Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01633931
• Other study ID #: PR0038
• Status: Active, not recruiting
• Phase: N/A
• First received: July 2, 2012
• Last updated: January 30, 2018
• Start date: March 2012
• Est. completion date: October 2018

Study information

• Verified date: January 2018
• Source: Ellipse Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 2018
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Adolescent Idiopathic Scoliosis

• Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing

• Skeletally immature (Risser Sign 0, 1, 2, or 3)

• In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months

• Age between 10 and 15

• Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion

• Candidate for surgical implantation of spinal instrumentation

• Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol

• Must sign informed consent to permit the use of personal health data

Exclusion Criteria:

• Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant

• Patients who require an MRI following implantation

• Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)

• Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature

• History of previous surgical treatment for AIS

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong	Pokfulam

Sponsors (1)

Lead Sponsor	Collaborator
Ellipse Technologies, Inc.

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in major scoliotic curve magnitude	Measured in degrees	Change from baseline to 36 months postoperative
Primary	Number and Types of Adverse Events		Operative through 36 months postoperative
Secondary	Radiographic evaluation coronal balance compared to baseline		Change from baseline to 36 months postoperative
Secondary	Radiographic evaluation sagittal balance compared to baseline		Change from baseline to 36 months postoperative
Secondary	Percent of patients indicated for surgical spine fusion		Change from baseline to 36 months postoperative
Secondary	Quality of life assessment via SRS-30 questionnaire		Change from baseline to 36 months postoperative
Secondary	Comparison of Rib Hump prominence		Change from baseline to 36 months postoperative
Secondary	Expected vs. Actual Device Lengthening		All postoperative visits where lengthening is conducted

External Links

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