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Trauma

ECIMA AS A NEXT GENERATION, ADVANCED BEARING MATERIAL

European Federation of National Associations of Orthopaedics and Traumatology (EFORT) - 12th Congress



Abstract

Introduction

Cobalt chrome on polyethylene remains a widely used bearing combination in total joint replacement. However wear induced osteolysis, bulk material property degradation of highly cross-linked polyethylene (HXLPE) [1], and oxidation after implantation (thought to be as a result of lipid absorption or cyclic loading [2]) remains a concern. ECIMA is a cold-irradiated, mechanically annealed, vitamin E blended next generation HXLPE developed to maintain mechanical properties, minimise wear and to improve the oxidation resistance in the long-term. The aim of this study was to compare the in-vitro wear rate and mechanical properties of three different acetabular liners; conventional UHMWPE, HXLPE and ECIMA.

Methods

Twelve liners (Corin, UK) underwent a 3 million cycle (mc) hip simulation. Three conventional UHMWPE liners (GUR1050, Ø32 mm, 30 kGy sterilised in Nitrogen), three HXLPE liners (GUR1020, Ø40 mm, 75 kGy cross-linking and EtO sterilised) and six ECIMA liners (0.1 wt% vitamin E GUR1020, Ø40 mm, 120 kGy cross-linking, mechanically deformed and annealed, and EtO sterilised) articulated against CoCrMo alloy femoral heads to ASTM F75 (Corin, UK). Wear testing was performed in accordance with ISO 14242 parts 1 and 2, with a maximum force of 3.0 kN and at a frequency of 1 Hz. The test lubricant used was calf serum with a protein content of 30 g/l and 1% (v/v) patricin added as an antibacterial agent. Volumetric wear rate was determined gravimetrically after the first 0.5 mc and every 1 mc thereafter.

ASTM D638 type V specimens (3.2 mm thick) were machined from ECIMA material for uniaxial tension testing to ASTM D638. Ultimate tensile strength (UTS), yield strength and elongation values were measured. These values were compared to mechanical data available for the other material types.

Results

There was a 94% and a 68% reduction in the wear rate for the ECIMA liners compared to the conventional UHMWPE and HXLPE liners respectively.

There was an increase in UTS, yield strength and elongation of 11%, 11% and 15% respectively, for ECIMA compared to HXLPE.

Discussion

The wear results reported in this study indicate that ECIMA is a very low wearing material which has the potential to reduce wear related osteolysis in-vivo. Importantly, the mechanical properties were generally maintained unlike the degradation found in many modified polyethylene materials and were more comparable to conventional UHMWPE than HXLPE. The reduced wear rate during in-vitro hip simulation of ECIMA compared to conventional UHMWPE, coupled with improved mechanical properties in comparison to HXLPE, makes ECIMA a promising next generation, advanced bearing material.