Distal tibia shaft fractures are a common consequence of road traffic accidents or sports injuries and account for approximately 37.8% of all tibial injuries.1 The fractures are prone to delayed union or nonunion due to limited soft tissue coverage and poor vascular supply.2 To date, the management of these injuries remains challenging, and several treatment options are available for orthopedic surgeons.
External fixation combined with limited open reduction and internal fixation (EF + LORIF) has been recommended by some authors, with minimal soft tissue complications, good functional results, and no local soft tissue irritation or implant removal.3–6 With the development of locking plates and biological fixation for treating fractures of the extremities, the use of minimally invasive percutaneous plate osteosynthesis (MIPPO) has grown in recent years.1,7–9 MIPPO has been used extensively as a safe and reliable method for treating distal tibia fractures, and good outcomes have been obtained.1,7–11 Intramedullary nailing (IMN) allows minimally invasive, symmetric, and dynamic fracture fixation following the principles of biological fracture fixation, and this technique also has been widely used for distal tibia shaft fractures with good results.1,4,8,12–15
Although EF + LORIF, MIPPO, and IMN are 3 well-accepted and effective minimally invasive therapies, each has been historically related to complications. Pin-tract infection and prolonged healing time are inherent problems in external fixation, whereas infections, wound complications, and implant prominence have been associated with tibia plating in some series, and malalignment and knee pain frequently have been reported after nailing.15–23 As a result, the optimal management of distal tibia shaft fractures remains controversial. Although previous studies have compared external fixation with plates,24,25 external fixation with intramedullary nails,26,27 or plates with intramedullary nails,8,14,15,28,29 few studies have compared these 3 methods together.
To determine the best treatment for such fractures, the current study compared EF + LORIF, MIPPO, and IMN for distal tibia shaft fractures by assessing complications, functional results, and secondary procedures. The current authors hypothesized that EF + LORIF would have fewer complications, the same functional outcome, and fewer secondary operations compared with MIPPO and IMN.
Materials and Methods
From April 2005 to April 2013, a total of 84 patients with displaced distal tibia shaft fractures (Orthopaedic Trauma Association 42) with or without fibula fracture were treated with EF + LORIF (n=28), MIPPO (n=28), or IMN (n=28) at the authors' hospital. The study was approved by the Ethics Committee, and informed consent was obtained from all patients before surgery.
Inclusion criteria were: (1) all fractures were extra-articular distal tibia shaft fractures that were located between 6 and 12 cm from the tibial plafond, (2) soft tissue injury of Tscherne grade 0–2, (3) Gustilo type I or II open fractures, and (4) follow-up length greater than 1 year. Patients with any of the following were excluded: (1) ipsilateral or contralateral lower limb fractures, dislocations, or both, (2) pathologic fractures, (3) soft tissue injury of Tscherne grade 3, (4) Gustilo type III open fractures, (5) fractures associated with nerve or vascular injury requiring repair, and (6) metabolic bone disease, previous ipsilateral lower limb surgery, or mental illness.
Soft tissue grading was assessed by the same surgeon (L.-J.S.). Simple randomization was used in this study. At admission, type of treatment was randomized by computer allocation and assigned to patients prospectively through sequentially numbered opaque envelopes. The groups were evenly matched with respect to patient demographics and fracture characteristics (Table 1).
Baseline Characteristics of the 3 Groups
Surgical Technique and Postoperative Management
Initial management consisted of closed reduction and cast immobilization. For patients with grade 2 swelling (swelling of the skin with striae disappearing, no blisters) and grade 3 swelling (tension blisters appear), braces were used for immobilization. Urgent debridement and irrigation were performed for all open fractures, and fractures were stabilized definitively in the same surgical setting. Surgery usually was performed on the day of injury, but patients with excessive swelling or bruising of the soft tissues underwent delayed surgery. Patients were placed supine under general or spinal anesthesia, and all operations were performed by the same group of surgeons (J.-H.F., Y.-S.W., L.-J.S.). If patients also had a fibular fracture, a 2- to 3-mm diameter titanium elastic nail (TEN) (Synthes Bettlach Inc, Oberdorf, Switzerland) was inserted in a retrograde fashion through the tip of the lateral malleolus to fix the fibular fracture first.
EF + LORIF. A limited incision approximately 3 to 4 cm was made for cleaning soft tissue and blood clots embedded in the fracture site under direct vision. Any anteroposterior (AP) or mediolateral displacement was reduced and provisionally stabilized by large AO reduction clamps. The fractures were fixed with cortical bone screws of 3.5- to 4.5-mm diameter, K-wires, or both depending on the size of the fracture. Last, parallel pins were fixed in the proximal and distal fracture throughout the tibia bone diaphysis and connected with a unilateral external fixator (Orthofix Srl Inc, Bussolengo, Italy).
MIPPO. An appropriate length of distal tibia locking plate (Synthes Bettlach Inc, Switzerland) was placed parallel to the tibia axial line and on the medial surface of the operated leg under fluoroscopy. Two 3- to 4-cm longitudinal incisions were made on the skin beneath the 2 ends of the plate based on the plate location in vitro. One incision was at the middle line of the medial malleolus, and the other was along the medial aspect of the tibia located at the proximal end of the plate. An extra-periosteal, subcutaneous tunnel then was formed between these 2 incisions using blunt dissection. The great saphenous vein was protected, and the plate was inserted percutaneously from the distal to the proximal site. Closed reduction by manipulative traction was performed under fluoroscopy to restore the length and coronal alignment of the leg. The plate position was adjusted when reduction was achieved. No less than 6 cortical layers should be purchased for each side of the fracture.
IMN. An interlocked intramedullary unreamed tibial nail (Synthes Bettlach Inc) was used in all fractures. Access to the proximal tibia was provided by a transtendinous approach. The starting point was made with an awl, and the nail was inserted in an antegrade manner by hyperflexing the knee. Reduction of the fracture often was achieved with gentle manipulation and traction by an assistant. Static locking was performed in 23 cases (82.1%), and primary dynamic locking was performed in 5 cases (17.9%).
Postoperative care was the same for each group. Ankle and knee joint exercises were performed starting 2 days after surgery. Partial weight bearing was allowed when radiologic evidence of progress toward union was seen, usually at 6 weeks after surgery. Full weight bearing was allowed when there was radiologic evidence of bone union with no pain at the fracture site. All of the external fixators were removed under local anesthesia in the outpatient department at an average of 3.2 months (range, 2.5–5.4 months).
If patients did not have a fibula fracture, timing of the surgery began when the first incision was made (at the distal tibia or the medial malleolus or anterior knee) and stopped when all of the incisions were closed at the end of surgery. If the patient had a fibula fracture, timing began when the distal incision at the lateral malleolus was made and stopped when all of the incisions were closed at the end of surgery. Fluoroscopy time was obtained from the fluoroscopy logger.
Plain radiographic evaluation consisted of AP and lateral tibial views obtained pre-operatively and at approximately 6-week intervals thereafter until fracture union. Radiographs were reviewed by 1 trained examiner (X.-S.G.) who was not involved in the patients' care. Fracture union was defined as the absence of pain and the presence of bridging callus in 3 of the 4 cortices seen on the AP and lateral radiographs of the tibia. A healing time of less than 6 months was considered as normal, whereas a healing time from 6 months to 9 months was considered to be a delayed union. Fractures not healed within 9 months were classified as nonunion.
The length of the tibia was defined as the distance between the anterior intercondylar area and the inferior articular surface of the tibia. Shortening was defined as a left/right difference in the length of the tibia of greater than 1 cm. Malalignment was defined as greater than 5° ante-/recurvation, greater than 5° varus/valgus deformity, or greater than 15° rotation difference.8 Rotational deformity was measured with the patient supine with the bilateral patella overturning. The angles were measured between the lateral edge of the feet and the surface of the bed. The left and right sides were compared.
Other complications, the time of recovery to work, and secondary operations also were recorded. At the last follow-up examination, the American Orthopaedic Foot and Ankle Society (AOFAS) scoring system21 was used to evaluate ankle function. The maximum score was 100 points. A value greater than 90 points was considered an excellent result, 75 to 89 was considered good, 50 to 74 was considered fair, and less than 50 was considered poor.
Statistical analysis was performed using SPSS software version 11.0 (SPSS Inc, Chicago, Illinois). Continuous variables during the study period are presented as mean±SD, and differences in continuous variables among (between) groups were examined using analysis of variance (ANOVA) and Wilcoxon rank sum test. Frequency distributions for category variables and excellent or good ratings were compared among (between) groups using chi-square and Fisher exact tests. The level of significance was set at P<.05.
The EF + LORIF group was assessed at a mean of 26.5 months (range, 21–35 months), the MIPPO group was assessed at a mean of 28.3 months (range, 25–34 months), and the IMN group was assessed at a mean of 29.4 months (range 21–40 months). For the EF + LORIF group, mean total operative time was 73.2 minutes (range, 63–85 minutes) and mean total radiation time was 0.3 minutes (range, 0.21–0.40 minutes). For the MIPPO group, mean operative time was 89.7 minutes (range, 76–108 minutes) and mean radiation time was 3.8 minutes (range, 2.8–4.5 minutes). For the IMN group, mean operative time was 77.4 minutes (range, 66–90 minutes) and mean radiation time was 2.3 minutes (range, 1.5–3.4 minutes). Mean operative and radiation times were longer in the MIPPO group than in the IMN or EF + LORIF groups (P<.05) (Table 2).
Details of Intra- and Postoperative Variables in the 3 Groups
Mean time to union was 22.8 weeks (range, 17–36 weeks) in the EF + LORIF group vs 21.8 weeks (range, 16–35 weeks) in the MIPPO group and 22.6 weeks (range, 18–36 weeks) in the IMN group. Delayed union occurred in 3 patients (10.7%) who underwent EF + LORIF, 4 patients (14.3%) who underwent MIPPO, and 5 patients (17.9%) who underwent IMN. Angular malalignment of 5 or greater occurred in 1 patient with EF + LORIF, 4 patients with MIPPO, and 5 patients with IMN. No patient in any group had greater than 10° varus/valgus or ante-/recurvatum malalignment, rotational malalignment greater than 15°, or shortening greater than 1 cm. No patient developed nonunion after EF + LORIF, whereas 1 patient developed infected nonunion after MIPPO and 1 patient developed aseptic nonunion after IMN. The delayed-union, malunion, and nonunion rates did not show significant differences among the groups (P>.05) (Table 2).
The IMN group had no wound complications, whereas 7 patients in the MIPPO group had superficial infections and 1 patient had a deep infection. The EF + LORIF group had 1 case of local skin necrosis around the incision; this healed after 6 weeks. In the MIPPO group, 13 patients (46.4%) had symptoms of soft tissue irritation (plate or screw impingement on the medial tibial shin region). Secondary surgery was performed in 13 patients to remove the plates and in 1 patient to manage the infected nonunion. In the IMN group, 2 cases had local soft tissue irritation symptoms from the nails, and 9 patients still had anterior knee pain 1 year postoperatively. Secondary operations were performed in 9 patients to remove the IMN and in 1 patient to resolve the nonunion. Among the 28 patients treated by EF + LORIF, 4 patients (14.3%) had pin-tract infections. One thin young woman patient in the EF + LORIF group underwent secondary operations to remove the loose and back screws due to soft tissue irritation.
At last follow-up, the average AOFAS scores were 93.5±6.4 (range, 72–100) in the EF + LORIF group, 92.7±7.5 (range, 67–98) in the MIPPO group, and 92.5±7.4 (range, 68–100) in the IMN group. There were no significant differences in the excellent or good results of ankle function among the 3 groups (P>.05) (Table 3).
Functional Outcome Scores as Measured by AOFAS
Although EF + LORIF, MIPPO, and IMN have proven to be effective and widely accepted treatment options for distal tibia fractures, none of these 3 fixation techniques is ideally suited for all combinations of bony and soft tissue injuries to the distal tibia.4 A systematic review22 suggested that plate fixation, especially MIPPO, would be preferred for extra-articular distal tibia fractures without serious soft tissue injuries. However, for fractures with serious soft tissue injuries, intramedullary fixation should be given priority.22 The EF + LORIF technique also could be used for some fractures with serious soft tissue injuries, such as for a location with relatively minor soft tissue damage or a location away from the damaged soft tissue for a small incision. As a result, EF + LORIF and IMN have broader indications compared with MIPPO.
In the present study, MIPPO had a longer operative time and more radiation exposure compared with EF + LORIF and IMN. The reason for this might be that the indirect reduction techniques of MIPPO were more complicated.12 As for EF + LORIF, a big advantage was that fewer secondary operations were needed for painful implant removal (Table 2). In contrast, after MIPPO and IMN, the implant had to be removed surgically in some symptomatic patients, which might increase treatment costs and lead to complications. Moreover, the removal of locking screws might be challenging because of stripping of the hexagonal recess and threads of the locking screw head.
High primary union rates were observed following EF + LORIF (28 of 28 fractures), MIPPO (27 of 28 fractures) and IMN (27 of 28 fractures), and the mean time to union was 22.8 weeks in the EF + LORIF group, 21.8 weeks in the MIPPO group, and 22.6 weeks in the IMN group, which was consistent with other studies.3,14,15,18 There were no significant differences in primary union rates and the mean time to union among the EF + LORIF, MIPPO, and IMN groups (Table 2).
The delayed union, malunion, and nonunion rates also did not show significant differences among the groups (Table 2). Twelve fractures (3 in EF + LORIF, 4 in MIPPO, and 5 in IMN) showed delayed union but did not require secondary procedures. The reported nonunion rates ranged from 0% to 12.7% for external fixators,23 2.4% to 10.9% for plates,18 and 3.7% to 8.1% for nails.18 The incidence of non-union in the 3 groups was within the scope of nonunion rates reported previously in the literature.18,23 Different from the MIPPO and IMN groups, fracture reduction in the EF + LORIF group was performed under direct vision and consequently better alignment could be expected. The current study showed a relatively low rate of malunion in the EF + LORIF group (1 in EF + LORIF, 4 in MIPPO, and 5 in IMN). However, there was no significant difference in the incidence of malunion among the EF + LORIF, MIPPO, and IMN groups; this might be due to the small sample size of the groups.
As for complications, wound complications were more common after MIPPO compared with EF + LORIF or IMN (P<.05). Given the similar grade of primary soft tissue injury in the 3 groups, EF + LORIF and IMN probably could be applied earlier to reduce patients' suffering without increasing the frequency of wound complications, even for patients with obvious soft tissue swelling and bruising. However, MIPPO was not a good choice for such patients. Pain caused by plate impingement on the medial tibial shin region also was common (13 cases), although bone union was not affected by the irritation. Lau et al30 reported similar results; in their study, 52% of distal tibia fractures treated by MIPPO required plate removal due to skin impingement. The thin subcutaneous tissue and suboptimal premolding of plates were responsible for the impingement. In addition, the residual malreduction also contributed to the inexactness of plate and bone contouring.
Residual anterior knee pain after nailing also has been commonly reported.12,31 A recent meta-analysis by Katsoulis et al31 included 1469 patients and suggested the incidence of knee pain ranged from 10% to 86% in these studies. In the current study, a high anterior knee pain rate of 32.1% also was observed. The most frequent causes of pain were the extent of soft tissue injury, particularly injury to the patellar tendon and retropatellar fat pad, the entry point of the nail, and the protrusion of the nail.31 External fixation rarely caused anterior knee pain because it did not interfere with the extensor apparatus of the knee.
However, EF + LORIF also had its own drawbacks. Pin-tract infection remained the most common complication, with an incidence of 14.3%. Compared with previous studies,3,4,23,26 a relatively low incidence of pin-tract infection was present in the current study. Pin-tract infections were often the result of an unstable bone-fixation interface and caused further loosening of the screws.23,26 Consequently, in the current study, hydroxyapatite coating often was used on the screws, and more attention was paid to pin-site care, which might lower the rate of pin-tract infection.
There were a few limitations of the present study. First, this was a single-center study that enrolled only a small number of patients. To further support these results, high-quality randomized controlled trials with larger sample size are needed. Second, although patients were allocated randomly to either surgical group, it was impossible to blind both the surgeon and patients, which might influence the results. Third, this study contained only a small number of open fractures and comminuted fractures. A larger sample size containing more fracture patterns would be helpful in a future study.
The results of this study indicated that EF + LORIF, MIPPO, and IMN all achieved similar good functional results. However, EF + LORIF had some advantages to MIPPO and IMN in reducing the operative and radiation times, postoperative complications, and reoperation rate.
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- Janssen KW, Biert J, van Kampen A. Treatment of distal tibial fractures: plate versus nail. A retrospective outcome analysis of matched pairs of patients. Int Orthop. 2007; 31(5):709–714. doi:10.1007/s00264-006-0237-1 [CrossRef]
- Ronga M, Longo UG, Maffulli N. Minimally invasive locked plating of distal tibia fractures is safe and effective. Clin Orthop Relat Res. 2010; 468(4):975–982. doi:10.1007/s11999-009-0991-7 [CrossRef]
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Baseline Characteristics of the 3 Groups
|Characteristic||EF + LORIF||MIPPO||IMN||P|
|Age, mean±SD, y||36.5±5.2||38.6±7.5||35.0±9.2||>.05|
|Sex, male:female, No.||16:12||21:7||19:9||>.05|
|Weight, mean±SD, kg||67.2±10.5||65.0±11.6||68.0±8.2||>.05|
|Tscherne grade, No.||>.05|
|Type of injury mechanism, No.||>.05|
| Low energy||9||10||10|
| High energy||19||18||18|
|OTA classification, No.||>.05|
|Cause of injury, No.||>.05|
| Traffic injuries||14||12||10|
|Open fracture, No.||>.05|
|Fibula fracture, No.||>.05|
|Interval from injury to surgery, mean±SD, d||3.3±2.6||3.4±2.8||3.1±2.5||>.05|
Details of Intra- and Postoperative Variables in the 3 Groups
|Variable||EF + LORIF||MIPPO||IMN||P|
|Follow-up time, mean±SD, mo||26.5±9.1||28.3±9.5||29.4±10.5||>.05|
|Operative time, mean±SD, min||73.2±12.2a||89.7±16.5||77.4±13.5a||<.05|
|Radiation time, mean±SD, min||0.3±0.1a||3.8±10.9||2.3±0.8a||<.05|
|Bone union time, mean±SD, wk||22.8±10.5||21.8±14.0||22.6±13.2||>.05|
|Time of recovery to work, mean±SD, wk||23.4±12.5||24.0±11.50||24.3±13.0||>.05|
|Pin-tract infection, No.||4 (14.3%)||0 (0%)||0 (0%)||>.05|
|Anterior knee pain, No.||0 (0%)||0 (0%)||9 (32.1%)a,b||<.05|
|Soft tissue irritation, No.||1 (3.6%)a||13 (46.4%)||2 (7.1%)a||<.05|
| ≥ 5°||1 (3.6%)||4 (14.3%)||5 (17.9%)||>.05|
| ≥ 10°||0||0||0|
|Delayed union, No.||3 (10.7%)||4 (14.3%)||5 (17.9%)||>.05|
|Nonunion, No.||0 (0%)||1 (3.6%)||1 (3.6%)||>.05|
|Wound complications, No.||1 (3.5%)a||8 (28.6%)||0 (0%)a||<.05|
|Secondary procedures, No.||1 (3.6%)a,c||14 (50.0%)||10 (35.7%)||<.05|
Functional Outcome Scores as Measured by AOFAS
|EF + LORIF||20||5||3||0|