The VANCO Trial Findings Are Generalizable to a North American Trauma Registry

Joseph T. Patterson, Gerard P. Slobogean, Joshua L. Gary, Renan C. Castillo, Reza Firoozabadi, Anthony R. Carlini, Manjari Joshi, Lauren E. Allen, Yanjie Huang, Michael J. Bosse, William T. Obremskey, Todd O. McKinley, J. Spence Reid, Robert V. O'Toole, Nathan N. O'Hara, Martha B. Holden, Christopher M. McAndrew, Michael J. Gardner, Anna N. Miller, Amanda Spraggs-HughesMichael L. Brennan, Jessica C. Rivera, Clinton K. Murray, Joseph E. Kimmel, Joseph R. Hsu, Madhav A. Karunakar, Laurence B. Kempton, Rachel B. Seymour, Stephen H. Sims, Christine Churchill, Rachel M. Reilly, Robert D. Zura, Cameron Howes, Hassan Mir, Barbara Steverson, Michael J. Weaver, Andrew H. Schmidt, Emily A. Wagstrom, Greg E. Gaski, Roman M. Natoli, Anthony Sorkin, Walter Virkus, Robert A. Hymes, A. Stephen Malekzadeh, Jeff E. Schulman, Lolita Ramsey, Olivia C. Lee, Andrew Choo, John W. Munz, Sterling Boutte, H. Michael Frisch, Adam M. Kaufman, Thomas M. Large, C. Michael Lecroy, Christopher S. Smith, Andrea Horne, Christopher Lebrun, Jason Nascone, Marcus F. Sciadini, Yasmin Degani, Andrea L. Howe, Joshua Rudnicki, Andrew R. Evans, Clifford B. Jones, Debra L. Sietsema, Stanislaw P. Stawicki, Thomas R. Wojda, Julius A. Bishop, Saqib Rehman, Cyrus Caroom, Elizabeth Sheridan, Thomas F. Higgins, Justin M. Haller, Patrick F. Bergin, Eldrin Bhanat, Matt L. Graves, John Morellato, Clay A. Spitler, David Teague, William Ertl, Gele B. Moloney, John C. Weinlein, Boris A. Zelle, Animesh Agarwal, Ravi A. Karia, Ashoke Sathy, Drew Sanders, David B. Weiss, Seth R. Yarboro, Paul S. Whiting, Gerald J. Lang, Natasha M. Simske, Alexander B. Siy, Basem Attum, Eduardo J. Burgos, Vamshi Gajari, Andres Rodriguez-Buitrago, Manish Sethi, Karen M. Trochez, Susan C. Collins, Tara J. Taylor

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVES:To estimate the generalizability of treatment effects observed in the VANCO trial to a broader population of patients with tibial plateau or pilon fractures.METHODS:Design and Setting: Clinical trial data from 36 United States trauma centers and Trauma Quality Programs registry data from more than 875 Level I-III trauma centers in the United States and Canada.Patient Selection Criteria: Patients enrolled in the VANCO trial treated with intrawound vancomycin powder from January 2015 to June 2017 and 31,924 VANCO-eligible TQP patients admitted in 2019 with tibial plateau and pilon fractures.Outcome Measure and Comparisons: Deep surgical site infection and gram-positive deep surgical site infection estimated in the TQP sample weighed by the inverse probability of trial participation.RESULTS:The 980 patients in the VANCO trial were highly representative of 31,924 TQP VANCO-eligible patients (Tipton generalizability index 0.96). It was estimated that intrawound vancomycin powder reduced the odds of deep surgical infection by odds ratio (OR) = 0.46 (95% confidence interval [CI] 0.25-0.86) and gram-positive deep surgical infection by OR = 0.39 (95% CI, 0.18-0.84) within the TQP sample of VANCO-eligible patients. For reference, the trial average treatment effects for deep surgical infection and gram-positive deep surgical infection were OR = 0.60 (95% CI, 0.37-0.98) and OR = 0.44 (95% CI, 0.23-0.80), respectively.CONCLUSIONS:This generalizability analysis found that the inferences of the VANCO trial generalize and might even underestimate the effects of intrawound vancomycin powder when observed in a wider population of patients with tibial plateau and pilon fractures.LEVEL OF EVIDENCE:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Original languageEnglish
Pages (from-to)10-17
Number of pages8
JournalJournal of orthopaedic trauma
Volume38
Issue number1
DOIs
StatePublished - Jan 1 2024

Keywords

  • external validity
  • fracture
  • generalizability
  • intrawound
  • orthopaedic trauma
  • pilon
  • randomized trial
  • surgical site infection
  • tibial plateau
  • vancomycin

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