Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment
Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment
Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children
 with scoliosis; the primary constituent metal alloy in these is titanium.

 Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating
 to known issues with the function of the rods that increase the risk of early failure and
 unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the
 most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted
 in the UK until further notice and (2) all patients already implanted with this device should
 be followed up as soon as is possible.

 At the time of writing, hospitals across the world are facing incredible challenges in
 dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for
 MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the
 virus spreading.

 Recent retrieval studies have shown that mechanical wear and corrosion of these rods is
 common, with a risk that the debris generated is released into surrounding tissue. This wear
 and corrosion is thought to be the primary cause of implant failures and the underlying
 implant factors leading to the issuing of FSNs and MDAs.

 Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this
 alloy in biological fluids are poorly understood. Additionally, a better understanding of
 blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of
 wear and corrosion of the rods. This may help surgeons identify earlier those patients who
 may develop implant related problems.

 Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may
 be one of the most suitable ways in which to continue patient monitoring (and identify those
 at greatest risk of implant related issues), in the absence of regular clinic visits.

 Previous work from the RNOH involved a similar study investigating patients with titanium hip
 implants.
Inclusion Criteria:

 -  Patients that have been treated with, and still have, a MAGEC rod.

 Exclusion Criteria:

 -  Patients that do not have a MAGEC rod implant.