Congenital Progressive ScoliosisNCT00689533
VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities
An observational study of Congenital Progressive Scoliosis and Infantile, run by Shriners Hospitals for Children at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 10 years
- Conditions the study is for
- Congenital Progressive Scoliosis, Infantile
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2008to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will be selected from participating children's hospitals, most likely during spine clinic.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
John M Flynn, MD
- Not yet recruiting
Shriners Hospital for Children
Philadelphia, Pennsylvania
Randal Betz, MD
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah
John Smith, MD
About this study
Official title: 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.
Read the 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
- Conditions
- Congenital Progressive Scoliosis, Infantile
- Keywords
- VEPTR, TIS, scoliosis, juvenile
- Medical subject headings
- Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's Cobb angle at the final surgery is less than or equal to the patient's pre-operative Cobb angle
Measured: 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
Measured: Anticipate 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2012 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Progressive ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- Chest Wall and Spine Deformity Research Foundation
- Investigators
- John M Flynn, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689533
- Sponsor's protocol ID
- CWSD0003
- Status last verified
- May 2008
- First submitted
- 29 May 2008
- Last updated
- 3 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEPTR Implantation to Treat Children With Early Onset Scoliosis Without Rib Abnormalities: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT00689533
- Acronym / sponsor ID
- CWSD0003
- Conditions
- Congenital Progressive Scoliosis, Infantile
- Keywords
- VEPTR, TIS, scoliosis, juvenile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- Chest Wall and Spine Deformity Research Foundation
- Study start
- Jan 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will be selected from participating children's hospitals, most likely during spine clinic.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2008.
Related trials for Congenital Progressive Scoliosis
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Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Flynn, MD principal investigator
Children's Hospital of Philadelphia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Progressive Scoliosis and Infantile, run by Shriners Hospitals for Children at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Mumford, MBA (801-662-5637, sarah.mumford@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2008.