Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion.

Abstract

Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves. 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. 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. 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 (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial. 159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll. Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial. II.