JOT - 2026-09-01 - Journal Article; Randomized Controlled Trial; Multicenter Study; Comparative Study
Adverse Mental Health Outcomes After Modern External Ring Fixation Versus Internal Fixation for Severe Open Tibia Fractures: A Secondary Analysis of the FIXIT Study.
Simske NM, Solarczyk JK, Thompson AR, Reider L, O'Toole RV, Carroll EA, Karunakar MA, Obremskey W, Quinnan SM, Reid JS, Vallier HA, Morshed S, METRC
Topics
Key Takeaway
At 12 months after severe open tibial shaft fracture, 34% had moderate-to-severe depression, 45% met PTSD criteria, and 49% reported moderate-to-severe pain interference, with none of these outcomes differing by fixation modality (external ring vs. internal fixation).
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Summary
This secondary analysis of the FIXIT RCT examined mental health and pain outcomes at 1 year in 254 patients (ages 18–64) with Gustilo IIIA/IIIB tibial shaft fractures randomized to modern external ring fixation (n=121) or internal fixation (n=133). Depression (PHQ-9), PTSD (PCL-S), and pain (Brief Pain Inventory) rates were high across both groups, with no significant between-group differences (all P>0.37). Independent risk factors for depression included female sex (RR 1.70), ≤high school education (RR 1.93), and baseline mental health diagnosis (RR 1.91); higher self-efficacy at 6 weeks was protective against both depression and PTSD.
Key Limitation
The 16% female representation limits generalizability of sex-based risk factor findings, and loss to follow-up rates at 12 months are not reported, potentially introducing attrition bias toward healthier or better-functioning survivors.
Original Abstract
OBJECTIVES
To report the prevalence of adverse mental health outcomes 1 year after severe open tibial shaft fractures and their association with treatment and complication risk factors.
DESIGN
Randomized controlled trial.
SETTING
Multicenter.
PATIENT SELECTION CRITERIA
Eligible patients were 18-64 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 scores for depression symptoms, posttraumatic stress disorder (PTSD) Checklist for DSM-IV (PCL-S), and the Brief Pain Inventory. Primary comparisons assessed depression, PTSD, and pain between treatment groups (modern external ring fixation vs. internal fixation).
RESULTS
A total of 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 Patient Health Questionnaire-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 (eg, 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 postinjury (RR: 0.53 [0.38-0.74]), both P < 0.05. Fixation modality (external ring fixation vs. 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 sequelae and moderate to severe pain were common 1 year after sustaining a severe open tibial shaft fracture. Adverse mental health outcomes and pain were not influenced by fixation modality (external ring fixation vs. internal fixation).
LEVEL OF EVIDENCE
Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.