Metal-on-metal versus polyethylene in hip arthroplasty: a randomized clinical trial.
A prospective, randomized, blinded clinical trial was done to evaluate polyethylene versus metal bearing surfaces in total hip replacement. Forty-one patients were randomized to receive either a metal (23 patients) or a polyethylene (18 patients) insert. The femoral and acetabular components were identical with the acetabular insert the only variable. Patients were assessed preoperatively and postoperatively using radiographs, multiple outcome measures (Western Ontario MacMaster University Score, Harris hip score, Short Form-12), erythrocyte metal ion analysis (cobalt, chromium, titanium), and urine metal ion analysis (cobalt, chromium, titanium). Patients were followed up for a minimum of 2 years (mean 3.2 years; range, 2.2-3.9 years). There were no differences in radiographic outcomes or outcome measurement tools between patients. Patients receiving a metal-on-metal articulation had significantly elevated erythrocyte and urine metal ions compared with patients receiving a polyethylene insert. Patients who had metal-on-metal inserts had on average a 7.9-fold increase in erythrocyte cobalt, a 2.3-fold increase in erythrocyte chromium, a 1.7-fold increase in erythrocyte titanium, a 35.1-fold increase in urine cobalt, a 17.4-fold increase in urine chromium, and a 2.6-fold increase in urine titanium at 2 years followup. Patients receiving a polyethylene insert had no change in erythrocyte titanium, urine cobalt, or urine chromium and a 1.5-fold increase in erythrocyte cobalt, a 2.2-fold increase in erythrocyte chromium, and a 4.2-fold increase in urine titanium. Forty-one percent of patients receiving metal-on-metal articulations had increasing metal ion levels at the latest followup.