240
Participants
Start Date
December 17, 2015
Primary Completion Date
March 25, 2017
Study Completion Date
March 25, 2017
Intramedullary nailing with standard SIGN nail
Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the standard SIGN nail (SIGN Fracture Care International, Richland, WA). The number of interlocking screws is at the discretion of the treating surgeon, who also has the option to use an external fixator for damage control, and later conversion to IMN when clinically appropriate. The experimental group procedure is less common in the study setting, and thus, viewed as the experimental group.
External Fixation with uniplanar Dispofix external fixator
Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the uniplanar Dispofix external fixator with two Shanz screws placed proximally and two Schanz screws placed distally to fracture site with a single stainless steel bar.The active comparator group procedure is more common in the study setting, and thus, viewed as the comparator group.
Wyss Foundation, Inc
UNKNOWN
Doris Duke Charitable Foundation
OTHER
University of California, San Francisco
OTHER