The purpose of this study was to compare oxinium versus metal-on-polyethylene wear in two consecutive prospective randomized series of low friction total hip arthroplasty at a minimum 10-year follow-up.

A total of 100 patients with a median age of 60.9 years were randomized to receive either oxinium (50 hips) or metal (50 hips) femoral head. The polyethylene socket was EtO sterilized in the first 50 patients, whereas it was highly cross-linked and remelted (XLPE) in the following 50 patients. The primary criterion for evaluation was linear head penetration measurement using the Martell system by an investigator blinded to the material. Also, a survivorship analysis was performed using wear related loosening revised or not as the end point.

Complete data were available for analysis in 40 hips at a median follow-up of 12.9 years (11 to 14), and in 36 hips at a median follow-up of 12.3 years (10 to 13) in the EtO sterilized and XLPE series, respectively.

In the EtO sterilized series, the mean steady-state wear rate was 0.245 ± 0.080 mm/year in the oxinium group versus 0.186 ± 0.062 mm/year in the metal group (p = 0.009). In the XLPE series, the mean steady-state wear rate was 0.037±0.016 mm/year in the oxinium group versus 0.036±0.015 mm/year in the metal group (p = 0.94). The survival rate at 10 years was 100% in both XLPE series, whereas it was 82.9% (IC 95%, 65–100) and 70.5% (IC95%, 50.1–90.9) in the metal-EtO and oxinium-EtO series, respectively.

This RCT demonstrated that up to 14-year follow-up, wear was significantly reduced when using XLPE, irrespective of the femoral head material. Also, no osteolysis related complication was observed in the XLPE series. In the current study, oxinium femoral heads showed no advantage over metal heads and therefore their continued used should be questioned related to their cost.

The purpose of this study was to compare the effect of femoral head material (delta ceramic versus metal) on polyethylene wear in a consecutive prospective randomized series of low friction total hip arthroplasty.

A total of 110 patients with a mean age of 60.6 ± 9.3 (34–75) years were randomized (power of 90%, alpha of 5%) to receive either a metal (55 hips) or a delta ceramic (55 hips) femoral head. The polyethylene socket was moderately cross-linked (3 Mrads of gamma radiation in nitrogen) and annealed at 130°C in all hips. All other parameters were identical in both groups. The primary criterion for evaluation was linear head penetration measurement using the Martell system, performed by an investigator blinded to the material of the femoral head. Creep and steady state wear values were calculated.

At the minimum of 3-year follow-up, complete data were available for analysis in 38 hips at a median follow-up of 4.4 years (3.0 to 5.7), and in 42 hips at a median follow-up of 4.0 years (3.0 to 5.4) in the metal and delta ceramic groups, respectively. The mean creep, measured as the linear head penetration at one year follow-up, was 0.42 ± 1.0 mm in the metal group versus 0.30 ± 0.81 mm in the delta ceramic group (Mann and Whitney test, p = 0.56). The mean steady state penetration rate from one year onwards measured 0.17 ± 0.44 mm/year (median 0.072) in the metal group versus 0.074 ± 0.44 mm/year (median 0.072) in the delta ceramic group (Mann and Whitney test, p = 0.48). No case of delta ceramic femoral head fracture was recorded, and no hip had signs of periprosthetic osteolysis.

This study demonstrated that up to 5-year follow-up, delta ceramic femoral head did not significantly influence creep neither wear of a contemporary annealed polyethylene. Longer follow-up is necessary to further evaluate the potential clinical benefits of delta ceramic.

Purpose of the study: The purpose of this prospective study was to evaluated the risk of fracture of 22.2 mm Delta ceramic heads.

Material and methods: A preclinical study was performed on twenty 22.2 mm Delta ceramic femoral heads with a medium neck with 20 22.2 mm Delta ceramic femoral heads with a short neck. A V40TM cone was used in all cases with a 5 40 angle. In vitro tests consisted in the assessment of the fracture force under static pressure before and after stress tests, and with a static force shock test (Charpy model) simulating a microseparation during subluxation phenomena. Between April 2007 and April 200, a consecutive series of 55 composite Delta heads were used in 55 patients undergoing cemented total hip arthroplasty (THA). A polyethylene cup was sterilised under vacuum at 3 Mrads with a post-radiation temper (Duration^®), and a stainless steel femoral piece with a highly polished surface and a V40TM Morse cone (Legend^®). This series issued from a randomised prospective study designed to compare wear with 22.2mm Delta ceramic heads with stainless steel heads with the same diameter. Inclusion criteria were age < 75 years, degenerative disease on naive hip and patient residing in France. Mean patient age was 59.2±6.9 years (range 44–70).

Results: The resistance of the 22.2 mm heads was significantly less during the static tests before and after the stress tests. Nevertheless, the mean resistance was higher than the FDA recommendations of 46K. The tests simulating a microseparation showed a significantly superior resistance for the 22.2 mm heads. All patients had from 1 to 2 years follow-up (usual delay for 80% of in vivo ceramic fractures). There were no cases of femoral head fracture in this series. There were no cases of early wear at this same follow-up and no case of femoral or acetabular osteolysis.

Discussion and Conclusion: The results of this study indicate that the resistance of the 22.2mm ceramic Delta heads is very much superior to the recommendations for in vitro tests. In this series, the risk of fracture in vivo remained nil to two years follow-up. The pertinence of this ceramic implant for decreasing polyethylene wear in vivo is under evaluation.

Purpose of the study: The purpose of this prospective randomised study was to evaluate the wear of cemented polyethylene cups as a function of the material of the femoral head: oxinium versus metal.

Material and methods: This series included 50 primary arthroplasties implanted from January 2006 to May 2006 in 50 patients (27 women and 23 men), mean age 60.6±11.4 years (21–75). The same femoral piece made of highly polished M30NW stainless steel with a quadrangular section was used for all implants. Similarly, all patients had a polyethylene cup sterilised with ethylene oxide (CMK21, Smith and Nephew). The femoral head was made of stainless steel for 25 hips and oxinium for 25 hips. The major outcome was penetration of femoral head into the cup (associated with true wear and creep) measured at minimum two years follow-up using the Martell method modified according to the recommendations of the author for an all-polyethylene cup. Patient-related and technique-related factors were studied. Non-parametric tests were used for the statistical analysis.

Results: There was no significant difference between the two groups regarding preoperative data. Two patients died, one was lost to follow-up; for three patients, the radiographs were excluded by the software. The analysis thus included 44 hips with a median follow-up of 2.01 years (1.9–2.3), 22 in the Oxinium™ group and 22 in the metal group. The median penetration rate was 0.16 mm/year in the Oxinium^® group versus 0.19 mm/year in the metal group (Mann-Whitney, p=0.46). Annual volumetric penetration in the Oxinium™ group was comparable with that of the metal group (Mann-Whitney, p=0.76). conversely, using the radiograph taken at one year as the reference value (true wear), wear was 0.066 mm/y in the Oxinium™ group versus 0.19mm/y in the metal group (Mann-Whitney, p=0.38).

Discussion and Conclusion: The results of this series indicate that using an oxinium femoral head reduces polyethylene wear. Mid-term results appear to be necessary to confirm these findings.