Effect of perioperative multistrain probiotics on the CT callus volume fraction at 12 weeks after surgery for closed tibial shaft fracture: a single-center randomized controlled study
Abstract
Background: Conventional radiographs lack sensitivity for early healing, whereas computed tomography (CT)-derived bone volume fraction (BV/TV) allows quantitative assessment of callus mineralization. Perioperative antibiotics and surgical stress disrupt gut microbiota, potentially impairing fracture healing. Multistrain probiotics may enhance bone repair via immunomodulation and the gut-bone axis.
Objective: To evaluate the effect of perioperative multistrain probiotics (Lactobacillus rhamnosus GG plus Bifidobacterium longum) on CT-measured BV/TV at 12 weeks.
Methods: This single-center, randomized, double-blind, placebo-controlled trial enrolled 84 patients with closed tibial shaft fractures. The modified intention-to-treat population included participants who received at least one dose and completed follow-up. Probiotics or placebo were administered from the preoperative period through postoperative week 6. The primary outcome was BV/TV at 12 weeks, analyzed using ANCOVA adjusted for age, sex, AO/OTA fracture classification, smoking status, and postoperative interfragmentary gap. Secondary outcomes included time to uncomplicated full weight bearing (defined as ambulation without assistive devices and without pain in the affected limb; analyzed using Kaplan-Meier with the log-rank test), rest-pain visual analog scale (VAS) scores at postoperative weeks 2 and 6, and Radiographic Union Score for Tibial Fractures (RUST) at 12 weeks. CT segmentation reliability was assessed…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 84 participants or records.
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