Scoliosis Clinical Trial
Official title:
Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the 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.
Status | Terminated |
Enrollment | 50 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 10 Years |
Eligibility |
Inclusion Criteria: - between the ages of 1 yr and 10 yrs - have severe, progressive scoliosis unresponsive to bracing - have severe, progressive scoliosis who cannot tolerate bracing Exclusion Criteria: |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Childrens Hospital | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. | 5 yrs | No | |
Secondary | Patients will have continued spinal growth | 5 yrs | No |
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