Clinical Trial: Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine

Brief Summary:

The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth.

The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.

Detailed Summary: Traditional "growing rod" constructs of spinal instrumentation to treat severe scoliosis in young children require a return to the operating room every six to nine months until skeletal maturity. The Shilla system allows for more spinal growth with fewer surgical procedures necessary for lengthenings. This is a major advantage over existing growth permitting systems and allows surgery to be performed at younger ages with better deformity correction without concerns of repeated surgeries.
Sponsor: Arkansas Children's Hospital Research Institute

Current Primary Outcome: Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. [ Time Frame: 5 yrs ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Patients will have continued spinal growth [ Time Frame: 5 yrs ]

Original Secondary Outcome: Same as current

Information By: Arkansas Children's Hospital Research Institute

Dates:
Date Received: December 18, 2007
Date Started: April 2005
Date Completion:
Last Updated: May 4, 2016
Last Verified: May 2016