Sensitivity, robustness, and reproducibility of U-shaped delamination test for evaluation of candidate ultra-high molecular weight polyethylene materials for joint replacements.

Autor:	Sakoda H; Division of Medical Devices, National Institute of Health Sciences, Kawasaki, Japan., Tamazawa K; KYOCERA Corporation, Kyoto, Japan., Shoyama Y; KYOCERA Corporation, Kyoto, Japan., Osaka Y; Teijin Nakashima Medical Co., Ltd., Okayama, Japan., Uetsuki K; Teijin Nakashima Medical Co., Ltd., Okayama, Japan., Okamoto Y; Division of Medical Devices, National Institute of Health Sciences, Kawasaki, Japan., Yamamoto E; Division of Medical Devices, National Institute of Health Sciences, Kawasaki, Japan.
Jazyk:	angličtina
Zdroj:	Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine [Proc Inst Mech Eng H] 2024 Jul; Vol. 238 (7), pp. 764-773. Date of Electronic Publication: 2024 Jun 03.
DOI:	10.1177/09544119241253322
Abstrakt:	The delamination of ultra-high molecular weight polyethylene (UHMWPE) in artificial joints is a major cause limiting the long-term clinical results of arthroplasty. However, the conventional test method using simple reciprocation to evaluate the delamination resistance of UHMWPE materials has insufficient detection sensitivity. To reproduce delamination, the unconformity contact must be maintained throughout the test so that the maximum stress is generated below the surface. Therefore, a test method that applies a U-shaped motion comprising two long-linear and one short linear sliding motion was developed. The sensitivity, robustness, and reproducibility of the U-shaped delamination test were investigated and compared with the traditional test method. The traditional test method could reproduce delamination only in materials that had degraded considerably, whereas the U-shaped delamination test could reproduce delamination in a wide range of materials, demonstrating its superior sensitivity. Additionally, using a higher load helped accelerate the test without affecting the test results. The optimal length of the short linear sliding motion was confirmed to be 1 mm. Finally, the inter-laboratory reproducibility of the U-shaped delamination test was confirmed using the round-robin test. The U-shaped delamination test demonstrates high sensitivity, robustness, and reproducibility and contributes to the selection and development of UHMWPE materials and artificial joints with a lower risk of delamination. Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: HS, YO, and EY have no conflicts of interest to declare. KT and YS are employees of KYOCERA Corporation, and YO and KU are employees of Teijin Nakashima Co., Ltd., both of which are medical device manufacturers.
Databáze:	MEDLINE
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