Measurement and production of traditional prosthetic sockets are time-consuming, labor-intensive, and highly dependent on the personnel involved. An alternative way to make prostheses is using computer-aided design (CAD) and computer-aided manufacturing (CAM). Fused Filament Fabrication (FFF) may be an alternative to make low-cost prosthetic sockets. This study investigates the tensile properties of potential printing materials suitable for FFF according to ISO527 (Standard Test Method for Tensile Properties of Plastics). To ensure that FFF-printed sockets are safe for patient usage, the structural integrity of the 3D-printed prosthesis will be investigated according to ISO10328 (International Standard Structural Testing of Lower Limb Prostheses). Tough PLA was the most suitable print material according to ISO 527 testing. The Tough PLA printed socket completed 2.27 million cycles and a static test target value of 4025 N. Future research remains necessary to continue testing new potential materials, improve print settings, and improve the socket design for the production of FFF-printed transtibial prosthetic sockets. FFF using Tough PLA can be used to create transtibial prostheses that almost comply with the International Standard for Structural Testing of Lower Limb Prostheses.
ShuxianZWanhuaZBinghengL.3D reconstruction of the structure of a residual limb for customising the design of a prosthetic socket. Med Eng Phys2005; 27: 67–74.
2.
PaternoLIbrahimiMGruppioniE, et al. Sockets for limb prostheses: a review of existing technologies and open challenges. IEEE Trans Biomed Eng2018; 65: 1996–2010.
3.
ChitreshNSinghAHimanshuC.Customised prosthetic socket fabrication using 3D scanning and printing. In: Conference additive manufacturing society of India, Bangalore, India, 2014.
4.
ColomboGRizziCRegazzoniD, et al. 3D interactive environment for the design of medical devices. Int J Interact Des Manuf2018; 12: 699–715.
5.
NayakCSinghAChaudharyH, et al. A novel approach for customized prosthetic socket design. Biomed Eng Appl Basis Commun2016; 28. DOI: https://doi.org/10.4015/S1016237216500228.
6.
KarakoçMBatmaz SariyildizMA, et al. Sockets manufactured by CAD/CAM method have positive effects on the quality of life of patients with transtibial amputation. Am J Phys Med Rehabil2017; 96: 578–581.
7.
HerbertNSimpsonDSpenceWD, et al. A preliminary investigation into the development of 3-D printing of prosthetic sockets. J Rehabil Res Dev2005; 42: 141–146.
RogersBBoskerGWCrawfordRH, et al. Advanced trans-tibial socket fabrication using selective laser sintering. Prosthet Orthot Int2007; 31: 88–100.
10.
KuznetsovVESoloninANUrzhumtsevOD, et al. Strength of PLA components fabricated with fused deposition technology using a desktop 3D printer as a function of geometrical parameters of the process. Polymers2018; 10: 2018.
11.
GohJCHLeePVSNgP.Structural integrity of polypropylene prosthetic sockets manufactured using the polymer deposition technique. Proc IMechE, Part H: J Engineering in Medicine2002; 216: 359–368.
12.
VitaliARegazzoniDRizziC, et al. Design and additive manufacturing of lower limb prosthetic socket. In: International mechanical engineering congress and exposition, Tampa, FL, 2017, vol. 7, p.7.
13.
HsuLHHuangGFLuCT, et al. The application of rapid prototyping for the design and manufacturing of transtibial prosthetic socket. Mater Sci Forum2008; 594: 273–280.
14.
AllumJMoetazedianAGleadallA, et al. Interlayer bonding has bulk-material strength in extrusion additive manufacturing: new understanding of anisotropy. Addit Manuf2020; 34: 101297.
15.
MarotiPVargaPAbrahamH, et al. Printing orientation defines anisotropic mechanical properties in additive manufacturing of upper limb prosthetics. Mater Res Express2018; 6: 035403.
16.
SauerMJ.Access institutional evaluation of the mechanical properties of 3D printed carbon fiber composites, 2018.
17.
EzehOHSusmelL.On the fatigue strength of 3D-printed polylactide (PLA). Procedia Struct Integr2018; 9: 29–36.
van der SteltMVerhulstACVas NunesJH, et al. Improving lives in three dimensions: the feasibility of 3D printing for creating personalized medical aids in a rural area of Sierra Leone. Am J Trop Med Hyg2020; 102: 905–909.
20.
van der SteltMGrobuschMPKoromaAR, et al. Pioneering low-cost 3D-printed transtibial prosthetics to serve a rural population in Sierra Leone: an observational cohort study. EClinicalMedicine2021; 35: 100874.
21.
European Committee for Standardization. NEN-EN-ISO 527-2, 2012.
22.
European Committee for Standardization. NEN-EN-ISO 527-1, 2012.
WangSDaelemansLFiorioR, et al. Improving mechanical properties for extrusion-based additive manufacturing of poly(lactic acid) by annealing and blending with poly(3-hydroxybutyrate). Polymers2019; 11: 1529.
32.
European committee for Standardization. NEN-EN-ISO 10328, 2016.
33.
ButtJBhaskarR.Investigating the effects of annealing on the mechanical properties of FFF-printed thermoplastics. J Manuf Mater Process2020; 4: 38.
34.
SrithepYNealeyPTurngL-S.Effects of annealing time and temperature on the crystallinity and heat resistance behavior of injection-molded poly(lactic acid). Polym Eng Sci2013; 53: 580–588.
HsuLHHuangGFLuCT, et al. The development of a rapid prototyping prosthetic socket coated with a resin layer for transtibial amputees. Prosthet Orthot Int2010; 34: 37–45.
38.
TzengMJHsuLHChangSH.Development and evaluation of a CAD/3DP process for transtibial socket fabrication. Biomed Eng Appl Basis Commun2015; 27: 9.
39.
OsswaldTAMengesG. Material science of polymers for engineers. Munich: Hanser Publisgers, 2012.
40.
GerschutzMJHaynesMLNixonDM, et al. Tensile strength and impact resistance properties of materials used in prosthetic check sockets, copolymer sockets, and definitive laminated sockets. J Rehabil Res Dev2011; 48: 987–1004.
41.
GerschutzMJHaynesMLNixonD, et al. Definitive laminated sockets. J Rehabil Res Dev2012; 49: 405–426.
42.
ZhangMTurner-SmithARTannerA, et al. Clinical investigation of the pressure and shear stress on the trans-tibial stump with a prosthesis. Med Eng Phys1998; 20: 188–198.
