Early Onset ScoliosisNCT01672749
Evaluation of a Modern System to Allow for Growth in Children With Scoliosis Versus a Conventional Treatment
An observational study of Early Onset Scoliosis, run by AO Innovation Translation Center at 3 sites in 2 countries.
Trial summary
The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Early Onset Scoliosis
- What is being tested?
- Growth guiding construct using TROLLEY system and Spine based dual growing rod or rib based VEPTR
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2015to Feb 2025
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: One third of the patients will be recruited in designated investigation sites using the TROLLEY system. For each trolley patient one to two comparative matched pairs will be generated from mining the database of the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG).
Who may be able to join
- Age 5 - 10 years
- Diagnosis of Early Onset Scoliosis with any of the following etiologies:
- Idiopathic Congenital Neuromuscular Syndromic Mesenchymal
- Significant growth potential defined by any of the following: pre peek growth velocity bone age < 10; open triradiate cartilage
- An expected significant spinal deformity of more than 80 degrees at skeletal maturity
- Signed informed consent as legally required (patient, parents, etc.)
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- Willingness and ability of the patient to participate in the clinical investigation including imaging and FU procedures
- Willingness and ability of the parents to support the patient in his/her study participation
- Ability of the patient and parents to understand the content of the patient information / informed consent form and participate in the clinical investigation
- Signed informed consent by patient / parent(s)
Who cannot join
- Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees
- Prior spinal surgery
- Skeletal maturity
- Any not medically managed severe systemic disease
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Queen's Medical Centre
Nottingham
Sheffield Children's Hospital
Sheffield, S10 2TH
About this study
Official title: Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control
The foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws
Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group
Read the detailed description
The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.
- Conditions
- Early Onset Scoliosis
- Being tested
- Growth guiding construct using TROLLEY system, Spine based dual growing rod or rib based VEPTR
- Keywords
- Scoliosis [MESH], Pediatrics [MESH], Early onset, Growth guidance, Growing rod, Trolley, Dual growing rod technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth guiding construct using TROLLEY systemDevice
Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
Spine based dual growing rod or rib based VEPTRDevice
spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)
| Study group | Role | What they receive |
|---|---|---|
| Spine based dual growing rod or VEPTR | Patients treated with the TROLLEY system will be compared with patients from the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG) treated with a spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America). For each patient in the TROLLEY group a patient from each of the databases will be selected to be matched based on diagnosis, age, gender, and spine deformity classification. Receives: Device: Spine based dual growing rod or rib based VEPTR | |
| TROLLEY system | Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs). The TROLLEY system is CE marked at the time of the study conduct. Receives: Device: Growth guiding construct using TROLLEY system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-operations
Number of re-operations of the spine per patient in both groups after 3 years of FU
Measured: 3 years FU
Secondary outcomes (8)
Sitting height
Measured: 10 years
Standing height
Measured: 10 years
Radiographic measurements
- Spine length: upper T1 to lower L5 end plates
- Chest length: upper T1 to Lower T12
- Instrumented spine length
Measured: 10 years
Curve / deformity type characteristics
- Lenke classification
- New EOS classification
Measured: 10 years
Adverse Events related to the procedure and/or device under investigation
Measured: 10 years
Quality of life
- EOS Questionnaire (EOSQ 24)
- Pediatric version of EQ-5D (EQ-5D-Y)
Measured: 10 years
Pulmonary function:
- Forced vital capacity (FVC), actual [L] and predicted [%]
- Forced expiratory volume in 1 second (FEV1), actual [L] and predicted [%]
- Total lung capacity (TLC), actual [L] and predicted [%]
- Use and rate of assisted ventilation
- Residual volume (RV)
Measured: 10 years
Growth potential
- Chronological age
- Bone age (based on radiograph of the hand)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJun 2015
- Primary completionFeb 2023
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Onset 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Ouellet, MD, Principal investigator, McGill University Health Science Centre, Montreal, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672749
- Sponsor's protocol ID
- EOS TROLLEY
- Status last verified
- Mar 2024
- First submitted
- 22 Aug 2012
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dayer R, Grevitt M, Breakwell L, Yoon W, Chen M, Ratz T, Szocik T, Zhu YY; Pediatric Spine Study Group (PSSG); Ouellet J. Management of early-onset scoliosis: modern Luque trolley technique led to fewer reoperations within 3 years than other growth-friendly techniques, a prospective cohort study with matched historical controls. Spine Deform. 2025 Sep;13(5):1611-1624. doi: 10.1007/s43390-025-01102-2. Epub 2025 May 28.
PubMed 40437325
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Growth Guiding Construct vs. Standard Dual Growing Rods and VEPTR for the Treatment of Early Onset Scoliosis Patients: A Prospective Multi-center Cohort Study With a Matched Historical Control
- ClinicalTrials.gov ID
- NCT01672749
- Acronym / sponsor ID
- EOS TROLLEY
- Conditions
- Early Onset Scoliosis
- Keywords
- Scoliosis [MESH], Pediatrics [MESH], Early onset, Growth guidance, Growing rod, Trolley, Dual growing rod technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2023 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Aug 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 foremost challenge when managing early onset scoliosis (curve deformity before the age of 10) is to prevent curve progression while maintaining growth of the spine. Current treatment options require repetitive interventions as the spine and the child grow. This study will compare two techniques of growth modulation: Standard dual growing rods versus the new Luqué Trolley screws
Hypothesis: Patients treated with the DePuy Synthes TROLLEY system will undergo fewer re-operations after 3 years of follow-up (FU) than patients included in the comparison group
Detailed description
The purpose of this clinical study is to show that the growth guiding construct with DePuy Synthes TROLLEY Gliding Vehicles allows for less re-operations and for ongoing spinal growth across an instrumented immature spine while preventing curve progression in early onset scoliosis patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spine based dual growing rod or VEPTR | – | Device: Spine based dual growing rod or rib based VEPTRPatients treated with the TROLLEY system will be compared with patients from the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG) treated with a spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America). For each patient in the TROLLEY group a patient from each of the databases will be selected to be matched based on diagnosis, age, gender, and spine deformity classification. |
| TROLLEY system | – | Device: Growth guiding construct using TROLLEY systemGrowth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs). The TROLLEY system is CE marked at the time of the study conduct. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- One third of the patients will be recruited in designated investigation sites using the TROLLEY system. For each trolley patient one to two comparative matched pairs will be generated from mining the database of the Chest Wall and Spine Deformity Study Group (CWSDSG) and the Growing Spine Study Group (GSSG).
Key inclusion criteria (10 listed)
- Age 5 - 10 years
- Diagnosis of Early Onset Scoliosis with any of the following etiologies:
- Idiopathic Congenital Neuromuscular Syndromic Mesenchymal
- Significant growth potential defined by any of the following: pre peek growth velocity bone age < 10; open triradiate cartilage
- An expected significant spinal deformity of more than 80 degrees at skeletal maturity
Key exclusion criteria (5 listed)
- Curve magnitude and rigidity: Cobb greater than 100 degrees or bends less than 50 degrees
- Prior spinal surgery
- Skeletal maturity
- Any not medically managed severe systemic disease
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth guiding construct using TROLLEY systemGrowth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs) | Device | TROLLEY system |
| Spine based dual growing rod or rib based VEPTRspine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America) | Device | Spine based dual growing rod or VEPTR |
Primary outcome
Number of re-operations
Time frame: 3 years FU
Number of re-operations of the spine per patient in both groups after 3 years of FU
8 secondary outcomes
Sitting height
Time frame: 10 years
Standing height
Time frame: 10 years
Radiographic measurements
Time frame: 10 years
Curve / deformity type characteristics
Time frame: 10 years
Adverse Events related to the procedure and/or device under investigation
Time frame: 10 years
Quality of life
Time frame: 10 years
Pulmonary function:
Time frame: 10 years
Growth potential
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 40437325Dayer R, Grevitt M, Breakwell L, Yoon W, Chen M, Ratz T, Szocik T, Zhu YY; Pediatric Spine Study Group (PSSG); Ouellet J. Management of early-onset scoliosis: modern Luque trolley technique led to fewer reoperations within 3 years than other growth-friendly techniques, a prospective cohort study with matched historical controls. Spine Deform. 2025 Sep;13(5):1611-1624. doi: 10.1007/s43390-025-01102-2. Epub 2025 May 28.
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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.
Jean Ouellet, MD principal investigator
McGill University Health Science Centre, Montreal, Canada
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Scoliosis, run by AO Innovation Translation Center at 3 sites in 2 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 10 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 20 Mar 2024. 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 Kingdom, Switzerland. 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?
Number of re-operations (time frame: 3 years FU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672749, which also lists 1 linked publication.
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 20 Mar 2024.