Functional Outcomes After Modern External Ring Fixation or Internal Fixation for Severe Open Tibial Shaft Fractures

This study compared the functional outcomes of patients with open tibial shaft fractures who were randomized to either modern external ring fixation (EF) or internal fixation (IF). We hypothesized that there would be differences in patient-reported function between the treatment groups. This preplanned analysis of secondary outcomes from the FIXIT study, a multicenter randomized clinical trial, included patients 18 to 64 years of age with a Gustilo-Anderson Type-IIIB or severe-Type IIIA diaphyseal or metaphyseal tibial fracture who were randomly assigned to either IF (n = 132) or EF (n = 122). Follow-up visits occurred at 6 weeks and 3, 6, and 12 months after randomization. Outcomes included Short Musculoskeletal Function Assessment (SMFA) scores, the Veterans RAND 12-Item Health Survey (VR-12) physical component score (PCS), use of ambulatory assistive devices, and ability to ambulate. The mean VR-12 PCS was slightly higher (better) for IF (24.8) than for EF (22.6) at 3 months (mean difference, 2.2 [95% confidence interval (CI): 0.2, 4.3]; p = 0.03) and trended higher for IF (27.0) compared with EF (25.3) at 6 months (mean difference, 1.8 [95% CI: -0.9, 4.4]; p = 0.19). However, there was no difference between the groups at 12 months. There were no clinically important or significant differences in SMFA Dysfunction and Bother scores between the treatment groups at any time point. EF was associated with a higher risk of using any ambulatory assistive device at 6 months (relative risk, 1.5 [95% CI: 1.21, 1.82]; p < 0.0001). The absolute percentage of patients using any ambulatory device was 37.6% for IF and 45.4% for EF at 1 year. There was no difference in ambulatory status between the treatment groups at any time point. We found no difference in physical function between patients with severe tibial fractures treated with IF versus EF. There was a high rate of impairment overall. Assistive devices for walking were more often utilized in the EF group at 6 months, and both treatment groups demonstrated similar overall impairment. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.