Recruiting

VEPTR Implantation

Sponsor:

Shriners Hospitals for Children

Code:

NCT00689533

Conditions

Congenital Progressive Scoliosis

Infantile

Eligibility Criteria

Sex: All

Age: 1 - 10

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Congenital Progressive Scoliosis

Infantile

Study ID

NCT00689533

Start date

Jan, 2008

Status verified date

May, 2008

Completion date

Jan, 2016

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 10

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • The patient's Cobb angle at the final surgery is less than or equal to the patient's pre-operative Cobb angle [ Time Frame: 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 [ Time Frame: Anticipate 6 years ]

Central Contacts and Locations

Central contacts

Sarah Mumford, MBA

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

Tricia St. Hilaire, BS

215-430-4147tst.hilaire@shrinenet.org

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States

Principal Investigator:

John M Flynn, MD

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States

Principal Investigator:

John Smith, MD

More Information

Sponsor

Shriners Hospitals for Children

Last update posted

Jun 3, 2008

Last verified

May, 2008

Keywords

  • VEPTR
  • TIS
  • scoliosis
  • juvenile

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shriners Hospitals for Children on 2008-06-03.