Table III.
Reference | Study design | Study group | Control group | Study group blood cobalt, µg/l | Findings |
---|---|---|---|---|---|
Prentice et al65 | Cross-section associational study | Aymptomatic patients with MoM hip resurfacings | Age- and sex-matched patients with non-MoM hip arthroplasties | Whole blood cobalt 1.75 µg/l compared to 0.38 µg/l in control group | Cardiac ejection fraction reduced and end diastolic volume increased in MoM group |
Lodge et al69 | Single centre, non-randomized, observational study | Patients with MoM hip arthroplasties in 3 groups, separated by cobalt levels | Age-matched controls with non-MoM hip arthroplasties | Plasma cobalt in 3 study groups 14.6 µg/l, 7.8 µg/l, and 1.3 µg/l compared to 0.6 µg/l in control group | Increasing cobalt values associated with increased heart volume but not with cardiac dysfunction and no clinical difference between groups was demonstrated |
Berber et al70 | Prospective, single centre, blinded trial | MoM bearing with elevated blood cobalt ions | MoM bearing with low blood cobalt ions and CoC bearing | Whole blood cobalt 30 µg/l and 2.47 µg/l in respective MoM groups compared to 0.17 µg/l in control group | No relationship between cobalt levels and ejection fraction. No differences between groups in the left atrial or ventricle size, B-type natriuretic peptide level, or troponin level, and all values were within normal ranges |
van Lingen et al71 | Longitudinal cohort study | 10 asymptomatic MoM patients with highest cobalt levels out of a population of 643 MoM patients | None | Whole blood cobalt 18 to 153 µg/l (mean 46.8 µg/l) | No signs or symptoms of cardiomyopathy could be identified |
Gillam et al67 | Observational cohort study from Australian Government Department of Veteran’s Affairs health claims database | 63 men with an ASR XL THA | 1,502 men with MoP THA, 199 men with other MoM THAs, 2,044 women with MoP, 58 women with ASR XL THA, and 153 women with other MoM THAs | Not recorded | Men with an ASR XL THA had a statistically significant higher rate of hospitalization for heart failure than men with a MoP THA. This higher rate of heart failure was not demonstrated in women or in men with other types of MoM implants |
Lassalle et al68 | Cohort study in the French National Health Insurance Databases | 11,298 patients with MoM hips | 93,581 patients with MoP, 58,095 patients with CoP, 92,376 patients with CoC | Not recorded | Small increase in heart complications in metal bearing surfaces compared to non-metal surfaces was identified after controlling for confounding factors, most pronounced in MoM vs CoC in women and men over 75 years of age |
Goodnough et al72 | Analysis of the Standard Analytics Files database in the USA | 29,483 patients with MoM hips | 24,175 patients with non-MoM hips | Not recorded | At 5 years there was no difference in cardiac complications such as cardiac failure, arrhythmia, acute myocardial infarction, or cardiomyopathy |
Sabah et al73 | Linkage study between the National Joint Registry, Hospital Episodes Statistics and records of the Office for National Statistics on death | 53,529 patients with MoM hips | 482,247 patients with non-MoM hips | Not recorded | At 7 years the risk of cardiac failure was lower in the MoM cohort compared with the non-MoM cohort. When the groups were matched their risk of cardiac failure was similar. |
Juneau et al66 | Cross-section study using cardiac magnetic resonance | 20 MoM resurfacing patients, 10 bilateral, 10 unilateral | 10 case-matched non-MoM total hip arthroplasty patients | Mean serum cobalt 1.3 µg/l in study group compared to 0.18 µg/l in control group | None of the MoM patients showed clinically significant cardiac functional abnormality. The MoM patients had larger end diastolic volumes. There was a small decrease in T2 time in the MoM patients. Higher metal ion levels were associated with larger LV volumes and with shorter T2 time. |
CoC, ceramic-on-ceramic; CoP, ceramic-on-polyethylene; LV, left ventricular; MoM, metal-on-metal; MoP, metal-on-polyethylene; THA, total hip arthroplasty.