Thoracic Insufficiency SyndromeNCT01716936
A Retrospective Review of Early Onset Spinal Deformity Patients Treated With the Ellipse MAGEC System
An observational study of Thoracic Insufficiency Syndrome, run by Ellipse Technologies, Inc. at 15 sites in 7 countries.
Trial summary
The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Thoracic Insufficiency Syndrome
- How many people
- 54 participants
- Where
- 15 sitesin 7 countries
- Study dates
- Jul 2012to Jan 2013
- 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 Up to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and Distraction System (Invitation to Volunteer Non-Probability Sample).
Who may be able to join
- Early onset spinal deformity with any etiology
- Cobb angle measurement of 30 degrees or greater at the time of primary surgery
- Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
- Age less than 11 years old at the time of MAGEC implant
- Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
- Patient has been implanted for a minimum of 6 months
- Patient signs informed consent for the use of their personal private data
Who cannot join
- Patient declines to sign informed consent for the use of their personal private data.
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
Turkey (Türkiye)5 sites
Ankara Gazi Universitesi Hastanesi
Ankara
Hacettepe University Hospital
Ankara
Florence Nightingale Hospital Ortopedi Bolumu
Istanbul, 34403
Marmara Üniversitesi Eğt.ve Arş.Hastanesi
Istanbul
Ege Sağlık Hastanesi
Izmir
United Kingdom3 sites
University Hospital of Wales
Cardiff, CF 14 4XW
The Harley Street Clinic
London
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, HA7 4LP
Finland2 sites
University of Helsinki
Helsinki, 00029
Turku University Hospital
Turku
About this study
Official title: A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System
The purpose of this study is to determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.
- Conditions
- Thoracic Insufficiency Syndrome
- Keywords
- Thoracic Insufficiency Syndrome, Early Onset Spinal Deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MAGEC Implant | All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cobb Angle
Measured in Degrees
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Thoracic Spine Height
Measured in millimeters (mm)
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Space Available for Lung
Measured as a percentage (%)
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Ocurrence of Procedure-Related Complications
Measured: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Adverse Events
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Secondary outcomes (4)
Change in Coronal Balance
Measured in millimeters (mm)
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Sagittal Balance
Measured in millimeters (mm)
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Subsequent surgical interventions following initial implantation
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Weight
Measured in kilograms (kg)
Measured: Baseline and 6, 12, 18 and 24 Months Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Insufficiency SyndromeStudies 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
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellipse Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Behrooz A Akbarnia, MD, Principal investigator, San Diego Center for Spinal Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716936
- Sponsor's protocol ID
- PR0056
- Status last verified
- Aug 2013
- First submitted
- 19 Sep 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicenter Review of Early Onset Spinal Deformity Patients That Underwent Either a Primary or Revision Spinal Bracing Procedure With the Ellipse Technologies MAGEC Spinal Bracing and Distraction System
- ClinicalTrials.gov ID
- NCT01716936
- Acronym / sponsor ID
- PR0056
- Conditions
- Thoracic Insufficiency Syndrome
- Keywords
- Thoracic Insufficiency Syndrome, Early Onset Spinal Deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ellipse Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Oct 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 determine the safety profile and probable benefit of the Ellipse Technologies Inc. MAGEC System in subjects with early onset spinal deformity associated with thoracic insufficiency syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAGEC Implant | – | –All patients implanted with the MAGEC System will be reviewed for inclusion into this retrospective study. |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients worldwide implanted with the Ellipse Technologies Spinal Bracing and Distraction System (Invitation to Volunteer Non-Probability Sample).
Key inclusion criteria (7 listed)
- Early onset spinal deformity with any etiology
- Cobb angle measurement of 30 degrees or greater at the time of primary surgery
- Thoracic spine height (T1 to T12) less than 22 cm at the time of primary surgery
- Age less than 11 years old at the time of MAGEC implant
- Implanted with the MAGEC system as either a primary or secondary revision spinal bracing procedure
Key exclusion criteria (1 listed)
- Patient declines to sign informed consent for the use of their personal private data.
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 Cobb Angle
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in Degrees
Change in Thoracic Spine Height
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured in millimeters (mm)
Change in Space Available for Lung
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Measured as a percentage (%)
Ocurrence of Procedure-Related Complications
Time frame: Baseline, Device Implant and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Adverse Events
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
4 secondary outcomes
Change in Coronal Balance
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Sagittal Balance
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Occurrence of Subsequent surgical interventions following initial implantation
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Change in Weight
Time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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 A Akbarnia, MD principal investigator
San Diego Center for Spinal Disorders
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Insufficiency Syndrome, run by Ellipse Technologies, Inc. at 15 sites in 7 countries.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Turkey (Türkiye), United Kingdom, Finland, Italy, Egypt and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Cobb Angle (time frame: Baseline and 6, 12, 18 and 24 Months Postoperatively). The study lists 5 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 15 Aug 2013.