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Randomized Trial of Reamed and Unreamed Intramedullary Nailing of Tibial Shaft Fractures

Investigation performed at McMaster University, Hamilton, Ontario, Canada

^* The Writing Committee included Mohit Bhandari, MD, MSc, FRCSC, Gordon Guyatt, MD, Paul Tornetta III, MD, Emil H. Schemitsch, MD, Marc Swiontkowski, MD, David Sanders, MD, and Stephen D. Walter, PhD. Please see note preceding reference section for additional details regarding the authors and investigators.

Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the Canadian Institutes of Health Research (MCT-38140), the National Institutes of Health (NIAMS-072; R01 AR48529), the Orthopaedic Research and Education Foundation, the Orthopaedic Trauma Association, a Hamilton Health Sciences research grant, Zimmer, and a Canada Research Chair in Musculoskeletal Trauma at McMaster University. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. Commercial entities (Canadian Institutes of Health Research, Stryker, Smith and Nephew) paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.

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.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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