Status:
UNKNOWN
VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities
Lead Sponsor:
Shriners Hospitals for Children
Collaborating Sponsors:
Chest Wall and Spine Deformity Research Foundation
Conditions:
Congenital Progressive Scoliosis
Infantile
Eligibility:
All Genders
18-10 years
Brief Summary
Primary Objective: To evaluate the use of unilateral or bilateral VEPTR devices, with or without expansion thoracoplasty, for preventing further progression of the Cobb angle, allowing for spinal grow...
Detailed Description
Number of Patients Planned: A total of 250 patients requiring treatment with the VEPTR device and meeting the inclusion/exclusion criteria will be enrolled in the study. All patients enrolled in this ...
Eligibility Criteria
Inclusion
- Progressive scoliosis: idiopathic, congenital, syndromic, neuromuscular
- Progressive scoliosis with a Cobb angle that has advanced beyond 45˚
- 18 months to 10 years of age with open triradiate cartilages
Exclusion
- Presence of fused ribs
- Presence of multiple absent ribs
- Thoracic dysplasia such as Jeune's syndrome or equivalent condition
- Prior spinal fusion or spinal instrumentation
- Patient is participating in another clinical trial using investigational devices/drugs
- Patient is unable or unwilling to sign a consent form
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00689533
Start Date
January 1 2008
End Date
January 1 2016
Last Update
June 3 2008
Active Locations (3)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
2
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States
3
Primary Children's Hospital
Salt Lake City, Utah, United States