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TerminatedNCT00577226Updated May 5, 2016

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

An observational study in Scoliosis, sponsored by Arkansas Children's Hospital Research Institute. Terminated at 1 site in United States. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2016-05-05.

Sponsored by Arkansas Children's Hospital Research Institute · Observational

Why this study was terminated
IRB has requested additional information regarding IDE
Study type
Observational
Time perspective
Prospective
Enrollment
50
Ages
1 Year to 10 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Scoliosis

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Keywords

  • scoliosis, immature spine
03

In context

Scoliosis

593 studies on the registry are indexed under Scoliosis; 138 are open to participants now.

This study's enrollment of 50 is below the median of 87 across 232 observational studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Arkansas Children's Hospital Research Institute is the lead sponsor of 118 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The patients whose data is observed are those who have undergone the shilla surgical technique.

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

Exclusion Criteria:

  • none
05

Study design

Time perspective
Prospective
Enrollment
50 participants (actual)

Groups and cohorts

  • 1 Shilla Technique

    The patients whose data is observed are those who have undergone the shilla surgical technique.

06

What researchers measure

Primary outcomes

  1. Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.

    Time frame: 5 yrs

Secondary outcomes

  1. Patients will have continued spinal growth

    Time frame: 5 yrs

07

Study locations

1 site
  • Arkansas Childrens Hospital
    Little Rock, Arkansas 72202, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00577226
Lead sponsor
Arkansas Children's Hospital Research Institute
Responsible party
Sponsor
First posted
Dec 20, 2007
Start date
Apr 2005
Primary completion
Apr 2015
Completion
Apr 2015
Last update
May 5, 2016

Study contacts

Richard E. McCarthy, M.D.
principal investigator · University of Arkansas for Medical Sciences/Arkansas Childrens Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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