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Completed

NCT Number: NCT01716936

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

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.

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Key information

Conditions

Thoracic Insufficiency Syndrome

Age range

Up to 11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cairo Public Hospital, Cairo, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Cobb Angle

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

    Measured in Degrees

  2. Change in Thoracic Spine Height

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

    Measured in millimeters (mm)

  3. Change in Space Available for Lung

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

    Measured as a percentage (%)

  4. Ocurrence of Procedure-Related Complications

    Time frame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively

  5. Occurrence of Adverse Events

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

Secondary outcomes

  1. Change in Coronal Balance

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

    Measured in millimeters (mm)

  2. Change in Sagittal Balance

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

    Measured in millimeters (mm)

  3. Occurrence of Subsequent surgical interventions following initial implantation

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

  4. Change in Weight

    Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively

    Measured in kilograms (kg)

Sponsors and collaborators

Lead sponsor

Ellipse Technologies, Inc.

Industry

Registry information

Official study title

A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Aug 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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