The Journal of Arthroplasty, Volume 35, Issue 3, 643 - 646
New Implant Introduction in Total Hip Arthroplasty Using Radiostereometric Analysis: A Cautionary NoteFrazer, Abigail R. et al.
It has been proposed that the introduction of new hip implant technology in orthopedic surgery be conducted in a more controlled manner in order to properly ensure patient safety and the likelihood of favorable outcomes. This stepwise introduction would first require a prospective randomized study in a small cohort of patients, using radiostereometric analysis (RSA). The aim of this study is to determine if the recent literature supports the use of RSA as an early screening tool to accurately predict the long-term outcomes of cementless femoral stems.
A review of the recent published literature identified 11 studies that used RSA to predict the long-term stability of a cementless femoral component. These RSA predictive data were compared to the 10-year revision rate reported in the Australian Registry or in the published literature to determine its reliability.
RSA data did not universally predict long-term stem fixation. In 2 of the 11 cases (18%), the RSA study incorrectly predicted the ability of the cementless stem to reliably osseointegrate. Of the 9 stems considered stable in the RSA studies, the 10 year registry and literature data confirmed that 6 implants had a low revision rate and were well performing. One stem has not performed well clinically and has been listed as having a higher than anticipated rate of revision in the registry. Two stems do not have sufficient follow-up. Of the 2 stems RSA predicted to do poorly, 1 is well performing at 10 years, and 1 has a high revision rate at 8 years.
In the stepwise introduction of new hip implants, RSA should be best considered as an adjunct tool in deciding whether or not an implant should be evaluated in a larger multicenter clinical studies, rather than the sole criterion.