Abstract
Purpose
A multiaxial correction (MAC) fixator is a monolateral type of fixator that can correct multi-planer deformities. The purpose of this study is to compare the clinical outcome of correction for tibial deformities with the MAC fixator and the circular external fixators.
Methods
We retrospectively reviewed consecutive patients reconstructed with the MAC fixator (MAC group) or circular external fixators (Ring group) due to the congenital diseases or residual conditions after treatment of trauma, infection, tumor, or limb lengthening between 2003 and 2016.
Results
The 30 patients who had angular tibial deformity were included. In patients with tibia vara or lateral bowing, the average pre-operative mechanical medial proximal tibial angle (mMPTA) of the MAC group and the Ring group was significantly increased to 86.9 ± 3.5° in the MAC group and 88.0 ± 3.6° in the Ring group postoperatively. Medial bowing was also successfully corrected in both groups. Regarding the sagittal alignment, post-operative anatomical posterior proximal tibial angle (aPPTA) of the MAC group was deteriorated after coronal correction. The operative time was significantly shorter in the MAC group than the Ring group (p < 0.05).
Conclusion
The MAC fixator successfully corrected coronal deformities of the tibia with shorter operative time, but it has a risk of occurrence of the procurvatum deformity compared with circular external fixators. Paying attention to the sagittal alignment, the MAC fixator can be one of the treatment options for correction of the coronal tibial deformities.
Keywords: External fixation, Multiaxial correction, Tibia, Deformity correction, Lower extremity
1. Introduction
Correction of limb deformity or shortening in children can be managed with distraction osteogenesis technique using various kinds of external fixators. The Ilizarov external fixator can successfully correct three-dimensional deformities,1 but it requires changes of the parts of the fixator during the course of treatment.2,3 A hexapod fixator, Taylor Spatial Frame (TSF), showed favorable correction of complicated deformities with minimal instrument operation.4, 5, 6 On the other hand, monolateral fixators, which seem to be less discomfort in wearing than circular fixators, have a limited capability of deformity correction.7,8 The DynaFix Multi-Axial Correcting (MAC) External Fixator device (Biomet, Parsippany, NJ, USA) is simple to apply and can achieve correction of multi-planar deformities.9 It can provide not only two planes (coronal and sagittal) of angulation or translation, but also compression, lengthening, and axial rotation.
Since external fixators could not harm the growth plate, external fixators rather than intramedullary nails have been indicated for the patients before skeletal maturity for bone lengthening.10 The external fixators can be also indicated for adults, because adjusting correction speed by using external fixators reduced the risk of nerve damage.11 Furthermore, external fixators could correct not only bone length but also coronal and sagittal deformities. Although the treatment results of Blount disease has been compared between the MAC and other external fixators,7 there has been limited comparative study for the treatment of tibial deformities between both fixators. The purpose of this study is to compare the coronal and sagittal alignment, lengthening results, operative time, and complications for correcting tibial deformities treated with the MAC fixator and circular external fixators in the patients with congenital or residual deformities.
2. Patients and methods
This is a retrospective case control study approved by an institutional review board. We reviewed the medical records and radiographs of consecutive patients who underwent corrective osteotomies of the tibiae at our two institutions between 2003 and 2016. The inclusion criteria were the patients who were treated with the MAC fixator or circular external fixators (Ilizarov fixator or TSF) for tibial deformities in coronal or sagittal planes with or without shortening, and who were followed up at least six months or more after removal of the external fixator. Patients who were treated with other monolateral fixators or who had inadequate medical records or radiographs were excluded. Finally, the 30 patients who had angular tibial deformity were included for the current study. All patients had a correction for coronal or sagittal deformities with or without simultaneous lengthening. We compared the radiographic outcomes of tibial corrective osteotomy using the MAC fixator and those using circular external fixators.
The MAC fixator was routinely used at one institution, while the circular fixator was applied at the other institution. The simultaneous lengthenings were intentionally performed for the patients who had leg length discrepancy or short stature. The fixators were removed based on the radiological principles of Fischgrund, Paley, and Suter12 which require three of four continuous cortices to have become >2 mm thick. The characteristics of patients and deformity sites of the tibia are shown in Table 1. There were 16 tibiae in 10 patients treated with the MAC fixator (MAC group) and 27 tibiae in 20 patients treated with the Ilizarov or the TSF fixator (Ring group). The average age of MAC group was higher than that of Ring groups and there were various deformity sites. Age at the operation and deformity site were potential confounders. Thirty tibiae were operated as a primary treatment for tibial deformities related to skeletal dysplasias, Blount disease, and fibular hemimelia. Thirteen tibiae were treated for residual deformities occurred after treatment of trauma, infection, tumor, or limb lengthening (Appendix A).
Table 1.
Patient Characteristics.
| MAC group | Ring group | |
|---|---|---|
| Number of patients (n) | 10 | 20 |
| Number of tibiae (n) | 16 | 27 |
| Male (n): Female (n) | 5:5 | 10:10 |
| Age at the operation (years) | 16.0 ± 4.5 | 11.4 ± 3.5 |
| Deformity sites | ||
| Proximal one-third (n) | 9 | 20 |
| Middle one-third (n) | 7 | 1 |
| Distal one-third (n) | 0 | 6 |
MAC; mutiaxial correction.
Radiographs taken six months or more after removal of the external fixator were adopted as post-operative radiographs. The coronal deformity was evaluated by the anteroposterior (AP) lower limb radiograph taken in a standing position.13 The mechanical medial proximal tibial angle (mMPTA) and the mechanical axis zone (MAZ) were measured for the coronal deformity.13,14 The mMPTA was analyzed separately in lateral bowing (or tibia vara) and medial bowing. The MAZ was expressed by absolute value in both deformities. The sagittal deformity was assessed by the lateral radiograph of the tibia taken with an unloading position and the anatomical posterior proximal tibial angle (aPPTA) was measured.13 We measured the amount of lengthening, which was calculated by the difference of total tibial length pre- and post-operatively. Limb length discrepancy (LLD) was measured from the distance between center of the femoral head and center of the articular surface of the talus based on the standing AP lower limb radiograph. The mMPTA, MAZ, aPPTA, and LLD were measured by attached software for our computerized medical records system (SVIM-DVR01; Toshiba Medical Systems, Japan). One orthopaedic surgeon (MM) performed all of the radiographic evaluations. To investigate interobserver reliability, the angles on radiograph were re-measured by other orthopaedic surgeons (TN and YK for MAC group, HK and HK for Ring group). We also evaluated the operative time per one tibia, blood loss during operation, and the rate of complications. The blood loss was routinely measured the amount of blood in the suction tube and gained weight of the gauze by the nurses during the operation. Antibiotics were prescribed when the patients had Grade II or higher of pin tract infection according to Checketts-Otterburn Grading System.15
Continuous variables were expressed as the mean ± SD. Clinical and radiographic parameters including mMPTA, MAZ, aPPTA, amount of lengthening, LLD, operative time, and blood loss were compared between the MAC and the Ring groups. Additionally, mMPTA, MAZ, and aPPTA were also compared between pre- and post-operative valuables. Statistical analyses were carried out by the unpaired Student t-test. Differences were considered statistically significant when p < 0.05. To verify of validity in grouping, we performed multiple linear regression analysis to assess the influence of characteristics (sex, age, and deformity site) and pre-operative MAZ on post-operative MAZ. Finally, we used the interclass correlation coefficient to assess the reproducibility of the data. All statistical analyses were performed by using SPSS, version 23 (IBM Corporation, Armonk, NY). The post-hoc power analysis comparing operative time per one tibia between MAC group and Ring group was performed by using the G∗Power 3.1 software program. The power (1-β) was 0.789 as a function of the two-tailed t-test, with effect size d = 0.893, α = 0.05, n1 = 16, n2 = 27.
3. Surgical technique and post-operative management
3.1. MAC fixator
The center of rotation of angulation (CORA) was determined by pre-operative AP and lateral radiographs and the degrees of angular deformity in both planes were measured.13 After diaphyseal fibular osteotomy, screw fixation was performed between the distal tibiofibular joint when the lengthening was needed. The 2.4 mm of Kirschner wire was anteroposteriorly inserted perpendicular to the tibial shaft at the level of CORA as a reference wire. The MAC monolateral device was temporarily fixed to the reference wire parallel to the tibial shaft, and two or three cortical screws were inserted under fluoroscopic guidance at the proximal and distal sides, respectively. The reference wire was then removed and open tibial osteotomy was done. We performed a dome-shaped osteotomy with multiple drill holes and an osteotome. When the CORA was near the growth plate, the osteotomy was performed at the level remote from the CORA to keep the screw insertion sites for avoiding growth plate damage. Acute or gradual correction was determined by the surgeon’s preference. Weight bearing was encouraged as early as possible post-operatively. Gradual distraction of 0.5 mm twice daily was started after a latency period of seven to 14 days for shortened tibia. The rate of distraction was adjusted depending on the callus formation based on the radiographs (Fig. 1).
Fig. 1.
A; 12-year-old girl with congenital bowing of the tibia had lateral bowing of the right tibia. B; Pre-operative sagittal alignment was unremarkable from the lateral radiograph of the right tibia. C; Anteroposterior radiograph of the right tibia showed that MAC system was fixed parallel to the tibial shaft during gradual correction. D; The coronal alignment was improved (81–86° of mMPTA) after 30 mm of lengthening with gradual correction. E; The sagittal alignment was slightly deteriorated (81–70° of aPPTA) with thickened cortical bone in posterior osteotomy site.
3.2. Circular fixators
After deciding the estimated correction angle, proximal rings and distal rings were generally prepared in advance before the surgery. Each ring was fixed perpendicular to the tibial shaft by screws or wires. Fibular osteotomy and distal tibiofibular fixation were done in the same way as the MAC fixator. We performed a closed-wedged osteotomy for acute correction and a dome-shaped osteotomy for gradual correction, respectively. When the CORA was located at the distal third of the tibia, we performed correction at the CORA and lengthening at the proximal metaphysis. Acute correction was done using the Ilizarov fixator and gradual correction was assisted by the TSF computer program. Post-operative management was performed in the same way as the MAC group.
4. Results
The characteristics were different between MAC group and Ring group including age at the operation and deformity site (Table 1). Then, we analyzed multiple linear regression of post-operative MAZ by each characteristic. Sex, age, and deformity site were not associated to post-operative MAZ (Table 2). These results could indicate that different characteristics in both groups did not influence on the post-operative alignment. Actually, there was no statistical difference of pre-operative mMPTA and pre-operative aPPTA in addition to pre-operative MAZ between both groups (Table 3).
Table 2.
Multiple linear regression analysis of post-operative MAZ by each parameter.
| Partial regression coefficient (95% CI) | p-value | |
|---|---|---|
| Female | −0.17 (−0.58, 0.22) | 0.387 |
| Age at the operation | 0.19 (−0.03, 0.06) | 0.379 |
| Deformity site | −0.03 (−0.30, 0.24) | 0.814 |
| Pre-operative MAZ | 0.32 (0.06, 0.59) | 0.019 |
MAZ; mechanical axis zone, MAC; mutiaxial correction.
Table 3.
Clinical Results.
| MAC group | Ring group | p-value | |
|---|---|---|---|
| Tibia vara or lateral bowing (n) | 9 | 22 | |
| Pre-operative mMPTA (degrees) | 73.8 ± 4.5 | 76.8 ± 7.9 | 0.291 |
| Post-operative mMPTA (degrees) | 86.9 ± 3.5∗∗∗ | 88.0 ± 3.6∗∗∗ | 0.437 |
| Medial bowing (n) | 7 | 5 | |
| Pre-operative mMPTA (degrees) | 100.5 ± 10.9 | 101.2 ± 8.6 | 0.910 |
| Post-operative mMPTA (degrees) | 90.0 ± 4.9∗ | 90.4 ± 4.6∗ | 0.892 |
| Total number of limbs (n) | 16 | 27 | |
| Pre-operative MAZ | 2.5 ± 0.6 | 2.4 ± 0.8 | 0.596 |
| Post-operative MAZ | 1.5 ± 0.7∗∗∗ | 1.3 ± 0.6∗∗∗ | 0.403 |
| Pre-operative aPPTA (degrees) | 76.8 ± 21.1 | 78.6 ± 10.2 | 0.711 |
| Post-operative aPPTA (degrees) | 69.6 ± 16.5 | 77.7 ± 11.4 | 0.064 |
| Operative time per one tibia (minutes) | 158.9 ± 23.3 | 193.8 ± 50.1 | 0.013 |
| Blood loss per one tibia (ml) | 17.3 ± 12.8 | 21.7 ± 25.8 | 0.551 |
| Time in the external fixator (days) | 200.8 ± 96.2 | 165.7 ± 77.5 | 0.196 |
| Pin tract infection requireing antibiotics (n) | 15 (93.8%) | 17 (63.0%) | 0.025 |
| Transient (n): Permanent peroneal nerve palsy (n) | 4 (25.0%)/1 (6.3%) | 5 (18.5%)/1 (3.7%) | 0.523 |
| Fracture after removing the fixator (n) | 1 (6.3%) | 1 (3.7%) | 0.710 |
| Early union (n) | 1 (6.3%) | 0 (0.0%) | 0.197 |
MAC; mutiaxial correction, mMPTA; mechanical medial proximal tibial angle, MAZ; mechanical axis zone, aPPTA; anatomical posterior proximal tibial angle.
∗p < 0.05; ∗∗∗p < 0.005 vs. pre-opetrative values.
Clinical results were shown in Table 3. There were 31 tibiae of tibia vara or lateral bowing (n = 9 in MAC group, n = 22 in Ring group) and 12 tibiae of medial bowing (n = 7 in MAC group, n = 5 in Ring group). There was no statistical difference of pre-operative mMPTA between the MAC group and the Ring group in both deformities, respectively. Significant improvement of the post-operative mMPTA was observed in both groups. The MAZ was also significantly improved in both groups. The average pre-operative aPPTA was within −1 SD of the normal population13 in both groups. Post-operative aPPTA was slightly deteriorated in the MAC group while unchanged in the Ring group (p = 0.064). Operative time was significantly shorter in the MAC group than in the Ring group, although there was no statistical difference in intraoperative blood loss between both groups. The rate of pin tract infection was significantly higher in MAC group than that in Ring group. Peroneal nerve palsy was observed in five patients of the MAC group and six patients of the Ring group, all of whom underwent intraoperative acute correction (Fig. 2). All but one patient in each group showed transient peroneal nerve palsy. There was one patient with fracture after removing the fixator in each group. One patient had early union in MAC group.
Fig. 2.
The nerve palsy was only observed after acute correction.
We performed a simultaneous lengthening in 9 tibiae of the MAC group and in 17 tibiae of the Ring group. The detail data of lengthening was shown in Appendix B. The unilateral lengthening for correction of LLD was done in 10 tibiae and bilateral lengthenings for short stature underwent in 16 tibiae. The average amount of lengthening was 40 mm or more in both groups. There was no statistical difference of time in the external fixator and external fixator index between both groups. Post-operative LLD was less than 5 mm in all cases. The data on interobserver reliability of the radiographic interpretations were summarized in Appendix C. The data indicated that interobserver agreement was acceptable.
5. Discussion
Current study demonstrated that coronal alignment was successfully corrected by the MAC monolateral fixator as well as ring fixators, while the MAC fixator tended to deteriorate sagittal alignment in tibial deformity regardless of simultaneous bone lengthening. Operative time was significantly shorter in the MAC fixator than in the Ring fixators. Peroneal nerve palsy was only observed in acute correction regardless of pre-operative deformity type or fixator type.
There have been only limited reports of corrective osteotomy with the MAC fixator, including tibial,7, 8, 9 femoral,9 and humeral deformities,16 radial club hand,17 Charcot midfoot arthropathy18 as well as severe slipped capital femoral epiphysis (SCFE).19 Using the MAC fixator, McCarthy et al.9 and Pandya et al.8 successfully corrected tibia vara deformity of Blount’s disease. Clarke et al.7 performed corrective osteotomy of 54 tibiae in 38 patients with Blount’s disease using the MAC fixator or other fixators, and showed that postoperative MPTA treated with the MAC system was similar to that treated with other fixators. In the current study, we demonstrated that the MAC fixator can correct not only tibia vara and lateral bowing of the tibia but also medial bowing in various etiologies. The MAC system can be indicated for correction of coronal tibial deformities with or without shortening.
With regard to sagittal alignment, Clarke et al.7 reported that postoperative PPTA in patients with Blount’s disease was slightly decreased after coronal correction by the MAC system (78.4° vs 74.3°, p > 0.05). Pandya et al.8 also showed decreased PPTA after the treatment with the MAC fixator. Similarly, current study indicated slightly deteriorated procurvatum deformity in the MAC group. Callus formation is generally predominant in the opposite side of the monolateral fixator.20 Leyes et al. suggested that stronger callus in the opposite side of the fixator may result from micromotion with an insufficient stabilization.20 They also cautioned that the monolateral fixator placed anteromedial aspect of the tibia tended to provide valgus angulation during tibial lengthening. Posterior cortical thickness was actually observed in some cases of the MAC group (Fig. 1e). Asymmetric callus formation can be one of the causes of deteriorating sagittal alignment in MAC monolateral fixator. In addition, high tensile force of the posterolaterally located muscles, including gastrocnemius, peroneal longus, and tibialis anterior, may tether the fragile callus and lead to anterolateral bowing during tibial lengthening.21 We should carefully pay attention to changes in sagittal alignment during the treatment by the MAC fixator.
Several investigators have reported that operative time was shorter in the MAC fixator than in the circular fixator.8,22,23 The circular fixator is technically demanding, while the MAC system is easy to handle with no need of intraoperative reconstruction of the instrument.24 This is one of the advantages of this system compared to circular fixators.
Pin tract infection is common complication in the studies of external fixator.7,25,26 The previous study demonstrated that pin tract infection tended to be increased in MAC group than in Other for Blount disease (80.0% vs 63.2%, p = 0.241).7 In the current study, there was more pin tract infection in MAC group than in Ring group probably due to the reduced stability in MAC fixator.
Peroneal nerve palsy was limited in patients underwent acute correction in the current study. In a systematic review comparing the outcome of acute versus gradual correction of child tibia vara, 10 of the 11 cases with peroneal nerve palsy underwent acute correction,27 which indicated a higher risk of acute correction in the occurrence of peroneal nerve palsy in this condition. Although peroneal nerve seems never to be stretched after correction of tibia vara anatomically, nerve palsy could be caused by intolerable elevated pressure of anterior compartment after correction.28,29 We should bear in mind that peroneal nerve palsy can occur even in acute correction of lateral deformity.
Current study demonstrated the advantage and disadvantage of correction for tibial deformities by using the MAC fixator compared to Ring fixators. Large multicenter study is, however, needed to make it clear. There were several limitations of the current study. First, there is a bias on the use of the fixator and operating surgeons between the institutions. Second, etiologies of the deformity were heterogeneous and there was different in age, deformity site, and etiology between both groups. Third, correction of axial deformities was not considered, because there were only a few patients with significant rotational deformities in the current study. Finally, we only examined radiological outcome after surgical correction without evaluating functional and patient satisfaction domains.
6. Conclusion
The MAC fixator successfully corrected coronal deformities of the tibia with shorter operative time compared with circular fixators. The procurvatum deformity, however, is a risk after the treatment by the MAC fixator. Gradual correction is recommended in any deformities or fixators. The MAC fixator can be one of the treatment options for correction of the coronal tibial deformities if the sagittal alignment is carefully monitored during the treatment.
Funding disclosure
No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.
Ethical approval
This research is a retrospective study based on patient data existing beforehand and does not directly involve human participants and/or animals. This study was approved by our Institutional Review Boards.
Author contribution
MM: analyzed data, and wrote the paper. HK: designed the study, and revised the manuscript. KM, TN, and YK: collected data. HK: analyzed data. TH and NI: Reviewed the manuscript and supervised the study.
Declaration of competing interest
All authors have no conflict of interest.
Footnotes
Supplementary data to this article can be found online at https://doi.org/10.1016/j.jcot.2020.05.004.
Appendix ASupplementary data
The following are the Supplementary data to this article:
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