3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals (NCT05631821) | Clinical Trial Compass
CompletedNot Applicable
3-D Correction of Adolescent Idiopathic Scoliosis (AIS) With Differential Metals
United States20 participantsStarted 2014-10
Plain-language summary
This study is designed to evaluate the coronal, sagittal, and axial correction of deformity secondary to adolescent idiopathic scoliosis utilizing a technique employing a posterior spinal fusion construct utilizing rods of different material rigidity and asymmetric bends determined using computer-based software to pre-operatively template a best-fit rod contour from pre-operative radiographs. To further evaluate the changes in contour of the rods from the pre-operative templates to the post-implantation radiographs.
Who can participate
Age range10 Years – 18 Years
SexALL
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Inclusion criteria
✓. Diagnosis of adolescent idiopathic scoliosis. Qualified patients will be confirmed for inclusion by patient history and radiographic studies
✓. Lenke Classification Curve type 1, 2, or 3.
✓. Willing and able to comply with the requirements of the protocol including follow-up requirements
✓. Willing and able to sign a study specific informed consent
✓. Skeletally mature (Risser grade III or higher, closed tri-radiate cartilage) between the ages of 10 and 18 years of age
Exclusion criteria
✕. Previous spine surgery
✕. Previous posterior spine surgery (e.g., posterior decompression) that destabilizes the lumbar spine
✕. Active systemic infection or infection at the operative site
✕. Co-morbid medical conditions of the spine or upper/lower extremities that may affect the lumbar spine neurological and/or pain assessment
✕. Metabolic bone disease such as osteoporosis and osteopenia that contraindicates spinal surgery
✕. History of an osteoporotic fracture
✕. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism