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

This study has been terminated.
(IRB has requested additional information regarding IDE)
Sponsor:
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00577226
First received: December 18, 2007
Last updated: July 21, 2010
Last verified: July 2010

December 18, 2007
July 21, 2010
April 2005
April 2015   (final data collection date for primary outcome measure)
Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs. [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577226 on ClinicalTrials.gov Archive Site
Patients will have continued spinal growth [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Scoliosis
Not Provided
1 Shilla Technique
The patients whose data is observed are those who have undergone the shilla surgical technique.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
1 Year to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577226
32975
No
Richard E. McCarthy, M.D., University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
Arkansas Children's Hospital Research Institute
Not Provided
Principal Investigator: Richard E. McCarthy, M.D. University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
Arkansas Children's Hospital Research Institute
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP