Abstract
The authors entered patients into a randomised trial to compare the results of the use of cemented and cementless acetabular prostheses between 1993 and 1995. The results of mid-term wear studies at average follow up of eight years were reported in the journal in 2004. We now present long-term results to show the eventual fate of the hip replacements under study.
The initial study group of 162 patients was randomly assigned to a modular titanium cup with a polyethylene liner or an all polyethylene cemented cup. All patients received a cemented stem with a 26 mm head and a standardised surgical technique. The polyethylene wear was estimated via head penetration measurement and the mid-term results showed a significantly higher wear rate in the cementless cups compared to the cemented cups (0.15mm/yr vs. 0.07mm/yr p<0.0001). The prediction was that this would lead to a higher rate of aseptic loosening in the cementless group.
Patients have now been re-examined at an average of 15 years with the main emphasis on prosthesis survival. Wear studies were also performed.
There were exclusions from the initial study because of death and reoperation for reasons other than aseptic loosening. The number of patients in this longer-term study had decreased as a result of death and loss to follow up. Revisions for aseptic loosening did not follow the path as suggested by the mid term wear studies. There were five cup revisions in the cemented group and one cup revision in the cementless group for aseptic loosening. No femoral stem was revised for aseptic loosening. Details of the long-term wear studies will be presented and osteolysis rates and extent documented.
Despite the statistically significant difference in wear rates at the mid term, an incorrect prediction of eventual loosening rates was made. The authors believe that there are many factors other than wear rates involved in longevity of fixation. We also believe there are many weaknesses in long term prospective, randomised trials in joint replacement and question whether they are, in fact, level 1 evidence in the age of evidence based medicine.
