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

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.

Evaluating the durability of UHMWPE biomaterials used for articulating surfaces of joint arthroplasty using delamination tests.

Ultra-high molecular weight polyethylene (UHMWPE) is the most popular material used for the articulating surface of joint replacements. Delamination is a common fatigue-related failure mode in UHMWPE components; however, the relationship between delamination resistance and fatigue crack growth has not been reported. Here, the delamination resistance of contemporary UHMWPE materials, including highly cross-linked UHMWPE (HXLPE), vitamin E blended UHMWPE (VEPE), and vitamin E blended HXLPE (VEXLPE), was measured to verify a previously proposed accelerated test method using a U-shaped sliding motion; the results were compared with those of fatigue crack growth tests. The oxidative stability of each material was estimated using Fourier transform infrared analysis. UHMWPE sterilized by gamma irradiation in an inert atmosphere and annealed HXLPE had lower delamination resistance than virgin UHMWPE after artificial aging. This was consistent with previous findings from retrieval studies, and in vitro knee simulator and ball-on-flat unidirectional reciprocation wear studies. In contrast, remelted HXLPE, VEPE, and VEXLPE showed excellent delamination resistance after artificial aging. The results of the delamination tests were not consistent with those of fatigue crack growth tests, indicating the complex delamination mechanism and importance of evaluating these factors separately. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 107B: 65-72, 2019.