UnknownNot Applicable

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

United States250 participantsStarted 2008-01

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

Who can participate

Age range18 Months – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

The patient's Cobb angle at the final surgery is less than or equal to the patient's pre-operative Cobb angle

Timeframe: Anticipate 6 years

The patient's trunk height or spinal length at final surgery is greater than or equal to the patient's immediate post-operative trunk height or spinal length

Timeframe: Anticipate 6 years

Trial details

NCT IDNCT00689533

SponsorShriners Hospitals for Children

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-01

Contact for this trial

Sarah Mumford, MBA

801-662-5637 sarah.mumford@hsc.utah.edu

View on ClinicalTrials.gov More Congenital Progressive Scoliosis trials