Behavior of Hylamer polyethylene in hip arthroplasty: comparison of two gamma sterilization techniques.
Hylamer polyethylene was introduced in the 1990s as an alternative to conventional polyethylene. Its chemical and physical properties, and especially its high crystallinity, were claimed to improve resistance to wear. Initially Hylamer devices were sterilized by gamma radiation in air, then the technique was changed and gamma radiation was performed in the absence of oxygen. Clinical experience has shown the early loosening of some devices made from Hylamer. The aim of this study was to ascertain whether early wear and consequent osteolysis was linked to the sterilization method. We retrospectively compared 31 patients with hip prostheses with Hylamer liners sterilized by gamma radiation in air (group 1) with 30 patients with the same prosthesis, but sterilized in the absence of oxygen (group 2). The groups were similar for sex, age, disease, head diameter and material. Mean follow-up was 84 months and no clinical signs of failure were present. Radiographic measurement revealed that wear of group 1 was significantly greater than that of group 2 (0.23 mm/year vs 0.09 mm/year, p=0.001). Periacetabular and femoral osteolysis in group 1 was significantly greater than group 2. In conclusion, the method of sterilization might have influenced the outcome of Hylamer polyethylene liners.
Stea
S
S
Laboratorio di Tecnologia Medica, Istituti Ortopedici Rizzoli, Via di Barbiano 1/10, Bologna, 40136, Italy. stea@tecno.ior.it
Antonietti
B
B
Baruffaldi
F
F
Visentin
M
M
Bordini
B
B
Sudanese
A
A
Toni
A
A
D019644:Arthroplasty, Replacement, Hip; D001672:Biocompatible Materials / Q000528:radiation effects; D005720:Gamma Rays / Q000627:therapeutic use*; D006621:Hip Joint / Q000473:pathology; D006622:Hip Prosthesis; D006801:Humans; D008422:Materials Testing; D008970:Molecular Weight; D020959:Polyethylene / Q000528:radiation effects*; D011475:Prosthesis Failure; D013242:Sterilization / Q000379:methods*
D001672:Biocompatible Materials; D020959:Polyethylene