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© 1997 The Journal of Bone and Joint Surgery, Inc. Locking Intramedullary Nailing with and without Reaming for Open Fractures of the Tibial Shaft. A Prospective, Randomized Study*  , VANCOUVER, BRITISH COLUMBIA, CANADAInvestigation performed at Vancouver Hospital and Health Sciences Centre, Vancouver
Ninety-one patients who had ninety-four open fractures of the tibial shaft were randomized into two treatment groups. Fifty fractures (nine type-I, eighteen type-II, sixteen type-IIIA, and seven type-IIIB fractures, according to the classification of Gustilo et al.) were treated with nailing after reaming, and forty-four fractures (five type-I, sixteen type-II, nineteen type-IIIA, and four type-IIIB fractures) were treated with nailing without reaming. The average diameter of the nail was 11.5 millimeters (range, nine to fourteen millimeters) in the group treated with reaming and 9.2 millimeters (range, eight to ten millimeters) in the group treated without reaming. Follow-up information was adequate for forty-five patients (forty-seven fractures) who had been managed with reaming and forty patients (forty-one fractures) who had been managed without reaming. No clinically important differences were found between the two groups with regard to the technical aspects of the procedure or the rate of early postoperative complications. The average time to union was thirty weeks (range, thirteen to seventy-two weeks) in the group treated with reaming and twenty-nine weeks (range, thirteen to fifty weeks) in the group treated without reaming. Four (9 per cent) of the fractures treated with reaming and five (12 per cent) of the fractures treated without reaming did not unite (p = 0.73). There were two infections in the group treated with reaming and one in the group treated without reaming. Significantly more screws broke in the group treated without reaming (twelve; 29 per cent) than in the group treated with reaming (four; 9 per cent) (p = 0.014). There was no difference between the two groups with regard to the frequency of broken nails (two nails that had been inserted after reaming broke, compared with one that had been inserted without reaming). The functional outcome, in terms of pain in the knee, range of motion, return to work, and recreational activity, did not differ significantly between the groups. We concluded that the clinical and radiographic results of nailing after reaming are similar to those of nailing without reaming for fixation of open fractures of the tibial shaft, although more screws broke when reaming had not been done.
Interlocking intramedullary nailing has become a popular method of fixation for closed tibial fractures, and a series of reports has confirmed excellent results with this technique6,11,20,24. However, the use of intramedullary nails for open tibial fractures is controversial. The standard treatment for these injuries has been external fixation, particularly for fractures associated with more severe soft-tissue injuries9,10,21. Intramedullary nailing with reaming of the medullary canal is generally considered to be contraindicated for open fractures of the tibia3,14,26, as the damage to the endosteal blood supply caused by reaming25 may theoretically increase the risks of non-union and deep infection. It has, therefore, been suggested that insertion of nails without reaming is safer. Recent studies have indicated, however, that nailing either with or without reaming can be used for open tibial fractures with acceptable results7,8,29. The purpose of the present study was to compare the clinical and radiographic results of intramedullary nailing of open fractures of the tibial shaft after reaming with those of nailing without reaming.
All adult patients who were seen at Vancouver Hospital and Health Sciences Centre, a tertiary care teaching hospital, because of an open fracture of the tibial diaphysis between October 1989 and September 1993 were evaluated for inclusion in the present study. Approval from the Hospital Ethics Committee was obtained before the investigation was begun, and the patients gave informed consent before they were entered into the study. All grades of open injury were considered suitable for the study. The patients were randomized with a sealed-envelope selection technique to either nailing with reaming or nailing without reaming. Patients were excluded if they had a fracture in the proximal fourth of the tibia or a fracture within four centimeters of the ankle, neither of which was judged to be amenable to intramedullary nailing; if they had been seen more than twenty-four hours after the injury; if they had initially been managed with external fixation at another institution; or if they had open growth plates. There were no other exclusion criteria. Ninety-seven patients who had 100 open fractures of the tibial shaft were entered into the study. Fifty patients (fifty-two fractures) were randomized to have a nail inserted after reaming, and forty-seven patients (forty-eight fractures) were randomized to have a nail inserted without reaming. Six of the patients were subsequently withdrawn from the study. Two patients who were randomized to treatment without reaming had a very narrow intramedullary canal, and a small nail could not be passed without reaming. Two patients needed a nail that was longer than the available Delta nails. All four of these patients were managed with nailing after reaming, and the fracture healed uneventfully; however, their data were excluded from the analysis. Two patients died within seventy-two hours after the injury. One of these patients, a man, had two femoral fractures and one open tibial fracture, and nailing after reaming was randomly chosen. After nailing of both of the femoral fractures with reaming, the patient became hypoxic and was difficult to ventilate. As tibial nailing began, the hypoxia worsened and the patient became profoundly hypotensive. A ten-millimeter-diameter nail was inserted without reaming. The patient died of respiratory failure. The autopsy demonstrated evidence of disseminated fat embolism. This patient was excluded from the analysis as the evidence of serious respiratory difficulty was established before the tibial nailing. The other patient who died within seventy-two hours was a fifty-two-year-old woman who had a type-I open tibial fracture12,13. The nailing with reaming was uneventful, but the patient died as a result of a severe head injury with an extensive intracerebral hematoma. This patient was also excluded from the analysis. Thus, ninety-one patients with ninety-four fractures were included in the study. The average age of the seventy-seven male and fourteen female patients was thirty-seven years (range, sixteen to eighty-eight years). Thirty-two patients had been struck by a motor vehicle as a pedestrian, seventeen were involved in a motor-vehicle accident as either the driver or a passenger, eleven were in a motorcycle accident, three were in a bicycle accident, eight had sustained the fracture as the result of a fall or a twisting movement during a sports activity, five were injured in a fall that was unrelated to a sports activity, eleven had an industrial accident, one sustained blunt trauma that was not work-related, two were injured as the result of an assault, and one sustained the injury as a result of a suicide attempt. Fifty fractures (forty-eight patients) were randomized to treatment with a nail with reaming and forty-four fractures (forty-three patients), to treatment with a nail without reaming. With the numbers available, the two groups were not significantly different in terms of average age (p = 0.23, analysis of variance), gender distribution (p = 0.29), and mechanism of injury (p = 0.65). The degree of comminution was graded with use of the classification of Winquist and Hansen30. Four uncomminuted, sixteen grade-I, fourteen grade-II, eleven grade-III, and five grade-IV fractures were treated with reaming, and five uncomminuted, twelve grade-I, ten grade-II, eleven grade-III, and six grade-IV fractures were treated without reaming. In the group treated with reaming, two fractures involved the proximal third of the tibia; two, the proximal and middle thirds; eighteen, the middle third; nineteen, the middle and distal thirds; seven, the distal third; and two, more than one level. Similarly, in the group treated without reaming, one fracture involved the proximal third of the tibia; seven, the proximal and middle thirds; eighteen, the middle third; twelve, the middle and distal thirds; two, the distal third; and four, more than one level. Six spiral, twenty-six oblique, fifteen transverse, and three segmental fractures were treated with reaming, and twenty-three oblique, thirteen transverse, and eight segmental fractures were treated without it. The levels of the fractures, the degrees of comminution, and the patterns of the fractures were evenly distributed between the two groups. The severity of the open injury was determined with use of the classification of Gustilo et al.12,13, on the basis of the initial appearance of the wound and the findings during débridement. No type-IIIC open fractures of the tibial shaft were treated at our institution during the time of this study. Nine type-I, eighteen type-II, sixteen type-IIIA, and seven type-IIIB fractures were treated with reaming, and five type-I, sixteen type-II, nineteen type-IIIA, and four type-IIIB fractures were treated without it. The difference in the distribution of the type of open injury was not significant (p = 0.69, Mann-Whitney U test). An injury severity score1 was calculated for all patients, and those who had a score of more than 18 points were considered to be multiply injured. The median injury-severity score for each group was 9 points. Thirty-two patients who were managed with reaming and twenty-nine who were managed without it had an isolated fracture of the tibia. After the initial clinical assessment, all patients began receiving one gram of cefazolin intravenously every eight hours and were given prophylaxis against tetanus, if necessary. Patients who had a grade-III fracture30 were also given gentamicin intravenously (three to five milligrams per kilogram of body weight every twenty-four hours in three divided doses). Antibiotic therapy was maintained postoperatively for seventy-two hours. The same antibiotic regimen was used at each subsequent operative intervention. All of the operative procedures were performed by, or under the direct supervision of, one of the senior ones of us (P. J. O'B., P. A. B., R. N. M., or H. M. B.). A standard operative protocol was followed. Wound débridement and nailing were performed with separate surgical setups as soon as possible after admission to the hospital. As part of the débridement protocol, a minimum of ten liters of saline solution was used for irrigation. After débridement, nailing was performed with the patient on a fracture table and skeletal traction applied through a calcaneal Kirschner wire. A longitudinal incision over the patellar ligament was used for insertion of the nail. A parapatellar or ligament-splitting approach was used to gain access to the intramedullary canal. In one group, the medullary canal was reamed with AO/ASIF reamers to a diameter that was one millimeter more than the diameter of the selected nail. All but two of the fractures that were treated with reaming were stabilized with a Grosse-Kempf nail (Howmedica, East Rutherford, New Jersey). The remaining two fractures were fixed with a long ten-millimeter-diameter Delta locking nail (Smith and Nephew Richards, Memphis, Tennessee) after reaming because of a long tibia and a narrow intramedullary canal. For most of the period of this study, the smallest Grosse-Kempf nail available was eleven millimeters in diameter, and this was the size most commonly used. Occasionally, a larger-diameter nail was used in a patient who had a wide medullary canal, and the decision regarding the size of the nail was made intraoperatively on the basis of the size of the reamer that first made cortical contact at the isthmus of the medullary canal. The fractures that were treated without reaming were stabilized with a Delta locking nail. The canal was broached with a large bone awl, and the point of entry was widened with a front-cutting twelve-millimeter-diameter reamer for the metaphysis to facilitate entry of the nail. No diaphyseal reaming was performed for any of the fractures in this group. Sounds were passed into the isthmus of the canal, and the diameter of the largest sound that could be passed through the isthmus of the tibia was selected as the diameter of the nail. One nail that was inserted without reaming and two nails that were inserted after reaming were dynamically locked in only the proximal or distal fragments. All remaining nails in the study were statically locked with screws in both the proximal and the distal fragments. At the end of the operative procedure, the wound was left open and was packed with a tobramycin-impregnated polymethylmethacrylate-bead pouch. Our protocol was to use 2.4 grams of tobramycin per package of cement and to insert as many beads as would easily fit into the wound. The operative blood loss; transfusion requirement; duration of the operation; and time needed for insertion of the nail, proximal and distal locking, and fluoroscopy were recorded. The average interval from the time of the injury to the nailing procedure was ten hours (range, 3.67 to 28.75 hours) in the group treated with reaming and nine hours (range, 3.43 to 27.17 hours) in the group treated without reaming. With the numbers available, this difference was not significant (p = 0.22). In the patients treated with reaming, two nine-millimeter nails, three ten-millimeter nails, twenty-four eleven-millimeter nails, thirteen twelve-millimeter nails, seven thirteen-millimeter nails, and one fourteen-millimeter nail were used. In the group treated without reaming, seven eight-millimeter nails, twenty-one nine-millimeter nails, and sixteen ten-millimeter nails were used. The average diameter of the nail was 11.5 millimeters in the group treated with reaming and 9.2 millimeters in the group treated without reaming. No wound was closed primarily. The median time to coverage of the wound was five days for both groups; the range was two to thirteen days for the group treated with reaming and two to fifteen days for the group treated without reaming. The fourteen type-I open wounds were allowed to heal by secondary intention. Split-thickness skin-grafting was performed for nine fractures. Sixty wounds were treated with delayed primary closure. One fasciocutaneous flap, eight gastrocnemius or soleus flaps, and two free flaps were used for the type-IIIB injuries. Early perioperative complications, including compartment syndrome, fat embolism, and pulmonary embolism, were recorded. Patients who had an isolated tibial fracture were discharged from the hospital when they had evidence of satisfactory wound-healing and were able to walk with crutches. These patients stayed in the hospital for a median of seven days (range, four to thirty-eight days) when the nailing had been done after reaming and a median of eight days (range, four to twenty-nine days) when it had been done without reaming. Patients in both groups were advised to remain non-weight-bearing for the first six weeks after the injury, irrespective of the fracture configuration. Patients who had multiple injuries were mobilized and discharged as soon as the other injuries allowed it. After discharge, we attempted to examine the patients clinically and radiographically on a monthly basis until union. Clinical union was defined as the ability to bear full weight with no pain at the site of the fracture, and radiographic union was defined as evidence of bridging of three of the four cortices on standard anteroposterior and lateral radiographs. Fractures that needed revision intramedullary nailing or bone-grafting in order to heal were designated as non-unions. Fractures for which elective bone-grafting was used to bridge segmental defects after wound-healing were not considered non-unions unless subsequent operative intervention was necessary to achieve union. The fracture was converted to a dynamic status with removal of the proximal or distal locking screws at the discretion of the treating surgeon, and this was not taken to be an indication of non-union unless the fracture subsequently failed to heal. Twenty-one fractures that had been treated with reaming and eleven fractures that had been treated without it were converted to a dynamic status. With the numbers available for study, we could not detect a significant difference with the chi-square test (p = 0.38). Malunion was defined as any angulation of more than 5 degrees in any direction as seen on the radiographs or shortening of more than one centimeter or rotation deformity of more than 15 degrees on clinical measurement. Failure of the implant and any action necessary as a result were recorded. A soft-tissue infection was defined as the presence of purulent discharge from the wound with positive bacteriological findings. Deep infection was diagnosed if operative exploration with osseous débridement was needed to eradicate the infection. The ranges of motion of the knee and ankle were recorded for each patient. Motion of the subtalar joint was compared with that on the contralateral, normal side and was designated as normal or reduced at the time of the most recent follow-up examination. The patient's occupation and level of recreational activity postoperatively were compared with those before the injury. The patients were designated as having returned to the same occupation as before the injury, as having changed occupation, or as having not returned to any occupation as a direct result of the injury. Similarly, the level of recreational activity was defined as the same as before the injury or as reduced or none as a consequence of the injury. The prevalence of pain in the knee and the necessity for removal of the implant were also recorded. The average duration of follow-up was twenty-two months (range, fourteen to fifty-four months). When possible, the most recent follow-up evaluation for the purpose of this study was performed by us. Patients who could not return for geographical reasons were interviewed by telephone, and follow-up radiographs were requested from their local orthopaedic surgeon. Thirty-four patients (thirty-five fractures) who had had reaming and twenty-eight patients (twenty-eight fractures) who had not were examined by us. Ten patients (eleven fractures) who had had reaming and eleven patients (twelve fractures) who had not were followed by telephone and by contact with the local orthopaedic surgeon who was supervising the follow-up care. Eight patients could not be contacted for the current review. Two of these patients (one who had had reaming and one who had not) died of causes unrelated to the injury but had been followed until osseous union, and adequate clinical data were available for inclusion of these patients in this study. Adequate follow-up data were therefore available for forty-five patients (forty-seven fractures) who had had reaming and for forty patients (forty-one fractures) who had not. The remaining six patients (three who had had reaming and three who had not), who had had six fractures, did not return for any clinical follow-up examinations. Four of these patients had a history of drug or alcohol abuse. The remaining two patients had moved and could not be located. Comparisons of the average durations of the operative parameters and the average times to union were performed with the Student t test. The prevalences of non-union, malunion, deep infection, and compartment syndrome were compared between the groups with use of the chi-square test with Yates correction or the Fisher exact test when appropriate. All tests were carried out as two-tailed tests; a p value of less than 0.05 was considered significant.
Technical Details
Early Postoperative Complications
Union of the Fracture
One fracture that had been treated with reaming and two that had not were treated with elective bone-grafting because of a segmental osseous defect. Four fractures (one type I, one type II, and two type IIIB) (9 per cent) that had been treated with reaming and five fractures (two type II and three type IIIA) (12 per cent) that had not did not unite (p = 0.73, Fisher exact test). For all nine non-unions, the original nail was replaced with a larger-diameter Grosse-Kempf nail with reaming. Two patients who had had reaming and one patient who had not needed bone-grafting in addition to revision of the nail in order for union to be achieved. At the time of the latest follow-up examination, seven non-unions (three in the group treated with reaming and four in the group treated without reaming) had healed with the second nail still in situ. The remaining two non-unions (one in the group treated with reaming and the other in the group treated without reaming) healed; however, pain developed in the knee, necessitating removal of the nail. Both patients had a refracture: one in a motor-vehicle accident, and one in a skiing accident. Repeat nailing was performed for one patient, and the other patient had a malunion after immobilization in a plaster cast. The malunion was corrected in an Ilizarov frame, and nailing was subsequently performed.
Infection One deep infection in the group treated with reaming developed in a twenty-seven-year-old man with chronic schizophrenia in whom a type-IIIB open fracture had been fixed with the use of a ten-millimeter-diameter Russell-Taylor Delta nail. Three days postoperatively, the wound was covered with a gastrocnemius flap and a split-thickness skin graft. The soft tissues healed satisfactorily, and the patient was discharged from the hospital. Compliance was poor, and the patient was not seen again until eleven months after the injury. Radiographs made at that time revealed that the proximal and distal locking screws had fractured, resulting in a non-union. There was no sign of infection, and no action was taken. Four weeks later, the patient was seen with an abscess under the flap that communicated with the site of the fracture. Radiographs revealed that the nail had broken at the site of the fracture. The abscess was drained, the site of the fracture and the soft tissues were debrided of infected material, and a twelve-millimeter-diameter Grosse-Kempf nail with intramedullary antibiotic beads were inserted after reaming of the canal to a diameter of thirteen millimeters. An antibiotic-bead pouch was implanted, and the wound was closed at five days. Bacteriological cultures were positive for Staphylococcus aureus, and the patient was managed with cloxacillin administered intravenously for fourteen days and then orally for an additional three months, by which time the fracture had healed with no sign of infection. One year after presentation of the infection, there had been no recurrence. The third infection developed in a patient in whom a type-II fracture had healed uneventfully after nailing with reaming and delayed closure of the wound. Pain developed in the knee when the patient returned to sports activity, and the patient requested removal of the nail. Ten days after removal of the nail, the patient was seen for a wound infection that communicated with the intramedullary canal. Incision and drainage with insertion of antibiotic beads and delayed closure of the wound was performed. One year later, there was no sign of infection.
Failure of the Implant
Malunion
Functional Outcome Ten patients (28 per cent) in the group treated with reaming and eleven (38 per cent) in the group treated without reaming were documented as having diminished motion of the ankle. Thirteen of these patients had a grade-III open fracture (seven had a grade-IIIA fracture, and six had a grade-IIIB fracture). All twenty-one patients had a loss of dorsiflexion of 10 degrees or less. Seven patients (19 per cent) in the group treated with reaming and eight (28 per cent) in the group treated without reaming had reduced motion of the subtalar joint. With the numbers available for study, the chi-square test did not show the differences between the two groups with regard to loss of motion of the ankle (p = 0.38) and loss of motion of the subtalar joint (p = 0.44) to be significant. Data regarding occupation and recreational activity were reported only for the patients who had had an isolated tibial fracture (thirty-two patients who had had reaming and twenty-nine who had not). Twenty-five patients (78 per cent) in the group treated with reaming and twenty (69 per cent) in the group treated without reaming had returned to their original occupation, four patients (13 per cent) in the former group and seven (24 per cent) in the latter had changed occupation as a consequence of the injury, and two patients (6 per cent) in the former group and two (7 per cent) in the latter had persistent disability from the injuries and had not returned to any occupation. One patient (3 per cent) who had been managed with reaming had died before the time of follow-up. We could not show these differences to be significant with the Mann-Whitney U test (p = 0.63). With respect to recreational activity, twenty-one patients (66 per cent) in the group treated with reaming and seventeen (59 per cent) in the group treated without reaming had returned to the preoperative level of sports or recreational activity, eight patients (25 per cent) in the former group and ten (34 per cent) in the latter had returned to sports activity but considered their capacity to be reduced compared with the pre-injury level, and two patients (6 per cent) in the former group and two (7 per cent) in the latter considered their disability to be too severe for them to participate in any recreational activity. One patient (3 per cent) who had been managed with reaming had died before the time of follow-up. We could not show these differences to be significant with the Mann-Whitney U test (p = 0.74). Data regarding pain in the knee were available for all forty-five patients who had had reaming and for thirty-nine patients who had not. Twenty-two patients (49 per cent) in the former group and sixteen (41 per cent) in the latter had pain in the knee. By the time of the most recent follow-up examination, the nail had been removed from the sites of sixteen (34 per cent) of the forty-seven fractures that had been treated with reaming and from the sites of twelve (29 per cent) of the forty-one fractures that had been treated without reaming. We could not show these differences with respect to pain in the knee (p = 0.6) and removal of the nail (p = 0.7) to be significant with use of the chi-square test.
The success of locking nails for the treatment of closed tibial fractures has stimulated interest in their use for open tibial fractures. Intramedullary nailing after reaming is now accepted as the method of choice to treat open femoral fractures4,22,23, but its use remains controversial with regard to open tibial fractures. The vascular damage inflicted by reaming in association with the soft-tissue injury has been thought to increase the risk of infection and delayed union to an unacceptable level5. Early reports of the use of unlocked nails with reaming for open tibial fractures seemed to confirm this view. Hamza et al.15 reported three infections after the treatment of twenty-two open fractures, and Smith28 subsequently reported six infections in eighteen patients. Recent authors have also been circumspect in their enthusiasm for the technique. Klemm and Börner reported six infections after treatment of ninety-three grade-I open fractures with insertion of a locking nail after reaming20. Bone and Johnson reported two infections after treatment of eight grade-II and III fractures with nailing after reaming2. On the basis of these studies, the current opinion is that insertion of a nail after reaming is contraindicated for the treatment of open tibial fractures3,14,26. The criticism that nailing after reaming is associated with high rates of infection and non-union is theoretical and is based on limited reports with small numbers of patients managed mostly with unlocked nails2,15. Kaltenecker et al. reported no infections after treatment of sixty-six type-I and II open tibial fractures with nailing after reaming17. Court-Brown et al. recently reported a rate of infection of 6 per cent (one of eighteen) for type-IIIA fractures and 13 per cent (three of twenty-four) for type-IIIB fractures treated with insertion of a Grosse-Kempf nail after reaming7,8. Rates of union and malunion compared very favorably with those reported with current designs of external fixation9,10. Locking nailing without reaming causes less damage to the intramedullary blood supply and is considered by some to be a safer method of treatment for open tibial fractures18,19,27. Although the concept of locking nailing without reaming has had widespread support, there have been few clinical reports of its use for open tibial fractures. In one recent study in which such nailing had been used, no infection developed after treatment of sixteen grade-I and II open tibial fractures and four infections developed after treatment of thirty-four type-III open fractures (a 12 per cent prevalence)29. As far as we know, we are the first to compare prospectively the results of locking nailing after reaming with those of nailing without reaming as treatment for open tibial fractures. The over-all rate of infection in the current series was low, three (3 per cent) of ninety-one patients, and we could not demonstrate a difference between nailing after reaming and nailing without reaming with regard to the rate of infection. We attempted to determine if the process of reaming was related to the rate of clinical complications. We did not find clear differences between our two groups. We did not demonstrate any clinically important differences with regard to the technical aspects of the operative procedure, and the rates of early complications were similar in the two groups. The over-all time to union and the rate of non-union were remarkably similar between the two groups, with no evidence that the reaming process delayed union. The need for bone-grafting was also rare; non-unions were usually treated successfully with revision of the nail. We were unable to show that the reaming process is associated with an increased risk of either deep infection or non-union. Although reaming damages the endosteal circulation, it did not seem to have a demonstrably detrimental effect in the present study. A recent experimental study revealed no difference in the mechanical strength of callus at three months when nailing after reaming was compared with nailing without reaming in a sheep model27. Schemitsch et al. also showed a rapid recovery of blood flow to the site of the fracture despite reaming27. The more important factor in fracture-healing and in the body's ability to resist infection is the viability of the surrounding soft tissue. Operative care of the soft-tissue wound is critical in the treatment of open fractures. The pluripotential mesenchymal cells that form fibrous tissue and eventually bone are thought to originate predominantly from surrounding tissue and the cambial layer of the periosteum. The reaming process is likely to have little detrimental effect on this aspect of fracture-healing. The role of the endosteal circulation in fracture-healing may therefore be less critical than has been supposed. We believe that adequate débridement of the soft tissue and bone followed by sound soft-tissue coverage is the key to minimizing deep infection after these injuries, irrespective of whether the bone is reamed or not. The rate of infection in this series is lower than has been reported by others7,8. This may be explained in part by our use of an antibiotic-bead pouch in the open wound. There is a gradually accumulating body of clinical evidence to suggest that this technique can help to decrease the prevalence of wound infection after open fractures16. The biomechanical stability afforded by locking nailing and the strength of the implant reduced the rate of malunion to negligible proportions in both groups, with lower rates than would be expected with external fixation. The increased prevalence of failure of the locking screws in association with nails inserted without reaming has been noted by other authors29 but was not associated with an increased risk of non-union or malunion. As might be anticipated, the functional outcomes in the two groups were broadly similar in the present study. Although this is the largest prospective trial of which we are aware, the number of patients in each group may not be large enough to demonstrate differences of small magnitude. On the basis of the results in this study, it seems likely that any relative advantage associated with either nailing after reaming or nailing without reaming is small and may only emerge in a study of much larger numbers of patients.
*No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. No funds were received in support of this study.
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Abstract
Introduction
0.59 for each analysis, Fisher exact test). 
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