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Intramedullary nailing versus minimally invasive plate osteosynthesis for

distal extra-articular tibial fractures: a prospective randomized clinical trial

Article in Journal of Orthopaedic Science · March 2015

DOI: 10.1007/s00776-015-0713-9 · Source: PubMed

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J Orthop Sci
DOI 10.1007/s00776-015-0713-9

ORIGINAL ARTICLE

Intramedullary nailing versus minimally invasive plate

osteosynthesis for distal extra‑articular tibial fractures:
a prospective randomized clinical trial
Atilla Polat1 · Ozkan Kose2,3 · Kerem Canbora1 · Serhat Yanık1 · Ferhat Guler2

Received: 18 December 2014 / Accepted: 9 March 2015

© The Japanese Orthopaedic Association 2015

Abstract higher in the IMN group (p = 0.012, p = 0.019, p = 0.004

Purpose The purpose of this randomized clinical trial is and p = 0.027, respectively).
to compare intramedullary nailing (IMN) versus minimally Conclusions Results of our study showed that both treat-
invasive plate osteosynthesis (MIPO) for the treatment of ment methods have similar therapeutic efficacy regarding
extra-articular distal tibial shaft fractures. functional outcomes and can be used safely for extra-artic-
Materials and methods Twenty-five consecutive patients ular distal tibial shaft fractures, and none of the techniques
with distal extra-articular tibial fractures which were had a major advantage over the other.
located between 4 and 12 cm from the tibial plafond (AO
42A1 and 43A1) were randomly assigned into IMN (n:
10) or MIPO (n: 15) treatment groups. All patients were Introduction
followed for at least 1 year. Foot function index, time to
weight bearing, union time, duration of operation, length Intramedullary nailing (IMN) is widely accepted as the
of incision, intra-operative blood loss, intra-operative fluor- treatment of choice for most open and closed tibial diaphy-
oscopy time, rotational and angular malalignment, rate of seal fractures [1]. However, reduction and stable fixation of
infection, secondary interventions and complications were distal extra-articular tibial fractures with IMN is often tech-
compared between groups. nically challenging due to a large medullary cavity within
Results All patients completed the trial and were fol- a short distal fragment [2]. In order to solve this problem,
lowed with a mean of 23.1 ± 9.4 months (range 12–52). new designs of nails have been developed and surgical
Foot function index, weight bearing time, union time, techniques have been described during the last two decades
rate of malunion, rate of infection and rate of secondary such as multi-directional and angle-stable distal locking
interventions were all similar between groups (p = 0.807, systems and locking screw holes at the tips of nails, and
p = 0.177, p = 0.402, p = 0.358, p = 0.404, p = 0.404, use of (poller) blocking screws to narrow the medullary
respectively). Intra-operative blood loss, length of surgical cavity [3–6]. Open reduction and plate and screw fixation
incision, radiation time and rotational malalignment were allows anatomic reduction and stable ostheosynthesis for
these fractures, but soft tissue complications, particularly
wound dehiscence and infection, are a major problem with
the open surgical technique, as well as disruption of vas-
* Ozkan Kose cularity, which may lead to nonunion. To overcome these
[email protected]
disadvantages, the minimally invasive plate osteosynthesis
1
Department of Orthopaedics and Traumatology, Haydarpasa (MIPO) technique, implants and instruments have been
Numune Education and Research Hospital, Istanbul, Turkey developed. In the MIPO technique, indirect reduction is
2
Department of Orthopaedics and Traumatology, Antalya performed, small stab incisions without evacuation of the
Education and Research Hospital, Antalya, Turkey fracture hematoma are used and the plate is placed by slid-
3
Present Address: Uncalı Mah. Toroslar cad., Samut Comfort ing over the periosteum without disturbing the vascularity.
Palace E2 Koyaaltı, Antalya, Turkey Furthermore, several distal locking screws can be used for

13
 A. Polat et al.

stable fixation of the short distal fragment and the whole Demographic characteristics of patients and duration of
implant behaves as an angle-stable construct [7]. hospital stay was recorded.
Currently, both MIPO and IMN are the most commonly
used treatment methods in distal extra-articular tibial frac- Operative technique and follow‑up
tures. However, which is the ideal treatment is still con-
troversial. Some authors argue that IMN is superior, while Timing of the surgery was decided according to the sta-
some authors suggest that the MIPO technique provides tus of the soft tissue envelope and degree of swelling. The
better functional and clinical results [8–12]. In the cur- type of anesthesia was decided with the collaboration of
rent literature, there are very few numbers of studies that the patient and the anesthesiologist. The operations were
provide strong evidence to clarify this subject. A recent carried out on a radiolucent fracture table in the supine
systematic review on this subject could identify only four position, without tourniquets. Closed reduction of the frac-
randomized clinical trials and concluded that further well- ture was performed with manual longitudinal traction and
designed randomized clinical trials are necessary to give a rotation and checked with fluoroscopy in both groups. In
clear answer to this problem [13]. The purpose of this rand- cases of poor reduction quality, external reduction clamps
omized clinical trial was to compare IMN versus MIPO for were used. Patients who needed open reduction were also
the treatment of extra-articular distal tibial shaft fractures. excluded from the study. The nail was inserted distal to the
subchondral plate of the plafond. Two distal static locking
screws in the coronal plane were used in all patients. No
Materials and methods blocking screws were used. During plate fixation, a small
incision was made over the medial malleolus and the plate
This study was a prospective randomized clinical trial was slid towards the proximal fragment. Screws were
which was held in an urban level 1 trauma center between placed with the help of the external guide through stab inci-
October 2009 and May 2012. All skeletally mature patients sions. In all cases, first tibial fixation was performed, and
(>18 years of age) with distal extra-articular tibial frac- then fibular fixation was performed through a lateral inci-
tures which were located between 4 and 12 cm from the sion. Total duration of operation was measured using a
tibial plafond (AO 42A1 and 43A1) were included in the chronometer starting with the first incision to final suture
study. Open fractures, pathological fractures, segmen- closure for tibial fixation. Operation time for fibular fixation
tal fractures, fractures with distal intra-articular exten- was not added, as not all patients had fibular plate fixation.
sion and comminuted fractures were excluded from the Fluoroscopy time was recorded. Total amount of bleeding
study. Furthermore, poly-trauma patients, patients with during the operation was measured with the sum of blood
simultaneous fractures of the ipsilateral extremity such as collected in suction and the used gauze for tibial fixation.
floating knee, patients with previous history of ipsilateral The total length of the incision that was used for fixation of
lower-limb fracture, congenital or neuromuscular disease the tibia was measured with a sterile tape measure.
or abnormality, chronic inflammatory joint disease and, All patients were followed at 3-week intervals until
finally, patients who refused participation in this clinical fracture union, with radiographic examinations. Later on,
trial, were excluded from the study. This study was carried radiographs were taken every 3–6 months until the last fol-
out in accordance with the ethical standards laid down in low-up. Patients were allowed weight-bearing when callus
the 1964 Declaration of Helsinki and its later amendments. was seen on a single cortex, either on AP or lateral radio-
Our institutional review board approved the study protocol graphs. At the final follow-up, all patients underwent clini-
and all patients gave informed consent prior to their inclu- cal and radiological assessments. Functional outcome was
sion in the study. assessed with the foot function index [14]. Anteroposterior
After making informed consent, patients were assigned and lateral radiographs were used to measure the alignment
into two treatment groups by flipping a coin. Patients in in both coronal and sagittal planes. Rotation was assessed
group 1 were treated with closed reamed IMN and patients clinically with foot thigh angle using a goniometer and
in group 2 were treated with MIPO. Additional plate and compared to the contralateral uninjured side, and the dif-
screw fixation was performed in cases of simultaneous dis- ference between sides was recorded. Union was defined
tal fibular fracture (fracture within the distal 7 cm of fibula) as detection of consolidation on at least three cortexes and
in both groups after the fixation of the tibia. All operations clinically by lack of pain on weight-bearing without assis-
were performed by the same surgeon (senior author). AO/ tance. Malunion was defined as varus or valgus greater than
OTA classification was used for fracture classification. The 5° in the coronal plane (anteroposterior X-ray), or recurva-
distance between the tibial plafond and the most proximal tum or procurvatum greater than 10° in the sagittal plane
end of the distal fragment was measured and recorded. (lateral X-ray) or external or internal rotation greater than

13
Intramedullary nailing versus minimally invasive plate osteosynthesis…

10° (physical examination). Any complication during the Of the 25 patients, 15 (60 %) were treated with MIPO, and
surgery and follow-up was recorded. 10 (40 %) were treated with IMN. There were 9 (36 %)
female and 16 (64 %) male patients with a mean age of
Statistical analysis 34.5 ± 10.2 years. All patients were followed for at least
1 year with a mean of 23.1 ± 9.4 months (range 12–52).
Continuous variables were stated as mean, median and Both groups were comparable with each other in terms of
standard deviation and categorical variables as percentages demographic characteristics and fracture pattern except
and frequency distribution. The comparison of continuous for sex distribution (Table 1). Nineteen patients were oper-
variables between independent groups was performed using ated on under spinal anesthesia, and the remaining 6 were
Student’s t-test or Mann–Whitney U test in accordance operated on under general anesthesia. Four patients in the
with normality testing. Comparison of categorical data was MIPO group and 2 patients in the IMN group underwent
performed using Fisher’s exact test. A value of p < 0.05 was simultaneous fibular fixation (p: 0.702). The mean duration
considered statistically significant. Power analysis showed of the operation was similar in both groups (51 min ver-
that a minimum of 7 patients in each group were needed to sus 57 min, p = 0.461). The mean blood loss, the length
detect a significant difference (D:13 SD:8) in FFI and reach of incision and the radiation time was higher in the IMN
80 % power with alpha at 0.05. group compared to the MIPO group (p: 0.012, p: 0.019 and
p: 0.004, respectively). The time between the initial injury
and operation time, and hospital stay was similar in both
Results groups (p: 0.953, p: 0.984, respectively) (Table 2).
The time until identification of callus on radiographs
A total of 25 patients were included in this study and all was similar between groups. Thus, weight bearing was
patients completed the clinical trial (100 % follow-up rate). allowed at a similar time on follow-ups in both groups (p:

Table 1  Comparison of Treatment Significance

baseline characteristics of the (p value)
patients MIPO (n:15) IMN (n:10)

Age, years ± SD 36.4 ± 10.7 34.0 ± 9.7 0.567

Sex (M/F) 7/8 9/1 0.040*
Side (right/left) 9/6 7/3 0.691
The distance between fracture and plafond, cm ± SD 8.0 ± 2.2 8.7 ± 1.7 0.376
Associated fibular fracture (yes/no) 6/9 8/2 0.402
AO/OTA classification
42A1 11 6 0.276
42A2 1 3
42A3 3 1

* Significant p

Table 2  Comparison of intra-operative variables

Treatment Significance
(p value)
MIPO (n:15) IMN (n:10)

Type of anesthesia (spinal/general) 12/3 7/3 0.653

Time interval between the injury and operation, days ± SD 6.5 ± 4.2 6.7 ± 2.8 0.953
Duration of operation, min ± SD 51.4 ± 19.1 57.0 ± 15.4 0.461
Blood loss, cc ± SD 84.3 ± 71.8 211.5 ± 161.6 0.012*
Length of incision, cm ± SD 5.6 ± 1.8 6.6 ± 0.9 0.019*
Radiation time, ms ± SD 398.6 ± 172.1 736.4 ± 337.8 0.004*
Fibular fixation (yes/no) 4/11 2/8 0.702
Hospital stay, days ± SD 9.2 ± 4.5 9.3 ± 3.1 0.984

* Significant p

13
 A. Polat et al.

Fig. 1  A patient treated with MIPO. a Pre-operative, b early post-operative, and c final radiograph

Fig. 2  A patient treated with IMN. a Pre-operative, b early post-operative, and c final radiograph

0.177). The union was achieved in all patients with a mean 10° varus) and 3 patients in the IMN group (12°, 15° and
of 131.8 ± 14.6 days (range 108–157), and union time was 20° external rotation) had malunion (p: 0.358). Foot func-
not different in treatment groups (p: 0.402) (Figs. 1, 2). tion index at the final follow-up was similar in both groups
Two patients in the MIPO group (15° external rotation and (p: 0.807). Patients in the IMN group had significantly

13
Intramedullary nailing versus minimally invasive plate osteosynthesis…

Table 3  Comparison of final Treatment Significance (p value)

outcome measures
MIPO (n:15) IMN (n:10)

Follow-up, months ± SD 22.7 ± 11.0 23.8 ± 7.1 0.790

Foot function index, score ± SD 25.3 ± 16.4 25.7 ± 11.1 0.807
Weight-bearing time, days ± SD 45.6 ± 22.2 39.5 ± 17.8 0.177
Union time, days ± SD 133.9 ± 15.2 128.8 ± 13.8 0.402
Malunion (yes/no) 2/13 3/7 0.358
Alignment
Coronal plane, degrees ± SD 1.9 ± 2.6 2.9 ± 2.5 0.375
Sagittal plane, degrees ± SD 1.8 ± 2.2 0.6 ± 1.3 0.131
Rotation, degrees ± SD 1.6 ± 4.4 7.2 ± 7.2 0.027*
Superficial infection 1 0 0.404
Secondary interventions (implant removal) 1 0 0.404

* Significant p

higher rotational malalignment (p: 0.027). Comparisons of choice. This study compared the clinical, radiographic and
final outcome measures are summarized in Table 3. functional results of IMN and MIPO in patients with distal
tibial extra-articular shaft fractures.
Complications The results of our study showed that both MIPO and
IMN are equally effective in terms of functional outcomes
One of the patients in the MIPO group presented with clini- (foot function index). Similarly, in several previous stud-
cal signs of implant-related infection at the end of the 4th ies, although different scores have been used for evalua-
month. The implants were removed and the wound was tion, functional outcomes have been found equal in both
debrided. Deep tissue samples were taken for bacterial treatment modalities, which is consistent with our findings.
culture and methicillin-sensitive Staphylococcus aureus Guo et al. [8] compared MIPO and IMN in a series of 85
(MSSA) was isolated. The patient received 4 weeks of anti- patients with distal tibial fractures and reported statistically
biotherapy and during this time interval he used a patel- similar AOFAS scores in both groups. Li et al. [11] com-
lar tendon-bearing (PTB) brace. At the final follow-up pared three different surgical techniques (MIPO, IMN and
he had completely recovered, without any signs of radio- external fixation) in the treatment of distal tibial fractures
graphic, clinical or laboratory signs of osteomyelitis. The using the Mazur ankle score and reported equal functional
rate of infection was similar between groups (p: 0.404). outcomes in all groups. Im et al. prospectively compared
Two patients in the IMN group complained about ante- closed reduction and IMN versus open reduction and plate
rior knee pain which lasted around 6 months and had sub- and screw fixation for distal tibial fractures in a series of
sided to a clinically irrelevant state at the final follow-up. 64 patients. Although they reported equal functional ankle
Two patients in the MIPO group complained about slightly scores, ankle dorsiflexion was better in patients in the IMN
prominent implants and screws over the medial malleolus. group [15]. In distal tibial extra-articular fractures, as the
No secondary intervention was performed in any other case ankle plafond is intact, the ankle function is usually pro-
(p: 0.404). tected regardless of the technique used for fixation. On the
other hand, it is well known that anterior knee pain can be
seen after IMN. As the MIPO technique does not involve
Discussion any surgical incision around the knee, it is free from this
complication. Although most of these symptoms (ante-
Distal tibial extra-articular fractures located between 4 and rior knee pain) regress with time, some patients may need
12 cm from the tibial plafond are a dilemma for orthope- removal of the IMN, and even removal may not solve the
dic surgeons in terms of management. If surgical treatment problem. Yang et al. compared the results of IMN versus
is decided on, the second question arises as to the type of open reduction and plating in distal tibial fractures and
fixation method: external fixation, open reduction and plate reported anterior knee pain in almost half of their patients
fixation, MIPO, or IMN, which can all be used as the defin- (6/13) whereas there were no patients with knee symptoms
itive surgical treatment [9, 11]. However, the advantages of in the plating group. Two of their patients’ symptoms con-
MIPO and IMN are addressed by many surgeons, and cur- tinued after the removal of IMN [6]. Janssen et al. [10] ret-
rently MIPO and IMN are widely accepted as treatments of rospectively compared MIPO and IMN in matched pairs

13
 A. Polat et al.

of patients with distal tibial fractures, and found statisti- similar between groups. Xue et al. reviewed 14 studies that
cally more frequent anterior knee pain during kneeling and compared IMN versus plating and analyzed 842 patients,
squatting in the IMN group. Similarly, in our series 2 out of and concluded that union time was equal in both techniques
10 patients treated with IMN had anterior knee pain. From [13].
a functional point of view, both treatment methods resulted The distal tibia is one of the locations where post opera-
in similar ankle function, but anterior knee pain seems to tive infection is likely to occur because of the thin soft tis-
be a disadvantage of the IMN technique. sue envelope and high incidence of open fractures. In the
An ideal fracture treatment method should provide ana- case of plate fixation, particularly on the medial side, the
tomic or at least acceptable fracture alignment in the tibia, subcutaneous location of the plates may also contribute to
because any malalignment or malrotation may cause post- the occurrence of infection. The rate of infection is reported
traumatic osteoarthritis in neighboring ankle and knee to be higher in plate fixation compared with IMN in studies
joints in the long term [16]. In recent systematic meta- in which an open reduction and plating technique was used
analysis, malalignment was found to be more common in [19]. On the other hand, when the MIPO technique is used,
IMN compared to plate and screw fixation in distal tibial the rate of infection seems to be equal in both groups. In
fractures [13, 17, 18]. However, in these meta-analyses, our study, there was one infection in the MIPO group and
studies that reported both open reduction and minimally infection subsided upon removal of the implants. In a meta-
invasive techniques were included. Open surgeries using analysis, the rate of infection was found to be equal with
direct reduction techniques provide direct visualization of both techniques [18]. The infection is not only dependent
the fracture and usually ensure accurate fracture reduction on the surgical technique itself. There are other factors
and alignment. On the other hand, the MIPO technique which may play a role in the occurrence of infection, such
uses an indirect reduction technique similar to IMN. Im as patient related co-morbidities, open fracture with con-
et al. [15] reported that the rate of malunion which exceeds tamination, operating room conditions and severity of soft
the acceptable range (>5° varus/valgus, >10° procurvatum/ tissue injury. According to our experience, MIPO should be
recurvatum) was significantly higher in the IMN group. delayed until the soft tissue coverage is adequately healed.
Similarly, Vallier et al. [9] reported that malalignment (>5°) Considering other variables, we have found statisti-
was more common in the closed IMN group compared with cally less blood loss, less fluoroscopy time, shorter dura-
the open reduction and plate fixation group. In both of these tion of operation and smaller incision length in the MIPO
randomized trials, plate fixation was performed under an group. Shorter incision length is an important advantage
open surgical approach; however, IMN was performed with in preventing post-operative infection and wound prob-
closed techniques. On the other hand, studies which com- lems. However, there was only 1 cm difference between
pared IMN and MIPO found a similar malunion rate. In the two groups in our study (5.6 versus 6.6 cm). Although
studies performed by Guo et al. and Li et al. [8, 11] mala- this difference was statistically significant, we think that it
lignment was found to be equal in both groups. Similarly, can be neglected clinically. We found greater blood loss in
we could not find any significant difference between angu- the IMN group (84 versus 211 cc). Intramedullary ream-
lar malalignment in our patients. There were only 2 patients ing may be the major reason for this difference. Finally, we
(1 in each group) who had angular malunion, among all found greater use of fluoroscopy in the IMN group. From
patients. However, malrotation was better restored in the the surgeon’s point of view, any surgical technique which
MIPO group. Thus, we believe that the rate of malunion is necessitates less fluoroscopic control during the operation
equal in IMN and MIPO techniques. Controversial findings is an important advantage. One of the problems with the
in the literature result from the evaluation of studies using IMN technique is the proper locking of the distal screws.
different surgical techniques in the same analysis. Several easier locking techniques and systems have been
The rate of union is another factor in final clinical out- proposed [20]. In our study we used a standard external
comes. Both treatment methods resulted in similar union guide system to lock the IMN. We have used fluoroscopy
rates in our study. This finding was also consistent with control mostly for distal locking in this series. This may
findings in the relevant literature. Although the etiology explain why the fluoroscopy time in the IMN group was
of nonunion is multifactorial, it is well known that surgi- greater than in the MIPO group. Furthermore, the difficul-
cal technique is one of the most important determinants of ties in distal locking increased the operation time in the
union. As both surgical techniques are minimally invasive, IMN group. Unlike in our study, Guo et al. [8] reported that
they do not disrupt the fracture hematoma and impair the fluoroscopy time was longer with MIPO due to the indirect
healing process. Guo et al. reported no patients with non- reduction technique, which is more complex than IMN.
union in their series. Li et al. reported only 2 patients (1 Lie et al. [11] reported longer operation times with MIPO.
patient in IMN and 1 patient in the MIPO group) with non- Fluoroscopy time and duration of operation may vary in
union [8, 11]. Besides the union rate, union time was also accordance with the fracture type, the type of implant and

13
Intramedullary nailing versus minimally invasive plate osteosynthesis…

surgeon’s experience with the technique. Thus, it is hard screws) in stabilizing tibia fractures with short proximal or distal
to standardize all these variables and to make a definitive fragments after insertion of small-diameter intramedullary nails.
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There are some strengths and limitations of this study. Treatment of distal tibial metaphyseal fractures: plating versus
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the power analysis was over 80 %. Secondly, although tib- trial comparing closed intramedullary nailing with percutane-
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Conflict of interest The authors declare that they have no conflict tive randomized trial of closed reduction and intramedullary nail
of interest. versus open reduction and plate and screws fixation. J Trauma.
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