CEMENT PRESSURE GENERATED IN MEDULLARY CANALS DEPENDS ON CEMENT PLUG DESIGN, CEMENT VISCOSITY, CANAL SIZE AND CANAL SHAPE

Abstract

Introduction: The failure rate of cemented hip replacements is about 1% per year, mainly due to aseptic loosening. PMMA acts as a grout, therefore high pressure is needed to ensure fixation. Various plug designs are used to increase pressure. No data is available on their ability to occlude the canal. Factors including canal size, canal shape and cement viscosity may affect performance. The two aims of this study are (I) to determine the effect of cement viscosity, canal shape and canal size on the ability of cement restrictors to withstand cementation pressures, and (II) to determine which of the currently commercially available designs of cement restrictor is able to withstand cementation pressures, regardless of values of other potentially influential factors.

Methods: Artificial femoral canals were drilled in oak blocks. Circular canals had diameters of 12 or 17.5 mm. Oval canals had short axes equal to the diameter of the circular canals and long axes 1.3 times longer. This ellipticity of 1.3 is average for human femoral canals. One of four types of cement plugs (Hardinge, DePuy, UK; Exeter, Stryker, UK; Amber Flex, Summit Medical, UK; and OptiPlug, Scandimed, Sweden) was inserted. A pressure transducer was fitted in the canal just proximal to the plug. Bone cement (Palacos LV-40 low viscosity or Palacos R-20 high viscosity, both Schering Plough, UK) was prepared in a mixing device for 1 min at 21°C, and inserted in the artificial canal after 4 minutes. A materials testing machine was used to generate pressure in the cement. Cement pressure and plug position were measured. All combinations of canal size and shape, plug design and cement viscosity were pre-selected according to a D-optimal experimental design which was optimised to perform a four-way ANOVA to analyse the four main factors plus the interactions between plugs and the other three factors. A total of 23 experiments was performed.

Results: Average cement pressures achieved differed between implants (OptiPlug 448±66 kPa, Hardinge 142±66, Exeter 705±66, Amber Flex 475±72; p=0.002, all mean±SEM). They also differed between canal sizes (12 mm 529±49, 18 mm 356±47; p=0.03), canal shapes (Round 631±45, Oval 254±51; p=0.004) and cement viscosity (High 535±54, Low 350±43; p=0.03). No significant interaction between factors was found.

Discussion and Conclusion: All plugs resisted lower pressures in large canals, oval canals or with low viscosity cement. When comparing plugs, these different circumstances should therefore be taken into account. Of the four tested, the Exeter plug performed best in all adverse circumstances. The OptiPlug and AmberFlex, which are both resorbable, had an intermediate performance. The Hardinge plug performed worse.