Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine
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|ClinicalTrials.gov Identifier: NCT00577226|
Recruitment Status : Terminated (IRB has requested additional information regarding IDE)
First Posted : December 20, 2007
Last Update Posted : May 5, 2016
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
1 Shilla Technique
The patients whose data is observed are those who have undergone the shilla surgical technique.
- Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. [ Time Frame: 5 yrs ]
- Patients will have continued spinal growth [ Time Frame: 5 yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|