Draft:SIGN Fracture Care
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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 | US$ 8,722,000 (2024) |
| Revenue | US$ 6,205,211 (2024) |
| Expenses | US$ 7,246,960 (2024) |
| Staff | 39 (2024) |
| Website | https://signfracturecare.org |
| Remarks | Vision: To create equality of fracture care throughout the world. |
Formerly called | Surgical Implant Generation Network |
SIGN Fracture Care International (SIGN) is a 501(c)(3) non-profit medical device manufacturing organization founded by Dr. Lewis G. Zirkle, Jr. Zirkle established SIGN after he patented a set of orthopaedic implants and instruments for use in low-resource hospitals. SIGN now manufactures and donates these instruments and implants to partner hospitals in low- and middle-income countries (LMIC). In addition to the distribution of orthopaedic products, SIGN provides surgical education to doctors operating in LMIC.[1]
History
[edit]In 1968, Zirkle was drafted into the United States Army to serve in the ongoing Vietnam War.[2] While operating as a surgeon with the 93rd Evacuation Hospital, Zirkle treated wounded American and Vietnamese soldiers. Eventually, he began operating on Vietnamese civilians.[3]
After returning from Vietnam, Zirkle rotated through several hospitals while finishing his Army contract.[2] During this time, he sought more ways to treat injured people in LMIC. In 1972, Zirkle traveled to Indonesia to provide training for local orthopaedic surgeons. Along with traveling, he also brought donations of medical equipment to the Indonesian hospitals.[4] It wasn't until 1996, when Zirkle encountered a patient who had been bed-ridden for three years due to a fractured femur, that he questioned the effectiveness of his travels. Zirkle questioned the Indonesian surgeon overseeing the patient as to why surgery had not been performed. The surgeon informed him that the patient could not afford an implant, nor were the supplied implants suitable for use.[5] This interaction led Zirkle to realize another solution was needed to treat patients who live in LMIC.[4]
Zirkle recognized that providing training for surgeons was inadequate without also supplying usable implants and instruments. To accomplish this goal, he needed to partner with a US-based surgical implant manufacturing company. After many rejections, Dr. Zirkle connected with Portland-based Acumed, Inc.[6] Along with Acumed engineers, Zirkle created a prototype set of intramedullary (IM) nails and instruments that Zirkle took to Vietnam. After receiving instruction in the SIGN system, the Vietnamese surgeons demonstrated their ability to use the nails.[7]
After Dr. Zirkle returned from Vietnam, SIGN officially launched on January 29, 1999.[8] 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).[7]
Operations
[edit]Medical Device Manufacturing
[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.[9] They are produced in a variety of lengths and thicknesses to allow surgeons to treat fractures on various patients. 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.[10]
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.[11]
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. Instead, SIGN’s Target Arm and Slot Finder guide insertion of the nail and positions screws for stabilization.[9]
Patents
[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)
Surgeon Education
[edit]SIGN partners with surgeons based in LMIC by providing orthopaedic education opportunities. SIGN hosts an annual conference for international surgeons and partners with global orthopaedic partners to provide regional trainings.[12]
SIGN Surgical Database
[edit]The SIGN Surgical Database is an online platform composed of patient information, pre-operative x-rays, and post-operative x-rays plus any comments the surgeon has about the case. Follow-up appointments are added to the case entry to track healing progress. Once a case is uploaded, experienced surgeons will review the procedure. The reviewers provide feedback to the surgeon, both on what they did well and any areas of improvement.[9]
Annual SIGN International Orthopaedic Conference
[edit]The Annual SIGN International Orthopaedic Conference has been held in Richland nearly every year since 2001. During the COVID-19 Pandemic, the in-person conference was canceled with leadership opting to instead utilize online training tools. The SIGN Conference began as a way for Dr. Zirkle to present SIGN's mission to US-based orthopaedic surgeons. In 2004, LMIC surgeons attended the SIGN Conference for the first time, representing Kenya and India. As the conference grew over time, the focus shifted from promotional to educational. Currently, the conference is attended by surgeons from low-resource countries who want to enhance their surgical skills.[13][14]
Activities by Location
[edit]As of January 2025, SIGN partners with more than 5,000 surgeons[15] at 447 hospitals in 60 countries. Surgeons trained by SIGN have cared for more than 450,000 patients with fractures since 1999[1].
Countries with Active SIGN Programs by Region
[edit]| Country | # of Programs | Active Since |
|---|---|---|
| Angola | 1 | 2013 |
| Benin | 1 | 2021 |
| Burkina Faso | 1 | 2022 |
| Burundi | 8 | 2010 |
| Cameroon | 6 | 2007 |
| Chad | 4 | 2012 |
| Dem. Rep. of the Congo | 6 | 2012 |
| Eswatini | 1 | 2024 |
| Ethiopia | 50 | 2009 |
| Gabonese Republic | 1 | 2010 |
| Ghana | 6 | 2014 |
| Guinea | 2 | 2019 |
| Kenya | 19 | 2007 |
| Lesotho | 1 | 2022 |
| Liberia | 4 | 2007 |
| Madagascar | 1 | 2020 |
| Malawi | 6 | 2007 |
| Mali | 1 | 2016 |
| Niger | 2 | 2007 |
| Nigeria | 18 | 2007 |
| Rwanda | 5 | 2007 |
| Sierra Leone | 2 | 2009 |
| Somalia | 2 | 2021 |
| Somaliland | 4 | 2019 |
| South Sudan | 3 | 2012 |
| Tanzania | 38 | 2007 |
| The Gambia | 1 | 2017 |
| Togo | 1 | 2014 |
| Uganda | 9 | 2010 |
| Zambia | 2 | 2013 |
| Zimbabwe | 6 | 2012 |
| Country | # of Programs | Active Since |
|---|---|---|
| Dominican Republic | 4 | 2007 |
| Ecuador | 3 | 2007 |
| Haiti | 17 | 2007 |
| Honduras | 3 | 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 | 8 | 2007 |
| Bhutan | 2 | 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 | 9 | 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 |
Awards and Honors
[edit]- 2010: Smart Map Expo Manufacturer of the Year Award[16]
- 2013: US Patents and Trademark Office Patents for Humanity Award, Medical--Diagnostics & Devices Category[17]
- 2024: ESOT Institutional Award
References
[edit]- ^ King, Anna (2 February 2018). "Tri Cities Doctor Honored for Healing Bones Around the Globe". nwpb.org.
- ^ a b "Lewis K. Zirkle, MD, Formally Recognized as an Honorary Alumnus of the Duke Orthopaedics Program". ortho.duke.edu. 3 October 2024.
- ^ Culverwell, Wendy (13 May 2021). "PBS puts spotlight on Richland's global miracle worker". tricitiesbusinessnews.com.
- ^ a b "Zirkle's efforts lead to worldwide SIGN IM nail program". Orthopedics Today International (1). 2006.
- ^ Hofheinz, Elizabeth (17 December 2010). "The SIGN of Hope Round the Globe". ryortho.com.
- ^ "Acumed celebrates 17 years of support for SIGN Fracture Care International". Acumed.net. 15 May 2014.
- ^ a b Foltz, Michelle (2009). A Leg to Stand On. iUniverse. pp. 53–57. ISBN 9780595529285.
- ^ Romero, Tracey (5 March 2018). "SIGN Founder Zirkle Receives DOD Distinguished Medal". ryortho.com.
- ^ a b c Young, Sven (23 July 2014). "Orthopaedic trauma in low-income countries". Acta Orthopaedica. 85 (356): 1–35. doi:10.3109/17453674.2014.937924. PMID 25052728.
- ^ Birner, Zachary H.; Hetzel, Scott J.; Wilson, Nathaniel M.; Whiting, Paul S. (29 July 2021). "Radiographic outcomes of femur fractures following SIGN Fin nailing in low- and middle-income countries". Journal of Orthopaedic Trauma. 4 (3): e141. doi:10.1097/OI9.0000000000000141. PMID 34746673.
- ^ 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. doi:10.1097/BOT.0000000000002076. PMID 33993174 – via DOI: 10.1097/BOT.0000000000002076.
- ^ "Institute for Global Orthopaedics and Traumatology (IGOT) Tanzania SMART Course". orthosurgery.ucsf.edu. 12 July 2023.
- ^ "Global Orthopaedic Conference Held at SIGN Headquarters in Richland". nbcrightnow.com. 17 September 2015.
- ^ "SIGN Fracture Care conference teaches global surgeons procedures, research". nbcrightnow.com. 7 October 2022.
- ^ Gellman, Richard (July 3, 2019). "What's Important: Humanitarian Orthopaedics". The Journal of Bone and Joint Surgery. 101 (13): 1230–1231. doi:10.2106/JBJS.19.00501. PMID 31274726 – via JSTOR.
- ^ Herald Staff (November 1, 2010). "Richland manufacturer receives growth award". Tri-City Herald.
- ^ "2013 Award Recipients". www.uspto.gov. Retrieved 2024-07-17.
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