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 Citation (Scopus)

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

Fingerprint

Randomized Controlled Trials
Reoperation
Tibial Fractures
Clinical Trials
Confidence Intervals
Clinical Protocols
Odds Ratio
Closed Fractures
Intramedullary Fracture Fixation
Trauma Centers
Nails
Patient Care

Keywords

  • nonunion
  • reamed
  • tibia fracture
  • unreamed

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

Lin, C. A., Bhandari, M., Guyatt, G., Walter, S. D., Schemitsch, E. H., Swiontkowski, M., ... 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

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

In: Journal of Orthopaedic Trauma, Vol. 30, No. 3, 01.03.2016, p. 156-161.

Research output: Contribution to journalArticle

Lin, CA, Bhandari, M, Guyatt, G, Walter, SD, Schemitsch, EH, Swiontkowski, M, Sanders, D, Tornetta, P, Sanders, DW, Sprague, S, Heels-Ansdell, D, Buckingham, L, Leece, P, Viveiros, H, Mignott, T, Ansell, N, Sidorkewicz, N, Agel, J, Bombardier, C, Berlin, JA, Bosse, M, Browner, B, Gillespie, B, Jones, A, O'Brien, P, Poolman, R, Macleod, MD, Carey, T, Leitch, K, Bailey, S, Gurr, K, Konito, K, Bartha, C, Low, I, MacBean, LV, Ramu, M, Reiber, S, Strapp, R, Tieszer, C, Kreder, HJ, Stephen, DJG, Axelrod, TS, Yee, AJM, Richards, RR, Finkelstein, J, Gofton, W, Murnaghan, J, Schatztker, J, Ford, M, Bulmer, B, Conlan, L, Laflamme, GY, Berry, G, Beaumont, P, Ranger, P, Laflamme, GH, Gagnon, S, Malo, M, Fernandes, J, Poirier, MF, McKee, MD, Waddell, JP, Bogoch, ER, Daniels, TR, McBroom, RR, Vicente, MR, Storey, W, Wild, LM, McCormack, R, Perey, B, Goetz, TJ, Pate, G, Penner, MJ, Panagiotopoulos, K, Pirani, S, Dommisse, IG, Loomer, RL, Stone, T, Moon, K, Zomar, M, Webb, LX, Teasdall, RD, Birkedal, JP, Martin, DF, Ruch, DS, Kilgus, DJ, Pollock, DC, Harris, MB, Wiesler, ER, Ward, WG, Shilt, JS, Koman, AL, Poehling, GG, Kulp, B, Creevy, WR, Stein, AB, Bono, CT, Einhorn, TA, Brown, TD, Pacicca, D, Sledge, JB, Foster, TE, Voloshin, I, Bolton, J, Carlisle, H, Shaughnessy, L, Obremskey, WT, LeCroy, CM, Meinberg, EG, Messer, TM, Craig, WL, Dirschl, DR, Caudle, R, Harris, T, Elhert, K, Hage, W, Jones, R, Piedrahita, L, Schricker, PO, Driver, R, Godwin, J, Kregor, PJ, Tennent, G, Truchan, LM, Sciadini, M, Shuler, FD, Driver, RE, Nading, MA, Neiderstadt, J, Vap, AR, Vallier, HA, Patterson, BM, Wilber, JH, Wilber, RG, Sontich, JK, Moore, TA, Brady, D, Cooperman, DR, Davis, JA, Cureton, BA, Mandel, S, Orr, RD, Sadler, JTS, Hussain, T, Rajaratnam, K, Petrisor, B, Drew, B, Bednar, DA, Kwok, DCH, Pettit, S, Hancock, J, Cole, PA, Smith, JJ, Brown, GA, Lange, TA, Stark, JG, Levy, BA, Swiontkowski, MF, Garaghty, MJ, Salzman, JG, Schutte, CA, Tastad, L, Vang, S, Seligson, D, Roberts, CS, Malkani, AL, Sanders, L, Dyer, C, Heinsen, J, Smith, L, Madanagopal, S, Frantz-Bush, L, Coupe, KJ, Tucker, JJ, Criswell, AR, Buckle, R, Rechter, AJ, Sheth, DS, Urquart, B, Trotscher, T, Anders, MJ, Kowalski, JM, Fineberg, MS, Bone, LB, Phillips, MJ, Rohrbacher, B, Stegemann, P, Mihalko, WM, Buyea, C, Augustine, SJ, Jackson, WT, Solis, G, Ero, SU, Segina, DN, Berrey, HB, Agnew, SG, Fitzpatrick, M, Campbell, LC, Derting, L, McAdams, J, Goslings, JC, Ponsen, KJ, Luitse, J, Kloen, P, Joosse, P, Winkelhagen, J, Duivenvoorden, R, Teague, DC, Davey, J, Sullivan, JA, Ertl, WJJ, Puckett, TA, Pasque, CB, Tompkins, JF, Gruel, CR, Kammerlocher, P, Lehman, TP, Puffinbarger, WR, Carl, KL, Weber, DW, Jomha, NM, Goplen, GR, Masson, E, Beaupre, LA, Greaves, KE, Schaump, LN, Jeray, KJ, Goetz, DR, Westberry, DE, Broderick, JS, Moon, BS, Tanner, SL, Powell, JN, Buckley, RE, Elves, L, Connolly, S, Abraham, EP, Steele, T, Ellis, T, Herzberg, A, Brown, GA, Crawford, DE, Hart, R, Hayden, J, Orfaly, RM, Vigland, T, Vivekaraj, M, Bundy, GL, Miclau, T, Matityahu, A, Coughlin, RR, Kandemir, U, McClellan, RT, Lin, CHH, Karges, D, Cramer, K, Watson, JT, Moed, B, Scott, B, Beck, DJ, Orth, C, Puskas, D, Clark, R, Jones, J, Egol, KA, Paksima, N, France, M, Wai, EK, Johnson, G, Wilkinson, R, Gruszczynski, AT & 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, vol. 30, no. 3, pp. 156-161. https://doi.org/10.1097/BOT.0000000000000533
Lin, Carol Alice ; Bhandari, Mohit ; Guyatt, Gordon ; Walter, Stephen D. ; Schemitsch, Emil H. ; Swiontkowski, Marc ; Sanders, David ; Tornetta, Paul ; Sanders, David W. ; Sprague, Sheila ; Heels-Ansdell, Diane ; Buckingham, Lisa ; Leece, Pamela ; Viveiros, Helena ; Mignott, Tashay ; Ansell, Natalie ; Sidorkewicz, Natalie ; Agel, Julie ; Bombardier, Claire ; Berlin, Jesse A. ; Bosse, Michael ; Browner, Bruce ; Gillespie, Brenda ; Jones, Alan ; O'Brien, Peter ; Poolman, Rudolf ; Macleod, Mark D. ; Carey, Timothy ; Leitch, Kellie ; Bailey, Stuart ; Gurr, Kevin ; Konito, Ken ; Bartha, Charlene ; Low, Isolina ; MacBean, Leila V. ; Ramu, Mala ; Reiber, Susan ; Strapp, Ruth ; Tieszer, Christina ; Kreder, Hans J. ; Stephen, David J G ; Axelrod, Terry S. ; Yee, Albert J M ; Richards, Robin R. ; Finkelstein, Joel ; Gofton, Wade ; Murnaghan, John ; Schatztker, Joseph ; Ford, Michael ; Bulmer, Beverly ; Conlan, Lisa ; Laflamme, G. Yves ; Berry, Gregory ; Beaumont, Pierre ; Ranger, Pierre ; Laflamme, Georges Henri ; Gagnon, Sylvain ; Malo, Michel ; Fernandes, Julio ; Poirier, Marie France ; McKee, Michael D. ; Waddell, James P. ; Bogoch, Earl R. ; Daniels, Timothy R. ; McBroom, Robert R. ; Vicente, Milena R. ; Storey, Wendy ; Wild, Lisa M. ; McCormack, Robert ; Perey, Bertrand ; Goetz, Thomas J. ; Pate, Graham ; Penner, Murray J. ; Panagiotopoulos, Kostas ; Pirani, Shafique ; Dommisse, Ian G. ; Loomer, Richard L. ; Stone, Trevor ; Moon, Karyn ; Zomar, Mauri ; Webb, Lawrence X. ; Teasdall, Robert D. ; Birkedal, John Peter ; Martin, David Franklin ; Ruch, David S. ; Kilgus, Douglas J. ; Pollock, David C. ; Harris, Mitchel Brion ; Wiesler, Ethan Ron ; Ward, William G. ; Shilt, Jeffrey Scott ; Koman, Andrew L. ; Poehling, Gary G. ; Kulp, Brenda ; Creevy, William R. ; Stein, Andrew B. ; Bono, Christopher T. ; Einhorn, Thomas A. ; Brown, T. Desmond ; Pacicca, Donna ; Sledge, John B. ; Foster, Timothy E. ; Voloshin, Ilva ; Bolton, Jill ; Carlisle, Hope ; Shaughnessy, Lisa ; Obremskey, William T. ; LeCroy, C. Michael ; Meinberg, Eric G. ; Messer, Terry M. ; Craig, William L. ; Dirschl, Douglas R. ; Caudle, Robert ; Harris, Tim ; Elhert, Kurt ; Hage, William ; Jones, Robert ; Piedrahita, Luis ; Schricker, Paul O. ; Driver, Robin ; Godwin, Jean ; Kregor, Philip James ; Tennent, Gregory ; Truchan, Lisa M. ; Sciadini, Marcus ; Shuler, Franklin D. ; Driver, Robin E. ; Nading, Mary Alice ; Neiderstadt, Jacky ; Vap, Alexander R. ; Vallier, Heather A. ; Patterson, Brendan M. ; Wilber, John H. ; Wilber, Roger G. ; Sontich, John K. ; Moore, Timothy Alan ; Brady, Drew ; Cooperman, Daniel R. ; Davis, John A. ; Cureton, Beth Ann ; Mandel, Scott ; Orr, R. Douglas ; Sadler, John T S ; Hussain, Tousief ; Rajaratnam, Krishan ; Petrisor, Bradley ; Drew, Brian ; Bednar, Drew A. ; Kwok, Desmond C H ; Pettit, Shirley ; Hancock, Jill ; Cole, Peter A. ; Smith, Joel J. ; Brown, Gregory A. ; Lange, Thomas A. ; Stark, John G. ; Levy, Bruce A. ; Swiontkowski, Marc F. ; Garaghty, Mary J. ; Salzman, Joshua G. ; Schutte, Carol A. ; Tastad, Linda ; Vang, Sandy ; Seligson, David ; Roberts, Craig S. ; Malkani, Arthur L. ; Sanders, Laura ; Dyer, Carmen ; Heinsen, Jessica ; Smith, Langan ; Madanagopal, Sudhakar ; Frantz-Bush, Linda ; Coupe, Kevin J. ; Tucker, Jeffrey J. ; Criswell, Allen R. ; Buckle, Rosemary ; Rechter, Alan Jeffrey ; Sheth, Dhiren Shaskikant ; Urquart, Brad ; Trotscher, Thea ; Anders, Mark J. ; Kowalski, Joseph M. ; Fineberg, Marc S. ; Bone, Lawrence B. ; Phillips, Matthew J. ; Rohrbacher, Bernard ; Stegemann, Philip ; Mihalko, William M. ; Buyea, Cathy ; Augustine, Stephen J. ; Jackson, William Thomas ; Solis, Gregory ; Ero, Sunday U. ; Segina, Daniel N. ; Berrey, Hudson B. ; Agnew, Samuel G. ; Fitzpatrick, Michael ; Campbell, Lakina C. ; Derting, Lynn ; McAdams, June ; Goslings, J. Carel ; Ponsen, Kees Jan ; Luitse, Jan ; Kloen, Peter ; Joosse, Pieter ; Winkelhagen, Jasper ; Duivenvoorden, Raphaël ; Teague, David C. ; Davey, Joseph ; Sullivan, J. Andy ; Ertl, William J J ; Puckett, Timothy A. ; Pasque, Charles B. ; Tompkins, John F. ; Gruel, Curtis R. ; Kammerlocher, Paul ; Lehman, Thomas P. ; Puffinbarger, William R. ; Carl, Kathy L. ; Weber, Donald W. ; Jomha, Nadr M. ; Goplen, Gordon R. ; Masson, Edward ; Beaupre, Lauren A. ; Greaves, Karen E. ; Schaump, Lori N. ; Jeray, Kyle J. ; Goetz, David R. ; Westberry, David E. ; Broderick, J. Scott ; Moon, Bryan S. ; Tanner, Stephanie L. ; Powell, James N. ; Buckley, Richard E. ; Elves, Leslie ; Connolly, Stephen ; Abraham, Edward P. ; Steele, Trudy ; Ellis, Thomas ; Herzberg, Alex ; Brown, George A. ; Crawford, Dennis E. ; Hart, Robert ; Hayden, James ; Orfaly, Robert M. ; Vigland, Theodore ; Vivekaraj, Maharani ; Bundy, Gina L. ; Miclau, Theodore ; Matityahu, Amir ; Coughlin, R. Richard ; Kandemir, Utku ; McClellan, R. Trigg ; Lin, Cindy Hsin Hua ; Karges, David ; Cramer, Kathryn ; Watson, J. Tracy ; Moed, Berton ; Scott, Barbara ; Beck, Dennis J. ; Orth, Carolyn ; Puskas, David ; Clark, Russell ; Jones, Jennifer ; Egol, Kenneth A. ; Paksima, Nader ; France, Monet ; Wai, Eugene K. ; Johnson, Garth ; Wilkinson, Ross ; Gruszczynski, Adam T. ; Vexler, Liisa. / Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial. In: Journal of Orthopaedic Trauma. 2016 ; Vol. 30, No. 3. pp. 156-161.
@article{cbf9877e91214b6c92a272e724f4827a,
title = "Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial",
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.",
keywords = "nonunion, reamed, tibia fracture, unreamed",
author = "Lin, {Carol Alice} and Mohit Bhandari and Gordon Guyatt and Walter, {Stephen D.} and Schemitsch, {Emil H.} and Marc Swiontkowski and David Sanders and Paul Tornetta and Sanders, {David W.} and Sheila Sprague and Diane Heels-Ansdell and Lisa Buckingham and Pamela Leece and Helena Viveiros and Tashay Mignott and Natalie Ansell and Natalie Sidorkewicz and Julie Agel and Claire Bombardier and Berlin, {Jesse A.} and Michael Bosse and Bruce Browner and Brenda Gillespie and Alan Jones and Peter O'Brien and Rudolf Poolman and Macleod, {Mark D.} and Timothy Carey and Kellie Leitch and Stuart Bailey and Kevin Gurr and Ken Konito and Charlene Bartha and Isolina Low and MacBean, {Leila V.} and Mala Ramu and Susan Reiber and Ruth Strapp and Christina Tieszer and Kreder, {Hans J.} and Stephen, {David J G} and Axelrod, {Terry S.} and Yee, {Albert J M} and Richards, {Robin R.} and Joel Finkelstein and Wade Gofton and John Murnaghan and Joseph Schatztker and Michael Ford and Beverly Bulmer and Lisa Conlan and Laflamme, {G. Yves} and Gregory Berry and Pierre Beaumont and Pierre Ranger and Laflamme, {Georges Henri} and Sylvain Gagnon and Michel Malo and Julio Fernandes and Poirier, {Marie France} and McKee, {Michael D.} and Waddell, {James P.} and Bogoch, {Earl R.} and Daniels, {Timothy R.} and McBroom, {Robert R.} and Vicente, {Milena R.} and Wendy Storey and Wild, {Lisa M.} and Robert McCormack and Bertrand Perey and Goetz, {Thomas J.} and Graham Pate and Penner, {Murray J.} and Kostas Panagiotopoulos and Shafique Pirani and Dommisse, {Ian G.} and Loomer, {Richard L.} and Trevor Stone and Karyn Moon and Mauri Zomar and Webb, {Lawrence X.} and Teasdall, {Robert D.} and Birkedal, {John Peter} and Martin, {David Franklin} and Ruch, {David S.} and Kilgus, {Douglas J.} and Pollock, {David C.} and Harris, {Mitchel Brion} and Wiesler, {Ethan Ron} and Ward, {William G.} and Shilt, {Jeffrey Scott} and Koman, {Andrew L.} and Poehling, {Gary G.} and Brenda Kulp and Creevy, {William R.} and Stein, {Andrew B.} and Bono, {Christopher T.} and Einhorn, {Thomas A.} and Brown, {T. Desmond} and Donna Pacicca and Sledge, {John B.} and Foster, {Timothy E.} and Ilva Voloshin and Jill Bolton and Hope Carlisle and Lisa Shaughnessy and Obremskey, {William T.} and LeCroy, {C. Michael} and Meinberg, {Eric G.} and Messer, {Terry M.} and Craig, {William L.} and Dirschl, {Douglas R.} and Robert Caudle and Tim Harris and Kurt Elhert and William Hage and Robert Jones and Luis Piedrahita and Schricker, {Paul O.} and Robin Driver and Jean Godwin and Kregor, {Philip James} and Gregory Tennent and Truchan, {Lisa M.} and Marcus Sciadini and Shuler, {Franklin D.} and Driver, {Robin E.} and Nading, {Mary Alice} and Jacky Neiderstadt and Vap, {Alexander R.} and Vallier, {Heather A.} and Patterson, {Brendan M.} and Wilber, {John H.} and Wilber, {Roger G.} and Sontich, {John K.} and Moore, {Timothy Alan} and Drew Brady and Cooperman, {Daniel R.} and Davis, {John A.} and Cureton, {Beth Ann} and Scott Mandel and Orr, {R. Douglas} and Sadler, {John T S} and Tousief Hussain and Krishan Rajaratnam and Bradley Petrisor and Brian Drew and Bednar, {Drew A.} and Kwok, {Desmond C H} and Shirley Pettit and Jill Hancock and Cole, {Peter A.} and Smith, {Joel J.} and Brown, {Gregory A.} and Lange, {Thomas A.} and Stark, {John G.} and Levy, {Bruce A.} and Swiontkowski, {Marc F.} and Garaghty, {Mary J.} and Salzman, {Joshua G.} and Schutte, {Carol A.} and Linda Tastad and Sandy Vang and David Seligson and Roberts, {Craig S.} and Malkani, {Arthur L.} and Laura Sanders and Carmen Dyer and Jessica Heinsen and Langan Smith and Sudhakar Madanagopal and Linda Frantz-Bush and Coupe, {Kevin J.} and Tucker, {Jeffrey J.} and Criswell, {Allen R.} and Rosemary Buckle and Rechter, {Alan Jeffrey} and Sheth, {Dhiren Shaskikant} and Brad Urquart and Thea Trotscher and Anders, {Mark J.} and Kowalski, {Joseph M.} and Fineberg, {Marc S.} and Bone, {Lawrence B.} and Phillips, {Matthew J.} and Bernard Rohrbacher and Philip Stegemann and Mihalko, {William M.} and Cathy Buyea and Augustine, {Stephen J.} and Jackson, {William Thomas} and Gregory Solis and Ero, {Sunday U.} and Segina, {Daniel N.} and Berrey, {Hudson B.} and Agnew, {Samuel G.} and Michael Fitzpatrick and Campbell, {Lakina C.} and Lynn Derting and June McAdams and Goslings, {J. Carel} and Ponsen, {Kees Jan} and Jan Luitse and Peter Kloen and Pieter Joosse and Jasper Winkelhagen and Rapha{\"e}l Duivenvoorden and Teague, {David C.} and Joseph Davey and Sullivan, {J. Andy} and Ertl, {William J J} and Puckett, {Timothy A.} and Pasque, {Charles B.} and Tompkins, {John F.} and Gruel, {Curtis R.} and Paul Kammerlocher and Lehman, {Thomas P.} and Puffinbarger, {William R.} and Carl, {Kathy L.} and Weber, {Donald W.} and Jomha, {Nadr M.} and Goplen, {Gordon R.} and Edward Masson and Beaupre, {Lauren A.} and Greaves, {Karen E.} and Schaump, {Lori N.} and Jeray, {Kyle J.} and Goetz, {David R.} and Westberry, {David E.} and Broderick, {J. Scott} and Moon, {Bryan S.} and Tanner, {Stephanie L.} and Powell, {James N.} and Buckley, {Richard E.} and Leslie Elves and Stephen Connolly and Abraham, {Edward P.} and Trudy Steele and Thomas Ellis and Alex Herzberg and Brown, {George A.} and Crawford, {Dennis E.} and Robert Hart and James Hayden and Orfaly, {Robert M.} and Theodore Vigland and Maharani Vivekaraj and Bundy, {Gina L.} and Theodore Miclau and Amir Matityahu and Coughlin, {R. Richard} and Utku Kandemir and McClellan, {R. Trigg} and Lin, {Cindy Hsin Hua} and David Karges and Kathryn Cramer and Watson, {J. Tracy} and Berton Moed and Barbara Scott and Beck, {Dennis J.} and Carolyn Orth and David Puskas and Russell Clark and Jennifer Jones and Egol, {Kenneth A.} and Nader Paksima and Monet France and Wai, {Eugene K.} and Garth Johnson and Ross Wilkinson and Gruszczynski, {Adam T.} and Liisa Vexler",
year = "2016",
month = "3",
day = "1",
doi = "10.1097/BOT.0000000000000533",
language = "English (US)",
volume = "30",
pages = "156--161",
journal = "Journal of Orthopaedic Trauma",
issn = "0890-5339",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

AU - Lin, Carol Alice

AU - Bhandari, Mohit

AU - Guyatt, Gordon

AU - Walter, Stephen D.

AU - Schemitsch, Emil H.

AU - Swiontkowski, Marc

AU - Sanders, David

AU - Tornetta, Paul

AU - Sanders, David W.

AU - Sprague, Sheila

AU - Heels-Ansdell, Diane

AU - Buckingham, Lisa

AU - Leece, Pamela

AU - Viveiros, Helena

AU - Mignott, Tashay

AU - Ansell, Natalie

AU - Sidorkewicz, Natalie

AU - Agel, Julie

AU - Bombardier, Claire

AU - Berlin, Jesse A.

AU - Bosse, Michael

AU - Browner, Bruce

AU - Gillespie, Brenda

AU - Jones, Alan

AU - O'Brien, Peter

AU - Poolman, Rudolf

AU - Macleod, Mark D.

AU - Carey, Timothy

AU - Leitch, Kellie

AU - Bailey, Stuart

AU - Gurr, Kevin

AU - Konito, Ken

AU - Bartha, Charlene

AU - Low, Isolina

AU - MacBean, Leila V.

AU - Ramu, Mala

AU - Reiber, Susan

AU - Strapp, Ruth

AU - Tieszer, Christina

AU - Kreder, Hans J.

AU - Stephen, David J G

AU - Axelrod, Terry S.

AU - Yee, Albert J M

AU - Richards, Robin R.

AU - Finkelstein, Joel

AU - Gofton, Wade

AU - Murnaghan, John

AU - Schatztker, Joseph

AU - Ford, Michael

AU - Bulmer, Beverly

AU - Conlan, Lisa

AU - Laflamme, G. Yves

AU - Berry, Gregory

AU - Beaumont, Pierre

AU - Ranger, Pierre

AU - Laflamme, Georges Henri

AU - Gagnon, Sylvain

AU - Malo, Michel

AU - Fernandes, Julio

AU - Poirier, Marie France

AU - McKee, Michael D.

AU - Waddell, James P.

AU - Bogoch, Earl R.

AU - Daniels, Timothy R.

AU - McBroom, Robert R.

AU - Vicente, Milena R.

AU - Storey, Wendy

AU - Wild, Lisa M.

AU - McCormack, Robert

AU - Perey, Bertrand

AU - Goetz, Thomas J.

AU - Pate, Graham

AU - Penner, Murray J.

AU - Panagiotopoulos, Kostas

AU - Pirani, Shafique

AU - Dommisse, Ian G.

AU - Loomer, Richard L.

AU - Stone, Trevor

AU - Moon, Karyn

AU - Zomar, Mauri

AU - Webb, Lawrence X.

AU - Teasdall, Robert D.

AU - Birkedal, John Peter

AU - Martin, David Franklin

AU - Ruch, David S.

AU - Kilgus, Douglas J.

AU - Pollock, David C.

AU - Harris, Mitchel Brion

AU - Wiesler, Ethan Ron

AU - Ward, William G.

AU - Shilt, Jeffrey Scott

AU - Koman, Andrew L.

AU - Poehling, Gary G.

AU - Kulp, Brenda

AU - Creevy, William R.

AU - Stein, Andrew B.

AU - Bono, Christopher T.

AU - Einhorn, Thomas A.

AU - Brown, T. Desmond

AU - Pacicca, Donna

AU - Sledge, John B.

AU - Foster, Timothy E.

AU - Voloshin, Ilva

AU - Bolton, Jill

AU - Carlisle, Hope

AU - Shaughnessy, Lisa

AU - Obremskey, William T.

AU - LeCroy, C. Michael

AU - Meinberg, Eric G.

AU - Messer, Terry M.

AU - Craig, William L.

AU - Dirschl, Douglas R.

AU - Caudle, Robert

AU - Harris, Tim

AU - Elhert, Kurt

AU - Hage, William

AU - Jones, Robert

AU - Piedrahita, Luis

AU - Schricker, Paul O.

AU - Driver, Robin

AU - Godwin, Jean

AU - Kregor, Philip James

AU - Tennent, Gregory

AU - Truchan, Lisa M.

AU - Sciadini, Marcus

AU - Shuler, Franklin D.

AU - Driver, Robin E.

AU - Nading, Mary Alice

AU - Neiderstadt, Jacky

AU - Vap, Alexander R.

AU - Vallier, Heather A.

AU - Patterson, Brendan M.

AU - Wilber, John H.

AU - Wilber, Roger G.

AU - Sontich, John K.

AU - Moore, Timothy Alan

AU - Brady, Drew

AU - Cooperman, Daniel R.

AU - Davis, John A.

AU - Cureton, Beth Ann

AU - Mandel, Scott

AU - Orr, R. Douglas

AU - Sadler, John T S

AU - Hussain, Tousief

AU - Rajaratnam, Krishan

AU - Petrisor, Bradley

AU - Drew, Brian

AU - Bednar, Drew A.

AU - Kwok, Desmond C H

AU - Pettit, Shirley

AU - Hancock, Jill

AU - Cole, Peter A.

AU - Smith, Joel J.

AU - Brown, Gregory A.

AU - Lange, Thomas A.

AU - Stark, John G.

AU - Levy, Bruce A.

AU - Swiontkowski, Marc F.

AU - Garaghty, Mary J.

AU - Salzman, Joshua G.

AU - Schutte, Carol A.

AU - Tastad, Linda

AU - Vang, Sandy

AU - Seligson, David

AU - Roberts, Craig S.

AU - Malkani, Arthur L.

AU - Sanders, Laura

AU - Dyer, Carmen

AU - Heinsen, Jessica

AU - Smith, Langan

AU - Madanagopal, Sudhakar

AU - Frantz-Bush, Linda

AU - Coupe, Kevin J.

AU - Tucker, Jeffrey J.

AU - Criswell, Allen R.

AU - Buckle, Rosemary

AU - Rechter, Alan Jeffrey

AU - Sheth, Dhiren Shaskikant

AU - Urquart, Brad

AU - Trotscher, Thea

AU - Anders, Mark J.

AU - Kowalski, Joseph M.

AU - Fineberg, Marc S.

AU - Bone, Lawrence B.

AU - Phillips, Matthew J.

AU - Rohrbacher, Bernard

AU - Stegemann, Philip

AU - Mihalko, William M.

AU - Buyea, Cathy

AU - Augustine, Stephen J.

AU - Jackson, William Thomas

AU - Solis, Gregory

AU - Ero, Sunday U.

AU - Segina, Daniel N.

AU - Berrey, Hudson B.

AU - Agnew, Samuel G.

AU - Fitzpatrick, Michael

AU - Campbell, Lakina C.

AU - Derting, Lynn

AU - McAdams, June

AU - Goslings, J. Carel

AU - Ponsen, Kees Jan

AU - Luitse, Jan

AU - Kloen, Peter

AU - Joosse, Pieter

AU - Winkelhagen, Jasper

AU - Duivenvoorden, Raphaël

AU - Teague, David C.

AU - Davey, Joseph

AU - Sullivan, J. Andy

AU - Ertl, William J J

AU - Puckett, Timothy A.

AU - Pasque, Charles B.

AU - Tompkins, John F.

AU - Gruel, Curtis R.

AU - Kammerlocher, Paul

AU - Lehman, Thomas P.

AU - Puffinbarger, William R.

AU - Carl, Kathy L.

AU - Weber, Donald W.

AU - Jomha, Nadr M.

AU - Goplen, Gordon R.

AU - Masson, Edward

AU - Beaupre, Lauren A.

AU - Greaves, Karen E.

AU - Schaump, Lori N.

AU - Jeray, Kyle J.

AU - Goetz, David R.

AU - Westberry, David E.

AU - Broderick, J. Scott

AU - Moon, Bryan S.

AU - Tanner, Stephanie L.

AU - Powell, James N.

AU - Buckley, Richard E.

AU - Elves, Leslie

AU - Connolly, Stephen

AU - Abraham, Edward P.

AU - Steele, Trudy

AU - Ellis, Thomas

AU - Herzberg, Alex

AU - Brown, George A.

AU - Crawford, Dennis E.

AU - Hart, Robert

AU - Hayden, James

AU - Orfaly, Robert M.

AU - Vigland, Theodore

AU - Vivekaraj, Maharani

AU - Bundy, Gina L.

AU - Miclau, Theodore

AU - Matityahu, Amir

AU - Coughlin, R. Richard

AU - Kandemir, Utku

AU - McClellan, R. Trigg

AU - Lin, Cindy Hsin Hua

AU - Karges, David

AU - Cramer, Kathryn

AU - Watson, J. Tracy

AU - Moed, Berton

AU - Scott, Barbara

AU - Beck, Dennis J.

AU - Orth, Carolyn

AU - Puskas, David

AU - Clark, Russell

AU - Jones, Jennifer

AU - Egol, Kenneth A.

AU - Paksima, Nader

AU - France, Monet

AU - Wai, Eugene K.

AU - Johnson, Garth

AU - Wilkinson, Ross

AU - Gruszczynski, Adam T.

AU - Vexler, Liisa

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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.

AB - 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.

KW - nonunion

KW - reamed

KW - tibia fracture

KW - unreamed

UR - http://www.scopus.com/inward/record.url?scp=84975784602&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84975784602&partnerID=8YFLogxK

U2 - 10.1097/BOT.0000000000000533

DO - 10.1097/BOT.0000000000000533

M3 - Article

C2 - 27326429

AN - SCOPUS:84975784602

VL - 30

SP - 156

EP - 161

JO - Journal of Orthopaedic Trauma

JF - Journal of Orthopaedic Trauma

SN - 0890-5339

IS - 3

ER -