The principle of the mechanical alignment made the prosthesis placed in the neutral position always the gold standard of TKR surgery[2-3]; this was considered to be closely related to the postoperative and the survival rate of the prosthesis. Despite the use of older designed prostheses and short-leg radiographs, the early study of the alignment after TKR confirmed the above mentioned view from clinical, imaging, simulator, cadaver, finite element, and retrieval research[26-32]. And even now, there are studies confirming the importance of neutral alignment for the long-term survival rate of prostheses . However, since a study from Mayo Clinic pointed out that neutral alignment does not represent a better prosthesis survival rate through a 15-year and 20-year follow-up study [4, 22], the controversy about neutral alignment is also increasing, and many surgeons even do not accept the neutral mechanical alignment as the golden standard anymore.
In addition to the survival rate of prosthesis, many scholars paid attention to the relationship between coronal alignment and clinical outcomes(Table 1) [13-25]. But we think these studies have some limitations. For example, some studies [15-16, 22, 25] did not take into account the preoperative varus or valgus of the knee. In order to remedy this defect, other studies [13-14, 17, 20-21, 23] only analyzed the varus or valgus knee, but they did not consider the two types of under- and over-correction in the patients with non-neutral alignment after surgery. Three recent studies [18-19, 24] have grouped preoperative varus osteoarthritis into neutral, mild varus, severe varus and valgus according to the postoperative alignment which made up for the above two shortcomings to a certain extent. However, this method can not analyzed the whole population. In addition, the clinical results about alignment on function are controversial.
Based on the above, we propose a new grouping method (under-correction, neutral and over-correction) which can reflects the preoperative knee condition and the change of coronal alignment. But there was no difference in the postoperative HSS score (88.27 vs 88.00 vs 85.62, p=0.25)and the incremental scores (26.23 vs 25.22 vs 22.88, p=0.54) among the three cohorts. Furthermore, the postoperative MFTA did not correlate with the clinical outcome score (R = -0.095, p = 0.072).
In order to have a intuitive and clear index to predict knee function after TKR, on the basis of previous grouping method, we also innovatively introduced the concept of correction rate for the first time and tried to explore whether there is a correlation between correction rate and clinical outcome score for the severe preoperative vasus and valgus deformities. Mainstream opinions the relationship between coronal alignment and clinical outcomes for the patients with preoperative varus is that the postoperative residual mild varus alignment as well as neutral alignment led to excellent functional outcomes, but the postoperative severe varus and valgus alignment should be avoided [14, 18-19, 24]. And some studies also reported that the restoration of a neutral alignment in preoperative severe deformities may be challenging and require more complex bone cuts and larger number of soft tissue releases , which in turn increased the injury of patients and lead to poor clinical outcomes. Therefore, according to the above conclusions, for preoperative severe varus deformities, we speculate that patients will get the best clinical outcomes when the correction rate is close to a certain value of 100%. This also mean the scatter plot of the clinical outcome score and the correction rate is likely to show the graphic distribution of the middle height and the gradual decrease of the two sides. But our analysis did not show any positive correlation between correction rate and HSS score as we expected (Figure 6).
Based on the results of the current study, we believe that it is unrealistic to predict clinical outcome scores only according to coronal alignment. Only reaching the so-called neutral alignment after surgery may not mean a excellent clinical result. In our study, the patients who have not realized the neutral alignment also can get a good knee function, while not all the patients with neutral alignment got good clinical results. On the other hand, TKR is a soft tissue procedure and clinical outcome depends on many factors. As far as the characteristics of the patient are concerned, such as age, cardiopulmonary disease, other sequelae that keep the patient from walking very far at a time, and pain from the lumbar disease pain, the contralateral knee disease, the onset of rheumatoid arthritis, they also exert certain effects on the HSS score. Besides, the success of surgery is related to a variety of factors. In addition to the coronal alignment, the axial and rotational alignment, the balance and release of the ligaments, the fixation and rotation of the prosthesis, the rehabilitation of the patient, and varieties of environmental factors have played very important roles in TKR. It is difficult to standardize all these factors. Therefore, it is not likely to be of great clinical value to predict the postoperative knee function score according only to whether the alignment is normal, especially by just the concept of the 0° ± 3° safety zone.
Finally, with regard to BMI, we also found that patients with lower preoperative BMI are more likely to be corrected to a postoperative neutral alignment, perhaps further research is needed. Besides, for the preoperative MFTA, we found that the preoperative varus deformity of patients in under-correction group was more serious than that in the other two groups. This finding reflects the problem that even though some studies have reported that residual varus alignment does not compromise clinical outcomes or has better clinical outcomes after TKR, a neutral mechanical axis still should be the initial objective for a TKR. Because the anatomy of the varus knees often leads already to under-correction. This is consistent with some studies to some extent[35-37].
There are some limitations in our study. First, we only conducted a retrospective analysis of cases of a single center by one single surgeon in our institution, and there was a large difference in the sample size among the groups, especially in group C, which had fewer patients with over-correction, so the study might have some bias. Second, the patients were selected over a very long period (2005 to 2017) which gives an average of 20-30 cases/year. Implants and surgical techniques might have changed during this long time. However, there was no statistical difference in follow-up time among three cohorts and most patients underwent surgery after 2012. Third, some studies reported that the HSS score is an obsolete tool to evaluate TKR outcome with obvious risk of a ceiling effect, however our institution still use it to evaluate clinical outcomes and the results are almost the same as other scales such as Knee Society Scores (KSS). Fourth, we did not analyzed the impact of coronal alignment of tibial or femoral components on clinical outcome score due to insufficient data. Lastly, we did not comment on the impact of coronal alignment on prosthetic survivorship due to the mean follow-up of our study was 3.62 years. However, this is not the purpose of our study, and our aim is to assess the impact of alignment on clinical functional outcomes.