202. IN VITRO AND IN VIVO RISK OF FRACTURE OF 22.2 MM DELTA CERAMIC FEMORAL HEADS

Abstract

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.