Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty.

Background: The aim of our prospective, multicenter, randomized, controlled trial (titled M2A-38 Ceramic-on-Metal RCT, NCT00754520) is to demonstrate noninferiority of a ceramic-on-metal (CoM) articulation compared with metal-on-metal (MoM) in total hip arthroplasty. The study arms are at 8 years since implantation, with metal ion and functional score analysis at 5 years.

Methods: We recruited 211 patients between 2009 and 2011.