Estimating the required number of patients
tibial fracture, femoral fracture nonunion
OF FRACTURE NONUNION
We estimated survival curves considering the healing period of fracture nonunion in four patients with tibial fracture nonunions in the previous phase I/II study; furthermore, a historical control group of nine patients with tibial fracture nonunions and a hazard ratio (HR) of 7.41 were estimated. Based on this, considering a 1-year follow-up period and the nine historical control patients, the number of patients required for the rejection of the null hypothesis with an HR of 1, at a two-tailed significance level of 5%, and with a probability of 80% or higher, was calculated to be 15. Additionally, we decided to include up to 10 patients with femoral fracture nonunion as participants in exploratory clinical research during the same study period.