Friday, March 14, 2014

Cancer incidence and cause-specific mortality in patients with metal-on-metal hip replacements in Finland

A population-based study with a mean follow-up of 4.6 (1–11) years
 
 
February 2014, Vol. 85, No. 1 , Pages 32-38 (doi:10.3109/17453674.2013.878830)            
1 Department of Orthopaedics and Traumatology,
Surgical Hospital, Turku University Hospital,
Turku
2 Hjelt Institute, Helsinki University, Helsinki
3 Coxa Hospital for Joint Replacement, Tampere
4 Department of Orthopaedics and Traumatology,
Peijas Hospital, Helsinki University Central Hospital,
Helsinki
5 School of Health Sciences,
University of Tampere, Tampere and the Finnish Cancer Registry, Institute for Statistical and Epidemiological Cancer Research, Helsinki,
Finland.
Correspondence:
 
 
Background and purpose — Metal-on-metal hip implants have been widely used, especially in the USA, Australia, England and Wales, and Finland. We assessed risk of death and updated data on the risk of cancer related to metal-on-metal hip replacements
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Patients and methods — A cohort of 10,728 metal-on-metal hip replacement patients and a reference cohort of 18,235 conventional total hip replacement patients were extracted from the Finnish Arthroplasty Register for the years 2001–2010. Data on incident cancer cases and causes of death until 2011 were obtained from the Finnish Cancer Registry and Statistics Finland. The relative risk of cancer and death were expressed as standardized incidence ratio (SIR) and standardized mortality ratio (SMR). SIR/SIR ratios and SMR/SMR ratios, and Poisson regression were used to compare the cancer risk and the risk of death between cohorts.

Results — The overall risk of cancer in the metal-on-metal cohort was not higher than that in the non-metal-on-metal cohort (RR = 0.91, 95% CI: 0.82–1.02). The risk of soft-tissue sarcoma and basalioma in the metal-on-metal cohort was higher than in the non-metal-on-metal cohort (SIR/SIR ratio = 2.6, CI: 1.02–6.4 for soft-tissue sarcoma; SIR/SIR ratio = 1.3, CI: 1.1–1.5 for basalioma). The overall risk of death in the metal-on-metal cohort was less than that in the non-metal-on-metal cohort (RR = 0.78, CI: 0.69–0.88).

Interpretation — The overall risk of cancer or risk of death because of cancer is not increased after metal-on-metal hip replacement. The well-patient effect and selection bias contribute substantially to the findings concerning mortality. Arthrocobaltism does not increase mortality in patients with metal-on-metal hip implants in the short term. However, metal-on-metal hip implants should not be considered safe until data with longer follow-up time are available.
 
Metal-on-metal hip implants have been widely used, especially in the USA, Australia, England and Wales, and Finland (AOANJRR 2010, NJR 2011, Cohen 2012, Seppänen et al. 2012). The theoretical health risks related to chronically elevated blood metal ion concentrations induced by abnormal wear and corrosion of the metal-on-metal implants—apart from local symptoms around the failing implant—include systemic symptoms of poisoning (Steens et al. 2006, Oldenburg et al. 2009, Rizzetti et al. 2009, Tower 2010, 2012, Mao et al. 2011, Sotos and Tower 2013, Zyviel et al. 2013) and carcinogenesis (Mäkelä et al. 2012, Smith et al. 2012, Brewster et al. 2013). Systemic metal ion toxicity cases due to a failed hip replacement are rare. However, there have been several recent reports of systemic cobalt toxicity following revision of fractured ceramic components, and also in patients with a failed metal-on-metal hip replacement (Steens et al. 2006, Oldenburg et al. 2009, Rizzetti et al. 2009, Tower 2010, 2012, Mao et al. 2011, Sotos and Tower 2013, Zyviel et al. 2013). Possible clinical findings include fatigue, weakness, hypothyroidism, cardiomyopathy, polycythemia, visual and hearing impairment, cognitive dysfunction, and neuropathy. Fatal cardiomyopathy due to systemic cobalt toxicity after hip replacement has been reported (Zyviel et al. 2013).
 
Metal debris from hip replacement may be associated with chromosomal aberrations and DNA damage (Case et al. 1996, Bonassi et al. 2000, Daley et al. 2004). However, the risk of cancer is not increased after conventional metal-on-polyethylene total hip replacement or after first-generation metal-on-metal total hip arthroplasty (Visuri et al. 1996, 2010a). The short-term overall cancer risk after modern metal-on-metal hip arthroplasty is not increased either (Mäkelä et al. 2012, Smith et al. 2012, Brewster et al. 2013). However, recent linkage studies of overall cancer risk are based on hospital episode statistics, which may have less quality assurance than cancer registry data (Smith et al. 2012, Brewster et al. 2013). Annual updating of cancer registry data concerning the metal-on-metal issue is advisable.

In this paper, we update our earlier published results on risk of cancer (Mäkelä et al. 2012) and give an assessment of the overall and cause-specific mortality in primary metal-on-metal and non-metal-on-metal hip replacement patients who were operated on from 2001 to 2010, by combining data from the Finnish Arthroplasty Register, the Population Register Centre, and the Finnish Cancer Registry. The reason for this early updating of the cancer data was to be able to detect a cancerogenic effect of metal-on-metal implants as early as possible.



Read More: http://informahealthcare.com/doi/full/10.3109/17453674.2013.878830

 


 

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