Ask your average U.S. orthopedist to operate without electricity or a C-arm and they will take such a request as a sign of senility…but to Dr. Lewis Zirkle, Jr. it was a sign to find a better way—a way that morphed into the remarkable charitable surgical program called SIGN. Because of Dr. Zirkle, millions of patients have a renewed hope that their lives can be healthy and fulfilling.
Rewind to 1968 when young Dr. Zirkle was an Army orthopedic surgeon in Vietnam. As a commanding officer he decided one day to venture out for a better look at war. “I wanted to see what the battle experience was like for an enlisted man in the 101st Airborne. What I found was an epiphany: I saw the futility of war and saw many civilians badly injured. This touched me as I have always had a soft spot for the underdog…ever since that time I have looked at war from the perspective of those who don’t have the power to do anything about the situation.”
For a physician accustomed to first world support including, as a surgeon, an operating room with advanced tools powered and otherwise, Lew Zirkle was deeply affected by the very different world he’d witnessed in Vietnam. Using whatever authority and power he had, Dr. Zirkle decided to bring the benefits he enjoyed at home to developing countries. “When you have a traumatic time in your life it really crystallizes your thinking. I decided to teach orthopedics in developing countries, starting out in Indonesia then returning to Vietnam. When I finally went back to Indonesia I found a patient who had been had been lying in traction for three years with broken femur. I was upset and perplexed—I had taught the local surgeons how to treat femur fractures. ‘Yes, ’ they told me, ‘but the patient can’t afford the implant.’”
They also said that they couldn’t use the implants I had made available because their electricity didn’t always work and they had no X-rays. In an instant I realized that I had wasted a lot of time; I became determined to create a system that could be used in developing countries.
Photo courtesy: Surgical Implant Generation NetworkSo Dr. Zirkle switched gears and, starting out in his hometown of Richland, Washington, took his revised plans and enthusiasm to those who could prototype new tools for orthopedic surgeons. There he hit a wall. “My attempts to get established manufacturers involved resulted in three years of frustration because while they never said ‘no’ they never said ‘yes.’ I decided to do it myself, and started working in my garage on bones I got from a butcher shop. With help from a friend who was innovative and good with his hands, we ‘suffered’ through the first stages of creating something from nothing. We were trying to do something that had not been done before, namely, find a slot in the nail and place a screw through the slot without using an X-ray. We ran a light down a hollow K-nail but there was not enough light. We tried a variety of things until one week—Eureka!—one thing led to another and we found our way to the slot using a clamp. Several iterations later we also developed a new drill bit to make thing easier. We then acquired a manufacturing facility and hired engineers in 1999. A new nonprofit organization was born…the Surgical Implant Generation Network (SIGN).”
Traveling to Vietnam in 2000, Dr. Zirkle and his team had their first surgical success with the SIGN system. “The first patient, who was selected by the Vietnamese surgeons, had a tibia nail implanted. We were thrilled that the patient fared well, but we wanted to see if the SIGN concept was working overall. Not only was the technology a concern, but we also wanted to ensure that if we brought over an implant for the poor that it would not be sold. We have never had a problem with this last issue, and the implants have gotten to where they need to be.”
Quality was of the utmost importance to Dr. Zirkle…there would be no knockoff implants being unloaded in ports around the globe. “From the outset I wanted to do this right, with my ultimate goal being FDA clearance. I must thank Randy Huebner, the founder of Acumed—my friend and I knew nothing about manufacturing and Randy walked us through the process. I took one look at the first nail I made and said, ‘This will never do.’ We have become increasingly sophisticated in our manufacturing processes.”
After receiving an FDA clearance for SIGN’s nail, Dr. Zirkle hit another unexpected roadblock and early SIGN growing pain. “We were in Bangladesh, and realized that due to the people’s bone density (bone density varies with world geography), we couldn’t use hand drills as we had done in Vietnam. So, we devised a different way of making a pilot hole, and then used a hand drill to enlarge it. It was later while working in Tanzania that we recognized that the longest part of the procedure is making that hole larger. Now we use sterilized commercial/carpentry drills which have much higher RPM’s.”
Dr. Zirkle knows that it’s best to leave the fast and furious aspects of SIGN to the technology. When it comes to working with his colleagues in other countries, he is anything but brazen. “I am continuously learning how to be a teacher. Each country has its own hierarchy, so you must adjust to that. In Vietnam our teaching had to be approved by the senior professors, many of whom were retired. In other places you can go in and work with the young people right away. “
I teach by process rather than by saying, ‘These are the facts.’ I go in as a blank sheet of paper and they put forth their own ideas. I demonstrate a procedure one time and then fade into the background as much as possible.
With more than 200 programs and 27 staff members, SIGN reaches across the globe and deep down into the lives of those it helps. “SIGN surgeons have performed approximately 60, 000 surgeries since 1999. I am really pleased that the SIGN nail is thought of as the standard of care in many countries. Our work addresses three areas. First, we work in developing countries where there a multitude of traffic injuries. Second, SIGN surgeons operate in areas of conflict—we owe it to the civilians. For example, we have 12 programs in Afghanistan and are adding two more. Lastly, we work in disaster relief, and have the only system that could be used in the Pakistani and Haitian crises because they can be used without a C-arm and electricity. At present we have nine programs in Haiti, and, as usual, are trying to get everyone on board with understanding how to treat orthopedic patients in disasters, i.e., not just sticking them in traction for three to six months.”
The serious operate…the ultra serious gather data so that everyone can operate better. “We have collected so much information over the years that we now have the largest database in the world on intramedullary nail interlocking screws for the femur, tibia, and humerus, meaning that at our fingertips we have a wonderful array of information about fracture healing. The SIGN surgeons around the world report on each procedure, and thus have a concrete stake in the database. In situations where we donate equipment, we have it set up such that surgeons must file their reports prior to receiving the next shipment.”
For those who would like to access this cornucopia of knowledge…hold on. Dr. Zirkle: “Some people want to mine our database in order to write a paper, but we like to preserve privacy so that surgeons will report their mistakes. If we do release any data, it is only done with permission from surgeons overseas. There are many ways that this data can be used to advance our knowledge of fracture healing, but as of yet we have not begun to research these possibilities.”
Photo courtesy: Surgical Implant Generation NetworkAs SIGN enters its second decade, the technology continues to evolve. “We have now added a stabilizer to fix hip fractures without a C-arm, and are testing it in Tanzania and Cambodia. The team is also working on a pediatric nail because in adolescents there is a gap in the spectrum of treatment for femur fracture. We used some of our existing technology for patients 10 and 14 years of age, but animal studies are still needed to see the effect on the epiphysis on distal femur fractures.”
When asked about what might be on the horizon for developing countries in the years to come, Dr. Zirkle says, “We are only scratching the surface of what is needed; there is a lot of room for other non-governmental organizations. But the philosophy must be that surgeons in these countries do the procedures because they are the ones actually following the patients. We also have a responsibility to help surgeons around the world to improve their efficiency in the operating room. It is a real challenge to tie all of the components together, including personnel, sterilization, infrastructure, etc. For example, while operating in Ethiopia the water went off twice so we couldn’t sterilize the implants and had to stop the procedure. These countries also need more and better trained anesthetists. Both nurses and anesthetists are typically given low government salaries and thus have private practices to augment their income. This means that they leave the hospital at 3:00pm.”
“Promptness in the OR is also an issue that we might help address. Western surgeons are almost made fun of when we talk about the whole team arriving on time to start the procedure as scheduled. The best news is that I have recently found that there are younger orthopedic surgeons out there who are wonderful thinkers and problem solvers. They are the future leaders in their medical communities and will ultimately make the difference in the lives of their compatriots.”
