VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities
1 other identifier
observational
250
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2008
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJune 3, 2008
May 1, 2008
4 years
May 29, 2008
May 29, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The patient's Cobb angle at the final surgery is less than or equal to the patient's pre-operative Cobb angle
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
Anticipate 6 years
Eligibility Criteria
The study population will be selected from participating children's hospitals, most likely during spine clinic.
You may qualify if:
- Progressive scoliosis: idiopathic, congenital, syndromic, neuromuscular
- Progressive scoliosis with a Cobb angle that has advanced beyond 45˚
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M Flynn, MD
Children's Hospital of Philadelphia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
January 1, 2008
Primary Completion
January 1, 2012
Study Completion
January 1, 2016
Last Updated
June 3, 2008
Record last verified: 2008-05