Nonfusion Spinal Deformity Correction in Idiopathic Scoliosis

Clinical Trial

Offered by: Nemours Children's Specialty Care, 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

Contact Nemours Clinical Trials

Trial Name: Nonfusion Spinal Deformity Correction in Idiopathic Scoliosis

IRB: 1571772

Contact Information

(800) 354-5690
ClinicalTrials@nemours.org