An observational study in Scoliosis, sponsored by Ellipse Technologies, Inc.. Completed at 2 sites in United Kingdom. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by Ellipse Technologies, Inc. · Observational
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.
594 studies on the registry are indexed under Scoliosis; 139 are open to participants now.
This study's enrollment of 14 is below the median of 89 across 233 observational studies indexed under Scoliosis.
Browse Scoliosis studies →Ellipse Technologies, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population will be recruited from secondary care
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
To Assess the Safety and effectiveness of a Magnetic Growth Rod
Time frame: 2 Years From Final Recruitment Date
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Ellipse Technologies, Inc.