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.
Study Type
OBSERVATIONAL
Enrollment
18
Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Queen's Medical Centre
Nottingham, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Number of re-operations
Number of re-operations of the spine per patient in both groups after 3 years of FU
Time frame: 3 years FU
Sitting height
Time frame: 10 years
Standing height
Time frame: 10 years
Radiographic measurements
* Spine length: upper T1 to lower L5 end plates * Chest length: upper T1 to Lower T12 * Instrumented spine length
Time frame: 10 years
Curve / deformity type characteristics
* Lenke classification * New EOS classification
Time frame: 10 years
Adverse Events related to the procedure and/or device under investigation
Time frame: 10 years
Quality of life
* EOS Questionnaire (EOSQ 24) * Pediatric version of EQ-5D (EQ-5D-Y)
Time frame: 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)
Time frame: 10 years
Growth potential
* Chronological age * Bone age (based on radiograph of the hand)
Time frame: 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.