The American Society for Testing and Materials (ASTM) standard, “ASTM F3047M-23 Standard guide for high-demand hip simulator wear testing of stiff-stiff joints,” provides recommendations for researchers on potential high-demand wear test features that should be included in the evaluation of stiff-stiff joints. This guideline provides recommendations for high-demand test features that should be included in an overall wear test regimen. Device joint components fabricated from other metal alloys, ceramics, or coated or elementally modified surfaces that do not have significant clinical use may be evaluated with this guideline. However, such materials may present risks and failure mechanisms not addressed in this guideline.
Rigid-rigid hip bearing systems include metal-metal, ceramic-ceramic, ceramic-metal, or other bearing systems in which both the head and cup components have high surface hardness. It has been suggested that rigid-rigid total hip replacement articulation may be better for younger, more active patients. These younger patients may be more physically fit and can expect to perform more vigorous activities. As a result, newer designs of rigid-rigid total hip replacement articulation may have some implants subject to more demanding and longer wear performance requirements.
A conventional hip simulator wear test should be performed to ISO 14242-1 or ISO 14242-3 for five million cycles. This is used as a basis for comparing the results of any high demand test regime. Any high demand wear test regime should use ISO 14242-1 or ISO 14242-3 as a starting point and the high demand parameters should be made as modifications to this standard. ISO 14242-3 may not be suitable for high demand wear tests that require variation in joint motion because the cycle of motion is built into the testing machine hardware and cannot be changed.
High demand wear testing can be performed as a continuation of traditional ISO 14242-1 or ISO 14242-3 testing or can be run as a separate test. High demand testing features will be added to the high demand wear testing and are clinically justified. This requires an understanding of the potential interactions of possible high demand modes that will prompt a series of shorter duration tests. Final high demand testing for preclinical evaluation of a device includes a test protocol consisting of at least 5 million cycles. These high demand wear testing cycles are in addition to the traditional 5 million cycle wear testing.
Current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3 standards) only require a load waveform and a set of joint motions. More versatile and rigorous wear test regimes are needed, but knowledge of what represents realistic high-demand wear test characteristics is limited. Clearly, more research is needed before a standard can be written that defines what representative high-demand wear testing should include. The purpose of this guideline is to advise researchers on possible high-demand wear test characteristics that should be included in the evaluation of stiff-stiff joints.
This guideline provides recommendations on which high-demand testing features may need to be added to a general high-demand wear testing regime. The features described here are not intended to be all-inclusive. Based on current knowledge, they appear to be relevant to adverse conditions that may occur in clinical use. All testing features, both conventional and high-demand, can have interactive effects on component wear.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, our organization also provides testing services defined in the standard “ASTM F3047M-23 Standard guide for high-demand hip simulator wear testing of rigid-rigid joints” with its trained and expert staff and advanced technological equipment.
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