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CompletedNCT01362881Updated Sep 1, 2017

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14
Ages
2 Years to 10 Years
Sex
All
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Study 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.

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Conditions studied

  • Scoliosis

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Keywords

  • Early
  • Onset
  • Scoliosis
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In context

Scoliosis

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14 participants (actual)
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What researchers measure

Primary outcomes

  1. To Assess the Safety and effectiveness of a Magnetic Growth Rod

    Time frame: 2 Years From Final Recruitment Date

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Study locations

2 sites
  • Leeds Teaching Hospitals
    Leeds, United Kingdom
  • Oxford University NHS Trust
    Oxford, United Kingdom
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01362881
Lead sponsor
Ellipse Technologies, Inc.
Responsible party
Sponsor
First posted
May 30, 2011
Start date
Jan 2012
Primary completion
Feb 2016
Completion
Aug 31, 2017
Last update
Sep 1, 2017

Study contacts

Colin Nnadi
principal investigator · Consultant Surgeon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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