Draft:SIGN Fracture Care

Overview
SIGN Fracture Care (SIGN) is a 501(c)(3) non-profit organization equipping orthopaedic surgeons in low-and middle-income countries (LMIC). It was founded in 1999 by Dr. Lewis G. Zirkle, Jr. to help surgeons care for patients with a fractured long bone.

SIGN’s vision is to create equality of fracture care throughout the world. 

SIGN empowers doctors in impoverished countries to improve the quality of care they can provide for patients with bone fractures. The SIGN Model is to provide ongoing educational support for LMIC surgeons, then donate the orthopaedic instruments and implants the surgeons need to care for patients with broken bones.

SIGN’s founder invented and patented a system of orthopaedic instruments and implants designed for use in low-resource hospitals.

After his experiences working and volunteering in Vietnam and Indonesia, he recognized that providing training for surgeons was not effective without also supplying the orthopaedic instruments and implants needed to use that knowledge.

The SIGN System enables surgeons to provide better more reliable healing and faster recovery from a fracture than they could using traction. One independent study shows that SIGN’s implants provide the same outcome as the gold standard for femoral shaft fractures, at a lower price for patients.

To measure success of the SIGN Surgery, patients are asked to perform what SIGN dubs the Squat and Smile test. Since SIGN operates in LMIC, which often lack access to x-ray technology, an alternative method to determine patient healing is needed. The Squat and Smile uses two metrics to show success: if a patient can squat, and do so comfortably with a smile. While this test has proven to be reliable, it cannot measure the same data as radiographic tests. Nevertheless, documentation exists showing SIGN patients to be mobile just days after a procedure.

Education
SIGN partners with surgeons based in LMIC by providing orthopaedic education opportunities. SIGN hosts an annual conference for international surgeons, and supports regional conferences and trainings around the world. In addition, mentor surgeons provide feedback on every surgery after reviewing x-rays and case notes submitted to the SIGN Surgical Database. SIGN also partners with medical schools in LMIC to support their orthopaedic residency programs, with the goal of increasing the number of qualified surgeons in their home countries.

Intramedullary (IM) Nails
SIGN designs, manufactures, and donates intramedullary nails used to treat fractures in the femur, tibia, and humerus. The SIGN Nail is a solid, stainless-steel rod inserted into the canal of a fractured bone and stabilized with screws on each end. They are produced in a variety of lengths to allow surgeons to treat fractures for optimal results based on patient presentation. A design variant called the SIGN Fin Nail does not require interlocking screws at the distal end, using instead the friction of flanged fins to lock into the bone canal. This has been shown to make surgery simpler and significantly faster.

SIGN’s Pediatric Fin Nail uses the fin design, but is scaled to fit in the bones of younger patients and avoids using screws in growth centers of the bone, allowing the patient to grow during healing and avoiding long-term complications.



Orthopaedic Instruments
SIGN manufactures a system of orthopaedic instruments used to insert the nail and stabilize it with interlocking screws. This system does not rely on live-view C-arm x-ray systems in the operating room, as most commercially available implants do. Instead, SIGN’s Target Arm and Slot Finder guide insertion of the nail and accurately positioning screws for stabilization.

The SIGN System can be used without electricity, making it possible to perform surgery in austere conditions, including after natural disasters or in conflict regions. This is notable, as the World Health Organization estimates nearly 1 billion people are served by healthcare facilities that lack reliable access to electricity.

Manufacturing Compliance
SIGN Fracture Care is registered with the United States Food and Drug Administration. SIGN manufactures finished medical devices in compliance with the United States Code of Federal Regulations, FDA Quality System Regulation (21CFR820) and maintains a quality management system that is certified to be compliant with ISO 13485:2016.

Patents Held
SIGN Instruments and Implants patented with the United States Patent and Trademarks Office include:


 * SIGN Hip Construct (US-8157803-B1)


 * SIGN Target Arm and Slot Finder (US-20020151897-A1, US-20040082955-A1, and                  US-7066943-B2)
 * SIGN Bone Fixation System (US-10441317-B2)

Natural Disaster Relief
Since 2004, SIGN and Dr. Zirkle have been providing aid to LMIC devastated by natural disasters. SIGN's response to natural disasters includes both healing and education aspects. By providing surgical implants and training local surgeons, SIGN establishes permanent programs in countries at high-risk for natural disasters.

Indonesia
Following a tsunami that struck Banda Aceh, Indonesia, SIGN Founder Dr. Lewis Zirkle and SIGN CEO Jeanne Dillner traveled to Jakarta and Banda Aceh to offer aid. Upon arriving in Banda Aceh, the SIGN team found that hospitals, equipment, and medical books had been destroyed in the tsunami. As a result, Dr. Zirkle and other surgeons had to operate out of mobile hospitals. After Dr. Zirkle's initial visit, Indonesian surgeons refined their skills in working with SIGN implants. When an earthquake hit Banda Aceh in 2016, Indonesian SIGN surgeons were able to operate independently. SIGN continues to provide implants and instruments for established programs in Indonesia.

Pakistan
After an earthquake occurred in the mountains outside of Abbottabad, Pakistan, SIGN offered their assistance. During the course of surgeries, Dr. Zirkle began to encounter difficulties. Due to the length of time between injury and the operative procedure, Pakistani patients suffered from misaligned fractures. Commonly, a distractor is utilized to correct the deformation. However, distractors require the use of C-arm technology; which is impractical to use in a natural disaster zone due to the risk of a power outage. In response, SIGN engineers created a distractor that would function without C-arm targeting. Four of these new distractors were then taken to Pakistan. As of 2024, SIGN continues to sponsor eight programs in Pakistan.

Haiti
SIGN came to aid Haiti after an earthquake ravished Port-au-Prince in 2010. In Haiti, SIGN Team Members rotated through multiple hospitals to perform surgery and teach the SIGN Technique to local surgeons. While in rotation, the SIGN Team was contacted by USNS Comfort, a hospital ship stationed outside Port-au-Prince.

Current Non-profit Operations
Through contributions from individuals and foundations, SIGN donates education, instruments, and implants at no cost to hospitals or patients. In some cases, hospitals and distributors purchase implants at or below production cost.

As of July 2024, SIGN partners with more than 7,000 surgeons at 434 hospitals in 58 countries. Surgeons trained by SIGN have cared for more than 430,000 patients with fractures since 1999, and provide surgery for around 30,000 patients per year.

Non-profit Industry Accreditation

 * SIGN has been rated as a 4-star charity by Charity Navigator since 2011.
 * The Better Business Bureau's Wise Giving Alliance reports that SIGN Fracture Care meets all of its standards for charity accountability.
 * Candid recognizes SIGN as a "platinum-level GuideStar participant, demonstrating its commitment to transparency".
 * GreatNonprofits lists SIGN as a "2023 Top-Rated Nonprofit".

Awards and Honors

 * 2007: SIGN Founder Dr. Lewis Zirkle received AAOS Humanitarian Award
 * 2010: SIGN is named Smart Map Expo Manufacturer of the Year Award
 * 2013: SIGN received the Patents for Humanity Award from the US Patents and Trademark Office, in the Medical--Diagnostics & Devices Category
 * 2018: SIGN Founder Dr. Lewis Zirkle received US Department of Defense Medal for Distinguished Public Service
 * 2024: SIGN receives ESOT Institutional Award