MAGEC Rod Clinical Trial
Official title:
Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment
| NCT number | NCT04337151 |
| Other study ID # | RNOH MAGEC |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2020 |
| Est. completion date | March 2021 |
| Verified date | April 2020 |
| Source | Royal National Orthopaedic Hospital NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | March 2021 |
| Est. primary completion date | January 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal National Orthopaedic Hospital | Stanmore |
| Lead Sponsor | Collaborator |
|---|---|
| Royal National Orthopaedic Hospital NHS Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Titanium level | Within 6 months |