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

Terminated

• Conditions: Scoliosis

• Registration Number: NCT00577226
• Lead Sponsor: Arkansas Children's Hospital Research Institute

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.	5 yrs

Secondary Outcome Measures

Name	Time	Method
Patients will have continued spinal growth	5 yrs

Trial Locations

Locations (1)

Arkansas Childrens Hospital; 🇺🇸 Little Rock, Arkansas, United States