WEAR OF HIGHLY CROSS-LINKED CEMENTED POLYETHYLENE CUPS AND ETO-STERILIZED ULTRA-HIGH MOLECULAR WEIGHT CEMENTED POLYETHYLENE CUPS WITH OXINIUM® OR COCR FEMORAL HEADS: A RANDOMIZED STUDY OF 150 HIPS USING RADIOSTEREOMETRIC ANALYSIS

Abstract

Introduction: Highly cross-linked polyethylene acetabular cups and Oxinium femoral heads were developed to reduce wear debris induced osteolysis. Laboratory tests have shown less wear with these new materials. This RSA-study was performed to compare these new materials in vivo with conventional bearing materials used in total hip arthroplasty.

Methods:150 patients were randomized to 5 groups. The patients received either a cemented Charnley mono-block stainless steel femoral stem with a 22.2 mm head or a cemented Spectron EF femoral stem with a 28 mm head. The Charnley stem articulated with a cemented Charnley Ogee acetabular cup. The Spectron EF stem was used with either cemented Reflection All-Poly EtO-sterilized ultra-high molecular weight polyethylene (UHMWPE) acetabular cups or cemented Reflection highly cross-linked polyethylene (XLPE) acetabular cups, combined with either Cobalt Chrome or Oxinium 28 mm femoral heads. Patients were followed up with repeated radiostereometric analysis (RSA) for two years to assess the rate of penetration of the femoral head into the cup (MTPM).

Results: At 2 years follow-up the mean MTPM (95 % CI) for Charnley Ogee (n=25) was 0.20 mm (0.11–0.29). For the Spectron EF femoral stem used with Reflection All-Poly UHMWPE acetabular cups the mean MTPM (CI) at 2 years was 0.40 mm (0.23–0.57) when combined with Cobalt Chrome femoral head (n=23) and 0.50 mm (0.29–0.71) when combined with Oxinium femoral head (n=16). When using the Spectron EF femoral stem with Reflection XLPE combined with Cobalt Chrome (n=27) or Oxinium (n=24) femoral head the mean MTPM (CI) at 2 years was 0.19 mm (0.10–0.28) and 0.18 mm (0.07–0.29), respectively. There were no differences in penetration between the Charnley/Ogee, XLPE/CoCr and XLPE/Oxinium groups (student t-test, p=0.5–0.8). There was no statistically significant difference between the two Reflection All-Poly UHMWPE groups (p=0.09). The groups with Reflection All-Poly cups had a statistically significant higher penetration than the three groups mentioned above (p< 0.001).

Discussion: The use of Reflection XLPE cups instead of Reflection All-Poly cups reduced femoral head penetration at 2 years. We used the Charnley Ogee cup as a reference due to a long clinical record. This cup was superior to Reflection All-Poly, but not Reflection XLPE, regarding femoral head penetration. Because the femoral head of Charnley Ogee is smaller than the Oxinium/Cobalt Chrome head it might be more clinical relevant to measure volumetric wear. The groups with Oxinium heads did not have less wear than the groups with Cobalt Chrome heads after 2 years follow-up. Further follow-up is needed to evaluate the benefits, if any, of Oxinium femoral heads in the clinical setting.