A new RCT provides Level I evidence for internal vs. external fixation of severe open tibial fractures. High-level data have been lacking until now.
In recent years, the standard of care for such fractures in major trauma centers has evolved toward the use of intramedullary (IM) nail fixation after careful debridement and irrigation of the wound. The use of external fixation for these injuries has migrated to only the most extensively contaminated open wounds. Even in that setting, fracture fixation is often converted to IM nail use after the wound is closed either primarily or with a rotational or free flap.
However, persistent concerns with the major complication of deep infection have stimulated a low-level debate. Should we use external fixation routinely? Only minimally contaminated open wounds associated with tibial shaft fractures would then be managed with internal fixation.
To date, adequately powered RCTs examining this question have been lacking.
FIXIT Study
In a new report in JBJS, the Major Extremity Trauma Research Consortium (METRC)* presents the results of a Level I RCT. The study compares modern external ring fixation vs. internal fixation using IM nails or plates.
- This was a multicenter trial conducted at 20 U.S. trauma centers. Included were patients 18 to 64 years of age with a severe open tibial shaft fracture.
- Primary outcome: the probability of at least 1 major limb complication within 1 year. Complications included amputation, infection, a soft-tissue problem, nonunion, malunion, and a loss of reduction/implant failure.
- 260 patients were randomized to treatment, and 254 were included in the final analysis (122 external fixation and 132 internal fixation). The mean age was 39 years. 84% of the patients were men.
Study Findings
- External fixation had a greater probability of at least 1 major complication by Kaplan-Meier estimate: 62.1% (95% CI, 53.4% to 70.8%) compared with 43.7% (95% CI, 35.5% to 52.9%) for internal fixation. The absolute risk difference was 18.4%.
- Of the 6 types of complications, loss of reduction/implant failure showed the most notable difference between the groups. A higher risk was seen for the external fixation group (risk difference: 14.4%).
- The authors found no notable difference in the probability of deep infection: 26.1% (external fixation) vs. 29.7% (internal fixation).
Say the authors: “These results argue against the routine use of modern external ring fixation for the treatment of these severe open tibial fractures.”
The findings confirm the long-understood issue of loss of fracture alignment with external fixation and the need for unplanned conversion to internal fixation to control fracture alignment. In essence, we have confirmation that the standard we have evolved to is likely correct and is now supported by 1 adequately powered RCT. We look for further confirmation of this treatment paradigm in future trials.
Read the full METRC report and access the JBJS Video Summary of this study.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
*Dr. Swiontkowski chairs the Data Safety Monitoring Board for the METRC but was not involved in the conduct of this RCT or in the initial peer-review process for this manuscript.
For further reading, see the JBJS Clinical Summary on tibial shaft fractures.
Related OrthoBuzz posts: “Machine Learning Algorithm May Predict Postfracture Infection” and “Risk Factors for Delayed Management of Open Tibial Fractures in Tanzania”
When I was in training, any hardware in an open fracture, particularly a tibial fracture, was close to malpractice. I would’ve been fired from my residency program at Emory. Thank God for progress and Mavericks.