Statistical analysis
nonunion, fracture, tibial fracture nonunion, UC
SECONDARY
The full analysis set (FAS) included all patients with CD34 + cell transplants with ≥ 1 × 10The treatment efficacy was assessed as follows: The accumulated radiological fracture healing rate after nonunion surgery was estimated using the Kaplan‒Meier method. In patients with tibial fracture nonunion, the accumulated radiological fracture healing rate was compared with that of the historical group using the log-rank test; furthermore, the HR and 95% CI were estimated using a Cox proportional hazard model. The scores of the modified RUST and RUSH at each time point were recorded in the summary statistics. Changes from the baseline were compared using the Wilcoxon signed-rank test. The eight-scale scores and three component scores of SF-36v2 and the scores of the AAOS Lower Limb Core Scale at each time point were also recorded in the summary statistics. Changes from the baseline were compared using the Wilcoxon signed-rank test. For each fracture type, scatter plots and correlation coefficients between the number of transplanted CD34 + cells per body weight and the period from cell transplantation to radiological fracture healing were obtained. The observed AEs were aggregated according to the fracture type, time of occurrence, and cause of occurrence by system organ class and preferred term; thereafter, the frequency and rate of occurrence were calculated. For the measured values considering the blood examination and vital signs, summary statistics from the baseline to each time point were calculated; thereafter, the frequency of abnormal changes in the blood examination results was measured. Missing values were not imputed for primary or secondary endpoints. All analyses were conducted using SAS version 9.4 and R version 4.1.3 (Cary, UC, USA). A 