Clinical outcomes of kinematic alignment versus mechanical alignment in total knee arthroplasty: a systematic review

in EFORT Open Reviews
Authors:
Mark Anthony Roussot Department of Trauma and Orthopaedics, University College London Hospitals, London, UK
Department of Orthopaedic Surgery, University of Cape Town, South Africa

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Georges Frederic Vles Department of Trauma and Orthopaedics, University College London Hospitals, London, UK

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Sam Oussedik Department of Trauma and Orthopaedics, University College London Hospitals, London, UK

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Mark Anthony Roussot, University College London Hospitals, Department of Orthopaedic Surgery, 235 Euston Rd, Bloomsbury, London, UK. Email: Mark.Roussot@nhs.net
Open access

  • Although mechanical alignment (MA) has traditionally been considered the gold standard, the optimal alignment strategy for total knee arthroplasty (TKA) is still debated.

  • Kinematic alignment (KA) aims to restore native alignment by respecting the three axes of rotation of the knee and thereby producing knee motion more akin to the native knee.

  • Designer surgeon case series and case control studies have demonstrated excellent subjective and objective clinical outcomes as well as survivorship for KA TKA with up to 10 years follow up, but these results have not been reproduced in high-quality randomized clinical trials.

  • Gait analyses have demonstrated differences in parameters such as knee adduction, extension and external rotation moments, the relevance of which needs further evaluation.

  • Objective improvements in soft tissue balance using KA have not been shown to result in improvements in patient-reported outcomes measures.

  • Technologies that permit accurate reproduction of implant positioning and objective measurement of soft tissue balance, such as robotic-assisted TKA and compartmental pressure sensors, may play an important role in improving our understanding of the optimum alignment strategy and implant position.

Cite this article: EFORT Open Rev 2020;5:486-497. DOI: 10.1302/2058-5241.5.190093

Abstract

  • Although mechanical alignment (MA) has traditionally been considered the gold standard, the optimal alignment strategy for total knee arthroplasty (TKA) is still debated.

  • Kinematic alignment (KA) aims to restore native alignment by respecting the three axes of rotation of the knee and thereby producing knee motion more akin to the native knee.

  • Designer surgeon case series and case control studies have demonstrated excellent subjective and objective clinical outcomes as well as survivorship for KA TKA with up to 10 years follow up, but these results have not been reproduced in high-quality randomized clinical trials.

  • Gait analyses have demonstrated differences in parameters such as knee adduction, extension and external rotation moments, the relevance of which needs further evaluation.

  • Objective improvements in soft tissue balance using KA have not been shown to result in improvements in patient-reported outcomes measures.

  • Technologies that permit accurate reproduction of implant positioning and objective measurement of soft tissue balance, such as robotic-assisted TKA and compartmental pressure sensors, may play an important role in improving our understanding of the optimum alignment strategy and implant position.

Cite this article: EFORT Open Rev 2020;5:486-497. DOI: 10.1302/2058-5241.5.190093

Introduction

Since the development of the total condylar prosthesis during the 1970s, 1 the optimal implant alignment for total knee arthroplasty (TKA) has been recognized as an important factor determining outcome, 2 and is still a matter of debate. 3,4

Hungerford and Krackow proposed anatomical alignment, striving to achieve a neutral hip-knee-ankle (HKA) angle with the anatomical joint line orientation of 2–3° from the horizontal to bring the joint line parallel to the floor during single leg stance. 5 Insall, on the other hand, focussed on restoring neutral mechanical alignment (MA) with orthogonal femoral and tibial resections, subsequently balancing flexion and extension gaps with soft tissue releases (Fig. 1). 1 The orthogonal implant position was intended to evenly distribute load through the implant–bone interface and minimize laterally directed ground reaction force (GRF) during gait in the hope that this would achieve longevity, though at the cost of normal knee kinematics. 1,611

Fig. 1
Fig. 1

Long-leg standing radiograph demonstrating the mechanical axis (MA) relative to the anatomical axis (AA) of the lower extremity (a). Note the joint line forms an angle that is 93° with the MAT, or 3O of varus. Anatomical alignment (b) mimics the native joint line of 3O varus to the mechanical axis of the tibia corresponding 3O valgus to the AA. Mechanical alignment (c) involves resections perpendicular to the mechanical axis of the tibia and distal femur.

Note. mLDFA, mechanical lateral distal femoral angle; aLDFA, anatomical lateral distal femoral angle; MPTA, medial proximal tibial angle.

Citation: EFORT Open Reviews 5, 8; 10.1302/2058-5241.5.190093

MA has been regarded as the gold standard alignment strategy and is supported by biomechanical studies, finite element analyses, and clinical studies. 1,2,9,10,1218 However, closer inspection reveals that much of this data is based on small numbers of patients, rudimentary component designs, and variable methods of determining alignment, 2,3,7,9,16,19 and the majority of the population do not have a perfectly neutral MA. 16 A study of 250 healthy, young adults revealed that 32% of males and 17% of females have constitutional varus > 3°. 20 Furthermore, an orthogonal distal femoral resection may raise the medial joint line and cause mid-flexion instability. 21

Our understanding of native knee motion has evolved. 22 Three axes of rotation have been described, namely the primary femoral axis (tibio-femoral flexion and extension), the secondary femoral axis (patella-femoral flexion and extension), and the longitudinal tibial axis (tibial internal and external rotation), all of which are intricately related to and influenced by implant position. 23

This evolving understanding, coupled with the desire to improve TKA performance and recent evidence that variance in alignment beyond the traditional safe zone of neutral ± 3° may not impact survival as originally thought, 19,2426 has provided the impetus to revisit the alignment strategy.

Kinematic alignment (KA), an alternative alignment method in TKA, is based on a three-dimensional appreciation for the three axes of rotation of the knee. 2729 Here, the objective is to position the implants so as to restore the pre-arthritic knee anatomy, 29,30 permitting motion more akin to the native knee. The pre-arthritic alignment is estimated pre-operatively with the use of proprietary software to create patient-specific cutting guides (PSGs) based on cylinders of best fit for the femoral condyles, or intra-operatively by resecting the femoral condyles symmetrically (distally and posteriorly), after correcting for cartilage and bone wear. 29,3133 This provides an individualized primary femoral axis of rotation, which has been shown to deviate from the transepicondylar axis by as much as 11.3° (Fig. 2). 28 In the coronal plane, the mechanical distal femur valgus and mechanical proximal tibia varus are restored to pre-arthritic alignment, which will vary from patient to patient, and incorporates a joint line orientation angle that may or may not be orthogonal to the mechanical axis. 23,28 The HKA angle is usually restored to neutral (0° ± 3° from neutral in 73% of patients according to Howell et al 34 ) and, in theory, accommodates for the proportion of the population that has pre-arthritic constitutional varus or valgus alignment. 20,28,29,34 Furthermore, restoration of left-to-right symmetry of the lower limb HKA is achieved in 95% of patients within ± 3°, according to a recent study by Nedopil et al. 35 Of note, the studies by Howell et al 34 and Nedopil et al 35 utilized non-weight-bearing CT scanograms to measure alignment.

Fig. 2
Fig. 2

Three-dimensional knee model constructed from the Visible Human database (University of Colorado Center for Human Simulation), demonstrating the differences between the epicondylar (yellow) axis, which is the basis of MA TKA, and the axis derived from cylinders of best fit for the femoral condyles (green), which is the basis of KA TKA.

Reproduced with permission from: Eckhoff DG, Bach JM, Spitzer VM, Reinig KD, Bagur MM, Baldini TH, Flannery NM. Three-dimensional mechanics, kinematics, and morphology of the knee viewed in virtual reality. J Bone Joint Surg (Am). 2005 Dec 1;87(suppl_2):71-80.

Citation: EFORT Open Reviews 5, 8; 10.1302/2058-5241.5.190093

In the sagittal plane, since the implants most frequently used in KA TKA are cruciate retaining (CR), a sufficient posterior tibial slope to protect the posterior cruciate ligament (PCL) (5–7°) is required. Restoring the antero-posterior position of the tibial component is necessary to achieve correct tension in the PCL and thereby facilitate more native motion. 29 Flexion of the femoral component is largely determined by the design of the implant and the avoidance of ‘notching’ the distal femur in both techniques.

In the axial plane, the two strategies may differ somewhat. Proponents of MA tend to aim for slight external rotation of the femoral components to prevent patella maltracking, which accommodates for the relatively greater lateral tibial resection with a 90° tibial bone cut, 1,4 whereas the KA strategy aims to achieve symmetrical posterior condylar resections of the distal femur after correcting for the cartilage wear, which would place the implant in a native, rotationally neutral position. 29 In both techniques, cross referencing with alternative landmarks, including Whiteside’s line and the transepicondylar axis, may be required in cases with extreme deformity, although the reliability of the transepicondylar axis has been questioned. 27,28 Proponents of KA believe that this strategy may require less soft tissue release, preserve bone, reduce post-operative pain, and improve post-operative function, thereby reducing the proportion of patients who remain discontent following TKA. 29,36

Whether these changes in prosthetic alignment translate to improvements in subjective or objective outcomes or have an impact on survivorship of the TKA remains unknown. In this systematic review, we will present and critique the current clinical evidence to determine whether, compared to MA, KA (1) translates to improvement in subjective patient-reported outcomes or objective measures of knee function following TKA and (2) has an impact on implant survivorship.

Methods

In keeping with the Preferred Reporting Items for Systematic review and Meta-analysis (PRISMA) guidelines, we conducted a literature search on PubMed, Embase and Cochrane databases for publications between 1975 and January 2020, using the following criteria for titles and abstracts: “(kinematic alignment) AND ((total knee arthroplasty) OR (total knee replacement))”. This yielded 592 results. After duplicates were removed, a fellowship-trained orthopaedic surgeon screened the titles and abstracts for relevance. The full texts of 23 publications were selected and assessed for appropriateness by two authors (both fellowship-trained orthopaedic surgeons), who then independently performed the quality assessment for each of the 15 selected studies. The authors then discussed the quality assessments to ensure agreement.

Eligibility criteria included full-text articles written in English that reported clinical and/or radiological outcomes comparing KA and MA TKA. Case reports, letters, unpublished data, cadaver studies and studies of revision arthroplasty were excluded (Fig. 3).

Fig. 3
Fig. 3

PRISMA Flow Diagram

Note. RCT, randomized controlled trial.

Citation: EFORT Open Reviews 5, 8; 10.1302/2058-5241.5.190093

Quality assessment of individual studies was performed using the revised tool to assess Risk of Bias in randomized trials (ROB 2.0), 37 and Risk of Bias for Non-randomized Studies of Interventions (ROBINS-I) for all other non-randomized studies identified. 38

Owing to the small numbers of randomized controlled trials (RCTs) identified, quality of the methodology, and heterogeneity of outcome reporting, the data were not pooled.

Results

Twenty-three clinical articles were analysed, including two meta-analyses, 39,40 one systematic review, 41 eight RCTs, 11,4248 six case control studies, 30,33,36,4951 and six case series 29,31,32,34,52,53 (six level I, four level II, seven level III, and five level IV). Fifteen original research papers reporting clinical results and survivorship were included in the systematic review, summarized in Table 1 and Table 2.

Table 1.

Overview of the design characteristics of the article included in this review

Author, year Design Level of evidence Blinding Single surgeon Follow up in months N TKAs

(patients)
Implant Guide
PS/CR Patella resurfacing
MacDessi, 2020 RCT I Double No 12 MA

KA
68 (62)

70 (63)
PS

PS
Standard

Standard
Navigation

Navigation
McNair, 2018 RCT II Double No > 24 MA

KA
15 (15)

14 (14)
CR

CR
Selective

Selective
Navigation

PSG
Young, 2017 RCT I Double No 24 MA

KA
50 (50)

49 (49)
CR

CR
Selective

Selective
Navigation

PSG
Calliess, 2017 RCT II No No 12 MA

KA
100 (100)

100 (100)
CR

CR
NR

NR
Conventional

PSG
Waterson, 2016 RCT I Double No 12 MA

KA
35 (27)

36 (28)
CR

CR
Standard

Standard
Conventional

PSG
Dossett, 2014 RCT I Double Yes* > 24 MA

KA
44 (44)

44 (44)
CR

CR
Standard

Standard
Conventional

PSG
Dossett, 2012 RCT I Double Yes* 6 MA

KA
41 (41)

41 (41)
CR

CR
Standard

Standard
Conventional

PSG
Blakeney, 2019 Case control III No Yes 34 (12–96) MA

KA
18 (17)

18 (15)
CR

CR
NR

NR
Navigation

Navigation
Niki, 2018 Case control III No Yes 35 ± 5

26 ± 6
MA

KA
21 (19)

21 (18)
PS

PS
NR

NR
Conventional

Conventional
Spencer, 2009 Case control IV No Yes 6 MA

KA
30 (30)

21 (21)
CR

CR
None

None
Conventional

PSG
Howell, 2018 Case series III No Yes 120 KA 207 (203) CR Standard PSG
Howell, 2015 Case series III No Yes 76 (70–86) KA 219 (214) CR Standard PSG
Howell, 2013 CORR Case series IV No Yes 38 (31–43) KA 214 (198) CR Standard PSG
Howell, 2013 KSSTA Case series IV No Yes 6–9 KA 101 (101) CR Standard Conventional
Howell, 2008 Case series IV No Yes 3 KA 48 (48) CR Standard PSG

Note. RCT, randomized controlled trial; CR, cruciate retaining; KA, kinematic alignment; MA, mechanical alignment; N, number; NR, not reported; PS, posterior stabilized; PSG, patient-specific guide; TKA, total knee arthroplasty; CORR, Clinical Orthopaedics and Related Research; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.

*Single team of two surgeons.

Table 2.

Overview of the results of the controlled articles included in this review

Author, year Functional tests e.g.- gait lab analysis

- timed-up-and-go test

- ICPD
Complications and/or implant PROMs in favour of
survival in favour of WOMAC OKS AKSS cKSS FJS VAS EQ-5D SF-36 KOOS UCLA
MacDessi, 2020 Improved quantitative knee balance with KA N N N
McNair, 2018 Neither N N
Young, 2017 Neither N N N N N N
Calliess, 2017 Neither KA KA
Waterson, 2016 KA: better peak quadriceps torque up to three months N N N N N
Dossett, 2014 KA: 8.5° greater flexion at two years Neither KA KA KA
Dossett, 2012 KA: 5° greater flexion at six months KA KA KA
Blakeney, 2019 KA: better resembles healthy knee gait parameters than MA KA
Niki, 2018 KA: reduced first peak of KAM during gait at 2.2 years N
Spencer, 2009 Neither

Note. AKSS, American Knee Society Score; cKKS, combined Knee Society Score; EQ-5D, EuroQol 5-dimensional health questionnaire; FJS, Forgotten Joints Score; ICPD, intercompartmental pressure difference; KA, kinematic alignment; KAM, knee adduction moment; KOOS, Knee injury and Osteoarthritis Outcome Score; MA, mechanical alignment; N, neither; OKS, Oxford Knee Score; PROMs, patient-reported outcome measures; SF-36, Short Form 36; VAS, Visual Analog Scale; WOMAC, Western Ontario and McMaster Universities Arthritis Index; UCLA, University of California at Los Angeles (UCLA) Activity Score.

Quality assessment

The assessment for risk of bias for the 15 studies included (Table 3 and Table 4), revealed that all studies had at least moderate risk of bias and one had serious risk of bias.

Table 3.

Risk of bias assessment in randomized trials (ROB 2.0)

Domain Dosset, 2012 Dosset, 2014 Waterson, 2016 Calliess, 2017 Young, 2017 McNair, 2018 MacDessi, 2020
Randomization Some concerns Some concerns Some concerns Some concerns Some concerns Some concerns Some concerns
Deviations from intended intervention Low Low Some concerns Some concerns Low Low Some concerns
Missing data Low Low Low Low Low Low Low
Measurement of outcomes Low Low Low Low Low Low Low
Selection of the reported result Some concerns Some concerns Some concerns Some concerns Some concerns Low Low
Overall bias Some concerns Some concerns Some concerns Some concerns Some concerns Some concerns Some concerns
Table 4.

Risk of bias for non-randomized studies of interventions (ROBINS-I)

Domain Howell, 2008 Spencer, 2009 Howell, 2013 CORR Howell, 2013 KSSTA Howell, 2015 Niki, 2018 Blakeney, 2019
Confounding Moderate Moderate Moderate Low Moderate Moderate Low
Selection of participants Moderate Moderate Moderate Moderate Moderate Moderate Moderate
Classification of interventions Low Low Low Low Low Moderate Low
Deviations from intended intervention Low Low Low Low Low Low Low
Missing data Moderate Low Low Low Low Low Low
Measurement of outcomes Moderate Moderate Moderate Moderate Moderate Moderate Low
Selection of the reported result Moderate Moderate Moderate Moderate Moderate Low Serious
Overall bias Moderate Moderate Moderate Moderate Moderate Moderate Serious

Note. CORR, Clinical Orthopaedics and Related Research; KSSTA, Knee Surgery, Sports Traumatology, Arthroscopy.

Challenges in the randomization process were recognized in all studies, some of which are inherent to the nature of the research. For example, the inability to blind the treating surgeons who perform either KA or MA TKA, and incomplete blinding of participants – only Young et al, 11 McNair et al 46 and Dossett et al 43,44 conducted magnetic resonance imaging (MRI) on all patients regardless of the intervention, and MacDessi et al introduced a second observer to reduce the risk of measurement bias. 48

Outcome measures were heterogeneous and included the use of pain and functional indices, and 10 different patient-reported outcome measures (PROMs, Table 2). The Knee Society Score (KSS) was the most commonly used outcome measure. 11,4245,50 One study also reported the intercompartmental pressure difference measured intra-operatively using a pressure sensor insert (VERASENSE; OrthoSensor, Dania Beach, Florida, USA). 48

The measurement of alignment pre-operatively and post-operatively also varied among the studies, utilizing long leg standing radiographs, 42,45 or supine computed tomography (CT), 11,34,43,44,49 while one RCT utilized standing long leg radiographs pre-operatively and CT post-operatively. 48 However, methods of determining component alignment as well as overall limb alignment were standardized.

Gait analysis studies were performed in a similar manner in studies looking at kinematic and kinetic parameters, such as walking speed, range of motion (ROM), ground reaction force (GRF), and knee adductor moment (KAM), while patients were allowed to walk trials at a self-selected speed. 46,50,51

Potential confounding variables include the use of PSGs for KA TKAs and comparing these to MA TKAs performed with conventional instrumentation, 4245 or computer navigation. 11 CR, cemented implants and patella resurfacing were utilized in all studies, except for Young et al and McNair et al who reported selective resurfacing, Blakeney et al, Niki et al, and Calliess et al who did not mention patella resurfacing, Niki et al who used posterior stabilized (PS) TKAs with an uncemented trabecular metal tibial tray, and MacDessi et al who utilized cemented posterior stabilized implants. Notably, most studies reported the use of a proprietary system (OtisMed Inc., Alameda, California) for PSGs, which is no longer commercially available. 11,29,31,34,4345,49,52

The proportion of follow up (FU) for each study was good ( > 90%), although the duration of FU was short in all RCTs – MacDessi et al, Waterson et al and Calliess et al reported one year results, while Dossett et al and Young et al reported two year results. Medium-term results were only available from Howell et al, who reported results after 5.8–7.2 years FU in 2015, 52 and subsequently reported their results at 10 years FU in 2018. 34 While this group’s series have been well constructed, an inherent risk of bias will always exist in single, designer surgeon case series.

Statistical methods were questionable for all RCTs. Numerous variables were measured, yet no Bonferroni correction was performed in any of the studies reviewed, except for Blakeney et al. 51 They were conducted with small numbers of patients in each group, ranging from 14–100 patients. This is a result of researchers performing power analyses based on a single variable, e.g. Oxford Knee Score (OKS) 11,43,44 or Knee Injury and Osteoarthritis Outcome Score (KOOS), 42 and in at least one instance, the use of a two-tailed test for level of significance. 11

Does kinematic alignment translate to improvement in patient-reported outcomes or objective measures of knee function following TKA in comparison to mechanical alignment?

Significant improvements in PROMs or objective knee function following KA TKAs have been reported in five case series and two case control studies. However, results reported in the six RCTs and another case control study are less convincing, with small numbers of patients, short duration of FU, and methodological concerns. Formal gait analysis was performed in three comparative studies (one RCT and two case control studies), which reported subtle differences in parameters such as the knee adduction, extension and external rotation moments. The clinical relevance of this needs further evaluation.

Howell et al demonstrated an improvement in the mean OKS from 20 pre-operatively to 43 post-operatively, and post-operative Western Ontario and McMaster Universities (WOMAC) scores averaging 92 points in a case series of 198 patients undergoing 214 KA TKAs at a minimum FU of 31 months. 31 They concluded that KA TKAs restore a high level of function despite 75% of patients in the study group having tibial component varus, defined as > 0° varus. All patients in this study received CR, fixed-bearing, cemented implants with patella resurfacing using PSGs. In another series, Howell et al reported similar clinical outcomes at 6–9 months in 101 patients undergoing KA TKAs using the same implants this time with conventional instrumentation, and showed post-operative OKS and WOMAC scores of 42 and 89 respectively. 32 In 2015, Howell’s group reported on the results of 214 patients undergoing 219 KA TKAs at a median FU of 6.3 years (5.8–7.2 years) with post-operative OKS and WOMAC scores of 42.7 and 91.1 respectively. 52 At 10 years FU, the group reported OKS scores of 43 (48 best) and WOMAC scores of 7 (0 best). 34 Notably, any severity of pre-operative varus, valgus and flexion deformity was included in these case series. Spencer et al reported no complications or re-operations at six months FU in a small case control study of 21 patients undergoing KA TKAs using PSGs, with lower tourniquet time and similar blood loss and ROM in comparison to 30 MA TKAs performed with conventional instrumentation. 49

In 2012, Dossett et al published the first RCT of 41 KA versus 41 MA TKAs using CR cemented implants with patella resurfacing. 43 At six months FU, they reported that the WOMAC score was 16 points better, OKS 7 points better, combined Knee Society Score (cKSS) 25 points better, and flexion 5° greater in the KA group. In 2014, the same group published their two year FU results for 44 KA versus 44 MA TKAs, again reporting significantly better mean scores for the KA group. At two years, the KA group consisted of a greater proportion of pain-free patients (52% versus 18%).

In 2016, Waterson et al, compared 36 KA TKAs, performed with PSGs, and 35 MA TKAs, performed with conventional instrumentation. 42 They found no significant difference in any of the pain and functional indices or health and quality of life (QoL) scores, including ROM, the timed up-and-go test, two-minute walking test, timed up and down stairs test, peak quadriceps strength test, American Knee Society Score (AKSS), KOOS, Short-Form (SF)-36, University of California at Los Angeles activity score (UCLA) and EuroQol (EQ-5D) at one year FU. CR, cemented implants with patella resurfacing were used by three surgeons for all patients, who were not blinded. Some of the exclusion criteria are worth taking note of: patients with pre-operative varus or valgus > 10° or flexion contracture > 20°, patients who suffered a complication that could have influenced the functional outcome and 7 patients with class 1 device recall (KA group).

In 2017, Calliess et al reported that at one year FU, greater improvements in the KSS (190 versus 178) and WOMAC score (16 versus 26) were found in 100 patients undergoing KA versus 100 patients undergoing MA TKAs, but also noted a greater number of outliers (six patients) with poor functional scores (WOMAC > 40) in the KA group. 45 Patients with varus or valgus deformity > 10°, body mass index (BMI) > 40, post-traumatic osteoarthritis, and previous surgery were excluded from the trial; no mention was made of the proportion of patients with patella resurfacing, and patients were not blinded. In the same year, Young et al reported on the comparison of 49 KA TKAs (PSGs) with 50 MA TKAs (computer navigation) all performed by six fellowship-trained arthroplasty surgeons using CR, fixed-bearing, cemented implants with selective patella resurfacing. 11 Both groups underwent pre-operative MRI scans to ensure blinding. At two years FU, no difference was found in the OKS, KSS, visual analogue score (VAS), forgotten joint score (FJS), WOMAC or EQ-5D scores. Similar complications, including patella maltracking, were found in both groups. As a continuation of this study, patients with a non-arthritic, native contralateral knee with at least two years of FU were approached to participate in 3-D gait analysis on this topic. 46 Twenty-nine patients were enrolled, i.e. 15 with a MA TKA and 14 with a KA TKA. Kinematic and kinetic variables were collected while patients performed five trials of walking at a self-selected pace and overall were found to be similar. The only difference was that the KA group showed significantly lower internal rotation moments and a trend towards increased extensor moments during the mid to late stance phase, which is of uncertain clinical significance. Of note in this study, KAM, the main component of frontal knee kinetics, was lower than typically observed after TKA for both groups.

Niki et al conducted a gait analysis study focusing specifically on KAM, 50 as varus joint line orientation is perceived as a risk factor for premature tibial loosening. They matched a cohort of 21 MA TKAs (18 patients) against 21 KA TKAs (18 patients). For this Asian population, a posterior stabilized TKA with a cementless tibial tray was implanted via mini subvastus approach. Despite slight varus alignment, reduced KAM was found for KA TKAs compared to MA TKAs (p = 0.021) after a median FU of 2.6 years, and was attributed to a shorter lever arm (p = 0.028). Clinical outcome scores (Knee Society) did not differ between the two groups.

Recently, Blakeney et al performed a retrospective case control study in which 18 KA TKAs (15 patients) were matched against 18 MA TKAs (17 patients). 51 Both groups underwent gait analysis before inclusion and kinematic parameters were compared to those of a non-matched group of healthy controls (170 knees in 95 participants). The KA group showed no significant differences in knee kinematics compared to healthy controls. The MA group displayed several significant differences in knee kinematics compared to healthy controls, i.e. less sagittal plane ROM (p = 0.020), less maximum flexion (p = 0.002), adduction during the initial swing phase (p = 0.010), and knee external tibial rotation in mid-stance (p = 0.008). However, when comparing MA and KA groups directly, no significant differences in kinematics parameters could be shown. PROMs were significantly better for the KA group compared to the MA group at mean FU of 33.5 (12–96) months (KOOS).

MacDessi et al demonstrated that KA TKA with navigation results in significantly lower mean intercompartmental pressure difference at 10°, 45° and 90° knee flexion and less soft tissue release, but this did not translate into a difference in PROMs after one year follow up. 48 The authors acknowledged that using the pressure sensors resulted in intra-operative adjustments of bony resection and soft tissue balancing, which may encumber the comparison of clinical outcomes.

Two meta-analyses have been performed for KA versus MA TKAs. Li et al found that the group of 280 KA TKAs achieved better WOMAC, KFS, OKS and flexion, reduced operative time and increased walking distance to discharge in comparison to 281 MA TKAs, with similar KSS, VAS, post-operative haemoglobin, and length of hospital stay in both groups. 39 However, the authors included KA TKA revision of unicompartmental knee arthroplasty in the analysis. Courtney and Lee conducted a meta-analysis of four RCTs comparing 229 KA and 229 MA TKAs and reported higher post-operative KSS in the KA group, but no difference in complication rate (3.9% in KA group versus 4.4% in MA group). 40

Does kinematic alignment have an impact on implant survivorship when compared to mechanical alignment?

Currently, long-term survivorship (10 years) has been reported for KA TKAs in one designer surgeon case series, with RCTs reporting six to 24-month survivorship.

In their series of 101 patients undergoing KA TKA using conventional instrumentation, Howell et al reported no re-operations at 6–9 months FU. 32 Another case series of 214 KA TKAs using PSGs conducted at the same institution showed no revisions for loosening, wear or instability at 31–43 months FU, 31 and the group subsequently published their medium-term results for 219 KA TKAs after 5.8–7.2 years FU with implant survivorship of 97.5% and revision rate per 100 component years of 0.40. 52 Failures included two loose patella components, one loose tibial component, one with patella instability and one deep infection. At 10 years, the group reported implant survivorship of 97.5% for revision for any reason and 98.4% for aseptic loosening (number at risk 141 and 140 respectively). 34 Reasons for revision included PJI (two knees), patella instability/loosening (two knees), and tibial component loosening (one knee), and an additional two knees required arthroscopic lateral release for patella instability within the first year. 34

In their RCT, Calliess et al reported similar early revision rates in the KA (2%) and MA groups (1%) at one year FU, all for instability. 45 In 2012, Dossett et al reported similar complication rates and no revisions at six months. 43 In 2014, the same group reported one revision for infection in the KA group of 44 patients and one revision for instability in the MA group of 44 patients after two year FU. 44 Waterson et al excluded patients with complications that could affect functional outcome, and therefore were unable to report on survivorship in their RCT. 42 Young et al reported similar proportions of re-operations in the KA group (3 in 49 patients) and the MA group (4 in 50 patients), which included one patient with patella instability in both groups. 11

Courtney and Lee pooled the survival data of 877 KA TKAs from nine studies and reported a survivorship of 97.4% at a weighted FU of 38 months. 40 Patellofemoral problems was the most frequent reason for revision (8 patients, 1.2%). 40 However, when comparing the revision rate for patellofemoral complications in a meta-analysis of 229 KA and 229 MA knees, there was no difference between the two groups (1.3% versus 1.3%). 40

Discussion

This systematic review identified 15 studies evaluating the subjective and objective functional outcomes and survivorship of KA TKA, 10 of which compared KA to MA TKA. We chose to analyse these studies without pooling data because (1) all studies contained methodological concerns, including challenges in randomization, risk of bias, and inability to control confounding variables; (2) substantial heterogeneity in outcome measures was apparent, with 10 different PROMs utilized; (3) non-standardized objective measures of knee function were performed; and (4) the included clinical trials had 6–24 months FU and relatively small numbers of participants even when collated: MA 353 knees (339 patients) versus KA 354 knees (339 patients). Despite this, there are salient findings that are worthy of noting, which may be less apparent by pooling data in this instance.

Firstly, it is clear that excellent clinical and functional outcomes for KA TKA have been achieved in designer series, even at 10 years FU. 34 Secondly, the currently available level I and II evidence suggests that KA TKA appears to show equivalent or improved PROMs, objective measures of knee function, and implant survival. 11,4246 Thirdly, although the technique described in designer series may be difficult to reproduce given the unavailability of the property software used for determining the implant position and the use of PSG, it has been successfully reproduced with standard instrumentation and computer navigation. 32,48

Proponents of KA TKA suggest that correcting the arthritic deformity to the native or pre-arthritic alignment by positioning the tibial, femoral and patellar components in a manner that respects the three axes of rotation of the knee, as well as the native distal and posterior joint lines, 34 improves functional outcome and patient satisfaction. The studies reported herein demonstrate that PROMs such as OKS, WOMAC, AKSS, cKSS and KOOS appear equivalent or in favour of KA TKA, 11,4346,51 while FJS, VAS, EQ-5D, SF-36, and UCLA scores appear equivocal. 11,42 Since these PROMs have recognized limitations in terms of responsiveness and ceiling effects, comparative studies focussing on PROMs as the primary outcome may be unable to detect a meaningful difference. 54,55 Only four comparative studies reported on objective measures of knee function (none of which are standardized measures) including peak quadriceps torque, degrees of flexion, KAM and gait kinematics, which were in favour of KA TKA. 4244,50 The lower KAM seen in KA TKA suggests that this technique may be particularly suitable for patients with increased varus tibial bowing. 34,50 The proposed soft tissue benefits of KA that may be responsible for improvements in pain, function and patient satisfaction 29,44,49,52 were only quantified in one RCT, which showed reduced intercompartmental pressure difference in KA knees, but this did not translate into improvements in PROMs at 1 year follow up. 48

Studies reporting the outcomes in TKA tend to focus on static coronal alignment, but one should also appreciate the importance of sagittal and axial alignment. Femoral component flexion > 3° and tibial slope of 7° have been noted as risk factors for failure 56,57 Optimal axial rotation of the femoral component is important in obtaining balanced flexion gaps, as well as tibiofemoral and patellofemoral congruency, 5860 and it has been shown that external rotation of the femoral or tibial components of < 2° or > 5° is associated with increased risk of failure and patellar maltracking. 56,6164 Only two studies identified in this review commented on the sagittal alignment of the components, 34,43 and none of them reported the axial alignment objectively.

Patient selection criteria for KA TKA need to be clearly defined. While one would expect that it may be inappropriate for patients with large deformities, Howell et al included a range of 14° varus to 20° valgus, and any degree of flexion deformity. 34 The fact that poor clinical results are still reported in both KA and MA groups, suggests that careful evaluation of which patients benefit from either strategy is required. 65

The relationship between alignment and survivorship is unclear. Fang et al correlated the anatomical tibiofemoral angle with survivorship in 6070 TKAs and reported that the best survival rate (99% at 20 years) was seen for patients with post-operative anatomic knee alignment of between 2.4° and 7.2° valgus (which represents a nearly neutral or varus mechanical axis). 10 They showed that neutrally aligned TKAs (+/- 5°) showed significantly better survivorship compared to varus and valgus TKAs. 10 Other contemporary studies have recognized that patient age, polyethylene shelf age, and BMI may play an important role in survivorship of TKA. 66,67 In reality, the durability of TKA is to be multifactorial, and far more complex than a dichotomous description of ‘well aligned’ or ‘malaligned’ based on historical perspectives. 3 The utilization of modern technologies, especially robotics in TKA, will likely play a pivotal role in improving our understanding about optimal, functional alignment and implant position (Fig. 4). 68,69 Not only do they provide us with the ability to plan and position the implants with greater precision, taking into consideration the alignment, joint line and soft tissue balance, but will also assist in the collection of data through the acquisition of lower limb alignment and 3-D CT imaging required for pre-operative planning, and collection of intra-operative data regarding soft tissue balancing, which can then be evaluated with post-operative radiological and functional assessment. Robotic TKA also avoids the unique complication of incorrect seating of the PSG, which can cause symptomatic malalignment requiring revision. 34 Dynamic, in vivo methods of assessing alignment and quantifying joint contact pressures may be valuable adjuncts to quantifying the soft tissue balance and correlating functional outcome with alignment strategies. 7072

Fig. 4
Fig. 4

Operative plan for a robotic-assisted, kinematically aligned TKA. Note that the implant alignment is based on symmetrical 8 mm distal and posterior resections of the femoral condyles. The tibial resection is aligned to the native proximal tibial joint line, taking into consideration 1mm of asymmetrical bone loss from osteoarthritis.

Citation: EFORT Open Reviews 5, 8; 10.1302/2058-5241.5.190093

The main limitation of this study was that data from comparative studies was not pooled. This was deliberate, since it is our view that the studies were too heterogenous in design, methodology, surgical technique and reported outcome measures, and would still contain relatively few numbers to make relevant statistical inference.

In conclusion, there is some compelling evidence showing that using a KA strategy has equivalent or improved clinical outcomes, without increased risk of failure in the short, medium and even long term. However, further studies are warranted to determine reproducibility of the encouraging clinical results reported by the designer surgeons. Future RCTs should control for confounders such as surgical technique (PSGs, navigation or conventional instrumentation), perform adequate blinding of patients and outcome measurers, utilize outcomes measures that are less susceptible to a ceiling effect, and improve the integrity of the statistical methods by adjusting for the number of variables tested. The use of robotics and objective measures of soft tissue balance may play an important role in these future studies.

Open access

This article is distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 International (CC BY-NC 4.0) licence (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed.

ICMJE Conflict of interest statement

MAR reports funding to attend the 2019 AAOS Annual Meeting from Ascendis Medical, and funding to attend training workshops from Stryker, outside the submitted work.

GFV declares no conflict of interest relevant to this work.

SO reports Board membership of Bone & Joint Journal, consultancy for and payment for development of educational presentations from Stryker Orthopaedics, employment by University College London Hospitals NHS Trust, grants/grants pending from Digital Surgery, payment for lectures including service on speakers’ bureaus for Stryker Orthopaedics, royalties from Springer International, and travel/accommodations/meeting expenses unrelated to activities.

Listed from EFORT and Stryker Orthopaedics, all outside the submitted work.

Funding statement

The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other non-profit organization with which one or more of the authors are associated.

OA licence text

This article is distributed under the terms of the Creative Commons Attribution-Non Commercial 4.0 International (CC BY-NC 4.0) licence (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed.

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  • Collapse
  • Expand
  • Fig. 1

    Long-leg standing radiograph demonstrating the mechanical axis (MA) relative to the anatomical axis (AA) of the lower extremity (a). Note the joint line forms an angle that is 93° with the MAT, or 3O of varus. Anatomical alignment (b) mimics the native joint line of 3O varus to the mechanical axis of the tibia corresponding 3O valgus to the AA. Mechanical alignment (c) involves resections perpendicular to the mechanical axis of the tibia and distal femur.

    Note. mLDFA, mechanical lateral distal femoral angle; aLDFA, anatomical lateral distal femoral angle; MPTA, medial proximal tibial angle.

  • Fig. 2

    Three-dimensional knee model constructed from the Visible Human database (University of Colorado Center for Human Simulation), demonstrating the differences between the epicondylar (yellow) axis, which is the basis of MA TKA, and the axis derived from cylinders of best fit for the femoral condyles (green), which is the basis of KA TKA.

    Reproduced with permission from: Eckhoff DG, Bach JM, Spitzer VM, Reinig KD, Bagur MM, Baldini TH, Flannery NM. Three-dimensional mechanics, kinematics, and morphology of the knee viewed in virtual reality. J Bone Joint Surg (Am). 2005 Dec 1;87(suppl_2):71-80.

  • Fig. 3

    PRISMA Flow Diagram

    Note. RCT, randomized controlled trial.

  • Fig. 4

    Operative plan for a robotic-assisted, kinematically aligned TKA. Note that the implant alignment is based on symmetrical 8 mm distal and posterior resections of the femoral condyles. The tibial resection is aligned to the native proximal tibial joint line, taking into consideration 1mm of asymmetrical bone loss from osteoarthritis.

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    Insall JN , Binazzi R , Soudry M , Mestriner LA . Total knee arthroplasty. Clin Orthop Relat Res 1985; 192:1322 .

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    Lotke PA , Ecker ML . Influence of positioning of prosthesis in total knee replacement. J Bone Joint Surg Am 1977; 59:7779 .

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    Abdel MP , Oussedik S , Parratte S , Lustig S , Haddad FS . Coronal alignment in total knee replacement: historical review, contemporary analysis, and future direction. Bone Joint J 2014; 96-B:857862 .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 4.

    Cherian JJ , Kapadia BH , Banerjee S , Jauregui JJ , Issa K , Mont MA . Mechanical, anatomical, and kinematic axis in TKA: concepts and practical applications. Curr Rev Musculoskelet Med 2014; 7:8995 .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Hungerford DS , Krackow KA . Total joint arthroplasty of the knee. Clin Orthop Relat Res 1985; 192:2333 .

  • 6.

    Tew M , Waugh W . Tibiofemoral alignment and the results of knee replacement. J Bone Joint Surg Br 1985; 67:551556 .

  • 7.

    Bargren JH , Blaha JD , Freeman MA . Alignment in total knee arthroplasty: correlated biomechanical and clinical observations. Clin Orthop Relat Res 1983; 173:178183 .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    Jeffery RS , Morris RW , Denham RA . Coronal alignment after total knee replacement. J Bone Joint Surg Br 1991; 73:709714 .

  • 9.

    Ritter MA , Faris PM , Keating EM , Meding JB . Postoperative alignment of total knee replacement: its effect on survival. Clin Orthop Relat Res 1994; 299:153156 .

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10.

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