Scoliosis Clinical Trial
Official title:
A Prospective Cohort Study of the Surgical Treatment of Early Onset Scoliosis Using a Remotely Expandable Device for Non-invasive Lengthening of a Growing Rod (Magec™) and Its Performance in Prevention of Progression of Scoliosis.
It is current practice for children who have surgery for early onset scoliosis (EOS) to be
treated with insertion of extendable implants known as growth rod systems. This allows the
growth potential of the child to be maximised during the period of growth. However, the child
must undergo an average of 6 further surgeries to lengthen the rods every 6 months. Sometimes
this may continue for several years. This requires repeated general anaesthesia and places
the patient at risk of complications as well as on-going costs to the hospital with each
admission and theatre episode.
Magec is a magnetic growth rod from Ellipse technologies (distributed by SurgiC). The rod is
inserted in exactly the same way as the conventional growth rod systems. The base implants
i.e screws and hooks remain the preferred choice of the user. The only change is that a
different rod is used.
There are several advantages to this device. Firstly, after the initial insertion, further
lengthenings, unlike current systems, do not need to be carried out in theatre under a
general anaesthetic. In contrast, they can be done in an outpatients setting with a
non-invasive technique. The rods are lengthened using an external magnetic device. The
lengthenings are done in a controlled manner using an age related growth guide. Thirdly, the
change from a theatre based intervention to an outpatient procedure will have cost-savings.
The investigators also believe that there will be psychosocial benefits to the child and
family by the avoiding the stress associated with repeated surgery at such a young age.
In terms of risk assessment the device does not place the child at any more risk than would
be expected from inserting any of the existing systems. In the event of failure of the rods
the worst outcome is a revision to conventional rods.
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