Table 3.

Fracture gaps, protocol deviation status, and study event status

Size of Fracture Gap at the Time of the Initial Surgery*	Protocol Deviation if Re-Operation before 6 Months**	Study Event
0 (no fracture gap)	Yes	Yes – Primary Event
Fracture gap less than 1 cm	Yes	Yes – Primary Event
Fracture gap greater than or equal to 1 cm	No	No

* This refers to the magnitude of circumferential bone loss as judged by the adjudicator on review of the post-operative radiograph, or non-circumferential bone loss as judged by the adjudicator in the presence of cortical continuity of 0 or 25% as judged by the surgeon at the time of operation and recorded on our study forms.

** For nonunion, malunion, dynamization, not infection