Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania

NACompletedINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

December 17, 2015

Primary Completion Date

March 25, 2017

Study Completion Date

March 25, 2017

Conditions
Tibial FracturesOpen Fracture of TibiaTrauma
Interventions
PROCEDURE

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.

PROCEDURE

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.

All Listed Sponsors
collaborator

Wyss Foundation, Inc

UNKNOWN

collaborator

Doris Duke Charitable Foundation

OTHER

lead

University of California, San Francisco

OTHER

NCT03861624 - Intramedullary Nailing Versus External Fixation in Open Tibia Fractures in Tanzania | Biotech Hunter | Biotech Hunter