Abstract
Several options for high demand/high activity patients for bearings in THA exist. Each of them faces certain known and unknown risks of failure. There is a remarked trend to bigger diameter heads to reduce the incidence of dislocation for such patients. While combinations with hard-on-hard bearings have been used in such incidences, a Polyethylene (PE) option is desirable due to its less sensitivity to edge loading and price.
A highly crosslinked sequentially annealed PE of the 3rd generation was prepared by sequentially crosslinking with appropriate annealing steps with a cumulative dose of 90 kGy and subsequent gas plasma sterilization. The structure of this material was determined using TEM, DSC and SAXS. Free radicals and oxidation was determined by ESR and IR spectroscopy. Mechanical evaluation in the unaged and aged condition were performed by quasi-static, dynamic and functional dynamic tests in comparison with negative controls. Wear testing was performed by ball-on-plate tests and hip joint simulators. PE inserts of various internal diameters up to 44mm and thicknesses of 4-8mm in comparison with a historic inert gas irradiation sterilized PE as negative control. These tests have been carried out at 3 institutions using different set-up and protocols. To look at worst case scenarios the simulator testing was done in an impingement mode and fatigue tests of the thinnest components where performed in 2 different fatigue set-ups up to 10 million cycles.
The structure and crystallinity of the sequentially crosslinked PE were comparable to the controls. The radical concentration was reduced by more than 95% due to the sequential process employed and consequently the oxidation level after artificially aging remained at the level of untreated PE. 5 year storage data confirmed the stability of this polymer. All mechanical testing revealed the maintenance of the properties at the same level as the controls. The screening wear test revealed that the high sliding stress used in this set-up had no effect on the sequentially crosslinked PE even when aged, while the controls showed fatigue wear after a short time of testing.
The decrease in volumetric wear compared to a negative control (28 mm head size) was on average 90% in volumetric independent of the head size and thickness of the PE liner. This result was confirmed by the studies at 2 other institutions with a wear reduction of 86 and 95% respectively. Impingement increased the wear rate marginally, without causing any fractures or failures of the components. The analysis of the wear particles from the simulator studies showed a marked decrease in number with close similarity in appearance and morphology to that from the control tests. Fatigue testing even in a luxation model showed no negative effect on the impact on the rim after 10 million cycles also with the thinnest components.
Highly crosslinked, sequentially annealed PE from the perspective of tribological and fatigue testing can be used safely even in impingement and luxation situations. Other factors in the clinical usage of thin liners may play a role and need to be investigated further.
