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Nonunion Following Intramedullary Nailing of the Femur with and without ReamingResults of a Multicenter Randomized Clinical Trial

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In support of their research or preparation of this manuscript, one or more of the authors received grants or outside funding from AO North America, Alberta Heritage Foundation, Synthes Canada, and Foothills Hospital Foundation, Calgary General Hospital, and the Canadian Orthopaedic Foundation. None of the authors 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, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.
This manuscript was prepared by the Canadian Orthopaedic Trauma Society, c/o James N. Powell, MD, FRCS(C), AC144C, 1403-29th Street, N.W., Calgary, AB T2N 2T9, Canada. Principal Investigator: James Powell. Protocol Development: Russell DeGroote, Judy Seidel, Richard Buckley, Robert McCormack, Ross Leighton, Robert Feibel, Emil Schemitsch, Michael McKee, and James Powell. Site Coordinators: Richard Buckley, Robert McCormack, Robert Feibel, Ross Leighton, Emil Schemitsch, David Stephen, and James Powell. Statistical Analysis: Hans Kreder. Manuscript Preparation: Jorge Barla, Russell DeGroote, Richard Buckley, Robert McCormack, Ross Leighton, Robert Feibel, Emil Schemitsch, Michael McKee, David Stephen, Hans Kreder, and James Powell. Contributing Surgeons: R. McCormack, C. Fisher, S. Pirani, G. Pate, B. Perey, M. Spangehl, R. VandeGuchte, H. Kreder, J. Schatzker, R. Hu, D. Stephen, T. Axelrod, J. Finklestein, M. Tile, R. McBroom, E. Schemitsch, J. Waddell, D. Puskas, M. McKee, R. Richards, S. Bowden, D. Alexander, R. Leighton, P. Lammens, D. Petrie, C. Coady, M. Gross, D. Johnston, R. Feibel, G. Moreau, A. Giachino, J. McAuley, G. Dervin, J. Bouchard, D. Barei, J. Powell, R. Buckley, S. Miller, C. Fairbanks, C. Fennell, R. Dewar, J. Donaghy, N. Schachar, J. Splawinsky, and H. Dougall. Research Coordinators: K. Parkhill, L. Gillis, A. Russell, L. Wilde, L. Conlan, J. Grabowski, M. Zomar, and L. Elves.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2003 Nov 01;85(11):2093-2096
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Abstract

Background: Intramedullary nailing of the femur without reaming of the medullary canal has been advocated as a method to reduce marrow embolization to the lungs and the rate of infection after open fractures. The use of nailing without reaming, however, has been associated with lower rates of fracture-healing. The purpose of this prospective study was to compare the rate of union of femoral shaft fractures following intramedullary nailing with and without reaming.

Methods: Two hundred and twenty-four patients were enrolled in a multicenter, prospective, randomized clinical trial to compare nailing without reaming and nailing with reaming. One hundred and six patients with 107 femoral shaft fractures were treated with a smaller diameter nail without reaming of the canal, and 118 patients with 121 fractures had reaming of the canal and insertion of a relatively larger diameter nail. Patients were followed at six-week intervals until union occurred or a nonunion was diagnosed.

Results: The two groups were comparable with regard to the measured patient and injury characteristics. Eight (7.5%) of the 107 fractures in the group without reaming had a nonunion compared with two (1.7%) of 121 fractures in the group with reaming (p = 0.049). The relative risk of nonunion was 4.5 times greater (95% confidence interval = 1 to 20) without reaming and with use of a relatively small-diameter nail.

Conclusion: Intramedullary nailing of femoral shaft fractures without reaming results in a significantly higher rate of nonunion compared with intramedullary nailing with reaming.

Level of Evidence: Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). 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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    Singh Navdeep
    Posted on January 28, 2004
    Reamed V/S Unreamed nail in Femoral fractures
    DMC & Hospital, Ludhiana

    To the Editor:

    We read the article, "Nonunion Following Intra-medullary Nailing of the Femur With and Without Reaming" with interest and found it to be well planned and executed. However, we would like to point out an error in the Discussion

    The authors have compared their results with those of Clatworthy et al.(1), and state that Clatworthy et. al, used only 10mm diameter nails in their trial and that the trial was discontinued due to problems of fixation failure.

    We have read the original article of Clatworthy et al (1) and do not find this statement to be factual. Clatworthy et al did state that they used a variety of nails and failure was noted in nails of different diameters. Furthermore, of the six implant failures they reported, three were in reamed and three were in unreamed procedures.

    In our experience, unreamed nailing is a specialised procedure to be used in clinical circumstances where the aim is to shorten the operative time and stabilise the fracture with minimal intervention, especially in conditions where a patient is in a suboptimal medical state, e.g. polytrauma, pulmonary compromise, or cardiac compromise (2)

    References

    1. Clatworthy MG, Clark DI, Gray DH, Hardy AE. Reamed versus unreamed femoral nails. A randomised, prospective trial. J Bone Joint Surg Br. 1999 Jul;81(4):741-2.

    Bassi, JL, Selhi HS. Reamed versus unreamed nails. J Bone Joint Surg Br. 1999 Jul; 81(4): 741-2.

    Richard Stern, M.D.
    Posted on November 25, 2003
    Nonunion Following Intramedullary Nailing of the Femur
    Hopital Cantonal Universitaire de Geneve

    To the Editor:

    In the recent article entitled "Nonunion Following Intramedullary Nailing of the Femur With and Without Reaming" (2003;85:2093-2096), the authors missed an opportunity to analyze an important variable that is associatied with the development of nonunion--the level of the fractures.

    The authors correctly refer to the study of Tometta(1) which showed that the difference in healing time and nonunion between the reamed and nonreamed groups was most noticeable in those fractures of the distal third of the femur. This is very important information.

    While the authors acknowledge that one of their study's limitations was that "the level of fracture was not fully documented," I had to re-read the manuscript to be sure this was a prospective study! It is entirely unclear to me how in a prospective study where the AO/OTA classification of the femoral shaft fracture was applied in almost each and every case, something as simple as the level of fracture could not be recorded.

    References 1. Tornetta P III, Tiburzi D. Reamed versus nonreamed antegrade femoral nailing. J Orthop Trauma. 2000;14:15-9.

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