ANZ J. Surg. 2006; 76: 290–294
doi: 10.1111/j.1445-2197.2006.03714.x
ORIGINAL ARTICLE
RETROGRADE NAILING VERSUS FIXED-ANGLE BLADE PLATING FOR SUPRACONDYLAR FEMORAL FRACTURES: A RANDOMIZED CONTROLLED TRIAL NATHAN L. HARTIN,* IAN HARRIS*† AND KAUSHIK HAZRATWALA* *Department of Orthopaedics, Liverpool Hospital, and †Department of Orthopaedics, St George Hospital, Sydney, New South Wales, Australia Background: A variety of devices have been used in the treatment of supracondylar femoral fractures. The condylar blade plate relies on the principles of open reduction, absolute stability and interfragmentary compression to achieve union. The technique of retrograde nailing uses indirect reduction of the metaphyseal fracture component, offering relative stability and a less invasive approach. Randomized comparison of these common methods of fixation has not been reported. Methods: Twenty-two patients with 23 supracondylar femur fractures were recruited from two regional trauma centres over a 26-month period and randomized to receive either a retrograde intramedullary nail fixation (IM group, 12 fractures) or a fixed-angle blade plate fixation (BP group, 11 fractures). The groups were followed for 12–36 months. The primary outcome measures were revision surgery and general health. Results: Three patients in the IM group required revision surgery for the removal of implant components. No reoperations occurred in the BP group. There was a trend towards greater pain in the IM group, although there was no statistically significant difference in the scores for any of the SF-36 domains. Conclusion: Both distal femoral nailing and blade plating give good outcomes. There is a trend for patients undergoing retrograde nailing to complain of more pain and to require revision surgery for removal of implants. Key words: femoral fracture, internal fixation, intramedullary nail, randomized controlled trial, supracondylar fracture.
Abbreviations: AO, Association for the Study of Internal Fixation; ASA, American Society of Anaesthesiologists; BP, fixed-angle blade plate fixation; DCS, dynamic condylar screw; IM, retrograde intramedullary nail fixation; ISS, injury severity score; SF-36, short-form 36.
INTRODUCTION
PATIENTS AND METHODS
The diversity of approaches advocated for the surgical fixation of supracondylar femoral fractures indicates the lack of a gold standard for this challenging fracture type. The application of the Association for the Study of Internal Fixation (AO) principles of anatomical reduction and rigid fixation produced evidence of the benefit of internal fixation in the management of these injuries during the 1970s.1,2 These early studies used the AO fixed-angle blade plate. Many other devices have since been applied to these fractures.3–5 In recent years, efforts have focused on minimally invasive methods to increase the rate of fracture union and reduce the incidence of infection.6,7 The popularity of closed intramedullary nailing of long bones has extended to femoral nails inserted in a retrograde manner as an operative solution for supracondylar fractures.8 Although much has been written on the relative value of nail and plate fixation of the distal femur, randomized comparison of these treatment methods has not been reported.
Before inception, this trial was approved by the human research ethics committees of the two participating hospitals. Twenty-two patients with 23 supracondylar fractures were recruited from two regional trauma centres over a 26-month period between August 2001 and October 2003. Fractures were defined by the AO classification system. All type 33-A and 33-C fractures were included, except type A1.1 avulsion fractures, for which the fixation methods studied were not applicable. Skeletally immature patients and those sustaining ipsilateral proximal or midshaft femoral fractures were excluded. At diagnosis, patients were invited to participate in the trial. Once consent was obtained, patients were randomly assigned to either a retrograde intramedullary nail fixation (IM) group or a fixed-angle blade plate fixation (BP) group. Randomization was carried out by a remote source, contactable by telephone, using odd and even numbers from a random number table in blocks of 10. Twelve patients received a distal femoral nail (Synthes AG, Chur, Switzerland) and 11 were randomized to receive a 95° fixed-angle condylar blade plate (Synthes). There were no statistically significant differences in patient demographics or injury characteristics between the groups at inception (Table 1). Both the distal femoral nail and blade plate were inserted according to the standard AO technique. All intramedullary nails
N. L. Hartin BSc, MB BS (Hons); I. Harris MB BS, FRACS (Orth); K. Hazratwala MB BS. Correspondence: Dr Nathan L. Hartin, Department of Orthopaedics, Liverpool Hospital, Locked Bag 7103, Liverpool, NSW 2170, Australia. Email:
[email protected] Accepted for publication 7 December 2005. Ó 2006 Royal Australasian College of Surgeons
TREATMENT OF SUPRACONDYLAR FEMORAL FRACTURES
Table 1.
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Patient and injury characteristics
Characteristic Mean age (years) Sex (males : females) Residence Home Nursing home/hostel Walking aid Aid not required Aid required Minimal trauma fracture ISS >15 Open fracture AO classification 33-A 33-B 33-C Periprosthetic fracture Mean ASA score
Table 2.
IM group (n = 12)
BP group (n = 11)
P-value
66.3 4:8
70.1 3:8
0.61 0.77
10 2
10 1
NA NA
9 3 7 3 3
10 1 7 3 0
NA NA NA NA 0.10
3 0 9 1 2.5
3 1 7 1 2.8
NA NA NA NA 0.42
AO, Association for the Study of Internal Fixation; ASA, American Society of Anaesthesiologists; BP, fixed-angle blade plate fixation; IM, retrograde intramedullary nail fixation; ISS, injury severity score; NA, not applicable.
were inserted closed without anatomical reduction of the metaphysis. All blade plates were inserted open, with accurate reduction and interfragmentary compression where possible. Primary bone grafting was not applied to any cases in this series. Three patients in the BP group had their procedure altered at the time of surgery because of a decision by the surgeon regarding the optimum fixation device. One of these patients received an AO dynamic condylar screw (DCS), and in two patients, a condylar buttress plate was used, including one patient found to have a type 33-B fracture intraoperatively. All patients were analysed in the groups to which they were randomized, applying the intention-totreat principle. Postoperatively, all patients were subjected to a common protocol. Prophylactic i.v. antibiotics were given for 36 h. Active range of motion exercises were permitted immediately. Patients were not permitted to weight bear for 12 weeks postoperatively or until a callus was apparent on radiographs. The incidence of revision surgery was a primary measure of the relative effectiveness of the devices. The other main outcome measure was the short-form 36 (SF-36) general health survey, which provided a validated means of assessing subjects’ functional and pain status. Clinical assessment was made at follow up by the relevant operating surgeon. Data concerning problems with union, implant failure, angulation, clinical leg length discrepancy and rotational malalignment were recorded. Cases of revision surgery were documented. The range of motion in the affected knee was recorded. A final telephonic interview was conducted with patients at a minimum of 12 months from the date of the injury. At this time, reoperation data were confirmed and SF-36 general health surveys were completed. Data from the groups were analysed using the v2 test for binomial variables and Student’s t-test for continuous parametric variables.
RESULTS There were no statistically significant differences between the IM and BP groups in perioperative outcomes (Table 2). Operative Ó 2006 Royal Australasian College of Surgeons
Perioperative data
Variable Surgeon Consultant Registrar Mean operative time (minutes)† Mean blood transfused (units)† Mean length of stay (days) Wound infection Medical complications Pneumonia Urinary tract infection Renal failure Pressure ulcers Discharge destination Home Rehabilitation/nursing home Died in hospital
IM group (n = 12)
BP group (n = 11)
P-value
10 2 148 1.6 36 1
10 1 140 2.1 38 1
NA NA 0.68 0.63 NA NA
1 3 1 1
2 0 0 0
NA NA NA NA
6 6 0
4 6 1
NA NA NA
†Excluding seven patients undergoing multiple operations (four IM, three BP). BP, fixed-angle blade plate fixation; IM, retrograde intramedullary nail fixation; NA, not applicable.
times, blood requirements and length of hospital stay were similar. One patient in the IM group, who had sustained a grade 2 compound fracture, developed a wound infection that required surgery for debridement 6 days postoperatively and the wound healed without further intervention. One patient in the BP group developed a superficial infection that resolved with i.v. antibiotics. Among the IM group, 11 of the original 12 patients were available for clinical assessment at 6 months. One patient had died. Of the BP group, 8 of the 11 patients were available for clinical assessment at 6 months. Two patients had died and one patient was not contactable after 2 months. No significant complications were found in the BP group (Table 3). One patient in the IM group experienced a persisting non-union at 6 months that was managed non-operatively and proceeded to union without intervention at 10 months, although with 15° of valgus deformity. A second patient in the IM group had significant osteoporosis and developed fracture collapse and shortening resulting in protrusion of the nail into the knee joint. The nail was removed at 8 months and no further operative intervention was undertaken. The fracture healed with 2 cm of shortening and 20° of valgus angulation. A similar range of knee motion was achieved by both groups. Table 3.
Clinical assessment at 6 months
Outcome Available for assessment Died Lost to follow up Delayed union Angulation >10° Leg shortening >10 mm Infection Flexion (degrees) Extension loss (degrees)
IM group (n = 12)
BP group (n = 11)
11 1 0 1 2 1 0 108 5
8 2 1 0 0 0 0 105 3
BP, fixed-angle blade plate fixation; IM, retrograde intramedullary nail fixation.
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Final assessment by telephonic interview was carried out at an average of 21.1 months for the IM group (range, 12–35 months) and 18.8 months for the BP group (range, 13–36 months; Table 4). All 11 patients in the IM group and 8 patients in the BP group assessed at 6 months were available for final assessment. Full SF-36 data, however, were not available in one patient suffering dementia and two patients with limited ability to speak English. Over the follow-up period, three patients in the IM group and no patients in the BP group had undergone revision surgery. One patient underwent implant removal as described above for valgus collapse and nail protrusion. The other two reoperations involved patients who complained of persistent pain in the knee. Distal interlocking screws were removed from one patient for local irritation at 8 months; however, this patient continued to experience significant pain. The other patient experienced distal migration of the nail, intra-articular protrusion and patella impingement, which were resolved by removal of all implants at 10 months. SF-36 general health surveys were carried out for 10 patients in the IM group and 6 patients in the BP group. There were no statistically significant differences between the groups in any health domain (Table 4).
DISCUSSION The AO fixed-angle blade plate is a commonly used and reliable device for the surgical fixation of supracondylar femoral fractures.9–11 However, this method is not without complications. Infection is a significant risk in open fractures treated with the
Table 4.
Final assessment at minimum 12 months
Outcome Patient status Available for assessment Completed SF-36 assessment‡ Died Lost to follow up Mean follow-up period (months) Reoperations SF-36 assessment Functional Role – physical Pain General Vitality Social Role – emotional Mental Summary – physical Summary – mental Residence Home Nursing home Walking aid Aid not required Aid required
IM group BP group P-value (n = 12) (n = 11) 11 10 1 0 21.1 3
8† 6§ 2 1 18.8 0
NA NA NA NA NA 0.22
44.5 42.5 57.4 47.5 46.5 70.0 80.0 69.2 33.7 51.4
43.3 41.7 72.3 49.3 42.5 77.1 83.3 80.0 34.0 54.7
0.95 0.97 0.32 0.87 0.71 0.65 0.88 0.37 0.96 0.60
10 1
7 1
NA NA
5 6
4 4
NA NA
†Includes two patients randomized to a BP, but treated otherwise. ‡One patient in the IM group suffered dementia, and two patients in the BP group did not speak English. §Includes one patient randomized to a BP, but treated otherwise. BP, fixed-angle blade plate fixation; IM, retrograde intramedullary nail fixation; NA, not applicable.
blade plate.11–13 Chronic infection is associated with persisting non-union and not infrequently results in amputation.14 Other problems reported with blade plate fixation include the technical demands of plate placement,15 which have contributed to high levels of malreduction in a number of series.2,13 Whereas some studies suggest a significant incidence of non-union and consequent implant failure,2,14 recent series report improved rates of union,9,10 particularly where efforts are made to minimize soft tissue disruption. Retrograde femoral nails use a transarticular approach and permit the indirect reduction of fractures without disturbing the soft tissue envelope surrounding the metaphyseal fracture component. This technique seeks to maintain the length and alignment of the femur without pursuing anatomical reduction and interfragmentary compression of the metaphysis. Laboratory studies have shown the superiority of this implant over traditional plating techniques in maintaining blood supply to the bone.16 Clinical studies have suggested that these theoretical advantages have translated into higher rates of union and reduced the requirement for primary bone grafting.8,17–20 Some studies have suggested a lower risk of wound infection.17,21 Other reported benefits include a reduction in operative blood loss, operating time and length of hospital stay.8,19 It is important to note that these comparisons rely on historical controls and have not been confirmed by randomized trials. Biomechanical studies comparing angled blade plates and intramedullary nails in stabilizing supracondylar fractures have reported that the stiffness of the blade plate is superior or equivalent to that of intramedullary nails.22–24 This is particularly pronounced when torsional stability is examined. The AO DCS has biomechanical characteristics similar to those of the blade plate and has also shown superior stiffness on laboratory testing.25,26 It is important to note that the most common source of implant failure seen clinically is that experienced under varus loading. Nail and plate constructs both provide similar stiffness against a stress of this nature.22 It is widely believed that retrograde nailing has the advantage of being a simpler and faster operative technique than plating.6,8,27 However, this study found that operative time was similar for both nails and plates. This emphasizes that difficulties in establishing length, alignment and anatomical reduction of the articular surface may still be faced when placing nails. Our experience is that the principal determinant of operative time is the degree of comminution of the intra-articular fracture, regardless of the fixation device used. The established reliability of fixed-angle plating is confirmed by the absence of significant complications among the 11 patients randomized to receive a plate in this study. Among the IM group, one patient experienced a delayed union that healed with valgus angulation greater than 10° and another developed a leg length discrepancy in addition to valgus angulation. These complications all occurred among patients sustaining open injuries. The fact that there were no open injuries in the BP group suggests that the severity of the injury may explain the difference in outcome. The more significant finding of this study was the incidence of revision surgery among patients undergoing retrograde nailing. Over the follow-up period, 3 of the 12 patients in the IM group required reoperation for an implant-related complication, whereas no patients in the BP group required reoperation. Although these differences did not reach statistical significance, they do show some potential shortcomings of the distal femoral nail. Two reoperations involved patients who sustained closed injuries and re-presented with complaints of pain in the knee. The first Ó 2006 Royal Australasian College of Surgeons
TREATMENT OF SUPRACONDYLAR FEMORAL FRACTURES
had experienced distal migration of the nail and patella impingement. The second suffered soft tissue irritation (iliotibial band impingement) associated with distal interlocking screws, a complication documented in past series.17 Although because of the small number of participants, no statistically significant differences were established in any key area of function by the SF-36 survey, the greatest disparity between the groups occurred in the pain domain. Three of six patients treated with a plate reported being pain free at follow up, against only one of ten patients treated with a nail. This resulted in an average pain score of 72.3 in the BP group versus 57.4 in the IM group (higher scores represent less pain). Although good knee function has been shown over a period of up to 25 years in patients receiving plate fixation,11 concern exists that the intra-articular entry used for distal femoral nails may predispose patients to higher levels of knee pain over time.28 Previous studies have shown significant rates of component removal for patella impingement.17,27,28 Although this complication is sometimes caused by technical error in placement, it is clear that nails have the capacity to migrate distally as the fracture settles, especially in osteoporotic bone.29,30 Fractures close to the knee joint are particularly disposed to this problem as distal placement may be required to achieve interlocking. Whether nails increase the incidence of articular cartilage wear because of the presence of a surface defect or bone debris or contribute to synovial metallosis has yet to be properly investigated.31 Long-term follow-up studies involving a large number of patients are required to determine the ultimate risk imposed on the knee joint by retrograde nail insertion. Another factor contributing to the higher rate of reoperation in patients treated with an intramedullary nail may pertain to the perceived ease of removal of this implant, such that patients presenting with knee pain after fracture healing may be more likely to be offered the removal of components. According to the design of this study, each patient received one of two interventions regardless of bone quality or fracture morphology. It is reasonable to assume that optimum fixation methods may vary between healthy and geriatric populations and between simple extra-articular fractures and complex intraarticular injuries. Another limitation of this study is that the limited numbers of subjects may not have allowed significant differences between the two groups to be identified. Aside from patients suffering knee symptoms after retrograde nailing, the complications in this study occurred among patients with open fractures, osteoporotic bone or comminuted intraarticular extension. Fractures with these characteristics are a management challenge regardless of the implant. Minimally invasive plating techniques using locking screws are now being applied to these injuries.7 Similar to the blade plate, these implants are fixedangle devices, but offer the additional advantages of multiple points of distal fixation and a minimally invasive technique. Future research should focus on making direct comparison between new technologies and established techniques, to determine the indications, limitations and outcomes of the various treatment options.
CONCLUSIONS Distal femoral nails and fixed-angle blade plates provide good outcomes in the treatment of supracondylar femoral fractures. Ó 2006 Royal Australasian College of Surgeons
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There is a trend for patients treated with a femoral nail to undergo a second operation to remove their implants, and to complain of more pain.
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Ó 2006 Royal Australasian College of Surgeons
