Studies Open for Enrollment

Prospective Pediatric Scoliosis Study (PPSS)

• Purpose
• Who are eligible?
• Study Procedures/Recruitment
  • Preoperative Visit
  • 6 Weeks Postoperative Visit
  • 1 Year, 2 Years, 5 Years Postoperative Visit
• Enrolled Participants

Purpose

The primary objective of this study is to evaluate current surgical techniques used to correct idiopathic scoliosis in children and adolescents. We will study a group of patients (ages 8-18 years old) who require this surgery and follow them for a 5-year period to analyze their surgical outcomes. During this study period, patients and their parents will be asked to complete the Scoliosis Appearance Questionnaire (SAQ) and the Scoliosis Research Society Questionnaire (SRS-30) at several time points.

Who are Eligible?

Children and adolescents between the age of 8 and 18 years old at the time of initial radiographic diagnosis are eligible for the study. These patients must also be having surgery before the age of 21 years old and be treated with one of the specified surgical techniques.

Study Procedures/Recruitment

Eligible patients and their caregivers will be asked if they are willing to participate in this study. After obtaining informed consent, they will be enrolled into the study at the point of contact by the consulting pediatric orthopaedic surgeon and/or a study coordinator. This initial visit with the surgeon will only involve patient enrollment into the study. Once informed consent has been obtained at this visit, patients and their caregivers will be asked to come back for their study related visit.

Preoperative Visit

As part of standard care, surgical patients will be asked to come in for a preoperative visit. At this time the patients will have standard x-rays taken. Patients and their parents will also be asked to complete two questionnaires.

The Scoliosis Appearance Questionnaire (SAQ) will be completed by both the patient and their parent. This questionnaire is designed to evaluate various perceptions (patient, parent, physician) of the patient's clinical deformity.

For example:
Does your child want to have more even shoulders? (parent form)
And
Do you want to have more even hips? (patient form)

The Scoliosis Research Society Questionnaire (SRS-30) is to be completed be just the patient. This questionnaire is designed to evaluate the outcome of the patient's spine surgery.

For example:
Does your back limit your ability to do things around the house?

6 Weeks Postoperative Visit

As part of standard care, the patient will be asked to come back 6 weeks after the surgery. During this visit the physician will have a chance to assess the 6 weeks postoperative x-rays, as well as review the recovery of the patient. The patient will also be asked to complete the SRS-30 questionnaire again.

1 Year, 2 Years, 5 Years Postoperative Visit

As part of standard care, the patient will be asked to come back for 1 year, 2 year, and 5 year postoperative visits. This is essential in order to make sure the patient is healing correctly from the surgery. During this visit the patient will have x-rays taken and the doctor will evaluate the curve of the spine. Patients and their parents will also complete the SAQ questionnaires and the SRS-30 questionnaire.

Enrolled Participants