91大神

Clinical Trial</h3>\r\n<p><b>Offered by:</b> 91大神 Children's Health, Jacksonville<br>\r\n<b>Location:</b> Jacksonville, Florida</p>\r\n<h3>Trial Name</h3>\r\n<p>Nonfusion Spinal Deformity Correction in Idiopathic Scoliosis</p>\r\n<h3>What is the trial about?</h3>\r\n<p>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.</p>\r\n<h3>Who can participate?</h3>\r\n<p>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.</p>\r\n<h3>What is involved?</h3>\r\n<p>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.&nbsp; There could be more visits if determined by your/your child鈥檚 doctor.&nbsp; Information about you, your child (detailed below) will be collected at these routine care visits. You/your child can stop your/your child鈥檚 participation in the study at any time.</p>\r\n<h3>Pre-Op Visit:</h3>\r\n<ul>\r\n<li>Demographic information</li>\r\n<li>X-rays</li>\r\n<li>Questionnaire packet</li>\r\n<li>Pulmonary function test*</li>\r\n<li>Trunk shape measures</li>\r\n<li>Trunk flexibility evaluation*</li>\r\n<li>Beighton laxity*</li>\r\n<li>Neuro status</li>\r\n<li>Clinical photographs</li>\r\n</ul>\r\n<h3>Peri-Operative</h3>\r\n<ul>\r\n<li>Operation</li>\r\n<li>Hospital stay</li>\r\n</ul>\r\n<h3>First Erect Visit:</h3>\r\n<ul>\r\n<li>Demographic information</li>\r\n<li>X-rays</li>\r\n<li>Adverse events</li>\r\n<li>Trunk shape measures</li>\r\n<li>Trunk flexibility evaluation *</li>\r\n</ul>\r\n<h3>6, 18, 30, 42, 54 Months. 3, 4 Year. 1, 2 Year Post-Maturity:</h3>\r\n<ul>\r\n<li>Demographic information</li>\r\n<li>X-rays</li>\r\n<li>Adverse events</li>\r\n</ul>\r\n<h3>1, 2, 5, 10, 15 Year Post-Op Visit:</h3>\r\n<ul>\r\n<li>Demographic information</li>\r\n<li>X-rays</li>\r\n<li>Questionnaire packets</li>\r\n<li>Pulmonary function test* (2 year and 5 year visit only)</li>\r\n<li>Trunk shape measures</li>\r\n<li>Trunk flexibility evaluation*</li>\r\n<li>Neuro status</li>\r\n<li>Clinical photographs</li>\r\n</ul>\r\n"}} id=text-9008c3506a class=cmp-text>

Clinical Trial

Offered by: 91大神 Children's Health, Jacksonville
Location: Jacksonville, Florida

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.听 There could be more visits if determined by your/your child鈥檚 doctor.听 Information about you, your child (detailed below) will be collected at these routine care visits. You/your child can stop your/your child鈥檚 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

<strong>Trial Name: </strong>Nonfusion Spinal Deformity Correction in Idiopathic Scoliosis</p>\r\n<p><strong>IRB#: </strong>1571772</p>\r\n"}} id=text-b333337038 class=cmp-text>

Trial Name: Nonfusion Spinal Deformity Correction in Idiopathic Scoliosis

IRB#: 1571772