Of 2551 patients enrolled, the
adjudication committee (whose members were
unaware of the treatment assignments) determined
that 104 patients were ineligible owing to
no receipt of surgical treatment (47 patients), incorrect
fracture type (48), history of osteomyelitis
(1), retained hardware from a previous fracture
in the same extremity (2), use of immunosuppressive
medication (2), or age (4). The remaining
2447 patients were included in the final
analyses, with the patients’ data analyzed in the
treatment groups to which the patients had been
randomly assigned. We obtained 12-month follow-
up data for 90% of the patients (Figs. S1 and
S2 in the Supplementary Appendix).