Abstract
Background:
Patients with a tibial shaft fracture experiencing their first postoperative complication following treatment with intramedullary nails may be at greater risk of subsequent complications than the whole population. We aimed to determine whether the initial method of nail insertion influences outcome in patients with a tibial shaft fracture requiring multiple reoperations.
Methods:
Using the Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures trial data, we categorized patients as those not requiring reoperation, those requiring a single reoperation and those requiring multiple reoperations, and we compared them by nail insertion technique (reamed v. unreamed) and fracture type (open v. closed). We then determined the number of patients whose first reoperation was in response to infection, and we compared other clinical outcomes between the reamed and unreamed groups.
Results:
Among 1226 patients included in this analysis, 175 (14.27%) experienced a single reoperation and 44 patients (3.59%) underwent multiple reoperations. Nail insertion techniques (reamed v. unreamed) did not play a role in the need to perform multiple reoperations. Seventy-five percent of patients requiring multiple reoperations had open tibial shaft fractures. An equal number of these were reamed and unreamed insertions. The majority of patients had their course complicated by infection and almost 50% of patients whose first reoperation was for infection required more than 2 reoperations for management. The rest required multiple procedures for nonunion or bone loss.
Conclusion:
Our findings corroborate those of other studies, in which open fracture type rather than nail insertion technique was found to be the cause of morbidity following intramedullary nailing of tibial fractures.
Clinical trial registration:
Abstract
Contexte:
Les cas de fracture de la diaphyse tibiale qui présentent une première complication postopératoire après un enclouage centromédullaire pourraient être exposés à un risque plus grand de complications ultérieures comparativement à la population générale. Nous avons voulu déterminer si la technique initiale d’enclouage a une influence sur les résultats lorsqu’une fracture de la diaphyse tibiale requiert plusieurs réinterventions.
Méthodes:
À partir de l’essai intitulé Study to Prospectively Evaluate Reamed Intramedullary Nails in Tibial Shaft Fractures pour l’évaluation prospective de l’enclouage alésé des fractures de la diaphyse tibiale, nous avons établi les catégories suivantes : aucune réintervention, 1 seule réintervention et multiples réinterventions, et nous les avons comparées aux plans de la technique d’enclouage (avec c. sans alésage) et du type de fracture (ouverte c. fermée). Nous avons ensuite établi le nombre de cas pour lesquels la première réintervention découlait d’une infection, et nous avons comparé d’autres paramètres cliniques entre les groupes avec et sans alésage.
Résultats:
Sur les 1226 cas inclus dans cette analyse, 175 (14,27 %) ont subi 1 seule réintervention et 44 (3,59 %) en ont subi plusieurs. Les techniques d’enclouage (avec c. sans alésage) n’ont joué aucun rôle dans le recours à de multiples réinterventions. Soixante-quinze pour cent des cas soumis à de multiples réinterventions étaient des fractures ouvertes. Parmi ceuxci, il y avait autant d’enclouages alésés que non alésés. Dans la majorité des cas, la complication était une infection et près de 50 % dont la première réintervention découlait d’une infection ont eu besoin de 2 réinterventions pour en venir à bout. Dans les autres cas, les multiples interventions étaient justifiées par des fractures non consolidées ou une perte osseuse.
Conclusion:
Nos observations confirment les conclusions d’autres études selon lesquelles la cause de la morbidité suivant l’enclouage centromédullaire des fractures tibiales est le type de fracture ouverte plutôt que la technique d’enclouage.
Enregistrement de l’essai:
In the management of tibial shaft fractures, postoperative complications, specifically those that result in a reoperation, are a very important outcome to consider. The likelihood of experiencing a postoperative complication may be increased dramatically owing to the complexities of the injury and procedure. Tibia fractures may have high-energy mechanisms of injury with increasing soft-tissue damage and severity of comminution, which have been associated with greater likelihood of reoperation.1
Reported reoperation rates in closed and open tibial shaft fractures have varied between 17% and 50%.2–4 Common postoperative complications include infection, compartment syndrome, malunion and nonunion.3,5–9 Each complication may result in subsequent surgeries as standard of care. Reoperation not only exposes patients to perioperative risks associated with surgery, but also provides no guarantee that additional complications will not occur.3,10 Patients experiencing their first postoperative complication may be at a greater risk of a subsequent complication than the whole population. Thus, it is important to identify factors that are associated with multiple reoperations.
Current evidence shows that intramedullary nails are the most efficacious implant for the management of tibial shaft fractures.1,11–13 However, the characteristics of patients with tibial shaft fractures who undergo intramedullary nailing and require multiple reoperations have not been described. Evaluation of this subset of patients compared with those who do not require multiple operations is important to address potential differences in outcomes. Furthermore, a comparison of the initial method of nail insertion (reamed v. unreamed) has not been performed in this subset of patients. The Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a large, multicentre randomized clinical trial comparing reamed and unreamed intramedullary nails in patients with tibial shaft fractures. This study suggested a benefit for reamed intramedullary nail insertion in patients with closed tibial shaft fractures, largely owing to fewer dynamizations.2,14 Using data from SPRINT evaluating reamed and unreamed nail insertion, we conducted an analysis to determine if there was a difference in the number of patients requiring multiple reoperations, or their injury characteristics.
Methods
SPRINT study
The standardized protocol for the SPRINT study was approved by the relevant research ethics boards (REB #99–077). The methodological details and the results of the primary SPRINT analysis of reamed compared with unreamed nails have been published.2,14
The SPRINT study involved 29 clinical centres in Canada, the United States and the Netherlands. The surgical protocols for reamed and unreamed nailing were standardized, and all patients underwent the same perioperative protocol. There were 1226 patients who met the eligibility criteria and completed the full 1-year follow-up.
Inclusion criteria for the SPRINT study were skeletal maturity, open or closed tibial shaft fracture (Tscherne classification, grade 0 to 3; Gustilo–Anderson classification, type I–IIIB),15–20 amenability of fracture to surgical repair with an intramedullary nail and informed consent. Exclusion criteria were tibial shaft fractures not amenable to reamed or unreamed nailing, pathologic fractures, loss to follow-up and nonconsent.
In the SPRINT study, the primary outcome was a composite resulting in reoperation that included bone grafting, implant exchange or removal, debridement of bone and soft tissue owing to deep infection, fracture dynamization owing to locking screw removal, removal of locking screws owing to implant fracture or loosening, autodynamization (fracture of a locking screw that resulted in settling of the tibia), fasciotomy, failure of the construct (broken nail) and hematoma drainage. Patients were followed for 1 year postinjury, and we documented the reoperations that were planned after the 12-month follow-up period.
The SPRINT study found that there was a significant interaction between the randomized intervention (reamed v. unreamed) and open and closed fractures. In patients with closed fractures, SPRINT investigators found a significant decrease in risk for patients who received a reamed nail compared with those who received an unreamed nail. This effect was not seen in patients with open fractures.2,14
Study design and methods
Using the SPRINT data, we categorized patients in to the following 3 groups: patients who did not require a reoperation, patients who required a single reoperation and patients who required multiple reoperations, where reoperation is defined as the composite for the SPRINT study, during the 12-month follow-up period. We then determined if there were differences in the number of patients in these categories in the reamed compared with the unreamed treatment group, and in patients with open fractures compared with those with closed fractures. We compared patient and fracture characteristics across the 3 categories, including type of injury. High-energy injuries were defined as motor vehicle accidents, pedestrian–motor vehicle accidents, motorcycle accidents, snowmobile accidents, crush injuries and direct blunt trauma. We further investigated patients whose first reoperation was in response to infection and other clinical outcomes.
Statistical analyses
We performed 2-tailed Student t tests on continuous data and χ2 tests on categorical data to analyze all comparisons, with a p value of less than 0.05 considered statistically significant. All analyses were performed using SAS version 9.2 (SAS Institute).
Results
Among the 1226 patients included in the analysis of the SPRINT trial, 44 patients (3.59%) underwent multiple reoperations, 75% of which were for open fractures (Table 1). Sex, ethnicity, smoking history and leg fracture were similarly distributed among all 3 outcome categories. Furthermore, the nail insertion technique (reamed v. unreamed) had no effect on the number of reoperations (> 1 postindex procedure; p = 0.66).
Table 1.
Intramedullary nail and fracture characteristics among patients with single v. multiple reoperations
| Characteristic | Total n = 1226 |
No. (%) | |
|---|---|---|---|
| Patients with a single reoperation n = 175 |
Patients with multiple reoperations n = 44 |
||
| Randomized group | |||
| Reamed | 622 | 84/622 (13.5) | 21/622 (3.4) |
| Unreamed | 604 | 91/604 (15.1) | 23/604 (3.8) |
| Closed fractures | |||
| Reamed | 416 | 42/416 (10.1) | 3/416 (0.7) |
| Unreamed | 410 | 60/410 (14.6) | 8/410 (2.0) |
| Open fractures | |||
| Reamed | 206 | 42/206 (20.4) | 18/206 (8.7) |
| Unreamed | 194 | 31/194 (16.0) | 15/194 (7.7) |
A total of 11 closed tibial fractures required more than 1 reoperation (0.9%). Tscherne classification fracture type was similar across the 3 outcome categories (p = 0.06). Open fractures were more commonly associated with multiple reoperations than closed fractures (p < 0.001). The 33 patients with open fractures requiring multiple reoperations also had a higher Gustilo–Anderson classification type than the 73 patients with open fractures who had a single reoperation (p = 0.01). We did not find any differences in Orthopaedic Trauma Association classification between patients who had a single reoperation and those who had multiple reoperations (p = 0.31).15 In addition, the number of patients with open fractures who had bone loss was similar across all 3 outcome categories (p = 0.28).
Among the 44 patients with multiple reoperations, 26 had their initial reoperations to treat infection (Table 2). Of the remaining 18 patients who had their initial reoperation for a reason other than infection (nonunion or bone loss), 6 subsequently developed an infection; 32 of 44 (72.7%) patients with multiple reoperations had their course complicated by infection. Among patients with multiple reoperations, there was no difference between reamed and unreamed groups with respect to infection as the indication for the initial reoperation (p = 0.14). Finally, 12 of 44 (27.3%) patients had an additional reoperation planned after 12 months to achieve either union or treat infection. After 12 months, there were 7 patients with planned operations in the reamed group and 5 in the unreamed group (p = 0.50).
Table 2.
Reasons for the first reoperation among patients requiring multiple reoperations, by group*
| Reason for first reoperation | Total | No. (%) | |
|---|---|---|---|
| Patients with 2 reoperations | Patients with > 2 reoperations | ||
| All patients | |||
| Any | 44 | 27 (61.4) | 17 (38.6) |
| Infection | 26 | 14 (53.8) | 12 (46.2) |
| Other† | 18 | 13 (72.2) | 5 (27.8) |
| Reamed | |||
| Any | 21 | 11 (52.4) | 10 (47.6) |
| Infection | 15 | 7 (46.7) | 8 (53.3) |
| Other† | 6 | 4 (66.7) | 2 (33.3) |
| Unreamed | |||
| Any | 23 | 16 (69.6) | 7 (30.4) |
| Infection | 11 | 7 (63.6) | 4 (36.4) |
| Other† | 12 | 9 (75.0) | 3 (25.0) |
There were no statistically significant differences between reamed and unreamed groups (p > 0.05) for any of the variables assessed.
”Other” includes nonunion and bone loss.
Discussion
The SPRINT trial randomized patients with tibial shaft fractures to insertion of an intramedullary nail with either a reamed or unreamed technique. In patients with closed fractures, patients who received reamed nail insertion had a lower risk of reoperation than those who received unreamed nail insertion. This was not the case in patients with open fractures. However, no distinction was made between patients who required a single reoperation and those who required multiple reoperations.
The number of patients in the SPRINT study who underwent multiple reoperations within the first 12 months after primary intervention was relatively small (3.6%). Among patients with at least 1 reoperation before 12 months, 15% had an additional reoperation planned after 12 months, which is indicative of an extended recovery period. Patients who had multiple reoperations were more likely to have high-energy mechanisms of injury and open fractures. These findings are consistent with those of prior studies.3,4,21
Limitations
Our study had several strengths, including the large sample size of 1226 patients with tibial shaft fractures from 29 clinical centres from Canada, the United States and the Netherlands, which increased the generalizability of our results. To ensure uniformity, a Central Adjudication Committee consisting of 5 orthopedic surgeons adjudicated all of the outcomes, including reoperation.
The major limitation of this particular analysis is that we were unable to collect data beyond the 1-year follow-up period. Since tibial shaft fractures are associated with considerable complications following initial surgery, it is not uncommon for problems to exist beyond the first 12 months postsurgery, especially for open fractures and cases of nonunion or bone loss. Therefore, any additional reoperations that participants underwent after the study follow-up period would not have been captured in our analysis. This drawback introduces some bias in that the study period was not long enough to completely answer our research question.
Despite this limitation, our findings showed that nail insertion technique (reamed v. unreamed) did not play a role in the need for multiple reoperations. Seventy-five percent of patients requiring multiple reoperations had open tibial shaft fractures. An equal number of these patients received reamed and unreamed insertions. The majority of patients had their course complicated by infection, and almost 50% of patients whose first reoperation was for infection required more than 2 reoperations for management. The rest required multiple procedures for nonunion or bone loss. These data corroborate the findings of previous studies, that open fracture type rather than the technique of nail insertion is the main cause of morbidity following intramedullary nailing of tibia fractures.
Conclusion
In the subset of patients who require multiple reoperations after intramedullary nailing of tibial shaft fractures, nail insertion technique does not appear to influence the likelihood of requiring multiple reoperations 1-year postoperatively.
Acknowledgement
The authors thank Dr. Michel Saccone for his expertise and assistance throughout all aspects of the study and for his help in writing the manuscript.
Footnotes
Competing interests: Emil Schemitsch received research support from Biocomposites and Smith & Nephew. He also received publishing royalties from Saunders/Mosby-Elsevier and Springer and intellectual property royalties from Stryker and Implants for Trauma Surgery (ITS). He was a paid consultant for Acumed, LLC; Amgen Co.; Heron Therapeutics; ITS; Pentopharm; Sanofi–Aventis; Smith & Nephew; Stryker; Swemac and Synthes. He was also an editorial board member for the Journal of Orthopaedic Trauma and the International Orthopaedic Trauma Association. He was a board member for the Canadian Orthopaedic Association and the Orthopaedic Trauma Association. He also received financial and material support from DePuy (a Johnson & Johnson company), Smith & Nephew, Stryker and Zimmer Biomet. Mohit Bhandari received research support from the Canadian Institutes of Health Research, National Institutes of Health, Physicians’ Services Incorporated and the United States Department of Defense. He was a paid consultant for AgNovos Healthcare, Sanofi–Aventis and Smith & Nephew and a board member for the International Society of Orthopaedic Surgery and Traumatology. Marc Swiontkowski was a data safety and monitoring board chair for the Major Extremity Trauma Research Consortium. David W. Sanders received research support from Arthrex, Inc. and from Stryker, where he was also a paid consultant. He was a board member for the Orthopaedic Trauma Association and an editorial board member with Wolters Kluwer Health– Lippincott Williams & Wilkins. Paul Tornetta III received financial and material support and publishing royalties from Wolters Kluwer Health–Lippincott Williams & Wilkins. He received intellectual property royalties from Smith & Nephew. He was also an editorial board member for the Journal of Orthopaedic Trauma.
Contributors: M. Bhandari, A. Kumar, E. Schemitsch designed the study. D.W. Sanders, S. Sprague and P. Tornetta III acquired the data, which G. Guyatt, D. Heels-Ansdell, M. Swiontkowski and S.D. Walter analyzed. M. Bhandari, D. Heels-Ansdell, A. Kumar, E. Schemitsch and S.D. Walter wrote the article, which G. Guyatt, D.W. Sanders, S. Sprague, M. Swiontkowski and P. Tornetta III reviewed. All authors approved the final version to be published.
SPRINT committee members: Coprincipal investigators: Mohit Bhandari, Gordon Guyatt. Steering Committee: Gordon Guyatt (chair), Mohit Bhandari, David W. Sanders, Emil H. Schemitsch, Marc Swiontkowski, Paul Tornetta III, Stephen Walter. Central Adjudication Committee: Gordon Guyatt (chair), Mohit Bhandari, David W. Sanders, Emil H. Schemitsch, Marc Swiontkowski, Paul Tornetta III, Stephen Walter. Methods Centre Staff: McMaster University: Sheila Sprague, Diane Heels-Ansdell, Lisa Buckingham, Pamela Leece, Helena Viveiros, Tashay Mignott, Natalie Ansell, Natalie Sidorkewicz; University of Minnesota: Julie Agel. Data Safety and Monitoring Board: Claire Bombardier (chair), Jesse A. Berlin, Michael Bosse, Bruce Browner, Brenda Gillespie, Alan Jones, Peter O’Brien. Site Audit Committee: Julie Agel, Sheila Sprague, Rudolf Poolman, Mohit Bhandari.
SPRINT investigators: London Health Sciences Centre/University of Western Ontario: David W. 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; Sunnybrook Health Sciences Centre/University of Toronto: 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; Hôpital du Sacré-Cœurde-Montréal: G. Yves Laflamme, Gregory Berry, Pierre Beaumont, Pierre Ranger, Georges-Henri Laflamme, Sylvain Gagnon, Michel Malo, Julio Fernandes, Marie-France Poirier; St. Michael’s Hospital/ University of Toronto: 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; Royal Columbian Hospital/University of British Columbia: 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; Wake Forest Medical Center/Wake Forest University Health Sciences: 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; Boston Medical Center/Boston University School of Medicine: Paul Tornetta III, William R. Creevy, Andrew B. Stein, Christopher T. Bono, Thomas A. Einhorn, T. Desmond Brown, Donna Pacicca, John B. Sledge III, Timothy E. Foster, Ilva Voloshin, Jill Bolton, Hope Carlisle, Lisa Shaughnessy; Wake Medical Center: William T. Obremskey, C. Michael LeCroy, Eric G. Meinberg, Terry M. Messer, William L. Craig III, Douglas R. Dirschl, Robert Caudle, Tim Harris, Kurt Elhert, William Hage, Robert Jones, Luis Piedrahita, Paul O. Schricker, Robin Driver, Jean Godwin; Vanderbilt University Medical Center: 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; MetroHealth Medical Center: 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; Hamilton Health Sciences: 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; Regions Hospital: 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; University of Louisville School of Medicine: David Seligson, Craig S. Roberts, Arthur L. Malkani, Laura Sanders, Carmen Dyer, Jessica Heinsen, Langan Smith, Sudhakar Madanagopal, Linda Frantz-Bush; Memorial Hermann Hospital: Kevin J. Coupe, Jeffrey J. Tucker, Allen R. Criswell, Rosemary Buckle, Alan Jeffrey Rechter, Dhiren Shaskikant Sheth, Brad Urquart, Thea Trotscher; Erie County Medical Center/University of Buffalo: Mark J. Anders, Joseph M. Kowalski, Marc S. Fineberg, Lawrence B. Bone, Matthew J. Phillips, Bernard Rohrbacher, Philip Stegemann, William M. Mihalko, Cathy Buyea; University of Florida – Jacksonville: 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; Academic Medical Center, Amsterdam: J. Carel Goslings, Kees Jan Ponsen, Jan Luitse, Peter Kloen, Pieter Joosse, Jasper Winkelhagen, Raphaël Duivenvoorden; University of Oklahoma Health Science Center: David C. Teague, Joseph Davey, J. Andy Sullivan, William J.J. Ertl, Timothy A. Puckett, Charles B. Pasque, John F. Tompkins II, Curtis R. Gruel, Paul Kammerlocher, Thomas P. Lehman, William R. Puffinbarger, Kathy L. Carl; University of Alberta/University of Alberta Hospital/Royal Alexandra Hospital: Donald W. Weber, Nadr M. Jomha, Gordon R. Goplen, Edward Masson, Lauren A. Beaupre, Karen E. Greaves, Lori N. Schaump; Greenville Hospital System: Kyle J. Jeray, David R. Goetz, David E. Westberry, J. Scott Broderick, Bryan S. Moon, Stephanie L. Tanner; Foothills General Hospital: James N. Powell, Richard E. Buckley, Leslie Elves; Saint John Regional Hospital: Stephen Connolly, Edward P. Abraham, Trudy Steele; Oregon Health & Sciences University: Thomas Ellis, Alex Herzberg, George A. Brown, Dennis E. Crawford, Robert Hart, James Hayden, Robert M. Orfaly, Theodore Vigland, Maharani Vivekaraj, Gina L. Bundy; University of California/San Francisco General Hospital: Theodore Miclau III, Amir Matityahu, R. Richard Coughlin, Utku Kandemir, R. Trigg McClellan, Cindy Hsin-Hua Lin; Detroit Receiving Hospital: David Karges, Kathryn Cramer, J. Tracy Watson, Berton Moed, Barbara Scott; Deaconess Hospital Regional Trauma Center and Orthopaedic Associates: Dennis J. Beck, Carolyn Orth; Thunder Bay Regional Health Science Centre: David Puskas, Russell Clark, Jennifer Jones; Jamaica Hospital: Kenneth A. Egol, Nader Paksima, Monet France; Ottawa Hospital – Civic Campus: Eugene K. Wai, Garth Johnson, Ross Wilkinson, Adam T. Gruszczynski, Liisa Vexler.
Disclaimer: The funding sources had no role or influence on the project or manuscript.
Funding: The study was funded with research grants from: the Canadian Institutes of Health Research (#MCT-38140), National Institutes of Health (NIAMS-072 and R01-AR48529), Orthopaedic Research and Education Foundation of the American Academy of Orthopaedic Surgeons, Orthopaedic Trauma Association, Hamilton Health Sciences Research Grant and Zimmer Biomet.
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