Ensayos clínicos

Inclusion Criteria - Database Registry: 

• Patients aged  ≤ 26 years who present with a curve large enough that a definitive fusion for idiopathic scoliosis would be considered an option.
• Male or female.
• Diagnosis of idiopathic scoliosis for which definitive fusion surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement.
• Curve cobb of any magnitude – operative range.
• Spina bifida Oculta is permitted.
• Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
• Non-operative idiopathic scoliosis patients:
  • Aged  ≤ 26 years, male or female, curve cobb of ≥40º, whom elected not to proceed with surgery; or
  • Aged  ≤ 26 years, male or female, Curve cobb ≥ 30º and approaching skeletally mature (defined as Age:  girls > 14 yrs; Boys > 16 yrs and Risser of ≥ 4 or sanders ≥7).

Execlusion Criteria - Database Registry:

• Prior spinal surgery.
• MRI abnormalities (including > 4mm of Syrinx and/or Chiari malformation).
• Neuromuscular or other serious co-morbidities.
• Thoracogenic or cardiogenic scoliosis.
• Associated syndrome or developmental delay.
• Unable or unwilling to firmly commit to returning for required follow-up visits.