Fig. 1.

This CONSORT diagram demonstrates patient screening and enrollment, treatment cohort, and patients included in the final analysis. ^aSeveral patients had more than one reason for exclusion from the study. ^bPatients followed prospectively for the purposes of the cohort study were not included as part of the randomization module. Their treatment was left up to the discretion of the treating surgeon. ^cFollowing exclusion of 127 patients, those enrolled in the study consisted of 267 total patients with 240 from the RCT group and 27 from the cohort group ^dThis was an as-treated analysis of those patients completing 1-year follow-up in-person or by telephone. Follow-up was not different between RCT and cohort patients. All patients were part of a pooled analysis for the purposes of this study; OTA = Orthopaedic Trauma Association; TBI = traumatic brain injury; RCT = randomized controlled trials.