3D Printing in Prosthetics, Orthotics and Assistive Technology: Myth and Reality.

3D printing initially captured the public eye when mainstream media began writing about Enabling the Future, a volunteer network that had begun designing and 3D printing prosthetic hands. Many of the stories focused on how this technology was going to disrupt the prosthetic sector. The response from prosthetists was skepticism and concern, in particular warning that 3D printed components would not be robust enough to withstand the activities of daily living. Moreover, they emphasized that fit problems could potentially cause more harm than good. Several years on, this issue explores currant usage and experiences with the technology in prosthetics and, to a limited extent, orthotics.

Editorial Opinion: Value Within the Prosthetic and Orthotic Provision Process.

This Editorial presents an overview of the uptake of clinical outcome measures in the prosthetics and orthotics sector and considers how the use of objective measures contribute to demonstrating value provided. A decade ago, payors began to demand objective data to document costs vs. benefits from prosthetic and orthotic providers. The speed with which the sector responded to help develop measures and to begin to integrate them into practice is remarkable. This suggests an encouraging resilience and ability to adapt on the part of the sector as other trends such as Values-Based Health Care emerge to challenge the sector.

Technology Management as a Core Component of a Client-centric Prosthetic Orthotic Practice Model.

Technological innovation has transformed how we communicate, work, and conduct business. Over the next decade how we experience health care both as health care professionals and as client-patients will also change significantly. This presents both an opportunity and a challenge to medical clinical professionals that are device-focused, including prosthetists orthotists, as they consider how best to adapt. Current prosthetic orthotic education and practice is heavily clinically weighted, with less emphasis being given to engineering and business skills. Yet all three are essential core elements of a successful, sustainable prosthetics orthotics practice. Furthermore, it is the latter two that will heavily influence the future face of prosthetics & orthotics. It is not certain how current prosthetic orthotic practitioners can best adapt in response. One solution, proposed in this editorial, could be by rebalancing their professional persona to equally weight the three essential core elements. The result, a Clinical Prosthetic Orthotic Technology Management Professional, would engage in a professional practice that is functionally grounded, uses a client-centric model and incorporate eight professional attributes: professional, advocate, scholar, leader, communicator, collaborator, assistive technology expert and business justification specialist.

Editor's Perspective on Health Economics in Prosthetics and Orthotics.

There is a scarcity of literature exploring Health Economics in Prosthetics and Orthotics (P&O). The P&O sector has, over the past decades, moved to a Bachelor's or Masters Degree level as the requirement for entry to practice and, with that, there has been a growing body of research and knowledge generation focusing primarily on clinical aspects and engineering advances. No corresponding body of research has emerged on the economic aspects of P&O, creating a fundamental weakness in both technical and clinical research efforts to advance this field within an economically sustainable framework. This weakness will become critical as data driven engineering advances (e.g. exoskeletons, mass customizable prostheses) and clinical improvements (e.g. osseointegration, diabetes treatments) will make reimbursement for devices ever more complex and challenging. The tension between what is possible and what is fundable will increase unless what is possible also drives down costs. Finding the right balance in Prosthetics and Orthotics will be a challenge, as this sector already struggles to justify current standards of care. This Special Edition takes a snapshot of stakeholder perspectives and opinions on the topic of Health Economics in P&O and is organized around the following stakeholder groups: End-user, Researcher (Engineering and Clinical), Prosthetic and Orthotic Practitioner and, of critical importance, four papers describing an interdisciplinary project on the Health Economics of Osseointegration that was led by a payor. Each author was also asked to provide a "Call to Action" in which they identify one or more key areas that need to be addressed in order to move forward with the barriers or opportunities they have identified in their paper. The intent of the Special Edition is to generate discussion and encourage more in-depth research on this topic.

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.

Ultra-short laser-accelerated proton pulses have similar DNA-damaging effectiveness but produce less immediate nitroxidative stress than conventional proton beams.

Ultra-short proton pulses originating from laser-plasma accelerators can provide instantaneous dose rates at least 10(7)-fold in excess of conventional, continuous proton beams. The impact of such extremely high proton dose rates on A549 human lung cancer cells was compared with conventionally accelerated protons and 90 keV X-rays. Between 0.2 and 2 Gy, the yield of DNA double strand breaks (foci of phosphorylated histone H2AX) was not significantly different between the two proton sources or proton irradiation and X-rays. Protein nitroxidation after 1 h judged by 3-nitrotyrosine generation was 2.5 and 5-fold higher in response to conventionally accelerated protons compared to laser-driven protons and X-rays, respectively. This difference was significant (p < 0.01) between 0.25 and 1 Gy. In conclusion, ultra-short proton pulses originating from laser-plasma accelerators have a similar DNA damaging potential as conventional proton beams, while inducing less immediate nitroxidative stress, which probably entails a distinct therapeutic potential.

Test apparatus for the measurement of the flexibility of ankle-foot orthoses in planes other than the loaded plane.

Previous publications have reported on the flexibility of ankle-foot orthoses (AFO) only in the same plane as the applied load. This paper reports on a test apparatus developed to detect the flexibility of an AFO in 5 degrees of freedom when subjected to a plantar/dorsiflexion moment, a medial/lateral moment or a torque. A moment applied to an AFO in one plane induces angulation and translation in all planes.