Large diameter metal-metal total hip replacements (MM THRs) offer the advantages of low wear and low dislocation risk and are being increasingly used in high-demand patients whose bone quality rules out the possibility of a hip resurfacing. However suggests that large headed MM devices may result in greater systemic metal exposure compared to small diameter bearings. This raises fresh concerns of elevated systemic metal levels. Whole blood concentrations and daily output of cobalt and chromium in 28 patients with unilateral large diameter MM THRs (42 to 54mm bearings) were studied at 1-year follow-up. These were compared with the whole blood levels in 20 patients at 1 year and daily output of metal ions in 28 patients with 28mm MM THRs at 1 to 3 years. Both bearings are made of high carbon cobalt-chrome alloy, the larger bearing is as-cast alloy and the smaller is wrought alloy. High resolution inductively coupled plasma mass spectrometry was used for analysis. None of the patients had other metal devices or compromised renal function. They had either a cemented polished tapered stainless steel stem or a cementless porous ingrowth titanium alloy stem.Introduction
Methods
Secondary osteoarthritis in a dysplastic hip is a surgical challenge. Severe leg length discrepancies and torsional deformities add to the problem of inadequate bony support available for the socket. Furthermore, many of these patients are young and wish to remain active, thereby jeopardising the long-term survival of any arthroplasty device. For such severely dysplastic hips, the Birmingham Hip Resurfacing (BHR) device provides the option of a dysplasia component, a hydroxyapatite-coated porous uncemented socket with two lugs to engage neutralisation screws for supplementary fixation into the solid bone of the ilium more medially. The gap between the superolateral surface of the socket component and the false acetabulum is filled with impacted bone graft. One hundred and thirteen consecutive dysplasia BHRs performed by the senior author (DJWM) for the treatment of severely arthritic hips with Crowe grade II and III dysplasia between 1997 and 2000 have been reviewed at a minimum five year follow-up. There were 106 patients (59M and 47F). Eighty of the 113 hips were old CDH or DDH, 29 were destructive primary or secondary arthritis with wandering acetabulae and four were old fracture dislocations of the hip. Mean age at operation was 47.5 years (range 21 to 68 years – thirty-six men and forty-four women were below the age of 55 years). There were two failures (1.8%) out of the 113 hips at a mean follow-up of 6.5 years (range 5 to 8.3 years). One hip failed with a femoral neck fracture nine days after the operation and another failed due to deep infection at 3.3 years.Introduction
Methods and results
Evidence with respect to conventional hip arthroplasties suggests that device wear is related to patient activity rather than duration of usage. Activity level questionnaires appear to suggest that subjects with resurfacing arthroplasties continue to remain active after the procedure. However there is a paucity of objective evidence relating to the step rates of these patients in their daily lives and its effect on metal ions generated. The aim of this investigation is to assess
the activity levels of hip resurfacing patients as follow up progresses and if there is any correlation between activity and metal ions generated. Twenty-five consecutive male patients (average age 56 years) who underwent a unilateral 50 mm diameter hip resurfacing carried out by a single surgeon (DJWM) were recruited after informed consent. Patient step activity (Step Activity Monitor, SAM, Cymatech. Seattle WA, USA) was recorded at 1, 2, and 4-year follow-up stages and at the same time patient whole blood samples were collected and analysed using High Resolution Inductively Coupled Mass Spectroscopy (HR-ICPMS). All patients in this study had well functioning hips at the four year follow up stage. All femoral components implanted were within the desired range of neutral to 10°. The mean acetabular component inclination angle was 42° (33° – 55°). Patient overall step activity remains unchanged up to the 4-year follow-up period. At one year follow up, the whole blood cobalt and chromium concentrations show no correlation to mean number of steps taken per day by each patient (r2=0.02). The correlation between whole blood cobalt and chromium concentration versus a function of body weight and peak index is not significant (r2=0.11). This study provides objective evidence of the activity rates of patients at different stages of follow-up after a MoM surface replacement arthroplasty. It should be emphasised that the walking speeds of these patients on average was significantly slower than 1 Hz, which is generally used in laboratory hip simulator studies.
This is the first six-year report of a prospective longitudinal study of daily output of cobalt and chromium in urine and their levels in blood following hybrid metal-on-metal surface arthroplasty. Urine and whole blood specimens were analyzed before and periodically after hip resurfacing in 26 male patients after informed consent (mean age 52.9 years, mean BMI 27.9). Two of these patients have undergone contralateral hip resurfacings for progressive pain from end-stage arthritis and had to be excluded. All patients were found to have well-functioning resurfacings at 6-year follow-up. No patient complained of persistent pain or disability. The median 6-year Oxford hip score was 12. Urine chromium and cobalt at six years were 3.9 and 7.8 μg/24 hrs and blood levels were 1.11 and 1.17μg/l respectively. Both urine and blood levels show a statistically significant early increase reaching a peak six months to one year postoperatively followed by a steady decrease over the following five years, although the individual reductions are not statistically significant, except for blood chromium where the 4 and 6 year levels were significantly lower than the 1-year level. Elevated systemic metal exposure following MM bearing arthroplasty continues to cause concern. Our results show that metal release in these bearings shows a reducing trend after an initial peak dispelling the fear that a steady build-up of in vivo metal occurs with progressively increasing blood levels. However, as long as the significance of these elevated levels remains unknown, the need for continued vigilance persists.
It has been suggested that metal ion level elevations in certain bilateral MM bearing arthroplasties were overwhelming the renal threshold for metal excretion leading to systemic build-up of metal ions above the expected levels. In order to investigate this we studied renal concentrating efficacy through concurrent specimens of urine and whole blood over a range of metal levels. Concurrent specimens from 305 unselected patients were obtained. They include preoperative patients (76) and those with unilateral and bilateral hip arthroplasties (229) through to ten years after operation. 39 pre-operative specimens and 4 follow-up specimens had blood levels at or below the detection limit for cobalt or chromium and were excluded. The ratio of urine to whole blood concentration was 0.78 in the pre-operative patients. In patients with MM arthroplasties the different ratios in patients increased (from 3.1 to 9.2) with increasing urine concentrations. The ratio of urine cobalt concentration to blood cobalt concentration is a measure of renal concentrating efficacy. Amongst pre-operative controls, this ratio is 0.78, indicating that there is renal conservation of cobalt. In terms of cobalt, these patients’ urine was dilute in comparison to whole blood. In patients with MM bearings, the ratio went up to 4.8 indicating that the kidneys were now actively excreting against a concentration gradient in an attempt to maintain internal milieu. If renal threshold was being breached at higher levels, then the ratio should progressively fall at higher concentrations. The trend in this experiment shows quite the contrary effect and the ratio reached 9.2 in those with urine cobalt >
15 μg/l, demonstrating that renal clearance efficiency holds up even against this steep gradient and that the threshold is not breached within clinically relevant levels.
The mean difference in cord chromium between the study and control groups is not statistically significant (p >
0.05), although cord cobalt in the study group is significantly higher (p <
0.01) than that in controls. Whilst there is a four-fold elevation of maternal cobalt in the study patients and an almost 7-fold increase in maternal chromium levels as compared to the control group, the elevation in the cord cobalt and chromium in the study group are smaller.
Ion analysis: Serum was collected from test station and allowed to settle for 12 hours. An aliquot of 20 ml from lubricant was collected. Each sample was centrifuged at 2500 g-force for 10 minutes. A 10 ml aliquot was collected from each sample and was further centrifuged at 2500 g-force for 10 minutes. 1.5 ml aliquot was collected and stored at −20 °C. A high resolution inductively-coupled plasma mass spectrometry instrument (ELEMENT, ThermoFinnigan MAT, Bremen/Germany) was then used for the analysis of metal ions.
Some authors have suggested that metal wear in patients with well-functioning MM bearings occurs only during the run-in wear phase and that continued corrosion of metal particles released during that period is responsible for metal level elevation later on. However the reducing trend in the later phase following revision in this study suggests that metal ion elevation from corrosion is not sustained indefinitely and therefore cannot by itself account for the persistent elevation of systemic metal levels throughout. Bearing wear continues to occur throughout bearing life.