Table 1.

Study Inclusion and Exclusion Criteria.

Inclusion criteria

Signed informed consent Age 18 to 80 years old, inclusive Diagnosis of adult spinal deformity (ASD) with an apex of the major deformity in the cervicothoracic or thoracolumbar region (apex between C7 and L2, inclusive) with any of the following deformity characteristics: Primary scoliosis, kyphosis or kyphoscoliosis with a major Cobb angle ≥80° in the coronal or sagittal plane Congenital spinal deformity undergoing corrective spinal osteotomy Revision spinal deformity undergoing corrective spinal osteotomy Any patient undergoing a 3-column spinal osteotomy (ie, pedicle subtraction osteotomy, vertebral column resection) from C7 to L5, inclusive Any patient with preoperative myelopathy due to their spinal deformity Any patient with ossification of the ligamentum flavum or posterior longitudinal ligament and a deformity that needs concomitant reconstruction along with decompression of the spinal cord

Exclusion criteria

Unlikely to comply with follow-up Recent history ≤3 months of substance dependency or psychosocial disturbance Presence of active malignancy Has active, overt bacterial infection, systemic or local Recent (≤3 months) history of significant spinal trauma/injury/fracture/malignancy in the spinal region Patients with complete, long-term paraplegia Pregnant or nursing women; women unable to agree not to become pregnant for a period of 6 months after surgery Prisoners Institutionalized individuals