VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities

Status unconfirmed

Conditions studied: Congenital Progressive Scoliosis, Infantile

In brief

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 growth and improving pulmonary function in the treatment of children with progressive scoliosis without rib abnormalities.

Key facts

Study ID

NCT00689533

Run by

Shriners Hospitals for Children

People needed

250

Starts

2008-01-01

Expected to finish

2016-01-01

Last updated by the study team

2008-06-03

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
• Shriners Hospital for Children — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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