Intramedullary nailing versus proximal plating in the management of closed extra-articular proximal tibial fracture: a randomized controlled trial

Data allowing a comparison of tibial nail and minimally invasive plating for extra-articular proximal tibial fractures are scarce. The primary goal of this prospective study was to compare the results of tibial nailing and minimally invasive plating from various aspects.

Although early weight-bearing is inherently associated with a load-sharing device such as an IMN, the literature does not accurately predict an accepted time at which full weight-bearing should be initiated with either procedure. Various studies have often stated that weight-bearing should be initiated when it can be tolerated by the patient [6]. In previous studies of extra-articular proximal tibial fractures treated with IMN, full weight-bearing was initiated at various times ranging from 0 to 16 weeks, depending on the fracture location, fracture pattern, and surgeon’s preference [11, 19]. Similarly, in extra-articular proximal tibial fractures treated with PLP, time to full weight-bearing has ranged from 6 to 13 weeks for the same reasons [6, 8, 18]. In our study, the time required before full weight-bearing, which was done only after complete radiological union, was significantly less in the IMN group (18.26 weeks) as compared to the PTP group (22.84 weeks). Although these times are longer than those stated in previously published reports, we started full weight-bearing only after complete clinical and radiological fracture union. That being said, we started passive and active assisted movements early—from day 2, progressing later to partial weight-bearing. Hence, we found no significant differences in range of motion of the knee between the groups.

Reported infection rates range from 0 to 8 % in nailing patients [5, 12, 17] and from 0 to 14 % in plating patients [17, 18, 20]. But, in the study by Lindvall et al. [6], the authors reported significantly higher infection rates: 28 % in the nailing group and 24 % in the plating group. The most probable reason for this is the higher proportion (42.8 %) of patients with open fractures in their study [6]. In the systemic review by Bhandari et al. [17], the infection rates were 2.5 % in the nailing group and 14 % in the plating group. The infection rates in our series were 5.3 % in the IMN group and 8 % in the PTP group (p = 0.738).

Malunion is a documented complication of the nailing of proximal tibia fractures and has been reported to occur in 3–100 % of cases in previous studies (Table 2) [9, 11, 17]. In our study, there was a malreduction/malunion rate of >5° in the IMN group (four patients, 21.1 %): varus malalignment in one patient and anterior apex deformity in three patients. Various techniques have been described for preventing malreduction, including the use of blocking screws [5, 6], unicortical plating [13], a universal distractor [14], nailing in the semiextended position [15], or the use of a nail with a more proximal Herzog bend [16]. In our study, we used blocking screws in three cases, reduction plating in one case, and a universal distractor in two cases. In the other cases, a reduction clamp was used to prevent proximal fragment extension while inserting the nail. A common technique employed in all of the nailing cases was to make a slightly higher entry point than that normally used for tibial nail insertion. This modification brought our insertion point more in line with the medullary canal of the tibia, hence reducing the extension of the proximal fragment. The plating group also had four cases of malunion (16 %), but the difference was not statistically significant. In a systemic review of 17 studies by Bhandari et al. [17], the authors reported a higher malunion rate in the nailing group (20 %) than in the plating group (10 %). Similarly, Lindvall et al. [6] reported a higher malunion rate in the nailing group—apex anterior malreduction occurred in 36 % of the patients in the IMN group and 15 % of those in the locking plate group—although this difference was not statistically significant.

When union rates after the initial fixation were analyzed in our study, it was found that the union rate in the IMN group was 94.7 and that in the PTP group was 96 % (p = 0.849). The high union rates observed in our series are consistent with those stated in various published reports, which range from 91 to 100 % [6, 8, 11, 19]. Our results were, however, higher than seen in a study performed by Lindvell et al. [6], where the authors noted union rates of 77 % in the IMN group and 94 % in the PTP group. We believe that this difference in union rates arose because open fractures were excluded from our series, not because of the type of procedure performed. The locked nail technique demonstrated advantages in terms of the operation time, hospital stay, early full weight-bearing, and time required for bony union.

We concluded from our study that intramedullary nail is superior to minimally invasive plating in terms of brevity of hospital stay and speed of union along with early full weight-bearing, but there was no clear advantage of either technique in terms of operative time, infection rate, range of motion of the knee, and rates of malunion and nonunion. Both implants yielded promising results with extra-articular proximal tibial fractures and provided rigid fixation that prevented secondary fracture collapse.

Limitations of this study include the small number of patients, the involvement of multiple surgeons, the absence of long-term follow-up to evaluate the outcome of malalignment in terms of the development of osteoarthritis of the knee, and the use of both stainless steel and titanium implants, which may affect infection rates because titanium is more biocompatible than stainless steel, meaning that using titanium reduces the soft-tissue reaction and reduces the chance of infection.