Ensayos clínicos

Inclusion Criteria:  (may be modified based on the approved device HDE indications)

• ≥ 8 years old on date of surgery.
• Male or female.
• Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent progression of the curvature or to correct trunk disfigurement and a non-fusion surgery is scheduled within 4 months.
• Thoracic or lumbar primary curves.
• Preop Cobb Angle ≥ 30° and ≤ 65°.
• Skeletally immature: Risser (< 5) and Sanders (< 8).
• Spina bifida Oculta is permitted.
• Spondylolisthesis and Spondylolysis are permitted, as long as non-operative.
• Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
• Failed or intolerant to bracing.
• No prior spine surgery.

Exclusion Criteria:

• Presence of any systemic infection, local infection, or skin compromise at the surgical site.
• Skeletally mature: > 7 Sanders.
• Prior spinal surgery.
• Documented poor bone quality, defined as a T-score -1.5 or less (If DEXA collected as routine care).
• Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient’s unwillingness or inability to cooperate with postoperative care instructions.
• 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.
• Unwillingness, inability, or living situation (e.g., custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent.
• Unwillingness to sign Informed Consent Form and participate in study procedure.
• Subjects who are pregnant at the time of enrollment.