Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod

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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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeds Teaching Hospitals, Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient aged 2 - 10 years (male/female) with EOS and growth potential
Patient who surgeon feels would benefit from the implantation of a growth rod
Patient must be of appropriate size and age for use of the device
Patient's guardian is willing and able to give informed consent for participation in the study
Patient (and guardian) is willing and able to return for all follow-up visits and study related procedures
The patient's guardian is willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion criteria

The participant may not enter the study if ANY of the following apply:

Conversion patients with prior construct problems
Previous diagnosis of post-operative spinal infection or wound complication
Conversion patients with more than 3 previous distractions, or more than 2 years since initial surgery
Patients with prior failure of other devices
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Participants who have participated in another research study involving an investigational product in the past 12 weeks

Treatment and study plan

Primary outcomes

To Assess the Safety and effectiveness of a Magnetic Growth Rod

Time frame: 2 Years From Final Recruitment Date

Sponsors and collaborators

Lead sponsor

Ellipse Technologies, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2017
First posted: May 30, 2011
Registry last updated: Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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