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Clinical Trial

Offered by: ÀÖ²¥´«Ã½ Children's
Location: Delaware Valley

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Scoliosis Outcomes Database Registry

What is the trial about?

The purpose of this study is to develop a Database Registry containing standardized information from a large prospective, multi-center series of patients who undergo surgical correction for idiopathic scoliosis, as well as a group of patients who have not undergone surgical correction.

Who can participate?

• Patients aged >10 years and <21 years
• Male or female
• Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct deformityÌýÌýÌýÌýÌý
• A child can participate in this Database Registry whether or not he or she has had surgery

What is involved?

All study related evaluations will be performed during routine care visits with your doctor. Study-related evaluations will require an additional 20-30 minutes to complete during routine care visits. Patients are expected to come back for follow-up visits with their surgeon at approximately one month after surgery, six months, one year, two years and five years. These are the normal clinical visits for this condition.

The researchers will be collecting the following information about your surgery:

• Information from surgical, anesthesia, and neuromonitoring reports
• Complications
• Hospital course
• Overall spine curvature correction seen from X-rays
• A tracing of the shape of the rods will be taken on a piece of paper in the operating room before the rods are implanted

The information from the routine tests listed below will be used for the study. The trunk flexibility evaluation and the Body Image Disturbance Questionnaire-Scoliosis version (BIDQ-S) are study-related and are not a part of the patient's routine care. The following procedures are routine during the visit with the physician:

Pre-Op Visit:

• Trunk flexibility evaluation
• X-rays
• Scoliosis Research Society (SRS) outcomes questionnaire
• Scoliometer measurement
• Clinical photos
• BIDQ-S
• Menarche status/date of onset of menses

First Erect Visit: (first clinic visit after spine surgery):

• Scoliometer measurement

6-Month Post-Op Visit:

• X-rays
• SRS outcomes questionnaire
• Scoliometer measurement
• BIDQ-S
• Menarche status/date of onset of menses

1-Year Post-Op Visit:

• Trunk flexibility evaluation
• X-rays
• SRS outcomes questionnaire
• Scoliometer measurement
• Clinical photos
• BIDQ-S
• Menarche status/date of onset of menses

2-Year Post-Op Visit:

• Trunk flexibility evaluation
• X-rays
• SRS outcomes questionnaire
• Scoliometer measurement
• Clinical photos
• BIDQ-S
• Menarche status/date of onset of menses

5-, 10-, 15-, 20-, and 25-Year Post-Op Visit:

• Trunk flexibility evaluation
• Pulmonary function test for 5-year visit only
• X-rays
• SRS outcomes questionnaire
• Scoliometer measurement
• Clinical photos
• BIDQ-S
• Menarche status/date of onset of menses

Nonoperative patients require only radiographic data, SRS outcomes questionnaire and BIDQ-S questionnaire.

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