Arch Orthop Trauma Surg (2014) 134:793–802 DOI 10.1007/s00402-014-1970-3
Trauma Surgery
Ilizarov external fixation or locked intramedullary nailing in diaphyseal tibial fractures: a randomized, prospective study of 58 consecutive patients Telmo Ramos · Bengt I. Eriksson · Jón Karlsson · Lars Nistor
Received: 8 April 2013 / Published online: 25 March 2014 © Springer-Verlag Berlin Heidelberg 2014
Abstract Purpose The aim of this study was to compare the Ilizarov circular fixator (IL) and locked intramedullary nailing (IM). Patients and methods Patients with isolated tibia shaft fractures were randomly allocated to either the IL (n = 31) or IM (n = 27) method. Conventional radiographs, postoperative pain assessment, self-appraisal scores and complications were evaluated. At the clinical 1-year follow-up, the patients were also evaluated by an independent observer. Results The minority of patients had open fractures, two and nine patients in the IM and IL groups, respectively. Eight patients in the IM group and four in the IL group sustained major complications (p = 0.107). In the IM group, two patients developed compartment syndrome, one deep infection, one hardware failure, one delayed union, one pseudarthrosis and two had a malunion. In the IL group, two patients developed pseudarthrosis and two had a malunion. Superficial pin-site infections were observed in 16 patients in the IL group. The fractures had healed radiographically at 12 weeks in both groups. At the 1-year follow-up, there were differences in pain (VAS) and satisfaction (VAS) scores in favor of IL treatment (VAS, p = 0.03 and p = 0.02, respectively). There were no differences between the groups with regard to range of motion (ROM) in the knee and ankle joints. The registration of local T. Ramos (*) · L. Nistor Department of Orthopedics, Skaraborg Hospital Skövde, 54185 Skövde, Sweden e-mail:
[email protected] B. I. Eriksson · J. Karlsson Department of Orthopedics, Sahlgrenska University Hospital, Sahlgrenska Academy at Gothenburg University, 431 80 Mölndal, Sweden
tenderness and pain revealed that there were 19 patients with anterior knee pain in the IM group and one in the IL group at the 1-year follow-up (p < 0.001). Conclusion The IL is a safe and reliable alternative to IM for the treatment of tibial shaft fractures, with a low complication rate and good clinical outcome. Both treatments were well tolerated, but at the 1-year follow-up the patients in the IM group had more pain and were less satisfied. Finally, there was a high frequency of anterior knee pain in the IM group. Keywords Tibial fracture · Ilizarov · Intramedullary nail · Randomized study · Load · NHP · EQ-5D
Introduction Based on randomized studies, comparing the locked intramedullary nail (IM) and conservative treatment, IM has been recommended in the management of closed fractures and Gustilo I and II tibial shaft fractures [29, 34, 52]. Nailing the tibia diaphysisis currently accepted by the majority of orthopedic surgeons, as the gold standard [2, 9, 51]. This type of fixation is generally well tolerated, but it can sometimes lead to severe complications with clinically relevant sequels [10, 40, 50]. There are few reports that describe different external fixators in the treatment of closed tibial shaft fractures. They have claimed that this type of treatment might be demanding for the patient during the time when the frame is in situ and might be associated with negative effects, such as prolonged healing times, high rates of pin-tract infections, pin loosening and malunion rates of approximately 20 % or more [19, 20]. This has contributed to the limited use of external fixators as a definitive treatment and restricted the
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indications for the external fixator to fractures with major soft-tissue damage [14, 28, 36]. We found only one prospective, randomized study on tibial shaft fractures without severe soft-tissue problems (Gustilo 0-II) on comparing a locked intramedullary nail and an external fixator (a dynamic axial fixator, Ex-fi-re) [7]. This study concluded that the results were comparable in most respects, but there were more re-operations due to secondary dislocation in the external fixation group. According to the original recommendations, the classical Ilizarov external fixator [31, 32, 49] can be a valid alternative in the primary treatment of tibial fractures [47]. There are potential advantages to using this method, such as the ease of fracture reduction and the fixation of the fracture fragments that can be achieved with almost no soft-tissue exposure or blood loss. Moreover, this treatment does not leave implants in situ when the fracture is healed. The adjustment of the alignment with compression or distraction of the fracture fragments is easily performed both during and after primary surgical intervention and the fixator is stable enough to allow
early weight-bearing irrespective of the type of fracture [21]. The aim of this prospective, randomized study was to compare the circular Ilizarov external fixator (IL) and locked intramedullary nailing (IM) in the treatment of tibial diaphyseal fractures.
Patients and methods Study design This was an investigator-initiated study, with a prospective, open randomized design. The recruitment and followup schedule is shown in Fig. 1 and a Consort E-flowchart is presented in Fig. 2. Consecutive patients, 18–75 years of age, with isolated displaced tibial shaft fractures were included at Skaraborg Central Hospital in Skövde, Sweden; a referral trauma center for a population of approximately 280,000 inhabitants. The definition of fracture displacement was based on the radiographic appearance judged
Identification of patients
Direct referral
Data collected
Assessment of eligibility
Review eligibility criteria History of relevant medical conditions Physical examination Radiographs Eligibility criteria reviewed again
Eligibility form
Randomization
Randomization issued to patient before consent 24-hour randomization by sealed envelopes Study explanation Informed consent Key patient information saved All eligible patients who consent to the trial
↓
↓
Consent form
↓
Surgery
Either Ilizarov or nailing surgical protocols to be followed
Surgical form
↓
Follow-up schedule Discharge
Assessment of outcome events
Follow-up forms, gait analysis
2 weeks
Assessment of outcome measurements
Follow-up forms
4 weeks
Assessment of outcome measurements
Follow-up forms, EQ-5D, NHP, gait analysis
8 weeks
Assessment of outcome measurements
Follow-up forms, gait analysis
12 weeks
Assessment of outcome measurements
Follow-up forms, EQ-5D, NHP, gait analysis
1 year
Assessment of outcome measurements
Follow-up forms, EQ-5D, NHP
Post-operative
Fig. 1 Recruitment and follow-up schedule
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Fig. 2 The Consort E-flow chart
Assessed for eligibility (n=144)
Excluded (n= 79) Enrollment
Not meeting inclusion criteria Refused to participate (n= 5)
Randomization
Allocated to IM
Allocated to Ilizarov fixator
(n= 27)
(n=31) Allocation
Received allocated intervention
Received allocated intervention (n= 27)
(n=31)
Did not receive allocated intervention
Did not receive allocated intervention
(n= 0)
(n=0)
Lost to follow-up (n=0)
Lost to follow-up (n=1) The patient refused to follow the study protocol
Administrative reasons (n=2)
Follow-up
Intervention discontinued (n=0 )
Analyzed (n= 31)
Excluded from analysis (n=0)
by the attending consultant and was based on the following fracture pattern: >5° coronal angulation, >10° sagittal angulation, >10° rotation, >1 cm shortening and translation over 50 percent of the tibial diaphysis. Patients with other fractures or disorders affecting gait and patients not able to understand or follow instructions in Swedish were excluded. Randomization to treatment with the Ilizarov circular fixator (IL) or locked, intramedullary nailing (IM) was performed using sealed opaque envelopes. The randomization was stratified into three groups to avoid a skewed distribution according to the patient’s age: 18–30, 31–50 and 51–75 years, as age is considered to be of major prognostic importance. Patients who were not willing to participate in the study were treated according to their own preference, and all unopened envelopes were saved until the end of the trial.
Analyzed (n= 27) Analysis
Excluded from analysis (n=0)
The main outcome was a composite of the following significant factors: compartment syndrome, delayed union, pseudarthrosis, malunion, deep infection and hardware failure, defined as “major complications”. Radiographic fracture healing was defined as dense callus bridging of at least three cortices [48]. In patients treated with the Ilizarov technique, clinical healing was defined as no pain or instability by stressing the fracture or on walking (in the IL patients, after the extraction of the connection rods of the IL at the fracture level). Delayed union was diagnosed as consolidation between 36 weeks and 52 weeks. Pseudarthrosis was reported when consolidation was absent after 52 weeks and a further surgical procedure was necessary to promote the healing. Definition of malunion of the diaphysis was the same as the displacements used in the inclusions criteria.
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Deep infection was defined as purulent drainage or osteomyelitis presenting after definitive wound healing and was diagnosed by the treating surgeon based on clinical suspicion and subsequent cultures. Fracture types Fractures caused by a traffic accident or fall from a height of at least 3 m were classified as high-energy trauma [44]. The fractures were classified according to the AO/OTA [43] and Gustilo classifications [24, 25]. Surgical procedure Both IL and IM operations were performed under general anesthesia, with the patients in the supine position, using antibiotic prophylaxis (cloxacillin 2 g i.v., three doses in total) and calcaneal traction. Patients undergoing IM were operated on with 90° of knee flexion. Fluoroscopic visualization in the antero-posterior and lateral views was used in all patients. The external device was the original Ilizarov design (Smith & Nephew, Memphis, Tennessee, USA). Four or five steel rings, connected with parallel rods, were used. The external device was not assembled pre-operatively. The proximal ring was placed at the level of the fibular head and the most distal ring at the level of the distal metaphysis with wires. Each ring was fixated with three crossing wires. To eliminate residual displacement of the bone fragments, stabilizing olive wires were inserted at different levels. If necessary, additional techniques such as drop-wires and/or relocation of bone fragments using olive wires were used, together with arched bending of the wires. All the wires were tensioned to at least 110 kg. Reduction was confirmed radiographically and compression was performed as the final step. Permafoam® dressings were applied. The operations were performed by or under the supervision of one trauma surgeon with a special interest in limbre construction (TR). The IM was performed using the cannulated tibial nail (CTN, Syntes®). The nails were inserted using a longitudinal incision over patellar tendon. The incision was extended proximally from the level of the tibial tubercle to the mid-portion of the patella. The infra-patellar fat pad was retracted to expose the anterior surface of the proximal tibia. The patellar ligament was retracted laterally to obtain access to the insertion site. The IM nail was introduced after reaming the medullary canal according to the AO standard recommendations to 0.5–1 mm above the diameter of the nail. The proximal and distal locking screws were placed using a free-hand technique. The tendon and subcutaneous tissues were adapted with Vicryl® sutures. The skin was sutured with Ethilon® and thereafter cleaned
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with Klorhexidin®. Dry dressings were then applied. The surgery was performed by or under the supervision of experienced trauma consultants. The duration of the surgery was measured from the insertion of the first wire to the last nut adjustment including the pin-site dressing in the IL group and from the beginning of the wound incision to the last suture in the IM group. After the operation was completed, the patients received a post-operative continuous analgesia pump for the first 24 h. Compartment pressure monitoring was not used and the decision to perform fasciotomy was based on clinical judgment. Immediate full weight-bearing was encouraged in the IL group, but in the IM group, restricted weight-bearing was recommended by the surgeon if the fixation was not considered stable enough. Post‑operative treatment and follow‑up In the IL group, the “Kurgan protocol” [17] was used for post-operative pin-site dressings and the Checketts– Otterburns classification [13] was used to describe pin infections. All patients were discharged directly to their homes when they could walk independently with crutches after a median period of 5 days (range 2–13) in the IL group and 6 days (range 1–16) in the IM group (p = 0.07). Followups were performed with clinical and radiographic examinations at approximately 2, 4, 8, 12 weeks and 1 year and, if necessary, until wound problems were solved or radiological fracture healing was completed. Pain and patient satisfaction were registered (VAS 100 mm) at four and 12 weeks and at the 1-year follow-up. The validated Swedish versions of the EuroQol/EQ-5D [8] and the Nottingham Health Profile (NHP) [30, 56] were used for patient selfappraisal at the same time intervals. Standard antero-posterior and lateral radiographic projections were used to evaluate fracture healing and malunion. The radiographs were primarily evaluated by one of the authors (TR) for treatment purposes and the final assessment was made separately by an independent experienced radiologist. In the IL group, the healing was also assessed by manual stress and by judging whether the patients were able to walk without pain. In the IL group, this could be done after the connecting rods had been removed at the fracture level. The clinical 1-year post-operative outcome, including the range of movement (ROM) examination, was assessed by an independent observer, a physiotherapist, who also registered the localization of pain described by the patient as anterior knee pain, fracture site pain and ankle pain. Reoperation was defined as any surgical intervention in the operating room where regional or general anesthesia
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was needed after the primary procedure to treat compartment syndromes, to achieve fracture union, to eradicate infection, to stabilize the hardware, to achieve soft-tissue coverage or to remove all parts of the IL or IM. These procedures were subdivided into major and minor revisions. Revisions were classified as minor for the replacement or removal of all or parts of the IL under regional or general anesthesia or the removal of the static locking screw from the IM (dynamization). Major revisions included fasciotomy, the removal or exchange of the IM, bone grafting, amputation and soft-tissue coverage. Statistical analysis A power analysis was primarily based on the frequency of deep infections and compartment syndrome. The frequencies of these complications together were retrospectively approximately 20 % at our department (unpublished data) in intramedullary nailed fractures, which was higher than the data reported in the literature published before the start of our study. With 30 patients in each group, 80 % power is achieved to statistically detect a difference if there are no such complications in the patients treated with the Ilizarov method. This was accepted when the study was planned by the regional ethical review board at Sahlgrenska University Hospital in Gothenburg. Statistical analyses of the results were performed using χ2 or Fisher’s exact test when comparing categorical variables between the groups. Descriptive statistics were calculated for the variables of ordinal and continuous data type. The Mann–Whitney test was used to compare differences between the two groups with respect to part 1 of the VAS scores, NHP, the total NHP score and EQ-5D. To explore correlations between VAS Pain, NHP and EQ-5D, Spearman’s correlation analysis was used. The SPSS statistical package v. 19 was used to perform the statistical analyses. Significance was set at p < 0.05 unless otherwise indicated. Ethics All patients were informed about the study and gave their informed written consent to participate. The study was approved by the regional ethical review board at Sahlgrenska University Hospital in Gothenburg (ID: Ö 047-03).
Results Demographic data Between August 2003 and July 2010, 58 patients were randomly allocated to treatment with the IL (n = 31) or the
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IM method (n = 27). The age stratification was for the IL and IM group in 18–30 years with 9 and 11 patients, 31– 50 years with 11 and 9 patients and 51–75 years with 11 and 7 patients, respectively. Because the age could not be a confounding factor, there was no further discussion. The demographic data, including cause of injury and fracture type (AO and Gustilo classifications), are shown in Table 1. There were nine open fractures in the IL group and two open fractures in the IM group, (p = 0.037). The median delay between injury and surgery was 2 days in both treatment groups (range 0–9 and 0–6, for the IL and IM group, respectively). The median operation time was 137 min (range 65–195) in the IL group compared with 153 min (range 85–250) in the IM group (p = 0.094). Main outcome results Major complications such as compartment syndrome, deep infection, hardware failure, delayed union, pseudarthrosis Table 1 Summary of the demographic characteristics of patients enrolled in the Ilizarov (IL) study group or the intra-medullary nail (IM) study group Parameter
IL group
IM group
Number of patients (N)
31
27
Male N (%)
22 (71 %)
19 (70 %)
Female N (%) Age (years, median and range) Age stratification 18–30 31–50 51–75 Trauma type Low energy High energy Open fractures Gustilo I Gustilo II AO classification A1 A2 A3 B1
9 (29 %)
8 (30 %)
46 (18–71)
38 (19–70)
9 11 11
11 9 7
20 11
22 5
5 4
1 1
7 11 2 2
4 11 10 1
7 0 2
0 1 0
1 12
0 8
18
19
B2 B3 C2 Location in the diaphysis Proximal Middle Distal
All the patients have an isolated tibial shaft fracture
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Table 2 Complications at 1-year follow-up Parameter
IL group
IM group
Number of patients (N) Major complication Compartment syndrome Deep infection Hardware failure Delayed union Pseudarthrosis Malunion Varus > 5º Valgus > 5º Side view 5º–10º Rotation > 10º Shortening 5–10 mm Translation > 50 % Minor complication
31
27
0 0 0 0 2
2 1 1 1 1
0 2 0 0 0 0
0 1 0 1 0 0
16
0
Superficial infection
and malunion were recorded in four patients in the IL group and eight patients in the IM group (p = 0.107). All complications are summarized in Table 2. There were two cases of pseudarthrosis in the IL group and one in the IM group, all treated successfully with the Ilizarov technique. At this operation, the nail was also extracted in the patient in the IM group. In the IM group, two patients developed compartment syndrome and underwent fasciotomy within 24 h after the index operation. One of them developed a drop foot and disturbed peroneus nerve sensory function. Another patient in the IM group had hardware failure and was re-operated 2 weeks after the initial surgical procedure with removal of the proximal part of the nail and fixation with an Ilizarov external fixator. One patient in the IM group had a delayed union that healed without any further surgical intervention to promote healing after 110 weeks. In the IL group, there were two malunions, both with 6 degrees of valgus each and, in the IM group, there was one patient with 10 degrees of valgus while one patient had an external rotation of 40o. Only the patient treated with IM who had 10 degrees of valgus required corrective surgery. In the IM group, one patient (B3, Gustilo I) developed a deep infection which healed after debridement and prolonged antibiotic treatment with the IM still in situ. Minor complications and other observations In the IL group, 16 patients developed 35 superficial pinsite infections (Checketts–Otterburns II–III) (Table 2). In seven patients, 12 pin-site infections did not require any specific treatment except for single-wire extraction,
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but 23 pin infections healed after short-term antibiotics (flucloxacillin). The total time to healing in the IL group was calculated from the date of the injury to the removal of the frame at a median of 15 weeks (range 12–24), while the radiological healing was 12.5 weeks (range 4–241). The radiological healing in the IM group was also 13 weeks (6–110) (n.s.). There were no differences in terms of knee or ankle joint range of motion in the two groups at 1 year. All the patients were able to flex their knees more than 120 degrees. Compared with the uninjured side, there was a reduction of more than 15 degrees of passive dorsiflexion in two patients in each treatment group and of more than 15 degrees of passive plantar flexion in six patients in the IL group and seven in the IM group. In the IL group, all the patients were allowed unrestricted weight-bearing and in the IM group, eleven patients were instructed bear weight only “touch-down” during the first 6 weeks post-operatively, according to the instructions of the surgeons. In the IL group, new wires were introduced in five patients to improve the repositing of bone fragments and in one because of tethering of the extensor hallucis longus tendon. The removal of the frames took place ambulatory in all patients under local anesthesia. In the IM group, the nail was extracted in six patients due to proximal pain at the insertion site in the tibia. In another eight patients the proximal and/or distal locking screws were removed. Four of these had delayed healing for 4–6 months and the purpose of the surgery was dynamization of the nail. In another four the screws were removed to alleviate local tenderness (Table 3). Self‑appraisal tests and pain evaluation by the physiotherapist The patient’s pain assessment (VAS), satisfaction (VAS), EQ5D and the NHP total score at different time intervals are shown in Table 4. The correlation between the pain and function scores can be seen in Table 5. At the 1-year follow-up, there were differences in Pain (VAS) and Satisfaction (VAS) scores in favor of the IL treatment. Pain Table 3 Reasons for re-operation Indication for re-operation
IL
IM
Deep infection Pseudarthrosis Broken hardware Compartment syndrome Extraction of nail—knee pain
0 2 0 0 0
1 1 1 2 6
Extraction of screws or replacement of wires
4
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Table 4 The patient’s pain (VAS), satisfaction (VAS), the NHP totals score and EQ5D at different time intervals Parameter
IL group
IM group
Number of patients 30a (N) Pain (VAS) 4 weeks 18 (0–78) 12 weeks 14 (0–78) 1 year 5 (0–69) Patient satisfaction (VAS) 4 weeks 27 (0–42) 12 weeks 10 (0–48) 1 year 9 (0–69) NHP total score 4 weeks 17.5 (5.6–65.2) 12 weeks 17.9 (1.4–41.8) 1 year 1.6 (0–62.2) EQ-5D 4 weeks 0.59 (−0.003–0.85) 12 weeks 0.69 (0.088–1.0) 1 year
0.93 (−0.077–1.0)
p valueb
27
Discussion
28 (0–78) 18 (0–48) 18 (0–58)
ns ns 0.03
27 (0–67) 27 (0–99) 27 (0–99)
ns ns 0.02
19.0 (0–59.5) 12.2 (0–42.0) 5.2 (0–52)
ns ns ns
0.62 (0.10–0.88) ns 0.69 (0.18–0.85) ns 0.79 (0.16–1.0)
ns
The median values are indicated by 95 % CI ns not statistically significant a
One patient refused to comply with the study protocol
b
Comparisons between the groups using the Mann–Whitney test
Table 5 The correlation coefficient (Spearman’s) between the VAS pain and the NHP and EQ5-D functional scores at different time intervals NHP vs EQ5-D NHP vs VAS pain EQ5-D vs VAS pain 4 weeks −0.47 12 weeks −0.57
1 year
−0.61
0.52 0.40 0.57
each group and pain in the ankle was recorded in four and five of the IM and IL patients, respectively.
−0.38 −0.35
−0.79
All comparisons statistically significant if p ≤ 0.001
Table 6 Pain problems at 1 year Pain
IL group
IM group
Anterior knee Fracture site
1 5
19 5
Ankle
5
4
and local tenderness localization at the 1-year follow-up was registered (Table 6). There were 19 patients with anterior knee pain in the IM group and one in the IL group and this difference was statistically significant (p = 0.001). The number of patients with pain at the fracture site was five in
Four patients in the IL group and eight in the IM group sustained major complications. The absolute number of major complications was higher in the IM group compared with the IL group, even though there were more open fractures in the IL group. In the IM group, there were two patients with compartment syndrome, one deep infection, one hardware failure, one delayed union, one pseudarthrosis and two malunions. In the IL group, there were two patients with pseudarthrosis and two with a malunion. Two patients developed compartment syndrome both in the IM group, which is comparable to earlier reports with a prevalence of up to 10 % [4, 23]. One implant failure was observed in the IM group. The only deep infection occurred in the IM group, even though there were more high-energy trauma and soft-tissue injuries in the patients in the IL group. In an analysis of 1.106 patients with tibial shaft fractures operated on with reamed IM nailing, an incidence of 1.9 % was reported in closed fractures, 6.9 % in Gustilo type I and 6.6 % in Gustilo type II fractures [16]. Khatod et al. [38] showed that of 103 patients with open shaft fractures, 22.6 % became infected and 5.7 % went on to develop osteomyelitis within 10 months. Foster et al. [22] reported a study comprising 40 consecutive complex segmental shaft fractures (35 AO 42C fractures and five 42B3 fractures) treated with the Ilizarov method in adults and, like them, we did not observe any major complications such as deep infection or compartment syndrome using this method. Pin-site infection is a common problem in patients treated with external fixation [12], but in the present study, these infections were easily treated with short-term antibiotics or wire extraction and IL treatment could be completed without interruption. In long-term follow-ups after tibial shaft fractures, there is no evidence that the malalignment of the lower limb will lead to any restriction in motion, pain or osteoarthritis of the ankle, even with an angulation of 15° [37, 39, 42]. There were four malunions, two in the IL group and two in the IM group, respectively, of which one patient in the IM group needed a re-operation. Two patients in the IL group and one in the IM group developed pseudarthrosis. There was a difference between the radiological healing time and the time at which the fracture was considered to be clinically healed in the IL group (extraction of the external fixator). A corresponding difference was not possible to observe in the IM group,
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mainly due to the fact that the nail was left in situ until after radiological callus formation. There is a lack of consensus regarding the assessment of fracture healing of tibial shaft fractures since radiological callus formation is difficult to judge at an early stage and also because of the inaccuracy of the radiological definition of non-union and malunion [1, 15, 18, 26]. Blinding of the radiological outcome is ideal, but for obvious reasons, this was not possible in this type of study with two distinctly different surgical procedures [6]. Moreover, the inter-observer agreement regarding the radiographic assessment of fracture healing following the IM treatment of tibial shaft fractures is considered to be low [55]. It is impossible to apply identical clinical healing criteria in the two treatment groups in the present study. This was reflected by the difference in the IL group between the times at which the fracture was considered to be radiologically healed which was shorter than the time when the fixator was removed. Weight-bearing per se has been shown to increase with time post-fracture and it could, therefore, be used as an objective measurement of fracture healing [33]. Despite the fact that the IL patients were allowed to start loading at an earlier stage post-operatively, this did not prolong the radiological healing time, which was almost identical in both treatment groups and similar to that reported previously using different treatments [14, 35, 46]. The operating time in the IL group was slightly shorter than in the IM group and can be further shortened, at least theoretically, by preassembling the frame. As the Ilizarov technique is essentially a closed method, this is probably of minor importance. With regard to intramedullary nailing, however, as Malik et al. [41] pointed out that the length of the operation may affect the outcome. When using the Ilizarov technique, some tethering of muscles and tendons is inevitable and this would theoretically affect the range of motion in the knee and ankle joints. A study on adolescents has shown good or excellent articular function after IL fixation [45]. To the best of our knowledge, there is no previous study that addresses this issue in adults with tibial shaft fractures. In the present study, the range of motion was similarly affected in both groups. In terms of the treatment of tibial shaft fractures, there are some simple prognostic variables. If the fracture is open, transverse or if there is a postoperative fracture gap, high revision re-operation rate could be expected according to data published by Bhandari et al. [3] and they found a total re-operation of 22.4 % in 192 patients. Harris et al. [27] found that the overall re-operation rate in 151 consecutive patients with tibial shaft fractures was 35.8 %. With almost the same definition (the ambulatory extraction of wires was excluded), the rate was 19 % in the IL group and 70 % in the IM group. At the 1-year follow-up, anterior knee pain was a more common problem in the IM
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group compared with the IL group, 19 compared with one (Table 2). The anterior knee pain after tibial nailing can lead to substantial functional impairment, even if the pain syndrome appears to subside or disappear in the long term [54]. Compared with a transpatellar tendon approach, the paratendinous approach for nail insertion does not reduce the prevalence of chronic anterior knee pain or functional impairment after the IM of a tibial shaft fracture [53]. Kneeling was found to be the worst activity in terms of pain [11]. The reported incidence of this complication can be as high as 92 % [16]. This should be conveyed to the patient, especially in patients whose work involves kneeling and squatting, as the results of nail removal to alleviate pain are uncertain [5, 38]. Pain and function were also analyzed using several selfappraisal scores. There was a good correlation between the scores. There was a trend indicating that the patients in the IL group generally scored better than the IM patients and the differences in the VAS scores were statistically significant for Pain and Satisfaction at 1 year. This confirms that long-term physical disability remains a problem for many patients following tibial shaft fracture 12 months post-injury [22] and this should be considered when giving prognostic information to patients. To summarize, the equally high union rate, with little risk of secondary dislocation, in both treatment groups indicates that the Ilizarov external fixation is a valid, useful alternative to locked intramedullary nailing in the treatment of tibial shaft fractures. The pin infections in the IL group did not constitute a problem of clinical significance and the self-appraisals showed that the IL treatment, despite the voluminous external frame, was as well tolerated as the IM treatment. The minimally invasive IL technique allows early weight-bearing and avoids the frequently observed anterior knee pain reported in approximately 70 % the IMtreated patients. Conclusion The Ilizarov external fixator is an interesting alternative to intramedullary nailing in the treatment of tibial shaft fractures. This study has demonstrated that it is possible to successfully treat diaphyseal tibial fractures using the Ilizarov method, a minimally invasive technique allowing immediate weight-bearing. The patients undergoing surgery with IL appeared to have less anterior knee pain. The Ilizarov method also has the advantage of not leaving any implant behind. Acknowledgments Salmir Nasic, for help with the statistical analysis of the data. MalgorzataSoja, consultant for help with the radiological assessment. The authors did not receive any outside funding or grants directly related to the research presented in this
Arch Orthop Trauma Surg (2014) 134:793–802 manuscript. The first author received funding from the Research Fund at Skaraborg Hospital and from the Institute of Research and Development, Sweden to support this research. The authors state that this manuscript is an original work only submitted to this journal. All authors contributed to the preparation of this work. Conflict of interest None.
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