Shilla Growth Permitting Spinal Instrumentation System for Treatment of Scoliosis in the Immature Spine
Status
Conditions
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
- none
Trial design
50 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal