DIFFERENT OUTCOMES WITH TWO NEW POLYETHYLENES IN THR. A PROSPECTIVE RANDOMIZED STUDY

Abstract

Introdution. Gamma sterilisation in air produces free radicals in the polyethylene (PE) with the result of degrading its mechanical properties, increasing wear and debris, and producing osteolysis and loosening. PE sterilized in the absence of air and high cross-linked polyethylene (HXLPE) have been used to avoid osteolysis and loosening. This prospective randomized study has assessed results in a series using two different poly-ethylenes associated with the same prosthetic design.

Methods: We assessed 45 Allofit cups with Sulene-PE liner (sterilized with nitrogen) and 45 Allofit cups with Durasul-PE liner (HXLPE), both associated with an Alloclassic stem (28-mm femoral head) (Zimmer). The minimum follow-up is 5 years and the mean follow-up 66.3 months. The linear femoral head penetration was estimated at 6 weeks, at 6 and 12 months and annually thereafter, using a software package employing the Dorr method, given the nonspherical cup shape.

Results All assessed hips had good clinical and radiographic results. There was no loosening of any prosthetic component. There were no radiolucent lines or osteolysis. Femoral head penetration in the early postoperative radiographs was 47.4% less in the Durasul group (0.09+0.03 mm) than the Selene-PE group (0.19+0.06 mm)(p< 0.0001). The mean yearly linear femoral head penetration was 20% lower in the Durasul group (0.008+0.008) than the Sulene-PE group (0.04+0.02)(p< 0.0001). Differences increase after the third year. Mean linear femoral head penetration at 5 years was 39.1% less in the Durasul group (p< 0.0001).

Conclusions: Although the digitized method used is not totally accurate and is used only for a general estimate, there is a significant reduction in yearly linear femoral head penetration with Durasul-PE. Longer-term results are needed to confirm that this polyethylene generates less osteolysis.