The purpose of this study is to assess the affects of rod diameter and rod stiffness on radiologic outcomes of posterior correction of adolescent idiopathic scoliosis (AIS). To date, there is limited literature regarding rod diameter and rod stiffness. The few published studies focus on anterior instrumentation and posterior instrumentation solely in animal and synthetic models. Without empirical data, use of rods of one diameter over another is determined by ease of use and surgeon perspective on rod efficacy. This prospective randomized control study examines radiologic outcomes of children 10-17 years and 11 months old diagnosed with AIS who present at the Division of Pediatric Orthopaedics at the Morgan Stanley Children's Hospital of New York- Presbyterian and who will undergo corrective surgery utilizing posterior instrumentation.
Who are Eligible?
Children ages 8 to 17 years and 10 months at the time of initial radiographic diagnosis, with a curvature <70¡, and a weight between 40-70 Kg (88.18-154.32lbs). They will have a diagnosis of AIS as established by clinical and radiographic evaluation, and will undergo corrective spinal surgery utilizing posterior instrumentation with rod implantation, before the age of 21.
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.
Purpose