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

This study is currently recruiting participants.
Verified May 2008 by Shriners Hospitals for Children
Sponsor:
Collaborator:
Chest Wall and Spine Deformity Research Foundation
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00689533
First received: May 29, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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.


Condition
Congenital Progressive Scoliosis
Infantile

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities: a Prospective Multicenter Study

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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 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
  Eligibility

Ages Eligible for Study:   18 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will be selected from participating children's hospitals, most likely during spine clinic.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689533

Contacts
Contact: Sarah Mumford, MBA 801-662-5637 sarah.mumford@hsc.utah.edu
Contact: Tricia St. Hilaire, BS 215-430-4147 tst.hilaire@shrinenet.org

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States
Principal Investigator: John M Flynn, MD         
Shriners Hospital for Children Not yet recruiting
Philadelphia, Pennsylvania, United States
Principal Investigator: Randal Betz, MD         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States
Principal Investigator: John Smith, MD         
Sponsors and Collaborators
Shriners Hospitals for Children
Chest Wall and Spine Deformity Research Foundation
Investigators
Principal Investigator: John M Flynn, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Study Group Coordinator, Chest Wall and Spine Deformity Study Group
ClinicalTrials.gov Identifier: NCT00689533     History of Changes
Other Study ID Numbers: CWSD0003
Study First Received: May 29, 2008
Last Updated: May 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
VEPTR
TIS
scoliosis
juvenile

Additional relevant MeSH terms:
Congenital Abnormalities
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014