Effects of trehalose supplementation on bone healing, physical function, and pain in patients with pertrochanteric fractures: a randomized controlled trial.

Pertrochanteric fractures are common injuries associated with significant morbidity and delayed healing. Trehalose, a naturally occurring disaccharide with cytoprotective properties, has shown promise in preclinical fracture models. This randomized controlled trial evaluated the effects of trehalose supplementation on radiographic healing, hip function, and pain in patients with pertrochanteric fractures. This double-blind, placebo-controlled trial enrolled 64 patients (aged 18-60 years) with surgically treated pertrochanteric fractures at Taleghani Hospital, Tehran, Iran. Participants were randomly assigned to receive either trehalose (3.3 g/day) or placebo (sucrose) for 12 weeks. The co-primary outcomes were radiographic healing assessed by the Radiographic Union Score for Hip (RUSH) and physical function assessed by the Harris Hip Score (HHS). Secondary outcome was pain intensity assessed by the Visual Analog Scale (VAS). Assessments were conducted at baseline and weeks 2, 4, and 12. Fifty-seven participants completed the study (trehalose n = 28; placebo n = 29). The trehalose group showed significantly higher RUSH scores at week 12 compared with placebo (mean difference 2.09 points; 95% CI 0.45 to 3.72; p = 0.014), with significant group effect (p = 0.050) and group-by-time interaction (p = 0.021). Hip function improved more in the trehalose group, with significantly higher HHS at week 12 (mean difference 8.55 points; 95% CI 3.97 to 13.13; p < 0.001). Pain decreased substantially in both groups with no significant between-group difference.Trehalose supplementation improved radiographic healing and hip function in patients with pertrochanteric fractures. No serious adverse events were reported, but adverse events were not systematically monitored. Larger trials with longer follow-up and structured safety monitoring are needed to confirm these results and evaluate late complications.Trial registration: Iranian Registry of Clinical Trials. IRCT20240605062013N1. URL of the trial registry record https://irct.behdasht.gov.ir/trial/77212 , Registration date 16 June 2024.