THE 7 YEAR IN VIVO WEAR OF HIGHLY CROSS-LINKED POLYETHYLENE. A DOUBLE BLIND RCT

Abstract

Introduction: The use of second generation highly cross-linked polyethylene (HXLPE) is now commonplace for total hip arthroplasty, however there is no long-term data to support its use. Hip simulator studies suggest that the wear rate of HXLPE is ten times less than conventional polyethylene (UHMWPE). The outcomes of hip simulator studies are not always reproducible in vivo. Long term clinical data is required, as there is emerging clinical data, which suggests that some types of second generation HXLPE may have increased wear after 5 years.

Method: A prospective double blind randomised control trial was conducted using Radiostereometric analysis (RSA). Fifty-four subjects were randomised to receive hip replacements with either UHMWPE liners or HXLPE liners. All subjects received a cemented CPT stem and uncemented Trilogy acetabular component (Zimmer, Warsaw, IN, USA). The 3D penetration of the head into the socket was determined to a minimum of 7 years.

Results: The total liner penetration was significantly different at 7 years (p=0.01) with values of 0.33mm (SD 0.17mm) for the HXLPE group and 0.51mm (SD 0.14mm) for the UHMWPE group. The steady state wear rate from 1 year onwards was significantly lower for HXLPE (0.003 mm/yr, SD 0.04 mm/yr) than for UHMWPE (0.03 mm/yr, SD 0.03 mm/yr) (p=0.01). The direction of wear was in the antero-medial direction in both groups.

Conclusion: We have previously demonstrated that the penetration in the first year is creep-dominated, from one year onwards the majority of penetration is due to wear. The wear rate of this second generation HXLPE approaches that of metal on metal bearings. Second-generation HXLPE may have the potential to reduce the risk of revision surgery, due to wear debris induced osteolysis.