A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).
The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.
*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.
Robert V
RV
OʼToole
Joshua L
JL
Gary
Lisa
L
Reider
Michael J
MJ
Bosse
Wade T
WT
Gordon
James
J
Hutson
Stephen M
SM
Quinnan
Renan C
RC
Castillo
Daniel O
DO
Scharfstein
Ellen J
EJ
MacKenzie
D000293:Adolescent; D000328:Adult; D019544:Equipment Failure Analysis; D016267:External Fixators / Q000191:economics* / Q000706:statistics & numerical data; D005260:Female; D005597:Fractures, Open / Q000191:economics* / Q000453:epidemiology / Q000601:surgery*; D017048:Health Care Costs / Q000706:statistics & numerical data; D006801:Humans; D016268:Internal Fixators / Q000191:economics* / Q000706:statistics & numerical data; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011474:Prosthesis Design; D012307:Risk Factors; D013530:Surgical Wound Infection / Q000175:diagnosis / Q000191:economics* / Q000453:epidemiology; D013978:Tibial Fractures / Q000191:economics* / Q000453:epidemiology / Q000601:surgery*; D015599:Trauma Severity Indices; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D055815:Young Adult