SIGN Fracture Care International Programs
At this writing just under 110,000 poor patients have been treated in developing countries using the SIGN technique and implants. That number is growing both by increasing the number of SIGN programs and the number of types of implants to treat different fractures. Fractures in developing countries due to accidents, violence and natural disasters are steadily increasing. The impact on individuals, families, communities and health care systems is significant. Current treatments in these countries take place in overcrowded hospitals, often by a patient being put in a traction device, which requires a 3-6 month hospital stay. Traction consists of a weight attached to a pin inserted into the patient's bone. This time consuming method often fails to hold the fractures in the proper position to allow healing in a satisfactory position. If the fracture heals in a shortened or angled position, the patient will walk with pain for the rest of their life. Data from the WHO indicates that families with a parent left with a life-long disability will spiral into poverty for three generations.
The healthcare system in developing countries is also stressed because patients in traction occupy beds that could be used for sick patients. The wards are so crowded that medical personnel must step over patients lying on the floor during rounds. Surgeons often leave their home country because they cannot practice principles of fracture care that they have learned from books and over the Internet. Doctors are frustrated because they know that these implants exist to stabilize fractures, but their hospital doesn’t provide them and the patient cannot afford to purchase them. The patient must pay for all surgical supplies, including implants, prior to surgery. SIGN continues to expand to meet the demand.
SIGN now has 300 programs in 55 countries. At least 4,000 local surgeons have joined the SIGN network. The number of programs and surgeons is steadily increasing. When a new program is launched, a SIGN volunteer surgeon trains local in-country physicians to use the system. SIGN training programs include information about fracture healing, operative techniques and principles of stabilizing fractures. The program is established once SIGN is satisfied that the local surgeons can perform the surgery with skill and proper sterile technique and commit to provide the system to underprivileged patients. Once the SIGN IM Nail set has been presented to the new program, the surgeons report each surgery including pre and post operative x-rays on the SIGN surgical database. This facilitates evaluation of technique and communication between surgeons in North America and developing countries. Follow-up x-rays are encouraged to learn more about SIGN treatment as well as fracture healing in general. The SIGN surgical database dedicated to evaluation of long bone fractures is the largest in the world.
Centers of excellence are being designated to disseminate knowledge of fracture care to the other programs in the region, test new implants after they have been cleared by the FDA for use in United States and provide input for the design of new implants to treat fractures in different parts of the body. Surgeons from the centers teach SIGN technique to a prospective new program and monitor the quality of their surgery.
SIGN is headquartered in Richland, Washington, where all manufacturing, design, and education program development takes place. Currently, with 30 full-time employees, SIGN is increasing its manufacturing capacity, engineering staff and other support staff to accommodate the increase in demand for the SIGN IM Nail System and for new implants to treat other types of fractures. Currently, 93 percent of SIGN’s $3,500,000 budget supports training, education and the manufacture and donation of orthopedic implants. SIGN recently recived an award from Seattle Business Magazine for manufacturer of the year in the non-profit category.
SIGN is known throughout the international orthopedic community for designing low cost, effective solutions for use in hospitals with limited resources.
The first SIGN implant was created for treatment of tibia fractures. The SIGN network of surgeons, who had no other intramedullary implants available, soon used the same implants and instruments to treat fractures of the femur and humerus. SIGN surgeons observed that hip fractures required three weeks of traction and then a body cast for several months. SIGN engineers developed a new concept to treat hip fractures without a C-arm and then devised a bench testing system for the hip fixation. The bench testing of this device took three years. SIGN has obtained clearance from the FDA for its use in the United States and the system has been used successfully in 6 programs designated as Centers of excellence. Patients receiving this treatment can walk out of the hospital, on crutches, within a week or two. Their fractures can heal without the need of a body cast. The number of pediatric femoral fractures in developing countries has increased by 20%. Pediatric surgeons from the United States and developing countries collaborated with SIGN engineers to design a novel pediatric nail. Plans are being made to obtain FDA clearance and then use this new design in selected SIGN sites.
Orthopedic power drills, costing thousands of dollars, are necessary to accomplish placement of screws and other fixation devices but are often too expensive for developing countries. Battery-powered commercial drills are a good substitute, but cannot be sterilized. SIGN surgeons have developed reusable drill covers and chuck extensions that allow commercial drills to be used in a sterile fashion, decreasing infection risk.
SIGN delivers its support to areas of conflict. SIGN programs were established to treat civilian injuries in Iraq and Afghanistan. During their second visit to Afghanistan, Dr. Zirkle and SIGN CEO, Jeanne Dillner attended the first orthopedic conference ever held in Afghanistan. The meeting was organized by surgeons in the Afghanistan army and attended by surgeons from most of the civilian hospitals, NGO hospitals and government hospitals. Many of the surgeons had never met before. The meeting gave them an opportunity to show their areas of expertise and to develop their own professional network. The conference led to establishing the Afghanistan Orthopedic Society.
SIGN responds with equipment and personnel in disasters. SIGN surgeons responded immediately to provide treatment to the victims of the 2004 Tsunami in Banda Aceh. The four programs established in Indonesia after the Tsunami are still active. SIGN surgeons from these programs responded to the earthquake in Padang, Indonesia, obviating the need for foreign orthopedic assistance. SIGN surgeons were called to Pakistan after the earthquake in 2005 by local surgeons. The seven SIGN programs continue to be active. The two programs in Peshawar treat many blast injuries.
In Haiti the SIGN disaster response team was performing surgeries within six days after the quake. Once on site, they were invited to establish SIGN programs in nine hospitals. They trained the surgeons in these hospitals and left sets of instruments and implants so the surgeons could continue to treat the earthquake victims. In addition, the Navy medical ship, USS Comfort, had technical difficulties with their x-ray machines and requested SIGN surgeons to demonstrate the SIGN technique. SIGN left equipment for the Navy surgeons to continue treating victims of the earthquake.
Recent Successes and Current Challenges
SIGN has made a commitment to support existing programs by replacing implants that have been used. The implants used in each surgery are replaced after the surgical report is received on the SIGN database. As new devices to aid in treating fractures are designed and manufactured, they will be donated for use in treating the poor in existing programs. The annual SIGN Conference provides a regular opportunity for 150 SIGN surgeons to network and learn from each other. It attracts Orthopedic experts from North America as lecturers and provides a forum for SIGN surgeons to present the results of their research. Each year their presentations improve and many are asked to present their papers at the International Forum at the Orthopaedic Trauma Association. SIGN is recognized for its contributions by orthopedic societies. Three SIGN volunteer surgeons have been awarded the Humanitarian Award from the American Academy of Orthopedic Surgeons, the national society for U.S. orthopedic surgeons.
The SIGN database is continually refined and is one of the network’s most effective educational tools. The long-bone fracture treatment database is the largest surgical database in the world. The latest revision has made it possible for reports and x-rays to be compiled offline and then uploaded when an Internet connection is available which is important in developing countries where Internet infrastructure may be lacking. The complete review of each case in the database by U.S. SIGN surgeons allows the opportunity for continuing system refinements and program training. Consultation on difficult problems is facilitated through this database.
SIGN partners with several other NGO’s including Doctors without Borders, CURE International, Emergency, COAN, Medical Teams International, and more recently Project Hope, to accomplish its vision.
The future of SIGN is propelled by patient needs, surgeon’s requests, networking and funding available. The number of programs is increasing and the number of devices to treat fractures in each program is increasing. SIGN continues to innovate new ways to treat fractures in different parts of the body. SIGN is also increasing efficiency in teaching through centers of excellence and by giving more responsibility to SIGN surgeons in developing countries.
The most current need is financial support to expand research and development of new products in order to expand the types of injuries that SIGN surgeons can treat.