Draft:SIGN Fracture Care
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Last edited by Apilger2 (talk | contribs) 40 days ago. (Update) |
SIGN Fracture Care International | |
 | |
| Nickname | SIGN |
|---|---|
| Founded | January 29, 1999 |
| Founder | Dr. Lewis G. Zirkle, Jr., President |
| Type | Non-Profit Organization 501(c)(3) |
| 91-1952283 | |
| Purpose | Building orthopaedic capacity in LMIC by providing orthopaedic education and medical device design, manufacture, and donation of implants. |
| Headquarters | Richland, Washington, U.S. |
Region | Global |
Chief Executive Officer | Jeanne Dillner |
Budget (2022) | US$ 8,340,000 |
Revenue (2022) | US$ 7,838,000 |
| Expenses (2022) | US$ 8,534,000 |
Staff (2023) | 41 |
| Website | https://signfracturecare.org |
| Remarks | Vision: To create equality of fracture care throughout the world. |
Formerly called | Surgical Implant Generation Network |
Overview
[edit]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 empowers doctors in impoverished countries to improve the quality of care they can provide for patients with bone fractures. SIGN’s founder invented and patented a system of orthopaedic instruments and implants designed for use in low-resource hospitals. 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.
The SIGN System enables surgeons to provide better, more reliable healing and faster recovery from a fracture than they could using traction. [1] 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.[2]
To measure success of the SIGN Surgery, patients are asked to perform what SIGN dubs the Squat and Smile test. 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.[3] Nevertheless, documentation exists showing SIGN patients to be mobile just days after a procedure.
Founding
[edit]In 1968, Dr. Zirkle was drafted into the United States Army to serve in the ongoing Vietnam War. While operating as a surgeon with the 93rd Evacuation Hospital, Dr. Zirkle treated wounded American and Vietnamese soldiers. Eventually, he made a formal request to begin operating on Vietnamese civilians. Dr. Zirkle believed the civilians who suffered due to the war deserved as much care as was afforded to American troops.[4] This philosophy of equality would guide Dr. Zirkle in the years to come.
After returning from Vietnam, Dr. Zirkle rotated through several hospitals while finishing his Army contract. It was during this time that Dr. Zirkle became involved with CARE MEDICO. In 1970, Dr. Zirkle traveled to Indonesia to provide training for local orthopaedic surgeons. Besides traveling, Dr. Zirkle would also send donations of medical equipment to the Indonesian hospitals. It wasn't until 1996 that Dr. Zirkle realized his efforts did not have the results he expected. On this particular trip, he encountered a patient who had been bed-ridden for three years due to a fractured femur. Dr. Zirkle proceeded to question the Indonesian surgeon as to why this patient had not received surgery. The doctor informed Dr. Zirkle that the patient could not afford an implant, nor were the supplied implants suitable for use. All the donated implants required the use of instant imaging and power tools, neither of which were available in the hospital. This interaction led Dr. Zirkle to realize another solution was needed to treat patients who live in LMIC.[4]
Dr. Zirkle recognized that providing training for surgeons was inadequate without also supplying usable implants and instruments. To accomplish this goal, Dr. Zirkle needed to partner with a US-based surgical implant maufacturing company. After many rejections, Dr. Zirkle connected with Portland-based Acumed, Inc. Luckily for Dr. Zirkle, the founders of Acumed shared his desire to provide implants for people of LMIC. Acumed engineers then created a prototype set of intramedullary (IM) nails and instruments that Dr. Zirkle took to Vietnam. The trip proved successful, as the Vietnamese surgeons demonstrated their skill with the nails after receiving instruction from Dr. Zirkle.[5]
SIGN officially launched on January 29, 1999 after Dr. Zirkle returned from Vietnam. By September, Dr. Zirkle had set up a small shop in Richland, Washington with a manual lathe and a mill for metal working. Dr. Zirkle and Acumed founder Randall Huebner handcrafted two IM nails in Richland, which Huebner took to Acumed headquarters for mass production. By the end of 1999, the SIGN technique was piloted in four hospitals (two in Vietnam, one in Indonesia, and one in Nepal).[5]
Education
[edit]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.
Medical Device Manufacturing
[edit]Intramedullary (IM) Nails
[edit]
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.[6]
Orthopaedic Instruments
[edit]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. [7]
Manufacturing Compliance
[edit]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
[edit]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)
Current Non-profit Operations
[edit]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 August 2024, SIGN partners with more than 7,000 surgeons at 439 hospitals in 60 countries[1][8]. Surgeons trained by SIGN have cared for more than 440,000 patients with fractures since 1999, and provide surgery for around 30,000 patients per year.
Low- and Middle-Income Countries with Active SIGN Programs by Region
[edit]| Country | # of Programs | Active Since |
|---|---|---|
| Angola | 1 | 2013 |
| Benin | 1 | 2021 |
| Burkina Faso | 1 | 2022 |
| Burundi | 7 | 2010 |
| Cameroon | 6 | 2007 |
| Chad | 4 | 2012 |
| Dem. Rep. of the Congo | 5 | 2012 |
| Eswatini | 1 | 2024 |
| Ethiopia | 45 | 2009 |
| Gabonese Republic | 1 | 2010 |
| Ghana | 4 | 2014 |
| Guinea | 2 | 2019 |
| Kenya | 17 | 2007 |
| Lesotho | 1 | 2022 |
| Liberia | 4 | 2007 |
| Madagascar | 1 | 2020 |
| Malawi | 6 | 2007 |
| Mali | 1 | 2016 |
| Niger | 2 | 2007 |
| Nigeria | 17 | 2007 |
| Rwanda | 5 | 2007 |
| Sierra Leone | 2 | 2009 |
| Somalia | 2 | 2021 |
| Somaliland | 4 | 2019 |
| South Sudan | 3 | 2012 |
| Tanzania | 34 | 2007 |
| The Gambia | 1 | 2017 |
| Togo | 1 | 2014 |
| Uganda | 9 | 2010 |
| Zambia | 1 | 2013 |
| Zimbabwe | 6 | 2012 |
| Country | # of Programs | Active Since |
|---|---|---|
| Dominican Republic | 4 | 2007 |
| Ecuador | 3 | 2007 |
| Haiti | 15 | 2007 |
| Honduras | 2 | 2016 |
| Nicaragua | 2 | 2007 |
| Peru | 2 | 2007 |
| Saint Lucia | 1 | 2007 |
| Venezuela | 1 | 2019 |
| Country | # of Programs | Active Since |
|---|---|---|
| Afghanistan | 21 | 2007 |
| Armenia | 3 | 2020 |
| Bangladesh | 7 | 2007 |
| Bhutan | 1 | 2007 |
| Cambodia | 17 | 2007 |
| India | 1 | 2007 |
| Indonesia | 3 | 2007 |
| Iraq | 2 | 2007 |
| Lao PDR | 4 | 2012 |
| Mongolia | 2 | 2008 |
| Myanmar | 16 | 2007 |
| Nepal | 10 | 2007 |
| Pakistan | 8 | 2007 |
| The Philippines | 10 | 2007 |
| Vietnam | 1 | 2007 |
| Yemen | 1 | 2021 |
| Country | # of Programs | Active Since |
|---|---|---|
| Palau | 1 | 2024 |
| Papua New Guinea | 1 | 2018 |
| Solomon Islands | 1 | 2014 |
| Country | # of Programs | Active Since |
|---|---|---|
| Bosnia and Hezegovina | 1 | 2024 |
| Ukraine | 13 | 2022 |
Non-profit Industry Accreditation
[edit]- SIGN has been rated as a 4-star charity by Charity Navigator since 2011. [9]
- The Better Business Bureau's Wise Giving Alliance reports that SIGN Fracture Care meets all of its standards for charity accountability. [10]
- Candid recognizes SIGN as a "platinum-level GuideStar participant, demonstrating its commitment to transparency". [11]
- GreatNonprofits lists SIGN as a "2023 Top-Rated Nonprofit". [2]
Awards and Honors
[edit]- 2007: SIGN Founder Dr. Lewis Zirkle received AAOS Humanitarian Award[12]
- 2010: SIGN is named Smart Map Expo Manufacturer of the Year Award[13]
- 2013: SIGN received the Patents for Humanity Award from the US Patents and Trademark Office, in the Medical--Diagnostics & Devices Category[14]
- 2018: SIGN Founder Dr. Lewis Zirkle received US Department of Defense Medal for Distinguished Public Service[15]
- 2024: SIGN receives ESOT Institutional Award
References
[edit]- ^ Parkes, Rebekah J; Parkes, Gary; James, Kyle (19 May 2017). "A systematic review of cost-effectiveness, comparing traction to intramedullary nailing of femoral shaft fractures, in the less economically developed context". BMJ Global Health. 2 (3): e000313. doi:10.1136/bmjgh-2017-000313. ISSN 2059-7908 – via NCBI.
- ^ Panti, Juan Paulo L.; Geronilla, Mario; Arada, Ernesto Carlo (October 23, 2013). "Clinical outcomes of patients with isolated femoral shaft fractures treated with S.I.G.N interlock nails versus Cannulated Interlock Intramedullary nails". Journal of Orthopaedics. 10 (4): 182–187. doi:10.1016/j.jor.2013.09.003. ISSN 0972-978X.
- ^ Alves, K.M.; Lerner, A; Silva, G.S.; Katz, N.J. (April 2020). "Surgical Implant Generation Network Implant Follow-up: Assessment of Squat and Smile and Fracture Healing". Journal of Orthopaedic Trauma. 34 (3): 174–179 – via doi: 10.1097/BOT.0000000000001671.
- ^ a b Zirkle, Lewis (2017). We Walk the World. pp. 45–47. ISBN 978-1976239212.
- ^ a b Foltz, Michelle (2009). A Leg to Stand On. iUniverse. pp. 53–57. ISBN 9780595529285.
- ^ Benedick, Alex MD; Bazar, Batzorig MD; Zirkle, Lewis G. MD; Liu, Raymond W. MD (November 2021). "Retrograde Intramedullary Nailing of Pediatric Femoral Shaft Fractures Does Not Result in Growth Arrest at the Distal Femoral Physis--A Retrospective Cases Series". Journal of Orthopaedic Trauma. 35 (11): 405–410 – via DOI: 10.1097/BOT.0000000000002076.
- ^ "Close to one billion people globally are served by health-care facilities with no electricity access or with unreliable electricity". www.who.int. Retrieved 2023-11-14.
- ^ "SIGN Programs". SIGN Fracture Care International. Retrieved 2024-07-17.
- ^ "Charity Ratings and Donor Resources". Charity Navigator. Retrieved 2023-11-15.
- ^ "SIGN Fracture Care International charity review & reports by Give.org". Give.org | BBB Wise Giving Alliance. Retrieved 2023-11-15.
- ^ "SIGN Fracture Care International - GuideStar Profile". www.guidestar.org. Retrieved 2023-11-15.
- ^ Rogers, Carolyn (2007). "One AAOS surgeon can change the world". www.aaos.org. Retrieved 2024-07-17.
- ^ Herald Staff (November 1, 2010). "Richland manufacturer receives growth award". Tri-City Herald.
- ^ "2013 Award Recipients". www.uspto.gov. Retrieved 2024-07-17.
- ^ "SIGN Founder Zirkle Receives DOD Distinguished Medal | Orthopedics This Week". ryortho.com. 2018-03-05. Retrieved 2024-07-17.