147. Prospective randomized controlled trial of implant density in AIS: results of the Minimize Implants Maximize Outcomes study
Abstract
BACKGROUND CONTEXT The role of implant density (anchors per level fused) has not been prospectively studied for a large cohort of AIS patients. In the Minimize Implants Maximize Outcomes (MIMO) Clinical Trial of equivalence, patients with Lenke 1A curve patterns were randomized to more versus fewer screws (high or low density) to determine if there was a difference in percent coronal Cobb angle correction within a 10% margin. PURPOSE This prospective randomized cotrolled trial was designed to determine if there was a difference in curve correction between high density and low density pedicle screw placement in single right thoracic Lenke 1A curves where maximal curve correction was the desired goal. STUDY DESIGN/SETTING Fourteen sites accrued patients in the MIMO Clinical Trial (NCT01792609). Patients with Lenke 1A curves between 45-65° were randomized to a high- (>1.8 screws per level fused, HD) vs low- ( PATIENT SAMPLE Power analysis showed that 174 patients were needed to detect a difference in % correction with a 10% margin at each time point. Follow-up was performed at 3 month (189 patients), 1 year (156 patients), and 2 years (124 patients). OUTCOME MEASURES Data was centrally collected and X-ray images measured by trained reviewers. Cobb angle was the primary outcome variable. METHODS RCT. Surgeons were given assignment to high or low density for each patient. Preop 3-month, 1-year and 2-year radiographs were obtained. Demographic and process measure data were also…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 189 participants or records.
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