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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth guiding construct using TROLLEY system | Device | Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of re-operations | Number of re-operations of the spine per patient in both groups after 3 years of FU | 3 years FU |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting height | 10 years | |
| Standing height | 10 years | |
| Radiographic measurements |
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Inclusion Criteria:
Idiopathic Congenital Neuromuscular Syndromic Mesenchymal
- Significant growth potential defined by any of the following: pre peek growth velocity bone age < 10; open triradiate cartilage
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Jean Ouellet, MD | McGill University Health Science Centre, Montreal, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Genève | Geneva | Switzerland | ||||
| Queen's Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40437325 | Derived | 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. |
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| Spine based dual growing rod or rib based VEPTR | Device | spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America) |
|
| 10 years |
| Curve / deformity type characteristics |
| 10 years |
| Adverse Events related to the procedure and/or device under investigation | 10 years |
| Quality of life |
| 10 years |
| Pulmonary function: |
| 10 years |
| Growth potential |
| 10 years |
| Nottingham |
| United Kingdom |
| Sheffield Children's Hospital | Sheffield | S10 2TH | United Kingdom |