A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators or Internal Fixation with Intramedullary Nails or Plates.


Principal Investigator: Dr. Robert O’Toole

This study will compare two standard options for treating severe open tibia fractures: internal fixation with a nail or plate and external ring fixation.


Severe open tibia (shin) bone fractures are common military injuries and historically have high complication rates and poor outcomes. There are two ways to treat these injuries but the best treatment is not known. One way is to use “internal fixation” where the broken bone is fixed by placing a nail down the middle of the bone or a plate on top of the bone but under the skin. The other way is to use “external ring fixation” where the broken bone is fixed using pins in the bone attached to rings and rods outside of the leg. Both treatments are currently used in trauma centers throughout the United States to treat severe tibia fractures, but we do not know which treatment is best. This study is designed to better understand the differences and similarities of the two treatments and determine whether one treatment is better than the other. Our global hypothesis is that the use of modern ring external fixators for severe open tibia fractures will reduce complications and improve outcomes compared to treatment with internal fixation.


The FIXIT study is being carried out in more than 25 major trauma centers across the United States, including four military treatment centers that are taking care of service members who are injured in the line of duty. Approximately 600 patients with “severe” open tibia shaft fractures who meet the inclusion and exclusion criteria and agree to be in the study will be randomized to one of the 2 treatment groups (internal fixation versus external ring fixation) prior to the time of definitive fixation. Participants will be asked to complete 5 follow-up visits at 2, 6, 12, 26 and 52 weeks after definitive treatment of the injury. The primary outcome is hospital readmissions for complications. Secondary outcomes include infection, functional outcome, and patient reported outcomes. Acute hospitalization as well as one-year treatment costs will also be ascertained and compared between the two treatment groups.


This study is being funded by the DOD OETRP METRC Consortium Award (W81XWH-09-2-0108).