Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant densit
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CASE SERIES
Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion A. Noelle Larson1 · Lorena V. Floccari1 · Sumeet Garg2 · Mark A. Erickson2 · Paul D. Sponseller3 · Juan P. Brito4,5 · Carl‑Eric Aubin6 · David W. Polly Jr.7 · Minimize Implants Maximize Outcomes Study Group7 Received: 9 March 2020 / Accepted: 16 May 2020 © Scoliosis Research Society 2020
Abstract Study design Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves. Objective We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Summary of background data Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial. Methods This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (
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