Adverse Mental Health Outcomes after Modern External Ring Fixation Versus Internal Fixation for Severe Open Tibia Fractures: A Secondary Analysis of the FIXIT Study

OBJECTIVES: To report the prevalence of adverse mental health outcomes one year after severe open tibial shaft fractures and their association with treatment and complication risk factors. METHODS: Design: Randomized controlled trial. SETTING: Multicenter. PATIENT SELECTION CRITERIA: Eligible patients were 18 to 64 years of age with severe open tibial shaft fractures (AO/OTA 41-43) treated with modern external ring fixation or internal fixation. All Gustilo-Anderson type IIIB fractures were included and some type IIIA meeting specific severity criteria. OUTCOME MEASURES AND COMPARISONS: Outcome measures included Patient Health Questionnaire (PHQ) scores for depression symptoms, posttraumatic stress disorder (PTSD) Checklist for DSM-IV (PCL-S) and the Brief Pain Inventory (BPI). Primary comparisons assessed depression, PTSD and pain between treatment groups (modern external ring fixation versus internal fixation). RESULTS: 254 patients were treated with external ring fixation (n=121) or internal fixation (n=133). The mean age was 39 years (SD=13) and 16% were female. At 12-months after injury, 34% of patients had PHQ-9 scores consistent with moderate to severe depression. Risk factors for depression were female sex (RR: 1.70 [1.01, 2.86]), high school educational attainment or less (RR: 1.93 [1.27, 3.04]), and any baseline mental health condition (RR: 1.91 [1.22, 2.99]), all p<0.05. At 12-months, 45% of patients met criteria for PTSD. Any baseline mental health condition was a risk factor for developing PTSD (RR: 2.07 [1.50, 2.88]), p<0.001. Protective factors against the development of depression and PTSD included higher self-efficacy at 6 weeks after injury and any major limb complication (e.g. infection) within 12-months, both p<0.01. Moderate to severe daily pain interference was reported by 49% of participants at 12 months and was associated with high school level education attainment or less (RR: 1.41 [1.03, 1.94]) and was mitigated by self-efficacy at 6-weeks post injury (RR: 0.53 [0.38, 0.74]), both p<0.05. Fixation modality (external ring fixation versus internal fixation) was not associated with depression (RR: 0.82 [0.83, 1.27], p=0.37), PTSD (RR: 1.06 [0.77, 1.48], p=0.71), pain intensity (RR: 0.98 [0.63, 1.51], p=0.92) or pain interference (0.96 [0.70, 1.33], p=0.83). CONCLUSIONS: Mental health sequalae and moderate to severe pain were common one year after sustaining a severe open tibial shaft fracture. Adverse mental health outcomes and pain were not influenced by fixation modality (external ring fixation versus internal fixation). LEVEL OF EVIDENCE: Therapeutic Level 1.