Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine|
- Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
- Patients will have continued spinal growth [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
1 Shilla Technique
The patients whose data is observed are those who have undergone the shilla surgical technique.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577226
|United States, Arkansas|
|Arkansas Childrens Hospital|
|Little Rock, Arkansas, United States, 72202|
|Principal Investigator:||Richard E. McCarthy, M.D.||University of Arkansas for Medical Sciences/Arkansas Childrens Hospital|