Minimize Implants Maximize Outcomes (MIMO) Clinical Trial
Objectives Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial. Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety of low vs. high implant density instrumentation for spine deformity surgery in AIS patients with Lenke IA curve patterns. Interventions and Duration Intervention: low-implant density group or high-implant density group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174 subjects with 87 in each group.
• Patients aged ≥10 and ≤ 18 years
• Male or Female
• Diagnosis of idiopathic scoliosis for which surgery is recommended to prevent the curvature or to correct trunk disfigurement Lenke 1A curve pattern
• Curve cobb of 45° to 65°
• T5-T12 kyphosis measuring 0° to 40°
• Spina bifida Oculta is permitted
• Spondylolisthesis and Spondylolysis are permitted, as long as non- operative