Sunday, February 11, 2018

New Technology - let surgeons and patients beware

Implications of Introducing New Technology: Comparative Survivorship Modeling of Metal-on-Metal Hip Replacements and Contemporary Alternatives in the National Joint Registry

These authors point out that, "new medical technologies are often used widely without adequate supporting data, a practice that can lead to widespread catastrophic failure such as occurred with metal-on-metal (MoM) hip replacements". They determined how revision rates would have differed if, instead of receiving MoM hip replacements, patients had received existing alternatives.

Using a population-based longitudinal cohort study of patient data recorded in the National Joint Registry for England, Wales and Northern Ireland between April 2003 and December 2014, they ascertained implant failure rates separately among stemmed MoM total hip replacement (THR) and hip-resurfacing procedures and, using flexible parametric survival modeling, compared them with the failure rates that would have been expected had existing alternatives been used.

In all, 37,555 patients underwent MoM hip resurfacing, with a 10-year revision rate of 12.6% compared with a predicted revision rate of 4.8% if alternative implants had been used. 

The 32,024 stemmed MoM THRs had a 19.8% (95% CI: 18.9% to 20.8%) 10-year failure rate compared with an expected rate of 3.9% if alternatives had been used. 

For every 100 MoM hip-resurfacing procedures, there were 7.8 excess revisions by 10 years, and for every 100 stemmed MoM THR procedures, there were 15.9, which equates to 8,021 excess first revisions. 

The authors conclude by stating "This study highlights the consequences of widespread and poorly monitored adoption of a medical technology. Over 1 million MoM hip prostheses were implanted worldwide. The excess failure on a global scale will be enormous. This practice of adopting new technologies without adequate supporting data must not be repeated."

This post, along with the two prior ones, illustrates that the existing orthopaedic implant clearance processes do not assure that the devices are safe or effective.
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