JBJS - 2026-03-18 - Journal Article
Pain Outcomes Following Modern External Ring Fixation Compared with Internal Fixation for Severe Open Tibial Fractures: A Secondary Analysis of a Prospective Randomized Trial (FIXIT).
Shu HT, Hoveidaei AH, Reider LM, Vallier HA, Quinnan S, Gary JL, Carroll EA, Carlini AR, Higgins TF, Bosse MJ, Shafiq B, Tornetta P, O'Toole RV, Castillo RC, METRC (Major Extremity Trauma Research Consortium)
Topics
Key Takeaway
External ring fixation produced greater pain interference than internal fixation at 6 months (median 6.0 vs. 4.0, p=0.01), but no pain differences persisted at 12 months, with ~33% of all patients experiencing moderate-to-severe pain at both timepoints regardless of fixation type.
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Summary
This secondary analysis of the FIXIT RCT compared pain intensity and interference (Brief Pain Inventory) at 6 and 12 months in adults with severe open tibial fractures randomized to modern external ring fixation versus internal fixation. At 6 months, external fixation patients had significantly greater pain interference (median 6.0 vs. 4.0, p=0.01), with pin-site infections independently associated with greater pain intensity (p=0.01). By 12 months, all pain metrics were equivalent between groups, though patients who still had external fixation in situ had greater pain intensity (p=0.01) and interference (p<0.01) than those whose fixator had been removed.
Key Limitation
The 12-month subanalysis comparing patients with versus without retained external fixation is observational and confounded by indication—patients retaining fixators likely had more complex wounds, infections, or delayed union, making it impossible to attribute greater pain to fixator presence alone.
Original Abstract
BACKGROUND
It is unclear whether postoperative pain differs by treatment type for patients with severe open tibial fractures.
METHODS
We performed a secondary analysis of data from the FIXIT study. Adults with severe open tibial fractures were randomized to undergo definitive modern external ring fixation (n = 122) or internal fixation (n = 132). Primary outcomes were pain intensity and interference at 6 and 12 months, measured by the Brief Pain Inventory. Secondary outcomes were Numeric Pain Rating Scale (NPRS) scores and the incidence of moderate to severe pain. Post hoc subanalysis compared pain in patients with and without pin-site infections and with and without external fixation removal.
RESULTS
At 6 months, median pain intensity did not differ significantly between the external fixation group (4.1 [interquartile range (IQR), 2.2 to 5.5]) and the internal fixation group (3.0 [IQR, 1.8 to 5.8]) (p = 0.11); however, patients who underwent external fixation had greater median pain interference (6.0 [IQR, 3.3 to 8.0]) than patients who underwent internal fixation (4.0 [IQR, 1.9 to 7.4]) (p = 0.01). At 12 months, pain intensity, pain interference, and NPRS scores did not differ by treatment type. The overall incidence of moderate to severe pain was 33% at 6 months and 35% at 12 months. At 6 months, pin-site infections were associated with greater pain intensity (p = 0.01) but not greater interference (p = 0.10). At 12 months, the presence of external fixation was associated with greater pain intensity (p = 0.01) and interference (p < 0.01).
CONCLUSIONS
At 6 months after a severe open tibial fracture, patients treated with modern external ring fixation had greater pain interference than patients treated with internal fixation, partly because of pin-site infections. No differences in pain interference or intensity were seen at 12 months. At 12 months, patients with external fixation in place had greater pain intensity and interference than those whose external fixation had been removed, but this was not the case at 6 months. Approximately one-third of all patients had moderate to severe pain at both time points, highlighting that persistent pain is common, regardless of treatment type. These findings can guide surgeons in choosing ring external fixation or internal fixation for these fractures.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.