A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System

Ellipse Technologies

Status: Completed

Conditions: Thoracic Insufficiency Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01716936

PR0056

Details and patient eligibility

About

The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.

Enrollment: 54 patients

Sex: All

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early onset spinal deformity with any etiology
• Cobb angle measurement of 30 degrees or greater at the time of primary surgery
• Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
• Age less than 11 years old at the time of MAGEC implant
• Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
• Patient has been implanted for a minimum of 6 months
• Patient signs informed consent for the use of their personal private data

Exclusion criteria

• Patient declines to sign informed consent for the use of their personal private data.

Trial design

54 participants in 1 patient group

MAGEC Implant

Description:

All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study.