91´óÉñ

Clinical Trial

Offered by: 91´óÉñ Children's
Location: Delaware Valley

Trial Name

Prospective Study of Scoliosis in Children With Cerebral Palsy

What is the trial about?

The purpose of the study is to compare the outcomes of cerebral palsy patients with scoliosis who are treated with various surgical procedures with the outcomes of a group of cerebral palsy patients not treated surgically.

Who can participate?

• Patients age 8-21 years
• Diagnosis of cerebral palsy (standard definition of any brain injury before the age of 3 years) with total body involvement - any functional level
• Coronal curve >50 degrees on sitting film (as measured by 'greatest Cobb')
  OR
• Kyphotic curve >70 degrees on sitting film (as measured by T5-T12)
• A spinal fusion is being undertaken and the patient/family is proceeding with the spinal fusion (with any level of distal fusion)(operative patient); growing rod treatment will not be included
• A spinal fusion is not being undertaken (non-operative patient), for any of the following reasons:
  • Because the family has refused surgery
  • Because it is not recommended at this point
  • Surgery is recommended but is not being undertaken because patient will be on a waiting list for >18 months

What is involved?

The patient and/or parent will decide with the surgeon whether the child will have surgery or will not have surgery. Study visits include the preoperative visit, at time of surgery, first follow-up, and at 6 months, 1 year and at 2 years postoperative.
The following procedures will occur at visits:

• Clinical examination
• X-rays
• Questionnaires
• Blood work (surgery patients only)
• Spinal cord monitoring (surgery patients only)