3D printing and modelling of customized implants and surgical guides for non-human primates

Chen, Xing; Possel, Jessy K.; Wacongne, Catherine; Ham, Anne F. van; Klink, P. Christiaan; Roelfsema, Pieter R.

doi:10.1016/j.jneumeth.2017.05.013

Cited by 95 publications

(92 citation statements)

References 42 publications

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“…However, 3D printed parts still require considerable finishing processes. In the manufacture of locking osteosynthesis plates this usually includes cutting of screw threads, either by hand tapping or further machining 10 . Additional post‐printing manufacturing steps increase production costs and introduce risk of deviation from the original planned component geometry, particularly for anatomic parts lacking readily identifiable datums.…”

Section: Discussionmentioning

confidence: 99%

3D printed locking osteosynthesis screw threads have comparable strength to machined or hand‐tapped screw threads

MacLeod

Patterson

MacTear

et al. 2020

Journal Orthopaedic Research

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Additive manufacturing, aka three dimensional (3D) printing, is increasingly being used for personalized orthopedic implants. Additively manufactured components normally undergo further processing, in particular 3D printed locking osteosynthesis plates require post‐printing screw thread creation. The aim of this study was to compare 3D printed threads with machined and hand‐tapped threads for a locking plate application. Pushout tests were performed on 115 additively manufactured specimens with tapered screw holes; additive manufacture was performed at 0°, 20°, 45°, or 90° build orientations. The screw holes were either machined, hand‐tapped or 3D printed. The 3D printed screw holes were left as printed, or run through with a tap lubricated with water or with thread cutting oil. Printed threads run through using oil, with a build orientation of 90°, had comparable pushout force (median: 6377 N 95% confidence interval [CI]: 5616‐7739 N) to machined (median: 6757 N; 95% CI: 6682‐7303 N) and hand‐tapped (median: 7805 N; 95% CI: 7154‐7850 N) threads. As printed threads and those run through using water had significantly lower pushout forces. This study shows for the first time that 3D printed screw threads for a locking osteosynthesis plate application have comparable strength to traditionally produced screw threads.

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Section: Discussionmentioning

confidence: 99%

3D printed locking osteosynthesis screw threads have comparable strength to machined or hand‐tapped screw threads

MacLeod

Patterson

MacTear

et al. 2020

Journal Orthopaedic Research

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“…Recent study on custom‐designed bone implants has mainly focuses on dentures or teeth, maxillary or mandible, and femurs. Other notable implant types include those for the humerus, the cranium/skull, and the tibia …”

Section: Features Of Customized Bone Implant Devicesmentioning

confidence: 99%

“…Other notable implant types include those for the humerus, the cranium/skull, and the tibia. [11][12][13][14] . Among all the implants introduced, it should be noted that some are applied as a substitute for bone or scaffold, while others act as additions to support or fix an original bone in the correct position.…”

Section: Classificationmentioning

confidence: 99%

Correlation Between Conditional Approval and Customized Bone Implant Devices

Guo¹,

Liu²,

Lu³

2019

Orthopaedic Surgery

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This report aims to summarize key concerns regarding customized devices and conditional approval during the premarket evaluation of bone implants, and to explore the correlation between them. Based on the experience of approval of the first domestic custom‐designed bone implant, we consider the process of gaining conditional approval for urgently‐needed medical devices and medical devices for rare diseases, as well as the guidance available for clinical investigation. We also streamlined the scientifically administrative concept of this unique device, from the design and development of premarket technical evaluation to continuous post‐market study. The present study found that those two aspects have certain connections, but they are not directly correlated to each other. In contrast to the USA, Canada, Australia and the EU, where regulations and guidelines have been established for the use of customized devices, in this regard, China is still it its infancy. Thus, there is considerable potential for China to develop and perfect the policies relating to customized devices and to develop relevant strategies to ensure their efficacy with the aid of conditional approval. Appropriate scientific conditional approval for mass production of individualized anatomy‐matching bone implants could become a valuable approach for precision medicine.

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“…It is capable of making articles in exact compatibility with the patient's anatomy, haematology and pathology [72]. Recent studies on anatomical models, tissue specifications, surgical implants and prostheses fabrication by 3D manufacturing have specified promising results [72][73][74][75]. By using neuroimaging, patients anatomy information and software processing, an appropriate implant can be obtained [7], [72].…”

Section: Manufacturing Techniques Of Porous Nitinol Alloymentioning

confidence: 99%

Nitinol Spinal Vertebrae: A Favorable New Substitute

Sadrnezhaad

Parsafar

Rashtiani

et al. 2019

IJE

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A B S T R A C TScoliosis, kyphosis, and bone fracture are health problems, especially of the elderly throughout the world. The vertebra protects the spinal cord. Any impairment to the vertebra can lead to pain and nervousness. Ni-Ti alloy (Nitinol) helps to resolve the problem by fulfilling such requirements as for strength, durability, resistance to wear, and shockwave damping which is due to the shape memory effect. Nitinol medical applications have so far been restricted to surgical devices and orthopaedics. Little has been said about Nitinol use for medication of the spinal vertebra disorder. This article appraises the potential features of Nitinol for vertebral implantation and therapeutic prescription consistent with the specific anatomical variation. Staples, screws, cages, stents, and posterior-stabilizers made of Nitinol have passed in-vitro tests and in some cases in-vivo examinations. Using anatomically tailored Nitinol for treatment and administration of the damaged vertebra is proposed as a forecastable dream.

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3D printing and modelling of customized implants and surgical guides for non-human primates

Abstract: Graphical abstract

Cited by 95 publications

References 42 publications

3D printed locking osteosynthesis screw threads have comparable strength to machined or hand‐tapped screw threads

3D printed locking osteosynthesis screw threads have comparable strength to machined or hand‐tapped screw threads

Correlation Between Conditional Approval and Customized Bone Implant Devices

Nitinol Spinal Vertebrae: A Favorable New Substitute

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