The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 85, Issue 11

Scientific Articles | November 01, 2003

Nonunion Following Intramedullary Nailing of the Femur with and without Reaming: Results of a Multicenter Randomized Clinical Trial

View Disclosures and Other Information

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.

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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.

Figures in this Article

Despite the clinical success achieved with intramedullary nailing after reaming^1-5, several concerns have persisted about the biological consequences of reaming. Reaming disrupts the cortical blood flow⁶, and it causes variable degrees of thermal necrosis⁷ of the cortical bone⁸. Elevated intramedullary pressures associated with reaming can also result in marrow embolization⁹. Transesophageal echocardiography has shown large emboli in the inferior vena cava and the right atrium during reaming¹⁰. Embolization may trigger the development of adult respiratory distress syndrome. Reaming has also been associated with an increased consumption of coagulation factors¹¹ and a theoretical concern of an increased risk of infection in open fractures.

The use of small diameter nails without reaming may address some of the real and theoretical disadvantages of reaming. Recent studies have yielded contradictory results as to whether small diameter nails without reaming yield improved results, especially with regard to rates of fracture-healing^12-15.

The purpose of this prospective study was to compare the rate of union of femoral shaft fractures in patients treated with reaming of the canal and insertion of an intramedullary nail with that in patients in whom the femur was stabilized with femoral nailing without reaming.

Materials and Methods

Materials and Methods | Results | Discussion | Acknowledgements | References

This study was a prospective, randomized, multicenter clinical trial involving seven level-I trauma centers, including Foothills Medical Centre, Calgary, Alberta; Calgary General Hospital, Calgary, Alberta; Royal Columbian Hospital, New Westminster, British Columbia; Sunnybrook and Women's College Health Sciences Centre, Toronto; St. Michael's Hospital, Toronto; the Ottawa Hospital, Ottawa, Ontario; and Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada. Institutional Review Board approval for the study was obtained at each center.

Skeletally mature patients were eligible for the trial if the femoral shaft fracture was at least 1 cm distal to the lesser trochanter and =6 cm proximal to the distal femoral physeal scar. Patients were excluded if the femoral canal was <9 mm in diameter on preoperative anteroposterior and lateral radiographs, or if the elapsed time from the injury to the intramedullary nailing was greater than twenty-four hours. Additional exclusion criteria included a medical contraindication to surgery, a history of myocardial ischemia, a pathologic fracture, a previous joint dislocation or major fracture of the ipsilateral extremity, a grade-IIIB open fracture¹⁶ seen more than eight hours from the time of the injury to the time of irrigation and débridement, all grade-IIIC open fractures, an ipsilateral femoral neck or intertrochanteric fracture, or an intra-articular distal femoral fracture within 6 cm of the physeal scar or a patient who was not willing or able to return for follow-up visits or who was not willing to participate in the trial. All patients or their next-of-kin signed an informed-consent form.

Sequentially marked, sealed envelopes with computer-generated random numbers were used immediately before surgery to randomly assign patients to antegrade nailing either with or without reaming. Randomization was stratified according to the Injury Severity Score¹⁷ into two groups: those with a score of =18 or those with a score of <18 points. Patients with a bilateral femoral shaft fracture were randomized once, and the same technique was used for both femora. The only reaming permitted in the group managed without reaming was that required to create the entry point in the proximal part of the femur for nail insertion. The patients in the group managed with reaming underwent canal preparation with reamers from the same manufacturer as that of the nailing system until cortical chatter could be heard and felt, implying filling of the canal and endosteal contact at the isthmus of the diaphysis with the reamer. A nail measuring 1.0 to 1.5 mm less than the final reaming was then inserted. For the femora that had nailing without reaming, a Synthes solid titanium nail (Davos, Switzerland) was inserted into the canal without use of a guide-wire. In the femora that had nailing with reaming, the implants that were used included the Russell-Taylor femoral nail (Smith and Nephew Richards, Memphis, Tennessee), Synthes Universal femoral nail (Synthes USA, Paoli, Pennsylvania), Grosse-Kempf nail (Howmedica, Rutherford, New Jersey), ZMS (Zimmer, Warsaw, Indiana), and the Synthes solid titanium nail. All implants were approved by the Health Protection Branch of Health and Welfare Canada for femoral nailing. During nail insertion, care was taken to avoid distraction at the fracture site.

Patients were evaluated at two, six, twelve, twenty-six, and fifty-two weeks following surgery. If there was no evidence of union at twelve weeks, we examined the patient at roughly six-week intervals until union or nonunion was confirmed. An independent research assistant, without knowledge of the type of implant, assessed the patients at these times and collected clinical, radiographic, and functional information with use of a standardized data abstraction form.

A nonunion was defined as pain and motion at the fracture site and the radiographic persistence of a radiolucent line without progressive callus formation on three sequential radiographs following fracture fixation. The diagnosis of nonunion was made by the treating surgeon and was confirmed by the principal investigator. No attempt was made to define delayed union. A malunion was defined as angulation of >5° of varus or valgus and >10° of procurvatum or recurvatum.

Statistical analysis was performed with use of a two-tailed Fisher exact test to compare the rate of nonunion in the two treatment groups.

Results

Materials and Methods | Results | Discussion | Acknowledgements | References

Atotal of 224 patients who had 228 fractures of the femoral shaft were enrolled into the trial from April 1995 to February 1999 at the seven participating institutions. One hundred and six patients (107 fractures) were randomized to have femoral nailing without reaming, and 118 patients (121 fractures) were randomized to have femoral nailing with reaming. Three patients in the group managed with reaming had a bilateral fracture of the femoral shaft.

The average Injury Severity Score was 15.8 in the group managed with reaming and 16.2 in the group managed without reaming. The average age of the patients in the groups was thirty-one and thirty-two years, respectively. The male-to-female ratio was 2.3:1 in the group managed with reaming and 3.8:1 in the group managed without reaming. Ninety-four (89%) of 106 patients managed without reaming and 104 (88%) of 118 patients managed with reaming had a closed injury. The groups were comparable with regard to fracture type according to the ASIF fracture classification¹⁸. In the group managed with reaming, forty-nine fractures (41%) were type A; fifty-five (46%), type B; fifteen (12%), type C fractures; and two were not classified. In the group managed without reaming, fifty fractures (47%) were type A; forty-six (43%), type B; and twelve (11%), type C. Forty-three (36%) of 118 patients in the group managed with reaming and thirty-three (31%) of 106 patients in the group managed without reaming were smokers. The average diameter of the nail used for stabilization was 10 mm in the group managed without reaming^9-13 and 11 mm in the group managed with reaming^9-15.

In the group managed without reaming, eight (7.5%) of 107 fractures had a nonunion compared with two (1.7%) of 121 fractures in the group managed with reaming (p = 0.049). The relative risk of nonunion was 4.5 times greater (95% confidence interval = 1 to 20) with no reaming and insertion of a relatively smaller diameter nail. Although these results were significant, they should be interpreted with caution because of the small sample size and low event rate. A sample size of 420 patients would be necessary to achieve an 80% power for this study.

One of the two patients who had a nonunion in the group managed with reaming underwent an exchange nailing at seventy weeks, and the other had dynamization (locking screw removal) of the nail at fifty-two weeks. Both nonunions healed without additional surgery. Of the eight patients with a nonunion in the group managed without reaming, five underwent exchange nailing and two had application of a plate and bone-grafting after nail removal. All seven had healing of the nonunion. The eighth patient, who had been followed for fifty-two weeks, was subsequently lost to follow-up.

The other documented complications in this series included a superficial infection (three patients), foot drop (two), compartment syndrome (one), and deep infection (one).

Discussion

Materials and Methods | Results | Discussion | Acknowledgements | References

Most published investigations have noted fewer nonunions associated with nailing with reaming than with nailing without reaming. In a retrospective, nonrandomized study, Reynders and Broos compared the results of the treatment in 107 closed femoral fractures¹⁹. Fifty-four fractures underwent treatment with reaming, and fifty-three had treatment without reaming. All fractures in that series healed without further intervention, but five fractures in the group managed without reaming had a malunion. They found no difference between the groups with respect to healing time (19.2 compared with 19.6 weeks). A substantial decrease in operating time and the potential reduction in the risk of development of adult respiratory distress syndrome led the authors to recommend the use of a technique without reaming.

Giannoudis et al. reached similar conclusions in a retrospective study of fifty-one fractures in forty-nine patients, including twenty-four fractures that had nailing without reaming and twenty-seven that had nailing with reaming²⁰. One nonunion occurred in each group. The authors noted that the fractures in the group that had nailing without reaming healed at a mean 26.9 weeks compared with 20.5 weeks in the group that had nailing with reaming. Krettek et al.²¹ and Kropfl et al.²², although they did not directly compare femoral nailing with and without reaming, demonstrated good results with use of a femoral nailing technique without reaming. The mean time to healing in those studies was less than sixteen weeks, and none of the 138 femoral shaft fractures had nonunion. Hammacher et al. did not find the same results in a study of 129 acute femoral fractures treated with nailing without reaming in eight different centers¹³. Five percent of the patients had a nonunion, 2.9% had a delayed union, and 6.6% needed secondary intervention to achieve union. In a retrospective study, Herscovici et al. analyzed the treatment of 121 patients with 125 fractures that were treated with antegrade and retrograde nailing techniques without reaming²³. The rate of union was 93%.

Clatworthy et al. reported on twenty-three patients who had nailing without reaming and twenty-two who had nailing after reaming²⁴. The trial was discontinued because of problems with fixation failure. All nails were 10 mm in diameter. Nonetheless, the authors noted that the time to union was more than nine months for 57% of the fractures treated without reaming and for 18% of those that had reaming²⁴. In a prospective, randomized study, Tornetta and Tiburzi analyzed the results of eighty-nine fractures that had nailing without reaming and eighty-three that had nailing with reaming¹⁵. The mean time to union was eighty days for the group that had reaming and 109 days for the group without reaming. They noted that the difference was most disparate in fractures of the distal third of the femur. All fractures united, and no major complication was associated with delayed healing.

Reaming allows the insertion of a larger nail, which improves its mechanical purchase and provides greater stability^25-27. Grundnes et al. concluded that a tightly fit nail induced a greater periosteal reaction²⁸. Reaming of the canal deposits increased the amounts of cortical bone fragments and marrow elements at the fracture site. Even though they have not been studied in detail, these reamings are thought to have osteoinductive properties^25,29-32. Even though some investigators have found no biologic effect from the reamings³³, others have described an intensive new-bone formation around the reaming effluent seen both on histological sections and on radiographs²⁸. Reaming disrupts the circulation of the inner two-thirds of the cortex⁶, yet a sixfold increase in periosteal blood flow has been measured after reaming³³. The improved biomechanics associated with complete filling of the canal and the osteoinductive properties of the reamings may be responsible for the higher rate of union observed in our patients who had reaming.

The present study has some limitations. Several of the risk factors for nonunion were not quantified, bone loss was not measured, and the level of the fracture was not fully documented. Although we are not aware of any study that has shown a difference in the rate of union between male and female patients, we found a different gender ratio between the groups managed with and without reaming. The final limitation was the power calculation. An enrollment of 420 patients would have been necessary to achieve a power of 80%.

The results of this trial support the idea that intramedullary reaming of the femoral canal prior to nail insertion most predictably leads to union. We believe that intramedullary nailing with reaming should remain the standard of care for the majority of femoral shaft fractures.

Acknowledgements

Materials and Methods | Results | Discussion | Acknowledgements | References

Note: The authors wish to especially acknowledge the efforts of Ms. Leslie Elves in all aspects of this clinical investigation.

References

Materials and Methods | Results | Discussion | Acknowledgements | References

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Winquist RA, Hansen ST Jr, Clawson DK. Closed intramedullary nailing of femoral fractures. A report of five hundred and twenty cases. J Bone Joint Surg Am.1984;66: 529-39.66529 1984 [PubMed]

Trueta J, Cavadias AX. Vascular changes caused by the Kuntscher type of nailing. An experimental study in the rabbit. J Bone Joint Surg Br.1955;37: 492-505.37492 1955 [PubMed]

Schemitsch EH, Kowalski MJ, Swiontkowski MF, Harrington RM. Comparison of the effect of reamed and unreamed locked intramedullary nailing on blood flow in the callus and strength of union following fracture of the sheep tibia. J Orthop Res.1995;13: 382-9.13382 1995 [CrossRef]

Leunig M, Hertel R. Thermal necrosis after tibial reaming for intramedullary nail fixation. A report of three cases. J Bone Joint Surg Br.1996;78: 584-7.78584 1996 [PubMed]

Martin R, Leighton RK, Petrie D, Ikejiani C, Smyth B. Effect of proximal and distal venting during intramedullary nailing. Clin Orthop.1996;332: 80-9.33280 1996 [PubMed][CrossRef]

Wenda K, Runkel M, Degreif J, Ritter G. Pathogenesis and clinical relevance of bone marrow embolism in medullary nailing—demonstrated by intraoperative echocardiography. Injury.1993;24 (Suppl 3): 73-81.2473 1993 [CrossRef]

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Boyer MI, Ribeiro E, Hu R, Powell JN. Small versus large diameter closed-section femoral nails for the treatment of femoral shaft fractures: is there a difference? J Trauma.1996;41: 279-82.41279 1996 [CrossRef]

Hammacher ER, van Meeteren MC, van der Werken C. Improved results in treatment of femoral shaft fractures with the unreamed femoral nail? A multicenter experience. J Trauma.1998;45: 517-21.45517 1998 [CrossRef]

Tornetta P III, Tiburzi D. The treatment of femoral shaft fractures using intramedullary interlocked nails with and without intramedullary reaming: a preliminary report. J Orthop Trauma.1997;11: 89-92.1189 1997 [CrossRef]

Tornetta P III, Tiburzi D. Reamed versus nonreamed anterograde femoral nailing. J Orthop Trauma.2000;14: 15-9.1415 2000 [CrossRef]

Gustilo RB, Mendoza RM, Williams DN. Problem in the management of type III (severe) open fractures; a new classification of type III open fractures. J Trauma.1984;24: 742-6.24742 1984 [PubMed][CrossRef]

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Muller ME, Nazarian S, Koch P, Schatzker J.The comprehensive classification of fractures of long bones. New York: Springer; 1990. 1990

Reynders PA, Broos PL. Healing of closed femoral fractures treated with the AO unreamed femoral nail. A comparative study with the AO reamed femoral nail. Injury.2000;31: 367-71.31367 2000 [PubMed][CrossRef]

Giannoudis PV, Furlong AJ, Macdonald DA, Smith RM. Reamed against unreamed nailing of the femoral diaphysis: a retrospective study of healing time. Injury.1997;28: 15-8.2815 1997 [PubMed][CrossRef]

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Topics

fracture ; bone nails ; femur ; femoral shaft fracture ; intramedullary nailing

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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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Nonunion Following Intramedullary Nailing of the Femur with and without ReamingResults of a Multicenter Randomized Clinical Trial. The Journal of Bone & Joint Surgery. 2003 Nov;85(11):2093-2096.

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