An Investigation of the Structural Strength of Transtibial Sockets Fabricated Using Conventional Methods and Rapid Prototyping Techniques.

Background: Rapid Prototyping is becoming an accessible manufacturing method but before clinical adoption can occur, the safety of treatments needs to be established. Previous studies have evaluated the static strength of traditional sockets using ultimate strength testing protocols outlined by the International Organization for Standardization (ISO).

Objective: To carry out a pilot test in which 3D printed sockets will be compared to traditionally fabricated sockets, by applying a static ultimate strength test.

Methodology: 36 sockets were made from a mold of a transtibial socket shape,18 for cushion liners with a distal socket attachment block and 18 for locking liners with a distal 4-hole pattern. Of the 18 sockets, 6 were thermoplastic, 6 laminated composites & 6 3D printed Polylactic Acid. Sockets were aligned in standard bench alignment and placed in a testing jig that applied forces simulating individuals of different weight putting force through the socket both early and late in the stance phase. Ultimate strength tests were conducted in these conditions. If a setup passed the ultimate strength test, load was applied until failure.

Findings: All sockets made for cushion liners passed the strength tests, however failure levels and methods varied. For early stance, thermoplastic sockets yielded, laminated sockets cracked posteriorly, and 3D printed socket broke circumferentially. For late stance, 2/3 of the sockets failed at the pylon. Sockets made for locking liners passed the ultimate strength tests early in stance phase, however, none of the sockets passed for forces late in stance phase, all broke around the lock mechanism.

Conclusion: Thermoplastic, laminated and 3D printed sockets made for cushion liners passed the ultimate strength test protocol outlined by the ISO for forces applied statically in gait. This provides initial evidence that 3D printed sockets are statically safe to use on patients and quantifies the static strength of laminated and thermoplastic sockets. However, all set-ups of sockets made for locking liners failed at terminal stance. While further work is needed, this suggests that the distal reinforcement for thermoplastic, laminated and 3D printed sockets with distal cylindrical locks may need to be reconsidered.