a surgeon-innovator, one has to be 1/3 surgeon, 1/3 administrator, and 1/3 scientist. If you want to improve total joint replacement, you need to have help doing these three jobs, because there simply is not the time for it all. After the 1983 meeting, I asked Dr. Bobyn to work with me and run the Anderson Orthopaedic Research Institute. Dr Bobyn proved to be instrumental in the growth of the Anderson Orthopaedic Research Institute.
Until I met Dr. Bobyn, I never had published anything in a peer-review journal. I was inexperienced in scientific writing and found that having a busy total joint replacement practice and doing research is not possible without a research team. Good orthopaedic journals are not interested in publishing articles unless the research is solid and includes several years of followup. Before we published any papers, we wrote a textbook, commissioned by the Slack textbook company and published in 1985, called Biological Fixation in Total Hip Arthroplasty.We recorded all we knew about surgical technique, implant design, and various types of outcomes data at that point. Bobyn produced the histology illustrations and did most of the writing. I photographed radiographs and coordinated the medical illustrations.
Eventually I realized that my research was helping DePuy. A long-time employee and friend, Margaret Cummings, encouraged me to pursue a financial arrangement with DePuy. In 1985, we entered into our first licensing agreement. Dr. Lanny Johnson, a surgeon champion for an arthroscopic equipment company being pioneered at the same time, aided me. The income from these arrangements became the primary funding source for the Anderson Orthopaedic Research Institute. However, I would like to emphasize that I never have been obligated contractually to do any research directly for or under the direction of DePuy or any other company. Surgeons who do research that requires industry approval for publication lose their credibility.
In the early 1990s, the Anderson Orthopaedic Research Institute was producing approximately six major papers each year. These papers were written by biomedical engineers, visiting scholars, and fellows. Interestingly, the research institute was helping differentiate our practice from other practices and was increasing the visibility of the Anderson Clinic through our publications and presentations at scientific meetings.
To do worthwhile clinical research, a database of one's patients must be kept. I had maintained a research database since the beginning of my joint replacement practice. This originated because it was required when I registered in 1970 with the Food and Drug Administration as an investigator of new devices. Nas Eftekhar showed me how Charnley kept total joint replacement research data, and Dr. Mueller taught me about his International Documentation and Evaluation System. I met with some colleagues from Mayo Clinic and Brigham and Women's Hospital in an effort to make the International Documentation and Evaluation System better and more uniform. When the Anderson Orthopaedic Research Institute became strong financially, we began to use one database to generate a medical visit record, give us research material, satisfy institutional review boards, and generate mailing lists.
Anderson Orthopaedic Research Institute's most prolific authors have been biomedical engineers, J. Dennis Bobyn, Thomas McGovern (now an orthopaedic surgeon), and Christi Sychterz. These individuals have helped answer the important questions that were put to me in the early 1980s. "Does bone really grow into the porous coating?" "How much bone is lost in stress shielding?" "Are uncemented implants fixated as well as cemented implants?" With questions such as these, there was only one way to get definitive answers.
Following the models initially established by Charnley 10 and Charnley and Crawford 12 and followed by Harris and Galante, Anderson Orthopaedic Research Institute started promoting our postmortem retrieval program in 1977. Innovative research promotes the career of the surgeon-innovator-designer. In the 1980s, this innovation was autopsy implant retrieval. I am confident that no one has done postmortem retrieval better than the Anderson Orthopaedic Research Institute. We retrieved our first porous-coated hip replacement in 1983. The ingrowth found in that specimen was so dramatic that the photographs taken by Drs. J. Dennis Bobyn and John Collier were used by DePuy for marketing purposes. It gave DePuy a boost. At the time, I did not realize that the photomicrographs of the histology from these autopsy cases were part of the marketing arm of a new industry.
Now, we encourage all new patients having joint arthroplasty to sign a consent form allowing us to harvest their implants and unoperated contralateral joints after their deaths. Approximately 50% do so. We receive approximately 25 new postmortem specimens each year. To find our patients during the brief window of opportunity after their deaths, we match the Washington, DC, metropolitan obituaries with our research database. This effort is worthwhile. A few years ago, we thought nothing of dispatching a fellow on an airplane with no reservation, no luggage, and a duffel bag full of scalpels and saws. As we all know, times have changed, and we can no longer do this. I have had many coauthors on the papers produced at the Anderson Orthopaedic Research Institute. The best collaborators I have had are our former fellows, Dr. Andrew Glassman, now in Ohio, Dr. Thomas McGovern in New Hampshire, Dr. James Hooten in North Carolina, Dr. William Bugbee of University of California, San Diego, Dr. William Griffin, in North Carolina, and Dr. Philip Massin of Paris, France. I cannot forget collaborations with Dr. William Harris and his former fellow, William Maloney, and biomedical engineers Christi Sychterz and J. Dennis Bobyn.
The Anderson Clinic Total Joint Replacement Educational Program
If a surgeon innovator wants to spread the word about his or her techniques and perpetuate his or her philosophy, training fellows and participating in educational programs are necessary. In 1983, I started a fellowship program. Accreditation was not a concern, because total joint replacements are not a board-certified subspecialty, and none of the third-party payers have differentiated joint replacement subspecialists to date. Therefore, fellows could come to work with us simply to become more competent surgeons and researchers. Initially, I paid the fellow's salary myself with surgical assistant fees.Because my brother was pursuing his interest in total knee replacement and doing research at Anderson Orthopaedic Research Institute, we decided to begin a second public charity organization, Anderson Postgraduate Education Foundation, and to expand the number of fellows.
Today, we have four fellows each year. The Inova Health Care System matches the money that we surgeon-faculty members contribute personally. We now have an alumni society with more than 50 members, officers, and biannual meetings. Many foreign orthopaedists also have been visiting scholars with us. I frustrate my fellowship program administrator each time I return from a foreign meeting and announce that another foreign visitor will be arriving and will need a visa and housing. A Virginia license and hospital credentials are not possibilities for regulatory and liability reasons, so these doctors are research fellows. We allow foreign surgeons to observe clinical operations.
In 1983, when the concept of bone ingrowth fixation was new, there were so many visitors in my practice and the operating room that I decided to begin a training course. By 1985, approximately 20 attendees came to the courses each month. Today, we have six, 2-day Learning Center programs each year with as many as 50 physicians in attendance. We use closed circuit video surgical training with two-way communications to show surgical techniques. Many surgeons find these smaller meetings useful.
Advice to Future Total Joint Replacement Innovators
Many changes have taken place in total joint replacement that must be considered by the new generation of orthopaedic surgeons. In the early 1970s, implant companies were small and had small research and development departments. The Food and Drug Administration gave little attention to them, and the companies had not yet developed their own management bureaucracies. They were free to take risks and to bring new products into the marketplace without long-term followup. Since that time, larger companies systematically have engulfed the smaller implant companies. Today, six companies, Depuy-a Johnson & Johnson Company (Warsaw, IN), Zimmer (Warsaw, IN), Stryker-Howmedica (Rutherford, NJ), Biomet (Warsaw, IN), Sulzer (Austin, TX), and Smith and Nephew (Memphis, TN) hold the majority of the total joint replacement market in America. All these companies have an internal mandate to constantly improve their products and increase their market share, so their research and development functions have become increasingly important.
Globalization also is changing the landscape for total joint replacements and the implant companies. With people migrating globally to achieve better lifestyles and more opportunities, we see increasing diversity in all the developed countries. At the same time, manufacturers are eager to find untapped markets in which to expand. The surgeon innovator now must have a global understanding of the needs of patients. Because of responsibilities to investors, implant companies have put their efforts into countries where the healthcare systems and the marketplace provide a profit potential. Because of this, total joint replacement technology will remain unavailable to the average citizen in many countries for the foreseeable future. However, there now are enough variations in components to fit any phenotype on earth, something that could not be said 5 years ago. If there are 250,000 total hip replacements implanted each year in patients in America, where most of the 280 million people are covered by Medicare or private insurance, imagine the market growth potential for implant manufacturers in the world with 6 billion people.
Implant companies currently are selling products in countries (including the United States) where consumers have come to demand that products do not fail. In the more widely-defined field of medical implants, lawsuits with huge damage awards now are routine. Breast implants started a new public awareness of the real and unsubstantiated potential dangers of implanted foreign bodies. This means a substantial new business cost for implant companies. After the Sulzer recall of cups for failed manufacturing processes, the managers of companies now realize that when they have good reason to recall a product in good faith and for ethical reasons, they will face lawsuits. Class action lawyers continuously are listening for this type of news to bring business to their own law practices.
I am sure many younger orthopaedists would like to improve joint replacements and become product-champions for industry. The type of blanket contracting and licensing agreements given in the 1980s and 1990s are no longer offered. Industry now offers consulting contracts with more proscribed scopes and specific deliverables. Implant companies are much better organized, and the executives must show a targeted return on their consulting investments. Surgeon-champions must contribute something that can be tied to a measurable advantage for the company. I would advise any young orthopaedist wishing a contract from industry to undertake a prestigious total joint replacement fellowship and leave it with a large wake of publications and earned name recognition. This is something like the concept of box-office draw in Hollywood. A young surgeon wishing to develop a product also should study parallel medical technologies and learn how its champions came into their roles.
I would guess that most parallel technologies also have parallel developmental processes. It may be possible to find innovative ways for orthopaedists to distinguish and position themselves by looking outside our own box. Parallel medical technology developed in the past 20 years includes organ transplants, coronary artery bypass graft surgery, angioplasty, cancer chemotherapy, systemic birth control, in vitro fertilization, three-dimensional imaging techniques such as magnetic resonance imaging and computed tomography scans, and laser vision correction surgery.
Companies also have found that it is difficult to get surgeons to change their habits. Because surgeons sell to other surgeons best, companies need surgeon champions who truly believe in the features of their products. Irrespective of the quality and impartiality of a company's own message, company-generated product information is subject to more skeptical reception by surgeons than information delivered by surgeons. Being a great scientist alone is not enough to be attractive to industry. Even the best scientists are more likely to be chosen as champions if they are articulate, likeable, and excellent technical surgeons. This has been true for many years, and I do not think it ever will change. Any orthopaedist who develops a new design still can sell it to an implant company, but inventors should apply for a patent and have a good attorney represent his or her interests in the sale. Potential product liability is so great that it is not feasible for a doctor to have his or her own product manufactured privately anymore.
In this environment, it is less risky for an orthopaedist to be a consultant to help a company influence and instruct other orthopaedists than to develop bold new products. That is not to say that bold new products will not appear, but it is not possible to simply begin using them as we did in the 1970s and 1980s without a concern for liability. For young orthopaedists the landscape now is established, because all successful total joint replacement products have a rather narrow range of features that have been determined successful. New improvements will be incremental and more subtle, unless some revolutionary new concepts, materials, or techniques lead joint disease or total joint replacements in completely new directions.
For references, see Clinical Orthopaedics and Related Research 2003; 407:35-49.