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

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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.
Investigation performed at McMaster University, Hamilton, Ontario, Canada

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2008 Dec 01;90(12):2567-2578. doi: 10.2106/JBJS.G.01694
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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.

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

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    References

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Mohit Bhandari, MD
    Posted on January 08, 2009
    The SPRINT investigators respond to Drs. Sarmiento and Latta
    Department of Clinical Epidemiology and Biostatistics, McMaster University

    We read with interest the letter from Drs Sarmiento and Latta in response to our recently published multinational S.P.R.I.N.T. trial comparing reamed versus non-reamed tibial nail insertion in patients with closed and open tibial shaft fractures (1). They raised concerns about omissions in our publication, including the following: 1) no infection rates presented for all patients, 2) lack of radiographic assessments on fracture healing times, x-ray shortening, and malunions and 3) lack of reporting of knee pain.

    The S.P.R.I.N.T. primary outcome, re-operation at 12 months was a composite including bone grafts, implant exchanges, and dynamizations in patients post intramedullary nail insertion and operations for infections and fasciotomies (the latter two irrespective of the fracture gap). Infections in both open and closed fractures were presented in tables 3 and 4 of the publication. We focused on only those infections that required an operative procedure.

    While radiographic assessments of shortening and malunion and time to healing are traditionally important, they are less important to patients than are reoperations, function, and pain. Our article focused on what we believe is the most important issue in tibial fracture management: the need for a re-operation. Tables 3 and 4 provide details about the types of re-operations in response to non-unions.

    Drs Sarmiento and Latta raised greatest concern with our omission of knee pain and related functional issues – these issues are indeed important. S.P.R.I.N.T. evaluated patient function at regular intervals up to 12 months after surgery using the Short Form 36, the Short Musculoskeletal Functional Assessment (SMFA), the Health Utilities Index (HUI) and a focused Knee Pain Questionnaire. We will provide functional and knee pain outcomes in a separate publication. As we stated in the manuscript, our JBJS publication presented only our primary outcome (i.e. re-operation rate) findings. We further referred readers to our trial registration and our previously published [S.P.R.I.N.T.] protocol paper1 in the first paragraph of the Methods section.

    Reference

    1. SPRINT Investigators, Bhandari M, Guyatt G, Tornetta P 3rd, Schemitsch E, Swiontkowski M, Sanders D, Walter SD. Study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design. BMC Musculoskeletal Disord. 2008;9:91.

    Augusto Sarmiento, MD
    Posted on December 20, 2008
    Important Information Missing
    NULL

    To the Editor:

    We write regarding certain important omissions in the recent article by the SPRINT investigators, "Randomized Trial of Reamed and Unreamed Intramedullary Nailing of Tibial Shaft Fractures.

    No conclusions were presented regarding the infection rate or healing time of the 1319 adult patients.

    No data were presented on final shortening. Shortening after intramedullary nailing has been reported by a number of investigators. Bone and Johnson (1) reported 10 mm shortening in 5% of patients, and Hooper et al. reported shortening in 3.4% of patients (2).

    Final angulation was not reported. It must have occurred, particularly in proximal fractures since this problem is well known to occur frequently.

    Perhaps the most important omission was the failure to discuss chronic knee pain following nailing, and the response to removal of the implant. Court-Brown reported an incidence of knee pain in 56.2% of patients, and 24.4% patients required removal of the nail (3). Keating et al. reported the need for removal of the nail because of knee pain in 80% of patients, and after 16 months, the pain had not resolved in 36% of the patients (4). Toivanen et al. reported knee pain in 86% of patients who had a transtendinous approach, and 81% in patients who had a paratendinous approach. 69% of their patients had anterior knee pain at an average of 1.5 years after nail removal (5). Quraishi et al. reported that 93.7% of patients had anterior knee sensory disturbance; 96.8% had pain on kneeling. Twenty-six percent of his patients had their nail removed. Of these, 53.5% had persistent anterior knee, 89.5% had anterior sensory knee disturbance, and 71.4% had pain on kneeling. Metal removal did not facilitate the desired reduction of symptoms (6). Karladani et al. reported that nail removal resulted in less pain in 54% of patients but they were not asymptomatic; pain remained unaltered in 10.7%; and 25% patients had increased pain (7).

    The authors did not receive any outside funding or grants in support of their research for or preparation of this work. 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. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

    References

    1. Bone L, Johnson K. Treatment of tibial fractures by reaming and intramedullary nailing. Journ of Bone and Joint Surgery 1986; 68:877-887.

    2. Hooper G, Keddell R, Penny I. Conservative management of closed nailing of tibial shaft fractures: a randomized prospective trial. Jour. Bone and Joint Surg. Br. 1991;73:83-85.

    3. Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary nailing: its incidence, etiology, and outcome. J Orthop Trauma 1997; 11(2):103-5.

    4. Keating JF, Orfaly R, O’Brien PJ. Knee pain after tibial nailing. J Orthop Trauma 1997; 11:10-3.

    5. Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen MJ.Anterior knee pain after intramedullary nailing of fractures of the tibial shaft. A prospective, randomized study comparing two different nail -insertion techniques. J. of Bone Joint Surg [Am] 2002; 84-A (4):580-5.

    6. Quraishi NA, Chaudhury A, Boerger TO. Persistent anterior knee pain following tibial intramedullary nailing [Poster Exhibit]. AAOS Annual Meeting, 2003. San Francisco, CA, USA.

    7. Karladani AH, Ericsson PA, Granhead H, Karlsson L. Nyberg P. Tibial Intramedullary nails-should they be removed? A retrospective study of 71 patients. Acta Orthopaedica Scandinavica, 2007 Oct. 78 (5):668-71.

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