Arch Orthop Trauma Surg (2013) 133:789–795 DOI 10.1007/s00402-013-1712-y
TRAUMA SURGERY
Treatment of large posttraumatic tibial bone defects using the Ilizarov method: a subjective outcome assessment Dietmar Krappinger • Alexander Irenberger Michael Zegg • Burkhart Huber
•
Received: 3 November 2012 / Published online: 5 March 2013 Ó Springer-Verlag Berlin Heidelberg 2013
Abstract Background The treatment of large posttraumatic tibial bone defects using the Ilizarov method was shown to be successful in several studies. These studies, however, typically focus on the radiological and functional outcome using objective parameters only. The aim of the present study was therefore to assess the objective and subjective outcome of a consecutive series of patients with large posttraumatic tibial bone defects using the Ilizarov method. Additionally, it was our goal to assess the physical and mental stress for the patients and their relatives during the long treatment period and the general health status at final follow-up. Methods A consecutive series of 15 patients with posttraumatic tibial bone defects of [30 mm after sustaining open tibial fractures and failure of internal fixation was included. The objective outcome was assessed at final follow-up using Paley’s criteria. For the assessment of the subjective outcome, all patients were asked to evaluate their satisfaction with the function of the lower leg, the cosmetic appearance and overall outcome as well. The physical and mental stress of the treatment for the patients and the nearest relative of patients were assessed at the time of frame removal using a custom-made questionnaire.
D. Krappinger (&) A. Irenberger M. Zegg B. Huber Department of Trauma Surgery and Sports Medicine, Innsbruck Medical University, Anichstraße 35, 6020 Innsbruck, Austria e-mail:
[email protected];
[email protected] A. Irenberger e-mail:
[email protected] M. Zegg e-mail:
[email protected] B. Huber e-mail:
[email protected]
The SF-36 was used to evaluate the general health status at final follow-up. Results Solid bone union with stable soft tissue coverage and eradication of infection was achieved in all patients despite a high complication rate. The functional outcome at final follow-up was excellent or good in all patients. The patients’ satisfaction with the overall outcome and the function of the lower extremity was high as well. The fear of amputation and complications was the major subjective burden for both the patients and their relatives. The long external fixation time is another relevant issue. Conclusion The Ilizarov method is a safe option for the treatment of large posttraumatic tibial bone defects after failure of internal fixation despite the high complication rate. It is essential to comment this to the patients and their relatives prior to the application of the frame increase their compliance with the long and emotionally draining treatment. The Ilizarov method is worth the effort only in patients, who will presumably comply with this treatment option and all of its drawbacks. Keywords Bone defects Distraction osteogenesis Ilizarov method Corticotomy Physical stress Mental stress
Introduction The treatment of large tibial bone defects is challenging for the orthopedic surgeon. Small bone defects may be treated using cancellous bone grafting. Larger defects require some sort of vascularized grafts. The fibula is a widely used graft [1, 10]. Besides relevant donor site morbidity [13], however, there are some additional disadvantages of this technique. Deformities and leg length discrepancies are not
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addressable in the presence of soft tissue contractures [16]. Good soft tissue coverage is crucial for the use of vascularized fibula grafts as well [8, 19]. This is a critical issue particularly in patients with posttraumatic bone defects after failed internal fixation, numerous previous surgical interventions and compromised soft tissues. The Ilizarov method of distraction osteogenesis is an alternative option, which offers considerable advantages. It is a minimally invasive method, which allows for the correction of shortening and deformity even in the presence of poor soft tissue coverage. Several studies reported high rates of successful reconstruction of tibial bone defects using this method [2, 3, 9, 12, 16]. The long treatment period and external fixation time are widely considered to be the major disadvantage [4, 16, 19]. The aforementioned studies, however, mainly focus on the radiological and functional outcome at final follow-up using objective parameters. The subjective outcome and patients’ satisfaction at final follow-up as well as the mental and physical stress for the patients during the long treatment period did not receive enough attention. The aim of the present study was therefore to assess the objective and subjective outcome of a consecutive series of patients with large posttraumatic tibial bone defects treated with the Ilizarov method. Additionally, it was our goal to assess the physical and mental stress for the patients and their relatives during the long treatment period and the general health status at final follow-up.
Materials and methods Between January 2004 and December 2009, a consecutive series of 15 patients was included in this prospective observational study. There were 11 male and 4 female patients with a mean age of 32.0 (16–61) years at the time of frame application. Nine patients had motorcycle accidents, two patients were hit by cars as pedestrians and four patients had sports injuries. All patients sustained open tibial fractures after high-energy trauma (Fig. 1a). Internal fixation using locking plates (4 patients), conventional plates (2 patients) or intramedullary nails (9 patients) was initially performed in all patients and failed in all patients. The mean posttraumatic tibial bone defect was 66.1 (30–147) mm and resulted from primary bone loss (4 patients), bone debridement (8 patients) or a combination of both (3 patients; Fig. 1b) [17]. There were positive microbiological cultures of the debrided bone in nine patients (3 Staphylococcus aureus, 3 Pseudomonas aeruginosa, 2 Enterococcus, 1 Streptococcus viridans). The time period between trauma and application of the Ilizarov frame was 13.0 (1–41) months with a mean of 10.1 (2–35) operations during this period.
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The Ilizarov frame (Smith & Nephew Orthopedics, Memphis, TN, USA) was applied in an index procedure after removal of remaining plates and nails, debridement of avital and infected bone and soft tissue coverage. Soft tissue coverage was achieved using split skin grafts (1 patient), local flaps (3 patients) and free vascularized flaps (9 patients). Two patients had no soft tissue defects. The Ilizarov rings were attached to the tibia using a hybrid fixation of transosseous 1.8 mm K-wires and threaded halfpins. Percutaneous corticotomy was performed using the multiple drill holes technique (DeBastiani method) [5, 20]. Bone transport started after a latency period of 10–14 days with a transport speed ranging from 0.5 to 1.0 mm/day. Bone grafting at the docking site was routinely performed in all patients immediately after finishing transport. The frame was dynamized prior to removal in order to assess the mechanical stability of the regenerated bone (Fig. 1c). All complications which occurred between the application of the frame and the final follow-up were registered. They were subclassified into problems, obstacles and sequelae [14]. Problems did not require surgical interventions, while obstacles needed surgical revisions to be resolved. Sequelae were not resolved before the end of the treatment and had a negative impact on the final outcome. The number of operations, the total number of X-rays and CT scans as well as the length of hospital stay and the number of outpatient controls between frame application and final follow-up were additionally assessed. The objective outcome was assessed at the final followup using Paley’s criteria. The Paley system is a score particularly designed for the outcome evaluation after bone transport on the lower extremity. It distinguishes between bone results and functional results [15, 16]. Both bone and functional results are based on five dichotomous criteria as shown in Tables 1 and 2. For the assessment of the subjective outcome, all patients were asked to evaluate their satisfaction with the function of the lower leg, the cosmetic appearance and overall outcome at final follow-up on a 10-point rating scale, with 0 indicating highest satisfaction and 10 indicating maximum dissatisfaction. The patients were additionally asked to rate the function of the affected lower extremity in percent with the contralateral uninjured side serving as a 100 % reference. The physical and mental stress of the treatment for the patients and the nearest relative of patients were assessed at the time of frame removal using a custom-made questionnaire on a 10-point rating scale, with 0 indicating no stress and 10 indicating maximum stress. The patients were additionally asked at the time of frame application if they consider lower leg amputation as an alternative treatment option. They were again asked at final follow-up, if they would retrospectively consider amputation as an option in their situation. The SF-36 was used to evaluate the general
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Fig. 1 a Grade IIIb open comminuted fracture in a 25-year-old male after sustaining a motorcycle accident. The initial management included emergent soft tissue debridement and monolateral external fixation. In the further course, soft tissue coverage was achieved using a gastrocnemius flap, while internal fixation was performed using a plate. b Failure of internal fixation [screw breakage and loosening, nonunion at two levels (arrows) and persistent fistula] after nine
revision surgeries. Debridement of avital bone tissue and application of the Ilizarov frame 299 days after trauma. Bone defect of 124 mm. c Final outcome after 524 days of external fixation time. Excellent bone results and good functional results according to Paley. No severe difficulties to perform daily activities. High satisfaction with the overall outcome
Table 1 Bone results according to Paley
health status at final follow-up [11]. The SF-36 allows the calculation of both a standardized physical and a mental component score, which are scaled to have a mean of 50 and a standard deviation of 10 for the average population in the USA and European countries. SPSS Statistics 18.0 (SPSS, Chicago, IL, USA) was used for the statistical analysis. Metric scaled data are reported as arithmetic mean and range and categorical data as absolute frequency and percentage distribution. Depending on the distribution form, a t test for independent variables or a nonparametric Mann–Whitney U test was used for the analysis of metric scaled data. The distribution form was determined using the Kolmogorov–Smirnov test. A Chi-square test or a Fisher’s exact test was used for the analysis of categorical data. Correlations for metric scaled data were quantified using Pearson’s coefficient. The probability level was set at p \ 0.05.
Bony union
Yes
15
No
0
Infection
Yes
0
No
15
Deformity
\5 Degrees [5 Degrees
Leg length discrepancy Need for bracing Bone result
\2.5 cm
8 7 12
[2.5 cm
3
Yes
0
No
15
Excellent
7
Good
6
Fair
2
Poor
0
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Table 2 Functional results according to Paley Pain requiring narcotics Need for walking aid
Yes
0
No
15
Yes
0
No
15
Foot, ankle or knee deformity or contracture [5 degrees
Yes
5
No
10
Anke or subtalar loss of range of motion
\20 Degrees
9
[20 Degrees
6
Relevant difficulties in activities of the daily life
Yes
0
No
15
Functional result
Excellent
6
Good
7
Fair
2
Poor
0
Results The mean external fixation time was 13.2 (7–25) months resulting in a healing index of 60.7 (42–107) days of external fixation time per centimeter of bone defect. Between frame application and final follow-up, a total number of 28.9 (13–70) X-rays and 2.9 (0–10) CT scans were performed. 44.3 (12–118) days of hospital stay and 27.3 (16–53) ambulatory controls were required. Fourteen of 15 patients (93.3 %) had complications during the treatment. The number of complications was 1.3 (0–3) per patient resulting in a total number of 20 complications. Pin infections were the most common complication (9 patients), delayed union/non-union at the docking site occurred in three and recurrent infection in two patients. Angulation of the transport bone segment requiring correction was seen in four patients, while we observed late bending of the regenerate bone after frame removal in two cases. Accordingly, problems were the most severe complication in four patients, obstacles requiring unplanned surgical revisions in eight patients and sequelae in two patients, while one patient had no complications. The mean number of operations was 5.8 (2–21) to treat the bone defect and the complications resulting in a mean of 3.8 (0–19) unplanned surgical revisions per patient. The final follow-up examination was performed at a mean of 17.3 (8–36) months after frame removal and 43.4 (18–75) months after trauma. Solid bone union with stable soft tissue coverage and eradication of infection was achieved in all patients. The results of the Paley score are shown in Tables 1 and 2 [16]. The bone results were graded as excellent in seven, good in six and fair in two patients. The functional results were graded as excellent in six, good in seven and fair in two patients. There was no patient with poor bone or functional results.
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The satisfaction with the overall outcome was high (1.2, 0–4), while the satisfaction with the function of the lower leg was 2.2 (0–7) and with the cosmetic appearance 2.9 (0–6). The number of surgical interventions correlated with the overall satisfaction. Patients with multiple surgical interventions showed a lower satisfaction (r = 0.55, p \ 0.05). The patients rated the function of the affected lower extremity with a mean of 67.0 % (50–90) compared to the uninjured contralateral side. Interestingly, there was no significant correlation between the satisfaction with the function of the lower leg and the patients’ rating of the function (p [ 0.05). The satisfaction with the cosmetic appearance was significantly lower in patients receiving free flaps for soft tissue coverage (Mann–Whitney U test, p \ 0.05). The results of the assessment of the physical and mental stress during the treatment period for the patients and the nearest relatives are shown in Fig. 2. The fear of amputation and fear of complications were highest for both the patients and the relatives, while the long external fixation time ranked third. Bone transport and pin care did not present a relevant burden. The fear of amputation was the major burden for 10 patients (67 %) and 11 relatives (73 %), while the long external fixation time was the major burden for both three patients and relatives (20 %). Seven patients (47 %) considered amputation as a valid treatment option at the time of frame application. No patient retrospectively considered amputation to be an option at final follow-up. The mean physical component score of the SF-36 at final follow-up was 52.7 ± 9.0 and therefore higher than in the average population, while the mean mental component score was 46.1 ± 5.3 and therefore lower than in the average population. Three patients rated their health state at final follow-up to to be about the same compared to the state at the time of frame removal, while three patients reported mild improvements and nine patients described their health state to be much better now.
Discussion Our data show that: 1.
2.
The Ilizarov technique is a reliable treatment option for large posttraumatic tibial bone defects after failure of internal fixation. This technique, however, requires a long treatment period and has a relatively high complication rate. The functional outcome at final follow-up was excellent or good in the vast majority of patients. But more importantly, the patients’ satisfaction with the overall outcome was high and the quality of life according to the SF-36 was comparable with the general population.
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Fig. 2 Results of the assessment of the physical and mental stress for the patients and the nearest relatives. A 10-point rating scale was used, with 0 indicating no stress and 10 indicating maximum stress
3.
The long treatment period is physically and emotionally draining for both the patients and their relatives with the fear of amputation and complications being the major subjective burden. The long external fixation time is another relevant issue.
The major requirements for successful distraction osteogenesis are stable fixation of the bone fragments, adequate blood supply of the distraction gap by preserving the periosteal blood supply and slow steady traction, as described by Professor Ilizarov himself in 1989 [7]. Thorough debridement and eradication of infection as well as stable soft tissue coverage may be added in the presence of posttraumatic bone defects following open tibial fractures and failure of internal fixation. Several studies reported high rates of successful distraction osteogenesis, if these requirements are met [2, 3, 12, 16]. Given the data from our and the aforementioned studies, we think that the technical feasibility is not a limiting factor even in large tibial bone defects. The technical feasibility, however, does not automatically imply the reasonability of this treatment option. We therefore tried to additionally assess some relevant subjective parameters in this study. The majority of patients will suffer from complications during the long treatment period according to our data. This is in particular a critical issue considering that the fear of complications is a major subjective burden for the patients. The majority of complications (problems and obstacles), however, may be resolved without negative impact on the final outcome. It is therefore crucial to thoroughly comment on the prospective high risk of
complications, but also on the high rate of successful solution of these complications, to the patients and their relatives prior to the application of the frame. This will decrease the patients’ fear and increase their compliance with the long and emotionally draining treatment. Our data showed that the number of surgical interventions during the treatment period correlated with the overall satisfaction at final follow-up. Patients with multiple surgical interventions showed a significant lower satisfaction (r = 0.55, p \ 0.05). We found that the vast majority of revision surgeries (50/57) in our patients collective were septic and soft tissue revisions. There were, for example, two patients with recurrent infections after initial debridement and soft tissue coverage. The successful treatment of these two complications required almost unbearable 19 and 13 surgical interventions, respectively. Insufficient initial bone and soft tissue debridement may account for the recurrence of infection in these two cases. It is therefore crucial to perform a thorough debridement of both the bone and the soft tissue during the index procedure, even if the more radical debridement leads to a larger bone defect and requires a free flap for soft tissue coverage. The aim of the treatment of large posttraumatic tibial bone defects is the restoration of a good function of the lower extremity and not just osseous healing of the bone defect. Our data show that the restoration of a good function is feasible in patients with large posttraumatic tibial bone defects after failure of internal fixation. There was, however, no patient with a full restoration of the function compared to the uninjured contralateral leg. Though, we
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think that the indicator for successful reconstruction is not the contralateral uninjured leg, but the expected functional outcome after amputation and prosthetic supply. A sound scientific assessment of the outcome after amputation versus reconstruction, however, will be hard to perform, as it will not be easy to get the approval of ethical review boards for a randomized controlled study assessing these two treatment options. We think that the satisfaction with the overall outcome and the function of the lower extremity, which was high in our study, are at least equally important in these patients than the results from the assessment of different objective scores. We therefore simply consider the outcome in these patients to be good, if the patients are satisfied with the outcome, although this may be an illegitimate oversimplification of the assessment. The treatment of large tibial bone defects using the Ilizarov method is a physically and emotionally draining treatment and therefore presents a major challenge for both the patients and their relatives. Our data show that the fear of amputation and the fear of complications are the major subjective burdens (Fig. 2). As mentioned before, a thorough briefing of the patients prior to the application of the frame is an essential part of the treatment to decrease these fears and increase the compliance with the treatment. The patients should be told that the Ilizarov method is an overall safe method with high rates of successful reconstruction despite the high complication rates. The establishment of personal contacts between patients with bone defects and patients after successful reconstruction may be an additional option. The long external fixation time is widely considered to be the major burden of this technique. We partially agree, as we found that it is a relevant, but not the major burden. Several techniques for reducing the external fixation time such as secondary internal fixation after distraction [21], double-level transport [16, 18] or the Masquelet technique [6] are described in the literature. We did not use any of these techniques and are therefore not able to discuss their assets and drawbacks. Shortening of the treatment period is always beneficial for the patients. We think, however, that safety is more important than speed especially in patients with large posttraumatic tibial bone defects after failure of internal fixation as their first treatment option. We used the SF-36 to assess the quality of life at final follow-up. The physical and mental status were within one standard deviation of the mean value and therefore comparable to the general population. This indicates that the patients are able to live a normal life despite the burden of the trauma and the following long treatment. Some limitations of our study have to be noted. This is an observational study with a limited number of patients included. This small number of patients, however, partially results from our homogeneous inclusion criteria.
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All patients had posttraumatic tibial bone defects after sustaining open fractures and failure of internal fixation. The lack of a control group is another limitation of our study. Custom-made questionnaires, which were not tested for validity and reliability, were used for the assessment of the subjective outcome. Finally, the SF-36 was assessed once at final follow-up only. Accordingly, we were not able to compare the general health status of our patients at different stages of the treatment. In conclusion, the Ilizarov method is a safe option for the treatment of large posttraumatic tibial bone defects after failure of internal fixation despite the high complication rate. It is essential to comment this to the patients and their relatives prior to the application of the frame increase their compliance with the long and emotionally draining treatment. The Ilizarov method is worth the effort only in patients, who will presumably comply with this treatment option and all of its drawbacks. Conflict of interest No author has a conflict of interest that relates to the content discussed in this manuscript.
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