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-Hughes; Michael 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

doi:10.1097/BOT.0000000000002704

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 journal › Article › peer-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 language	English (US)
Pages (from-to)	10-17
Number of pages	8
Journal	Journal of orthopaedic trauma
Volume	38
Issue number	1
DOIs	https://doi.org/10.1097/BOT.0000000000002704
State	Published - Jan 1 2024

Keywords

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

ASJC Scopus subject areas

Surgery
Orthopedics and Sports Medicine

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10.1097/BOT.0000000000002704

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Patterson, J. T., Slobogean, G. P., Gary, J. L., Castillo, R. C., Firoozabadi, R., Carlini, A. R., Joshi, M., Allen, L. E., Huang, Y., Bosse, M. J., Obremskey, W. T., McKinley, T. O., Reid, J. S., O'Toole, R. V., O'Hara, N. N., Holden, M. B., McAndrew, C. M., Gardner, M. J., Miller, A. N., ... Taylor, T. J. (2024). The VANCO Trial Findings Are Generalizable to a North American Trauma Registry. Journal of orthopaedic trauma, 38(1), 10-17. https://doi.org/10.1097/BOT.0000000000002704

Patterson, JT, Slobogean, GP, Gary, JL, Castillo, RC, Firoozabadi, R, Carlini, AR, Joshi, M, Allen, LE, Huang, Y, Bosse, MJ, Obremskey, WT, McKinley, TO, Reid, JS, O'Toole, RV, O'Hara, NN, Holden, MB, McAndrew, CM, Gardner, MJ, Miller, AN, Spraggs-Hughes, A, Brennan, ML, Rivera, JC, Murray, CK, Kimmel, JE, Hsu, JR, Karunakar, MA, Kempton, LB, Seymour, RB, Sims, SH, Churchill, C, Reilly, RM, Zura, RD, Howes, C, Mir, H, Steverson, B, Weaver, MJ, Schmidt, AH, Wagstrom, EA, Gaski, GE, Natoli, RM, Sorkin, A, Virkus, W, Hymes, RA, Malekzadeh, AS, Schulman, JE, Ramsey, L, Lee, OC, Choo, A, Munz, JW, Boutte, S, Frisch, HM, Kaufman, AM, Large, TM, Lecroy, CM, Smith, CS, Horne, A, Lebrun, C, Nascone, J, Sciadini, MF, Degani, Y, Howe, AL, Rudnicki, J, Evans, AR, Jones, CB, Sietsema, DL, Stawicki, SP, Wojda, TR, Bishop, JA, Rehman, S, Caroom, C, Sheridan, E, Higgins, TF, Haller, JM, Bergin, PF, Bhanat, E, Graves, ML, Morellato, J, Spitler, CA, Teague, D, Ertl, W, Moloney, GB, Weinlein, JC, Zelle, BA, Agarwal, A, Karia, RA, Sathy, A , Sanders, D, Weiss, DB, Yarboro, SR, Whiting, PS, Lang, GJ, Simske, NM, Siy, AB, Attum, B, Burgos, EJ, Gajari, V, Rodriguez-Buitrago, A, Sethi, M, Trochez, KM, Collins, SC & Taylor, TJ 2024, 'The VANCO Trial Findings Are Generalizable to a North American Trauma Registry', Journal of orthopaedic trauma, vol. 38, no. 1, pp. 10-17. https://doi.org/10.1097/BOT.0000000000002704

@article{557c4435857d40d9936ffb54ee10e32b,

title = "The VANCO Trial Findings Are Generalizable to a North American Trauma Registry",

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.",

keywords = "external validity, fracture, generalizability, intrawound, orthopaedic trauma, pilon, randomized trial, surgical site infection, tibial plateau, vancomycin",

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

year = "2024",

month = jan,

day = "1",

doi = "10.1097/BOT.0000000000002704",

language = "English (US)",

volume = "38",

pages = "10--17",

journal = "Journal of orthopaedic trauma",

issn = "0890-5339",

publisher = "Lippincott Williams and Wilkins",

number = "1",

}

TY - JOUR

T1 - The VANCO Trial Findings Are Generalizable to a North American Trauma Registry

AU - Patterson, Joseph T.

AU - Slobogean, Gerard P.

AU - Gary, Joshua L.

AU - Castillo, Renan C.

AU - Firoozabadi, Reza

AU - Carlini, Anthony R.

AU - Joshi, Manjari

AU - Allen, Lauren E.

AU - Huang, Yanjie

AU - Bosse, Michael J.

AU - Obremskey, William T.

AU - McKinley, Todd O.

AU - Reid, J. Spence

AU - O'Toole, Robert V.

AU - O'Hara, Nathan N.

AU - Holden, Martha B.

AU - McAndrew, Christopher M.

AU - Gardner, Michael J.

AU - Miller, Anna N.

AU - Spraggs-Hughes, Amanda

AU - Brennan, Michael L.

AU - Rivera, Jessica C.

AU - Murray, Clinton K.

AU - Kimmel, Joseph E.

AU - Hsu, Joseph R.

AU - Karunakar, Madhav A.

AU - Kempton, Laurence B.

AU - Seymour, Rachel B.

AU - Sims, Stephen H.

AU - Churchill, Christine

AU - Reilly, Rachel M.

AU - Zura, Robert D.

AU - Howes, Cameron

AU - Mir, Hassan

AU - Steverson, Barbara

AU - Weaver, Michael J.

AU - Schmidt, Andrew H.

AU - Wagstrom, Emily A.

AU - Gaski, Greg E.

AU - Natoli, Roman M.

AU - Sorkin, Anthony

AU - Virkus, Walter

AU - Hymes, Robert A.

AU - Malekzadeh, A. Stephen

AU - Schulman, Jeff E.

AU - Ramsey, Lolita

AU - Lee, Olivia C.

AU - Choo, Andrew

AU - Munz, John W.

AU - Boutte, Sterling

AU - Frisch, H. Michael

AU - Kaufman, Adam M.

AU - Large, Thomas M.

AU - Lecroy, C. Michael

AU - Smith, Christopher S.

AU - Horne, Andrea

AU - Lebrun, Christopher

AU - Nascone, Jason

AU - Sciadini, Marcus F.

AU - Degani, Yasmin

AU - Howe, Andrea L.

AU - Rudnicki, Joshua

AU - Evans, Andrew R.

AU - Jones, Clifford B.

AU - Sietsema, Debra L.

AU - Stawicki, Stanislaw P.

AU - Wojda, Thomas R.

AU - Bishop, Julius A.

AU - Rehman, Saqib

AU - Caroom, Cyrus

AU - Sheridan, Elizabeth

AU - Higgins, Thomas F.

AU - Haller, Justin M.

AU - Bergin, Patrick F.

AU - Bhanat, Eldrin

AU - Graves, Matt L.

AU - Morellato, John

AU - Spitler, Clay A.

AU - Teague, David

AU - Ertl, William

AU - Moloney, Gele B.

AU - Weinlein, John C.

AU - Zelle, Boris A.

AU - Agarwal, Animesh

AU - Karia, Ravi A.

AU - Sathy, Ashoke

AU - Sanders, Drew

AU - Weiss, David B.

AU - Yarboro, Seth R.

AU - Whiting, Paul S.

AU - Lang, Gerald J.

AU - Simske, Natasha M.

AU - Siy, Alexander B.

AU - Attum, Basem

AU - Burgos, Eduardo J.

AU - Gajari, Vamshi

AU - Rodriguez-Buitrago, Andres

AU - Sethi, Manish

AU - Trochez, Karen M.

AU - Collins, Susan C.

AU - Taylor, Tara J.

PY - 2024/1/1

Y1 - 2024/1/1

N2 - 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.

AB - 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.

KW - external validity

KW - fracture

KW - generalizability

KW - intrawound

KW - orthopaedic trauma

KW - pilon

KW - randomized trial

KW - surgical site infection

KW - tibial plateau

KW - vancomycin

UR - http://www.scopus.com/inward/record.url?scp=85179774010&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85179774010&partnerID=8YFLogxK

U2 - 10.1097/BOT.0000000000002704

DO - 10.1097/BOT.0000000000002704

M3 - Article

C2 - 38093438

AN - SCOPUS:85179774010

SN - 0890-5339

VL - 38

SP - 10

EP - 17

JO - Journal of orthopaedic trauma

JF - Journal of orthopaedic trauma

IS - 1

ER -

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

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Keywords

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