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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577226
• Other study ID #: 32975
• Status: Terminated
• Phase: N/A
• First received: December 18, 2007
• Last updated: May 4, 2016
• Start date: April 2005
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
United States	Arkansas Childrens Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

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