Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

Carol Alice Lin, Mohit Bhandari, Gordon Guyatt, Stephen D. Walter, Emil H. Schemitsch, Marc Swiontkowski, David Sanders, Paul Tornetta, David W. Sanders, Sheila Sprague, Diane Heels-Ansdell, Lisa Buckingham, Pamela Leece, Helena Viveiros, Tashay Mignott, Natalie Ansell, Natalie Sidorkewicz, Julie Agel, Claire Bombardier, Jesse A. BerlinMichael Bosse, Bruce Browner, Brenda Gillespie, Alan Jones, Peter O'Brien, Rudolf Poolman, Mark D. Macleod, Timothy Carey, Kellie Leitch, Stuart Bailey, Kevin Gurr, Ken Konito, Charlene Bartha, Isolina Low, Leila V. MacBean, Mala Ramu, Susan Reiber, Ruth Strapp, Christina Tieszer, Hans J. Kreder, David J G Stephen, Terry S. Axelrod, Albert J M Yee, Robin R. Richards, Joel Finkelstein, Wade Gofton, John Murnaghan, Joseph Schatztker, Michael Ford, Beverly Bulmer, Lisa Conlan, G. Yves Laflamme, Gregory Berry, Pierre Beaumont, Pierre Ranger, Georges Henri Laflamme, Sylvain Gagnon, Michel Malo, Julio Fernandes, Marie France Poirier, Michael D. McKee, James P. Waddell, Earl R. Bogoch, Timothy R. Daniels, Robert R. McBroom, Milena R. Vicente, Wendy Storey, Lisa M. Wild, Robert McCormack, Bertrand Perey, Thomas J. Goetz, Graham Pate, Murray J. Penner, Kostas Panagiotopoulos, Shafique Pirani, Ian G. Dommisse, Richard L. Loomer, Trevor Stone, Karyn Moon, Mauri Zomar, Lawrence X. Webb, Robert D. Teasdall, John Peter Birkedal, David Franklin Martin, David S. Ruch, Douglas J. Kilgus, David C. Pollock, Mitchel Brion Harris, Ethan Ron Wiesler, William G. Ward, Jeffrey Scott Shilt, Andrew L. Koman, Gary G. Poehling, Brenda Kulp, William R. Creevy, Andrew B. Stein, Christopher T. Bono, Thomas A. Einhorn, T. Desmond Brown, Donna Pacicca, John B. Sledge, Timothy E. Foster, Ilva Voloshin, Jill Bolton, Hope Carlisle, Lisa Shaughnessy, William T. Obremskey, C. Michael LeCroy, Eric G. Meinberg, Terry M. Messer, William L. Craig, Douglas R. Dirschl, Robert Caudle, Tim Harris, Kurt Elhert, William Hage, Robert Jones, Luis Piedrahita, Paul O. Schricker, Robin Driver, Jean Godwin, Philip James Kregor, Gregory Tennent, Lisa M. Truchan, Marcus Sciadini, Franklin D. Shuler, Robin E. Driver, Mary Alice Nading, Jacky Neiderstadt, Alexander R. Vap, Heather A. Vallier, Brendan M. Patterson, John H. Wilber, Roger G. Wilber, John K. Sontich, Timothy Alan Moore, Drew Brady, Daniel R. Cooperman, John A. Davis, Beth Ann Cureton, Scott Mandel, R. Douglas Orr, John T S Sadler, Tousief Hussain, Krishan Rajaratnam, Bradley Petrisor, Brian Drew, Drew A. Bednar, Desmond C H Kwok, Shirley Pettit, Jill Hancock, Peter A. Cole, Joel J. Smith, Gregory A. Brown, Thomas A. Lange, John G. Stark, Bruce A. Levy, Marc F. Swiontkowski, Mary J. Garaghty, Joshua G. Salzman, Carol A. Schutte, Linda Tastad, Sandy Vang, David Seligson, Craig S. Roberts, Arthur L. Malkani, Laura Sanders, Carmen Dyer, Jessica Heinsen, Langan Smith, Sudhakar Madanagopal, Linda Frantz-Bush, Kevin J. Coupe, Jeffrey J. Tucker, Allen R. Criswell, Rosemary Buckle, Alan Jeffrey Rechter, Dhiren Shaskikant Sheth, Brad Urquart, Thea Trotscher, Mark J. Anders, Joseph M. Kowalski, Marc S. Fineberg, Lawrence B. Bone, Matthew J. Phillips, Bernard Rohrbacher, Philip Stegemann, William M. Mihalko, Cathy Buyea, Stephen J. Augustine, William Thomas Jackson, Gregory Solis, Sunday U. Ero, Daniel N. Segina, Hudson B. Berrey, Samuel G. Agnew, Michael Fitzpatrick, Lakina C. Campbell, Lynn Derting, June McAdams, J. Carel Goslings, Kees Jan Ponsen, Jan Luitse, Peter Kloen, Pieter Joosse, Jasper Winkelhagen, Raphaël Duivenvoorden, David C. Teague, Joseph Davey, J. Andy Sullivan, William J J Ertl, Timothy A. Puckett, Charles B. Pasque, John F. Tompkins, Curtis R. Gruel, Paul Kammerlocher, Thomas P. Lehman, William R. Puffinbarger, Kathy L. Carl, Donald W. Weber, Nadr M. Jomha, Gordon R. Goplen, Edward Masson, Lauren A. Beaupre, Karen E. Greaves, Lori N. Schaump, Kyle J. Jeray, David R. Goetz, David E. Westberry, J. Scott Broderick, Bryan S. Moon, Stephanie L. Tanner, James N. Powell, Richard E. Buckley, Leslie Elves, Stephen Connolly, Edward P. Abraham, Trudy Steele, Thomas Ellis, Alex Herzberg, George A. Brown, Dennis E. Crawford, Robert Hart, James Hayden, Robert M. Orfaly, Theodore Vigland, Maharani Vivekaraj, Gina L. Bundy, Theodore Miclau, Amir Matityahu, R. Richard Coughlin, Utku Kandemir, R. Trigg McClellan, Cindy Hsin Hua Lin, David Karges, Kathryn Cramer, J. Tracy Watson, Berton Moed, Barbara Scott, Dennis J. Beck, Carolyn Orth, David Puskas, Russell Clark, Jennifer Jones, Kenneth A. Egol, Nader Paksima, Monet France, Eugene K. Wai, Garth Johnson, Ross Wilkinson, Adam T. Gruszczynski, Liisa Vexler

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

Objectives: To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients. Design: Retrospective review of prospectively collected data from a large clinical trial. Setting: Six level-1 international trauma centers. Methods: We compared rates and timing of reoperation in a subset of patients enrolled in the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) to concurrent patients who were eligible but not enrolled. This was a retrospective review of prospectively collected trial data. The records of 6 of the original SPRINT centers were searched for non-SPRINT patients who underwent intramedullary nailing of a closed tibial fracture. The rate and timing of reoperation were compared. A P < 0.05 was considered significant. Results: One hundred fourteen non-SPRINT patients were compared with 328 patients enrolled in SPRINT from those same sites. There were 7 reoperations (6.1%) in non-SPRINT patients versus 18 (5.2%) in SPRINT patients [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.41 to 3.13; P 0.811]. There was no difference in the time to reoperation between the SPRINT and non-SPRINT patients (6.2 vs. 6.8 months, 95% CI of the difference -3.8 to 2.6; P 0.685) or in the proportion of patients who underwent reoperation before 6 months (29% vs. 43%; OR 1.75; 95% CI 0.18 to 15.41; P 0.647). Conclusions: Patients not enrolled in SPRINT had similarly low rates of reoperation for nonunion, and the average time to reoperation for both groups was longer than 6 months. A 6-month waiting period may have allowed slow-to-heal fractures adequate time to heal, thereby reducing the rate of diagnosis of nonunion. As such, this waiting period could contribute to lower-than-expected reoperation rates for nonunion. It is possible that clinical trials may beneficially influence the care of nonenrolled patients.

Original languageEnglish (US)
Pages (from-to)156-161
Number of pages6
JournalJournal of Orthopaedic Trauma
Volume30
Issue number3
DOIs
StatePublished - Mar 1 2016
Externally publishedYes

Keywords

  • nonunion
  • reamed
  • tibia fracture
  • unreamed

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

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    Lin, C. A., Bhandari, M., Guyatt, G., Walter, S. D., Schemitsch, E. H., Swiontkowski, M., Sanders, D., Tornetta, P., Sanders, D. W., Sprague, S., Heels-Ansdell, D., Buckingham, L., Leece, P., Viveiros, H., Mignott, T., Ansell, N., Sidorkewicz, N., Agel, J., Bombardier, C., ... Vexler, L. (2016). Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. Journal of Orthopaedic Trauma, 30(3), 156-161. https://doi.org/10.1097/BOT.0000000000000533