We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Shriners Hospitals for Children.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689533
First Posted: June 3, 2008
Last Update Posted: June 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chest Wall and Spine Deformity Research Foundation
Information provided by:
Shriners Hospitals for Children
May 29, 2008
June 3, 2008
June 3, 2008
January 2008
January 2012   (Final data collection date for 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities
VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities: a Prospective Multicenter Study
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.

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 study will receive the VEPTR device.

Duration of Follow-up: Patients will be clinically followed post-surgery throughout the course of the patient's treatment. Follow-up appointments will be scheduled at 1, 6, and 12 months post-surgery and every year thereafter until 5 years after the index procedure, then every 2 years until the final planned procedure, or the completion or spinal growth (typically about 2 years after menarche in girls, or the equivalent in boys), whichever occurs first. Other patient visits may occur as deemed necessary.

General Design and Methodology: This is a prospective, multi-center, clinical study to evaluate the use of VEPTR devices for preventing further progression of the Cobb angle, a measure of the curvature of the spine, determined from measurements made on radiographs, allowing for spinal growth and improving pulmonary function in the treatment of children with progressive scoliosis without rib abnormalities. Unilateral vs. Bilateral, and use of an opening wedge thoracostomy, are at the discretion of the surgeon. The treatment would be used regardless of the study, therefore it is routine care. The primary study hypothesis is that, in regard to key clinical and radiographic outcomes, the success rate of the VEPTR device is at least 90%. A secondary study hypothesis is that in regards to key pulmonary outcomes (improvement in pulmonary function tests and increase in lung volume as measured by CT scans), the success rate of the VEPTR device is at least 90% (see Primary Study Endpoints below). Details of the patient outcomes and the study hypothesis are given below. With correction for 10% attrition, 250 patients split between the participating institutions will be enrolled.

Primary Study Endpoints: The primary endpoint will be based on the findings up to and including the last scheduled patient follow-up visit. An individual patient's treatment will be considered successful only if each of the following criteria are met:

  • The patient's Cobb angle at the final surgery is less than or equal to the patient's pre-operative Cobb angle and
  • 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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The study population will be selected from participating children's hospitals, most likely during spine clinic.
  • Congenital Progressive Scoliosis
  • Infantile
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
250
January 2016
January 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Months to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00689533
CWSD0003
No
Not Provided
Not Provided
Study Group Coordinator, Chest Wall and Spine Deformity Study Group
Shriners Hospitals for Children
Chest Wall and Spine Deformity Research Foundation
Principal Investigator: John M Flynn, MD Children's Hospital of Philadelphia
Shriners Hospitals for Children
May 2008