Fluid Composition Impacts Standardized Testing Protocols in Ultrahigh Molecular Weight Polyethylene Knee Wear Testing

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Abstract
Wear of total knee replacements is determined gravimetrically in simulator studies. A mix of bovine serum, distilled water, and additives is intended to replicate the lubrication conditions in vivo. Weight gain due to fluid absorption during testing is corrected using a load soak station. In this study, three sets of ultrahigh molecular weight polyethylene tibial plateau were tested against highly polished titanium condyles. Test 1 was performed in two different institutions on the same simulator according to the standard ISO 14243-1, using two testing lubricants. Test 2 and test 3 repeated both previous test sections. The wear and load soak rates changed significantly with the lubricant. The wear rate decreased from 16.9 to 7.9 mg weight loss per million cycles when switching from fluid A to fluid B. The weight gain of the load soak specimen submersed in fluid A was 6.1 mg after 5 × 106 cycles, compared with 31.6 mg for the implant in fluid B after the same time period. Both lubricants were mixed in accordance with ISO 14243 ( Implants for surgery - wear of total knee-joint prostheses), suggesting that calf serum should be diluted to 25 ± 2 per cent with deionized water and a protein mass concentration of not less than 17 g/1. The main differences were the type and amount of additives that chemically stabilize the lubricant throughout the test. The results suggest that wear rates can only be compared if exactly the same testing conditions are applied. An agreement on detailed lubricant specifications is desirable.

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