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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01362881
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : September 1, 2017
Information provided by (Responsible Party):
Ellipse Technologies, Inc.

Brief Summary:

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : January 2012
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Primary Outcome Measures :
  1. To Assess the Safety and effectiveness of a Magnetic Growth Rod [ Time Frame: 2 Years From Final Recruitment Date ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be recruited from secondary care

Inclusion Criteria:

  1. Patient aged 2 - 10 years (male/female) with EOS and growth potential
  2. Patient who surgeon feels would benefit from the implantation of a growth rod
  3. Patient must be of appropriate size and age for use of the device
  4. Patient's guardian is willing and able to give informed consent for participation in the study
  5. Patient (and guardian) is willing and able to return for all follow-up visits and study related procedures
  6. 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:

    1. Conversion patients with prior construct problems
    2. Previous diagnosis of post-operative spinal infection or wound complication
    3. Conversion patients with more than 3 previous distractions, or more than 2 years since initial surgery
    4. Patients with prior failure of other devices
    5. 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
    6. Participants who have participated in another research study involving an investigational product in the past 12 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01362881

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United Kingdom
Leeds Teaching Hospitals
Leeds, United Kingdom
Oxford University NHS Trust
Oxford, United Kingdom
Sponsors and Collaborators
Ellipse Technologies, Inc.
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Principal Investigator: Colin Nnadi Consultant Surgeon
Additional Information:
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Responsible Party: Ellipse Technologies, Inc. Identifier: NCT01362881    
Other Study ID Numbers: SC-11-001
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: June 2017
Keywords provided by Ellipse Technologies, Inc.:
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases