Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures

Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators, Mohit Bhandari, Gordon Guyatt, Paul Tornetta 3rd, Emil H Schemitsch, Marc Swiontkowski, David Sanders, Stephen D Walter, David W Gregory Tennent Sanders, 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, Michael Ford, Wade Gofton, John Murnaghan, Joseph Schatztker, 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, Emil H Schemitsch, 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, Paul Tornetta 3rd, William R Creevy, Andrew B Stein, Christopher T Bono, Thomas A Einhorn, T Desmond Brown, Donna Pacicca, John B Sledge 3rd, 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 3rd, Douglas R Dirschl, Robert Caudle, Tim Harris, Kurt Elhert, William Hage, Robert Jones, Luis Piedrahita, Paul O Schricker, Robin Driver, Jean Godwin, William T Obremskey, 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, Mohit Bhandari, Brian Drew, Drew A Bednar, Desmond C H Kwok, Shirley Pettit, Jill Hancock, Natalie Sidorkewicz, 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 2nd, Curtis R Gruel, Paul Kammerlocher, Thomas P Lehman, William R Puffinbarger, Kathy L Carl, Donald W Weber, Nadr M Jomha, Gordon R Goplen, Edward C O 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 3rd, 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, Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators, Mohit Bhandari, Gordon Guyatt, Paul Tornetta 3rd, Emil H Schemitsch, Marc Swiontkowski, David Sanders, Stephen D Walter, David W Gregory Tennent Sanders, 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, Michael Ford, Wade Gofton, John Murnaghan, Joseph Schatztker, 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, Emil H Schemitsch, 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, Paul Tornetta 3rd, William R Creevy, Andrew B Stein, Christopher T Bono, Thomas A Einhorn, T Desmond Brown, Donna Pacicca, John B Sledge 3rd, 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 3rd, Douglas R Dirschl, Robert Caudle, Tim Harris, Kurt Elhert, William Hage, Robert Jones, Luis Piedrahita, Paul O Schricker, Robin Driver, Jean Godwin, William T Obremskey, 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, Mohit Bhandari, Brian Drew, Drew A Bednar, Desmond C H Kwok, Shirley Pettit, Jill Hancock, Natalie Sidorkewicz, 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 2nd, Curtis R Gruel, Paul Kammerlocher, Thomas P Lehman, William R Puffinbarger, Kathy L Carl, Donald W Weber, Nadr M Jomha, Gordon R Goplen, Edward C O 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 3rd, 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

Abstract

Background: There remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.

Methods: We conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.

Results: One thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).

Conclusions: The present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.

Figures

Fig. 1
Fig. 1
Flow diagram showing patient enrollment and follow-up throughout the study.
Fig. 2
Fig. 2
Results of subgroup analysis.

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