학술논문
Modern External Ring Fixation Versus Internal Fixation for Treatment of Severe Open Tibial Fractures: A Randomized Clinical Trial (FIXIT Study)
Document Type
Academic Journal
Author
Franco, Kathy D.; Harriott, Paula J.; Boateng, Henry A.; Ringenbach, Kathy; Norkey, Merryjessica; Tummuru, Rajesh; O’Toole, Robert V.; Reider, Lisa; Gary, Joshua L.; Quinnan, Stephen M.; Hutson, James J., Jr.; Scharfstein, Daniel O.; Huang, Yanjie; McKinley, Todd O.; Reid, J. Spence; Castillo, Renan C.; Bosse, Michael J.; MacKenzie, Ellen J.; Stinner, Daniel J.; Beltran, Michael J.; Norton, Michelle M.; Hsu, Joseph R.; Karunakar, Madhav A.; Seymour, Rachel B.; Sims, Stephen H.; Barrett, Caroline M.; Churchill, Christine; Deans, Elizabeth C.; Hurst, Kaitlyn; Sietsema, Debra L.; Hak, David J.; Mauffrey, Cyril; Henderson Trujillo, Corey; Mir, Hassan; Shah, Anjan R.; Steverson, Barbara; Schmidt, Andrew H.; Yoon, Patrick; Westberg, Jerald R.; Gaski, Greg E.; Hill, Lauren C.; Achor, Timothy S.; Brinker, Mark R.; Choo, Andrew M.; Munz, John W.; Prasarn, Mark L.; Warner, Stephen J.; Galpin, Matthew C.; Vallier, Heather A.; Sontich, John K.; Breslin, Mary Alice; Frisch, H. Michael; Kaufman, Adam M.; Large, Thomas M.; LeCroy, C. Michael; Langford, Joshua R; Horne, Andrea; Eglseder, W. Andrew; LeBrun, Christopher T.; Nascone, Jason W.; Pensy, Ray; Sciadini, Marcus F.; Slobogean, Gerard; Degani, Yasmin; Amundson, Amanda; O’Hara, Nathan N.; Zych, Gregory A.; Watson, J. Tracy; Gardner, Michael J.; Miclau, Theodore; Morshed, Saam; Kandemir, Utku; Belaye, Tigist; Marsh, J. Lawrence; Fruehling, Catherine; Bergin, Patrick F.; Graves, Matt L.; Spitler, Clay A.; Maroto, Medardo; Kleweno, Conor P.; Whiting, Paul S.; Doro, Christopher; Goodspeed, David C.; Lang, Gerald J.; Simske, Natasha M.; Siy, Alexander B.; Obremskey, William; Burgos, Eduardo J.; Jahangir, Alex; Sethi, Manish; Gajari, Vamshi; Teasdall, Robert D.; Carroll, Eben A.; Halvorson, Jason J.; Miller, Anna N.; Goodman, James Brett; Holden, Martha B.; Gordon, Wade T.; Allen, Lauren E.; Ballreich, Jeromie M.; Carlini, Anthony R.; de Lissovoy, Gregory; Kirk, Rachel; Luly, Jason; Remenapp, Craig M.
Source
The Journal of Bone and Joint Surgery. Jun 15, 2022 104(12):1061-1067
Subject
Language
English
ISSN
0021-9355
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. LEVEL OF EVIDENCE:: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.