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General Orthopaedics

AN EXCURSION TO IN VITRO HIP WEAR TESTING AND STANDARDS

The International Society for Technology in Arthroplasty (ISTA), 29th Annual Congress, October 2016. PART 2.



Abstract

Wear testing of THR has chaperoned generations of improved UHMWPE bearings into wide clinical use. However, previous in vitro testing failed to screen many metal-on-metal hips which failed. This talk tours hip wear testing and associated standards, giving an assortment of THR wear test results from the author's laboratory as examples.

Two international hip wear-simulator standards are used: ISO-14242-1 (anatomic configuration) and ISO-14242-3 (orbital-bearing). Both prescribe 5 million (MC) force-motion cycles involving cross-shear synchronized with compression simulating walking gate of ideally aligned THRs. ISO-14242-1 imposes flexion (flex), abduction-adduction (ad-ab) and internal-external (IE) rotations independently and simultaneously. An orbital-bearing simulator more simply rotates either a tilted femoral head or acetabular component, switching from flexion-dominated to ad-ab-dominated phases in each cycle with some IE. In the latter, the acetabular component is typically placed below the femoral head to accentuate abrasive conditions, trapping third-body-wear debris.

Wear is measured (ISO-14242-2) gravimetrically (or volumetrically in some hard-on-hard bearings). Wear-rate ranges from negligible to >80mg/MC beyond what causes osteolysis. This mode-1 adhesive wear can therefore “discriminate” to screen hip designs-materials in average conditions.

Stair-climbing, sitting, squatting and other activities may cause THR edge-loading and even impingement with smaller head-to-neck ratios or coverage angle, naturally worse in metal-on metal hips. Deformation of thin acetabular components during surgical impaction may cause elevated friction or metal-metal contact, shedding more metal-ions and accelerating failure. Surgical misalignments in inclination angle, version and tilt can make this worse, even during modest activities in hard-on-hard bearings. Abrasive particulate debris from bone or bone-cement, hydroxyapatite, neck-impingement, normal wear, or corrosion can compound the above. Such debris can scratch the femoral head surface, or embed in the UHMWPE liner compromising the wear of even metal-on-plastic hips.

Much of the belated standardization activity for higher demand hip testing is in response to the metal-metal failures. ASTM F3047M is a recent non-prescriptive guide for what more rigorous testing can generally be done. Third-body particulate can be intentionally introduced or random scratching of the femoral component surface in extra abrasion testing. Also, the compressive load can be increased, more frequent start-stops to disrupt lubrication, and steepening acetabular shell-liner angles to reduce contact area and cause edge-loading, made harsher when combined with version misalignment. Transient separation can occur between head and liner during the swing phase in a lax THR joint with low coverage angle and misalignments; the separated head impacts the liner rim when reseating. An edge-loading ISO test is currently being discussed where (so-called) “microseparation” to a known distance is directly imposed by a lateral spring force in a hip simulator.

Friction testing of a THR in a pendulum-like setup undergoing flexion or abduction swings is being discussed in the ASTM, and so have multi-dimensional THR friction measurements during a long-term wear test simultaneously measuring and separating friction of three rotational (flex, ad-ab, and IE) axes.

THR wear test methods continue to evolve to address more challenges such as novel duo-mobility THR designs, where UHMWPE bearings cannot be removed for gravimetric wear measurements.


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