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Clinical Trial

Offered by: ¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾Ã¾«Æ· Children's
Location: Delaware Valley

Trial Name

Prospective Multicenter Evaluation of a New Predictive Model for the Progression of AIS

What is the trial about?

The purpose of this study is to find out more about how well our three dimensional X-ray model can predict if a spine curve will progress. We need to look at more three dimensional X-rays to understand which curve will progress faster.

Who can participate?

Patients diagnosed with Adolescent Idiopathic Scoliosis (AIS) who are at least 10 years old at the time of recruitment, with mild to moderate curves and who are skeletally immature.

What is involved?

Patients who consent to be in the study will have the same clinical procedure as those who did not. For patients who want to be in the study at first initial visit the researchers will collect: demographic data, past medical history, gender, body mass index (based on height and weight), family history sexual maturity (start of menses for girls), initial spine X-rays, Scoliosis Research Society Questionnaire, and rib prominence. Scoliometer measurements are the only research-specific procedure at the initial visit. All the rest of the data collected (including X-rays) are part of the normal clinical visit whether or not your child has decided to participate in this research study. After the initial visit, at each follow up visit (usually every six months) the following will be collected: body mass index, menarche status, skeletal maturity based on X-rays, Scoliosis Research Society Questionnaire, rib prominence, spine X-rays.

If your child has been prescribed a back brace, we will install a small sensor in the brace to track how long the brace is worn. At each follow-up visit the researchers will remove the sensor from the brace, read the data and reinstall the sensor. The only research specific procedures at follow-up visits are the scoliometer measurement of rib prominence and reading the data from the brace sensor. Your child will remain in the study until he or she is skeletally mature or the curve increases to the point that your child needs surgery. Skeletal maturity means that your child has completely stopped growing in height.

There will be no spine X-rays taken solely for research. The only spine X-rays that your child will have will be for clinical purposes to monitor his or her scoliosis.