91´óÉñ

Clinical Trial

Offered by: 91´óÉñ Children's Health, Jacksonville
Location: Jacksonville, Fla.

Trial Name

Nonfusion Spinal Deformity Correction in Idiopathic Scoliosis

What is the trial about?

This study is being done to develop a multicenter database of patients who are recommended to undergo surgical correction for idiopathic scoliosis. This database is expected to allow surgeons to choose a surgical pathway with the best outcome for patients with idiopathic scoliosis.

Who can participate?

Patients aged 8 years or older on the date of surgery that have a diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement and a nonfusion surgery is scheduled within four months can be in the study.

What is involved?

You/your child will be in the study for 15 years following surgery or transition to adult care. You/your child will be followed by his/her surgeon for 15 years as part of routine care or until you/your child transition to adult care. You/your child will return to the clinic for approximately 20 visits.  There could be more visits if determined by your/your child’s doctor.  Information about you, your child (detailed below) will be collected at these routine care visits. You/your child can stop your/your child’s participation in the study at any time.

Pre-Op Visit:

• Demographic information
• X-rays
• Questionnaire packet
• Pulmonary function test*
• Trunk shape measures
• Trunk flexibility evaluation*
• Beighton laxity*
• Neuro status
• Clinical photographs

Peri-Operative

• Operation
• Hospital stay

First Erect Visit:

• Demographic information
• X-rays
• Adverse events
• Trunk shape measures
• Trunk flexibility evaluation *

6, 18, 30, 42, 54 Months. 3, 4 Year. 1, 2 Year Post-Maturity:

• Demographic information
• X-rays
• Adverse events

1, 2, 5, 10, 15 Year Post-Op Visit:

• Demographic information
• X-rays
• Questionnaire packets
• Pulmonary function test* (2 year and 5 year visit only)
• Trunk shape measures
• Trunk flexibility evaluation*
• Neuro status
• Clinical photographs