Geriatric femoral intertrochanteric fractures (ITF) carry high morbidity and mortality despite early surgery, largely because of frailty and the physiologic stress of fracture and operative treatment. Prior work suggested perioperative low-dose glucocorticoids might improve short-term outcomes. This randomized, placebo-controlled clinical trial addressed whether a single preoperative low-dose dexamethasone dose improves 1-year survival after internal fixation in older patients with ITF.
This was a single-center, single-blinded, randomized, placebo-controlled trial conducted at Guangzhou First People's Hospital. Between June 2020 and October 2022, 160 participants meeting inclusion criteria for geriatric ITF and planned internal fixation were enrolled and randomized. Randomization allocated 80 participants to the dexamethasone arm and 80 to the placebo arm. All participants completed follow-up to one year as reported in the source.
The active treatment was a single preoperative intravenous injection of dexamethasone 10 mg (2 mL) administered 30 minutes before surgery. The placebo arm received 2 mL of normal saline administered in the same preoperative timeframe. The study was single-blinded; the abstract does not detail which parties (patients, clinicians, outcome assessors) were blinded beyond that designation.
The prespecified primary outcome was 1-year mortality after surgery. Secondary outcomes included adverse events during hospitalization and functional measures among survivors: Barthel activity of daily living (BADL) score and Parker-Palmer score (PPS) measured at 30 days, 90 days, 180 days, and 1 year postoperatively.
Statistical methods reported in the abstract included Student's t-test or Mann–Whitney U test for continuous variables, chi-squared test for categorical variables, and the Log-rank test for survival differences. Hazard ratios (HR) with 95% confidence intervals (CI) were calculated for the primary survival comparison.
All 160 participants completed the one-year follow-up. A total of 41 participants died within one year after surgery: 15 deaths (18.8%) occurred in the dexamethasone group and 26 deaths (32.5%) in the placebo group. The trial reported a hazard ratio of 0.51 (95% CI 0.27–0.96) favoring the dexamethasone group, with a Log-rank P value = 0.04, indicating a statistically significant reduction in 1-year mortality with the single preoperative dose of dexamethasone.
The abstract reports no statistically significant differences between groups for in-hospital infection events or hyperglycemia (P > 0.05). Functional outcomes (BADL and PPS) among survivors were numerically higher in the dexamethasone group at each measured time point (30, 90, 180 days and 1 year), but these differences did not reach statistical significance (P > 0.05) according to the abstract.
In-hospital safety monitoring specifically assessed infection events and hyperglycemia. The source reports no significant increase in risk for these events in the dexamethasone group compared with placebo (P > 0.05). The abstract does not provide detailed counts, timing, management, or other adverse event categories beyond those named.
The published article includes a study flowchart (Figure 1) documenting enrollment and follow-up, and a Kaplan–Meier survival comparison (Figure 2) showing the divergence in survival between the dexamethasone and placebo groups. The survival figure corresponds to the reported mortality counts and the hazard ratio described above.
In this single-center randomized trial of older patients with femoral ITF treated with internal fixation, a single preoperative low-dose IV dexamethasone (10 mg) administered 30 minutes before surgery was associated with a significant reduction in 1-year mortality (HR 0.51, 95% CI 0.27–0.96; P = 0.04). There were no significant differences in in-hospital infection or hyperglycemia reported, and functional scores among survivors trended higher with dexamethasone but without statistical significance.
These results suggest a potential mortality benefit from a single low-dose preoperative corticosteroid in this population and support further investigation into mechanisms, reproducibility across centers, and optimal dosing and timing.
The abstract reports key outcomes but does not present full details on baseline characteristics, blinding procedures, sample size calculation, subgroup analyses, exact counts for adverse events, or longer-term adverse effects. The source does not report other potential limitations or sensitivity analyses in the abstract; these would require review of the full text for comprehensive assessment. Trial registration is provided: Chinese Clinical Trial Registry ChiCTR2200055281. Conflict of interest: none reported in the source.