Journal article
Modern External Ring Fixation Versus Internal Fixation for Treatment of Severe Open Tibial Fractures A Randomized Clinical Trial (FIXIT Study)
Journal of bone and joint surgery. American volume, v 104(12), pp 1061-1067
15 Jun 2022
PMID: 36149241
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Background: Modern external ring fixation has been hypothesized to reduce complications requiring hospital readmission compared with internal fixation when treating patients with high-energy open tibial shaft fractures. In this study, the 1-year probability of a major limb complication was compared between external and internal fixation of severe open tibial fractures. Methods: This multicenter randomized clinical trial included patients 18 to 64 years of age with severe open tibial shaft fractures randomly assigned to either modern external ring fixation (n = 127) or internal fixation (n = 133). The primary outcome was a major limb complication within 365 days after randomization; these complications included amputation, infection, a soft-tissue problem, nonunion, malunion, and a loss of reduction/implant failure. Results: Of 260 randomized patients, 254 were included in the final analysis. Their mean age (standard deviation) was 39 (13) years; 214 (84%) were men. The probability of at least 1 major limb complication was higher for external fixation (62.1% [95% confidence interval (CI): 53.4% to 70.8%]) than internal fixation (43.7% [95% CI: 35.5% to 52.9%]), with a risk difference of 18.4% (95% CI: 5.8% to 30.4%); p = 0.005). The most notable difference was in loss of reduction/implant failure, the rate of which was higher for external fixation (risk difference: 14.4% [95% CI: 7.0% to 21.6%]; p = 0.002). There was no appreciable difference in the probability of deep infection between external fixation (26.1%) and internal fixation (29.7%) (risk difference: -3.5% [95% CI: -14.8% to 7.8%]; p = 0.54). There were also no appreciable differences in the probabilities of amputation, nonunion, soft-tissue problems, malunion, or fracture healing between the groups. Conclusions: These results argue against routine use of modern external ring fixation for the treatment of these severe open tibial fractures.
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Details
- Title
- Modern External Ring Fixation Versus Internal Fixation for Treatment of Severe Open Tibial Fractures A Randomized Clinical Trial (FIXIT Study)
- Creators
- Robert O'Toole - R Adams Cowley Shock Trauma Ctr, Baltimore, MD 21201 USALisa Reider - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USAJoshua L. Gary - College Station Medical CenterStephen M. Quinnan - University of MiamiJames J. Hutson - University of MiamiYanjie Huang - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USATodd O. McKinley - Indiana UniversityJ. Spence Reid - Pennsylvania State UniversityRenan C. Castillo - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USAMichael J. Bosse - College Station Medical CenterEllen J. MacKenzie - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USADaniel T. AltmanEdward R. WestrickGregoryT AltmanTraci SalopekHeather SilvaHope CarlisleJoseph R. Hsu - College Station Medical CenterRachel B. Seymour - College Station Medical CenterChristine Churchill - UNC Hlth, Chapel Hill, NC USAElizabeth C. Deans - UNC Hlth, Chapel Hill, NC USAKaitlyn Hurst - Indiana UniversityMadhav A. Karunakar - College Station Medical CenterStephen H. Sims - College Station Medical CenterCaroline M. Barrett - College Station Medical CenterDavid J. Hak - Denver Hlth & Hosp Author, Denver, CO USACyril Mauffrey - Rocky Vista UniversityPhilip F. StahelCorey E. Henderson Trujillo - Rocky Vista UniversityAnjan R. Shah - Florida Orthopaed Inst, Riverview, FL USAHassan R. Mir - Florida Orthopaed Inst, Riverview, FL USABarbara Steverson - Florida Orthopaed Inst, Riverview, FL USAAndrew H. SchmidtGudrun E. MirickPatrick Yoon - Minneapolis Vet Affairs Healthcare Syst, Minneapolis, MN USADavid TemplemanJerald R. WestbergGreg E. Gaski - Indiana UniversityLauren C. Hill - College Station Medical CenterTimothy S. Achor - College Station Medical CenterAndrew M. Choo - College Station Medical CenterStephen J. Warner - College Station Medical CenterJohn K. Sontich - College Station Medical CenterHeather A. Vallier - College Station Medical CenterH. Michael FrischC. Michael LeCroy - Nashotah House Theological SeminaryAdam M. Kaufman - Nashotah House Theological SeminaryChristina RiggsbeeThomas M. Large - Nashotah House Theological SeminaryJoshua R. Langford - College Station Medical CenterPaula J. HarriottAndrea H. Horne - Pennsylvania State UniversityW. Andrew Eglseder - Univ Maryland, R Adams Cowley Shock Trauma Ctr, College Pk, MD 20742 USAKathleen C. Ring-enbachJ. Tracy Watson - St Louis Univ, St Louis, MO 63103 USAMichael J. Gardner - Stanford UniversityDaniel J. Stinner - Vanderbilt UniversityMichael J. Beltran - University of CincinnatiMichelle M. Norton - Nashotah House Theological SeminaryMark L. Prasarn - College Station Medical CenterMark R. Brinker - College Station Medical CenterJohn W. Munz - College Station Medical CenterJose SantoyoMatthew C. Galpin - College Station Medical CenterSaam Morshed - Univ Calif San Francisco, San Francisco, CA 94143 USATheodore Miclau - Univ Calif San Francisco, San Francisco, CA 94143 USAUtku Kandemir - Univ Calif San Francisco, San Francisco, CA 94143 USATigist Belaye - Univ Calif San Francisco, San Francisco, CA 94143 USAJ. Lawrence Marsh - University of IowaCatherine Fruehling - University of IowaMichael WilleyGerard P. Slobogean - Univ Maryland, R Adams Cowley Shock Trauma Ctr, College Pk, MD 20742 USAYasmin Degani - Seattle Childrens Hosp, Seattle, WA USAAmanda AmundsonNathan N. O'Hara - R Adams Cowley Shock Trauma Ctr, Baltimore, MD 21201 USAChristopher T. LeBrun - Univ Maryland, R Adams Cowley Shock Trauma Ctr, College Pk, MD 20742 USATheodore MansonRaymond A. Pensy - Univ Maryland, R Adams Cowley Shock Trauma Ctr, College Pk, MD 20742 USAAmanda C. HolmesJason W. Nascone - Univ Maryland, R Adams Cowley Shock Trauma Ctr, College Pk, MD 20742 USAMarcusF Sciadini - Univ Maryland, R Adams Cowley Shock Trauma Ctr, College Pk, MD 20742 USAGregory A. Zych - University of MiamiPatrick F. Bergin - University of MississippiClay A. Spitler - University of MississippiMedardo Maroto - College Station Medical CenterConor P. Kleweno - University of WashingtonPaul S. Whiting - University of WashingtonChristopher Doro - University of WashingtonDavid C. Goodspeed - University of WashingtonGerald J. Lang - University of WashingtonNatasha M. Simske - University of WashingtonAlexander B. Siy - University of WashingtonGeorge RussellMatt L. Graves - University of MississippiJosie HydrickMedardo R. Maroto - College Station Medical CenterCindy G. DanielWilliam T. Obremskey - Vanderbilt UniversityManish K. SethiA. Alex JahangirVamshi GajariEduardo J. Burgos - Vanderbilt UniversityRajesh R. TummuruRobert D. TeasdallJason J. HalvorsonEben A. CarrollJ. Brett Good-manMartha B. HoldenJason J. Halvor-sonAnna N. MillerWade T. Gordon - New England Baptist HospitalLuz Maria KumpelSandra L. WaggonerXochitl CenicerosDebra L. Sietsema - Ctr Orthopaed Res & Educ, Phoenix, AZ USALauren E. AllenJeromie M. Ballreich - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USAAnthony R. Carlini - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USAGregory De Lissovoy - Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USARachel KirkJason LulyChristina D. OwensDaniel O. Scharfstein - Johns Hopkins Bloomberg Sch Publ Hlth, METRC Coordinating Ctr, Baltimore, MD USAMajor Extremity Trauma Res Consort
- Publication Details
- Journal of bone and joint surgery. American volume, v 104(12), pp 1061-1067
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 7
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Orthopedic/Orthopaedic Surgery
- Web of Science ID
- WOS:000811138200006
- Scopus ID
- 2-s2.0-85132763137
- Other Identifier
- 991021897409004721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Orthopedics
- Surgery