TROLLEY

• Research type

  Research Study

• Full 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.

• IRAS ID

  140565

• Contact name

  Michael Grevitt

• Contact email

  michael.grevitt@nuh.nhs.uk

• Sponsor organisation

  AO Documentation and Publishing Foundation

• Clinicaltrials.gov Identifier

  NCT01672749

• Duration of Study in the UK

  12 years, 1 months, 28 days

• Research summary

  The foremost challenge when managing early onset scoliosis (when a person's spine is curved from side to side) is to prevent curve progression while maintaining longitudinal growth of the spine. Current treatment options (Risser casting; growing rods; VEPTR) require repetitive interventions as the spine and the child grow. The TROLLEY device will help the spine to grow straight. It also allow the rods to "grow" at the same time as the child grows. The surgeon will put screws in the bones of the child's spine. Metal rods are attached to the screws. The rod will be attached to the screw with something that looks like a cable tie.This allows the rods to slide past each other while the child grows. This new operation may reduce the number of future operations because the screw and rods "grow" with the spine.

  Aim of this study
  compare two techniques of growth modulation: Standard dual growing rods and VEPTR (historical comparison group )versus the TROLLEY growth guiding construction with regards to:
  • Growth
  • Curve / deformity type characteristics
  • Pulmonary function
  • Predicted thoracic dimension
  • Complication rates
  • Quality of life

  Patient will be followed-up: postoperativly, 6 weeks, 6 months, 1 year, 1.5 years, 2 years, 2.5 years and 3 years after surgery
  Thereafter, the patients will be followed-up yearly up to and including 10 years or until the patient is skeletally mature (whichever occurs first).

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  15/EM/0419

• Date of REC Opinion

  18 Jan 2016

• REC opinion

  Further Information Favourable Opinion