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Table 3 Fracture gaps, protocol deviation status, and study event status

From: Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): Study rationale and design

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
  1. * 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.
  2. ** For nonunion, malunion, dynamization, not infection