Early Onset Scoliosis
Conditions
Keywords
Scoliosis [MESH], Pediatrics [MESH], Early onset, Growth guidance, Growing rod, Trolley, Dual growing rod technique
Brief 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. 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.
Interventions
DEVICEGrowth guiding construct using TROLLEY system
Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
DEVICESpine based dual growing rod or rib based VEPTR
spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)
Sponsors
AO Innovation Translation Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* 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.) * 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of re-operations | 3 years FU | Number of re-operations of the spine per patient in both groups after 3 years of FU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sitting height | 10 years | — |
| Radiographic measurements | 10 years | * Spine length: upper T1 to lower L5 end plates * Chest length: upper T1 to Lower T12 * Instrumented spine length |
| Curve / deformity type characteristics | 10 years | * Lenke classification * New EOS classification |
| Standing height | 10 years | — |
| Quality of life | 10 years | * EOS Questionnaire (EOSQ 24) * Pediatric version of EQ-5D (EQ-5D-Y) |
| Pulmonary function: | 10 years | * 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) |
| Growth potential | 10 years | * Chronological age * Bone age (based on radiograph of the hand) |
| Adverse Events related to the procedure and/or device under investigation | 10 years | — |
Countries
Switzerland, United Kingdom
Outcome results
None listed