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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00577226
Enrollment
50
Registered
2007-12-20
Start date
2005-04-30
Completion date
2015-04-30
Last updated
2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

scoliosis, 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 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.

Interventions

None listed

Sponsors

Arkansas Children's Hospital Research Institute
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.5 yrs

Secondary

MeasureTime frame
Patients will have continued spinal growth5 yrs

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026