Background: Participants in Sierra Leone received a Fused Filament Fabrication (FFF)-printed transtibial prosthetic socket. Follow-up was conducted on this group over a period of 21 months. To investigate the failure of some of the FFF-printed transtibial sockets, further strength investigation is desired. Methods: A finite element (FE) analysis provided an extensive overview of the strength of the socket. Using follow-up data and FE analyses, weak spots were identified, and the required optimization/reinforcement of the socket wall was determined. Results: Five sockets with a 4 mm wall thickness were tested by five participants. The strength of the 4 mm prosthetic socket seemed to be sufficient for people with limited activity. The 4 mm sockets used by active participants failed at the patella tendon or popliteal area. One socket with a wall thickness of 6 mm was used by an active user and remained intact after one year of use. An FE analysis of the socket showed high stresses in the patella tendon area. An increased wall thickness of 7 mm leads to a decrease of 26% in the stress corresponding to the observed failure in the patella tendon area, compared to the 4 mm socket. Conclusions: Follow-up in combination with an FE analysis can provide insight into the strength of the transtibial socket. In future designs, both the patella tendon and popliteal area will be reinforced by a thickened trim line of 7 mm. A design with a thickened trimline of 7 mm is expected to be sufficiently strong for active users. Another follow-up study will be performed to confirm this.
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