Adolescent Idiopathic ScoliosisNCT01633931
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
An observational study of Adolescent Idiopathic Scoliosis, run by Ellipse Technologies, Inc. at 1 site in Hong Kong.
Trial summary
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2012to Oct 2018
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients diagnosed with Adolescent Idiopathic Diagnosis
Who may be able to join
- Diagnosis of Adolescent Idiopathic Scoliosis
- Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
- Skeletally immature (Risser Sign 0, 1, 2, or 3)
- In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
- Age between 10 and 15
- Primary Cobb angle greater than 25 degrees but not yet requiring spine fusion
Show all 9Show fewer
- Candidate for surgical implantation of spinal instrumentation
- Patient resides locally with respect to the Investigator's clinic and is willing and able to comply with the requirements of the protocol
- Must sign informed consent to permit the use of personal health data
Who cannot join
- Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
- Patients who require an MRI following implantation
- Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- History of previous surgical treatment for AIS
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.
- Conditions
- Adolescent Idiopathic Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in major scoliotic curve magnitude
Measured in degrees
Measured: Change from baseline to 36 months postoperative
Number and Types of Adverse Events
Measured: Operative through 36 months postoperative
Secondary outcomes (6)
Radiographic evaluation coronal balance compared to baseline
Measured: Change from baseline to 36 months postoperative
Radiographic evaluation sagittal balance compared to baseline
Measured: Change from baseline to 36 months postoperative
Percent of patients indicated for surgical spine fusion
Measured: Change from baseline to 36 months postoperative
Quality of life assessment via SRS-30 questionnaire
Measured: Change from baseline to 36 months postoperative
Comparison of Rib Hump prominence
Measured: Change from baseline to 36 months postoperative
Expected vs. Actual Device Lengthening
Measured: All postoperative visits where lengthening is conducted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellipse Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Behrooz Akbarnia, MD, Principal investigator, San Diego Center for Spinal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633931
- Sponsor's protocol ID
- PR0038
- Status last verified
- Jan 2018
- First submitted
- 2 Jul 2012
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
- ClinicalTrials.gov ID
- NCT01633931
- Acronym / sponsor ID
- PR0038
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ellipse Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2018 (estimated)
- First posted
- 6 Jul 2012 (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.
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients diagnosed with Adolescent Idiopathic Diagnosis
Key inclusion criteria (9 listed)
- Diagnosis of Adolescent Idiopathic Scoliosis
- Failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing
- Skeletally immature (Risser Sign 0, 1, 2, or 3)
- In girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months
- Age between 10 and 15
Key exclusion criteria (5 listed)
- Patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant
- Patients who require an MRI following implantation
- Skeletally mature (Risser Sign 4 or 5; or fused tri-radiate cartilage)
- Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
- History of previous surgical treatment for AIS
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
Change in major scoliotic curve magnitude
Time frame: Change from baseline to 36 months postoperative
Measured in degrees
Number and Types of Adverse Events
Time frame: Operative through 36 months postoperative
6 secondary outcomes
Radiographic evaluation coronal balance compared to baseline
Time frame: Change from baseline to 36 months postoperative
Radiographic evaluation sagittal balance compared to baseline
Time frame: Change from baseline to 36 months postoperative
Percent of patients indicated for surgical spine fusion
Time frame: Change from baseline to 36 months postoperative
Quality of life assessment via SRS-30 questionnaire
Time frame: Change from baseline to 36 months postoperative
Comparison of Rib Hump prominence
Time frame: Change from baseline to 36 months postoperative
Expected vs. Actual Device Lengthening
Time frame: All postoperative visits where lengthening is conducted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
Behrooz Akbarnia, MD principal investigator
San Diego Center for Spinal Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis, run by Ellipse Technologies, Inc. at 1 site in Hong Kong.
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 9 inclusion and 5 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in major scoliotic curve magnitude (time frame: Change from baseline to 36 months postoperative). 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 1 Feb 2018.