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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362881
• Other study ID #: SC-11-001
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: August 31, 2017
• Start date: January 2012
• Est. completion date: August 31, 2017

Study information

• Verified date: June 2017
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 31, 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals	Leeds
United Kingdom	Oxford University NHS Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Assess the Safety and effectiveness of a Magnetic Growth Rod		2 Years From Final Recruitment Date

External Links

•   Ellipse Technologies Website
•   Oxford Spine Unit
•   Oxford University R&D