Peri-articular soft-tissue masses or ‘pseudotumours’ can occur after large-diameter metal-on-metal (MoM) resurfacing of the hip and conventional total hip replacement (THR). Our aim was to assess the incidence of pseudotumour formation and to identify risk factors for their formation in a prospective cohort study.

A total of 119 patients who underwent 120 MoM THRs with large-diameter femoral heads between January 2005 and November 2007 were included in the study. Outcome scores, serum metal ion levels, radiographs and CT scans were obtained. Patients with symptoms or an identified pseudotumour were offered MRI and an ultrasound-guided biopsy.

There were 108 patients (109 hips) eligible for evaluation by CT scan at a mean follow-up of 3.6 years (2.5 to 4.5); 42 patients (39%) were diagnosed with a pseudotumour. The hips of 13 patients (12%) were revised to a polyethylene acetabular component with small-diameter metal head. Patients with elevated serum metal ion levels had a four times increased risk of developing a pseudotumour.

This study shows a substantially higher incidence of pseudotumour formation and subsequent revisions in patients with MoM THRs than previously reported. Because most revision cases were identified only after an intensive screening protocol, we recommend close monitoring of patients with MoM THR.

We report 17 patients (20 hips) in whom metal-on-metal resurfacing had been performed and who presented with various symptoms and a soft-tissue mass which we termed a pseudotumour. Each patient underwent plain radiography and in some, CT, MRI and ultrasonography were also performed. In addition, histological examination of available samples was undertaken.

All the patients were women and their presentation was variable. The most common symptom was discomfort in the region of the hip. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. To date, 13 of the 20 hips have required revision to a conventional hip replacement. Two are awaiting revision.

We estimate that approximately 1% of patients who have a metal-on-metal resurfacing develop a pseudotumour within five years. The cause is unknown and is probably multifactorial. There may be a toxic reaction to an excess of particulate metal wear debris or a hypersensitivity reaction to a normal amount of metal debris. We are concerned that with time the incidence of these pseudotumours may increase. Further investigation is required to define their cause.