A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External
Robert V OʼToole1, Joshua L Gary, Lisa Reider
1*Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, MD; †Department of Orthopeadic Surgery McGovern Medical School, UTHealth Houston, Houston, TX; ‡Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §Department of Orthopaedic Surgery, Carolinas Medical Center, Charlotte, NC; ‖Department of Orthopaedics, Walter Reed National Military Medical Center, Bethesda, MD; ¶Department of Orthopaedic Surgery, University of Miami Miller, School of Medicine, Miami, FL; and **Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
This study compares modern external fixation to internal fixation for severe open tibia fractures. It aims to determine which method leads to fewer complications and better patient outcomes.
Area of Science:
- Orthopedic Surgery
- Trauma Care
- Clinical Trials
Background:
- High-energy open tibia fractures present significant treatment challenges.
- Modern ring external fixation may offer improved outcomes compared to traditional methods.
- A rigorous comparison between external and internal fixation for these fractures is lacking.
Purpose of the Study:
- To prospectively compare 1-year outcomes of modern ring external fixation versus internal fixation for severe open tibial shaft fractures.
- To evaluate rehospitalization rates for major limb complications as the primary outcome.
- To assess secondary outcomes including infection, healing, function, costs, and patient-reported results.
Main Methods:
- Prospective, multicenter randomized trial (FIXIT study).
- Inclusion of men and women aged 18-64 with severe open tibial shaft fractures.
- Comparison of modern external ring fixation with internal fixation.
Main Results:
- Primary outcome: rehospitalization for major limb complications.
- Secondary outcomes: infection rates, fracture healing, limb function, patient-reported physical function and pain.
- Economic and satisfaction outcomes will also be compared.
Conclusions:
- The FIXIT study will provide crucial data on the comparative effectiveness of external versus internal fixation for severe open tibia fractures.
- Findings will inform clinical decision-making and potentially reduce complications in trauma patients.
- The study will also estimate the salvage rate of Gustilo IIIB fractures without soft tissue flap using external fixation.
