Biomechanical Evaluation of The Surgical Implant Generation Network (SIGN) Intramedullary Tibial Nail

Biomechanical Evaluation of the Surgical Implant Generation Network (SIGN) Intramedullary Tibial Nail
+1Antkowiak, T; 1Khalafi, A; 1Neu, C; 1Moehring, D

+1University of California Davis, Sacramento, CA
Senior author: moehring.david@ucdmc.ucdavis.edu
INTRODUCTION: statistically significant differences in axial and torsional stiffness and

The orthopaedic community has become increasingly plastic deformation between each group. The level of significance was
cognizant of the disparity that exists in healthcare throughout the defined as PB 0.05.
developing world(1). Annually, there are nearly five million deaths
worldwide due to traumatic injuries; a number approximating that of RESULTS:
HIV/AIDS, malaria and tuberculosis combined(2). Motor vehicle trauma Mechanical testing was successfully performed on 10 SIGN
accounts for a large proportion of these deaths, and for every death there nail models and on 10 Russel-Taylor (RT) constructs. All tests were run
are many more left permanently disabled. In developing nations, to completion and no catastrophic hardware failures occurred.
significant rural-to-urban population shifts and industrialization are The torsional stiffness test revealed no statistically significant
causing significant increases in the number of industrial and motor difference between the SIGN nail and the RT nail. The mean torsional
vehicle accidents. These trends are expected not only to continue but to stiffness of the SIGN nail was 1.125 ± 0.057 Nm/degree, while mean
accelerate substantially. torsional stiffness for the RT nail was 1.242 ± 0.079 Nm/degree
Of all long bone fractures sustained during accidents tibial (p=0.221).
fractures are the most common(3). In developing countries the optimum Under axial loading the SIGN nail showed significantly more
treatment method for complex fractures of the tibia remains stiffness than the RT nail. The mean axial stiffness for the SIGN
controversial. Options for stabilization include cast immobilization, construct was 1897.29 ± 103.98 N/mm, whereas the mean axial stiffness
external fixation, open reduction and plate fixation, and intramedullary for the RT construct was 1290.78 ± 90.43 N/mm (p=0.001).
(IM) nailing. IM devices have become the most popular implant choice Cyclic loading protocols revealed that plastic deformity was
in developed nations(3). However, the significant costs and the equipment significantly greater in the SIGN nail than in the RT nail. Plastic
needed to place these devices have made their use challenging in the deformity was -1.627 ± 0.31mm for the SIGN construct and -0.633 ±
developing world. 0.056mm for the RT construct (p=0.006). However, total deformity for
In 1999, the Surgical Implant Generation Network (SIGN) of the two nails was not significantly different. Total deformity for the
Richland, Washington, was created as a non-profit humanitarian SIGN nail was -3.14 ± 0.322mm and for the RT nail it was 2.577 ±
organization aiming to provide quality orthopaedic equipment and care 0.094mm (p=0.108).
at little or no cost to developing nations in need. To date, more than
36,000 patients have been treated with the SIGN IM femoral or tibial DISCUSSION:
nail(2). The SIGN tibial system is a solid IM nail with interlocking In the developed world, IM fixation has become somewhat of
capability. Proximal and distal cross-locks are placed using a mechanical a gold standard for treatment of both open and closed fractures of the
aiming device thereby eliminating the need for costly, cumbersome and tibial shaft. A recent study by Bhandari et al. surveyed more than 400
largely unavailable C-arm systems. North American and international orthopaedic surgeons. They found that
A recent series published by Shah et al demonstrated a 90% over 95% preferred to use IMN for treatment of both high energy and
union rate in open tibial fractures treated with the SIGN system(4). To low energy tibial shaft fractures(3).
our knowledge, no previous study has evaluated the mechanical The SIGN nail provides the developing world with access to
properties of the SIGN tibial nail system. The purpose of this study was, IM technology at little or no cost. The efficacy of this construct in vivo
therefore, to elucidate the mechanical properties of this solid nail and has already been confirmed(4). Our study further elucidates the exact
compare them with those of a commonly used North American hollow mechanical properties of this solid nail. In direct comparison to a
construct. standard hollow nail we have shown that the SIGN nail is stiffer under
axial loading. This result is not surprising given the solid nature of this
MATERIALS AND METHODS: device. However, this axial stiffness does not appear to correlate with
A fracture gap model, 3cm wide and 18.5 cm proximal to the deformation under cyclical loading. Despite its solid nature, the SIGN
plafond, was created using tibial synthetic composite bones to simulate a nail exhibits significantly more plastic deformity than its hollow
comminuted mid-shaft tibia fracture (AO/OTA42-A3). Un-reamed counterpart. Interestingly, total deformity for the two nails was not
fracture fixation was achieved using either a 9mm x 340mm solid SIGN significantly different and neither construct experienced any catastrophic
661 tibial nail or a 10 mm x 34.5 mm Russel-Taylor tibial nail with two failures.
proximal and distal interlocks, respectively. Mechanical testing was Although some statistically significant differences exist
performed using a materials testing machine (Instron 5800 R, Canton, between the SIGN nail and the RT nail, the SIGN construct appears to
MA) with main outcome measures being stiffness in axial and torsional have the biomechanical potential for strength and longevity. As
loading, as well as total and irreversible (plastic) deformation in cyclical developing economies grow and expand, the incidence of traumatic
axial loading. Testing was stopped after either a visual loss of fixation or injuries will continue to rise. The availability and efficacy of the SIGN
a sudden change in construct stiffness, as reflected by the load- nail will allow surgeons in the developing world to provide gold
displacement curve. standard care to their trauma patients.
For torsional loading tests the constructs were preloaded to 5
Nm and then torqued to a maximum of 20 Nm at a rate of 20 REFERENCES:
degrees/min. Axial loading was assessed by loading the construct in 1. Dormans, J., Orthopaedic Surgery In The Developing World – Can
compression at a loading rate of 100 N/s. After stabilizing the construct Orthopaedic Residents Help? Journal of Bone and Joint Surgery. 2002;
with a preload of 100 N, axial loading was performed to a maximum 84A(6):1086-1094.
load of 500 N. Cyclical axial loading consisted of 10 incremental cycles 2. Zirkle, L Jr., Injuries in Developing Countries – How Can We Help?:
starting with 500 N. The load for each successive increment was The role of Orthopaedic Surgeons. Clinical Orthopaedics and Related
increased by 500 N, to a maximum load of 2500 N, with 10 seconds of Research. 2008; DOI 10.1007/s11999-008-0387-0.
rest between each increment. The preload and baseline load after each 3. Bhandari M, Guyatt G, Tornetta P 3rd, Swiontkowski M, Hanson B,
cycle was 100 N. Testing was conducted at a loading rate of 100 N/s. Sprague S, Syed A, Schemitsch E., Current Practice in the
For axial and torsional testing, a load-displacement curve was Intramedullary Nailing of Tibial Shaft Fractures: An International
plotted for each construct and the stiffness was calculated as the slope of Survey. The Journal of Trauma. 2002; 53(4):725-732.
the initial region of the curve. Plastic deformation was calculated by 4. Shah R, Moehring D, Singh R, Dhakal A., Surgical Implant
subtracting the amount of displacement present at the start of the first Generation Network (SIGN) Intramedullary Nailing of Open Fracture of
cyclical axial cycle (500 N) from displacement present after the final the Tibia. International Orthopaedics. 2004; 28:163-166.
cycle. Total deformation was recorded after the last testing cycle. A one-
way analysis of variance (ANOVA) was performed to determine
Poster No. 838 • 55th Annual Meeting of the Orthopaedic Research Society

Biomechanical Evaluation of The Surgical Implant Generation Network (SIGN) Intramedullary Tibial Nail

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Biomechanical Evaluation of the Surgical Implant Generation Network (SIGN) Intramedullary Tibial Nail

+1Antkowiak, T; 1Khalafi, A; 1Neu, C; 1Moehring, D

INTRODUCTION: statistically significant differences in axial and torsional stiffness and

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