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
  Purpose

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.


Condition
Scoliosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Use of the Shilla Growth Permitting Spinal Instrumentation System/Technique for the Treatment of Scoliosis in the Immature Spine

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Patients will have continued spinal growth [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2005
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 Shilla Technique
The patients whose data is observed are those who have undergone the shilla surgical technique.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577226

Locations
United States, Arkansas
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Richard E. McCarthy, M.D. University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
  More Information

No publications provided

Responsible Party: Richard E. McCarthy, M.D., University of Arkansas for Medical Sciences/Arkansas Childrens Hospital
ClinicalTrials.gov Identifier: NCT00577226     History of Changes
Other Study ID Numbers: 32975
Study First Received: December 18, 2007
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
scoliosis, immature spine

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014