Ensayos clínicos

Inclusion Criteria: 

• Diagnosis of progressive idiopathic scoliosis.
• Preoperative major Cobb angle 30°-65°.
• Preoperative flexibility to ≤ 30° on side bending radiograph (left or right).
• Skeletally immature at the time of surgery with Risser sign < 5 or Sanders score < 8.
• Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
• Failed or intolerant to bracing.
• Signed informed consent and/or assent forms specific to this study.

Exclusion Criteria:

• Prior spinal surgery at the level(s) to be treated.
• Documented poor bone quality, defined as a T-score of -1.5 or less.
• Presence of any systemic infection, local infection, or skin compromise at the surgical site P.
• Any 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 post-operative care instructions.
• 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.
• Active participation in a drug or device study that is more than minimal risk such that participation would confound the measurements of the present study.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/11/23. Questions regarding updates should be directed to the study team contact.