Original Article
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Navigated versus Conventional Total Knee Arthroplasty Joseph T. Moskal, MD1
Susan G. Capps, PhD2
John W. Mann, MD3
1 Department of Orthopaedic Surgery, Virginia Tech Carilion School of
Medicine, Roanoke, Virginia 2 BENSOL, Warsaw, Indiana 3 Department of Orthopaedic Surgery, Carilion Clinic Orthopaedics, Roanoke, Virginia 4 Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia
John A. Scanelli, MD4
Address for correspondence Susan G. Capps, PhD, BENSOL, 488 East Bell Drive, Warsaw, IN 46582 (e-mail: [email protected]).
Abstract
Keywords
► ► ► ► ►
arthroplasty reconstruction navigation survivorship clinical outcomes
Computer-aided navigation in total knee arthroplasty (TKA) promises improved alignment, performance, and survivorship. Previous meta-analyses demonstrated that navigation yields better component alignment; however, they did not discuss other indicators of performance. This meta-analysis compares navigated (NAV) and conventional (CONV) TKAs and includes clinical outcomes and adverse events. Forty-seven studies (22 randomized trials) of varying methodological quality involving 7,151 TKAs created the sample population. Statistical analyses included analysis of variance of weighted means and random effects modeling. As seen in previous meta-analyses, NAV is favored over CONV TKA. Analysis of surgical characteristics found that length of surgery and tourniquet times were lower for CONV, but not significant. Meta-analysis found that tourniquet times favored CONV but not a strong relationship for length of surgery. Analysis of individual adverse events did not reveal any significant differences. However, when examining adverse events in their totality, the NAV experienced significantly fewer complications. TKA performed with imageless navigation improves component alignment, provides for lower blood loss, improves clinical outcomes as measured by Knee Society and WOMAC scores, and has fewer total adverse events. Published data are insufficient to determine any correlations between component alignment and outcomes.
It is generally accepted that poor positioning and component orientation contribute to poor survivorship and performance in total knee arthroplasty (TKA).1–26 The number of patients receiving primary and revision TKA is expected to increase due to the aging population and the demands for functional, pain-free knees.27 If there are ways to improve TKA by improving component implantation, then there may be ways to improve quality of life, reduce failure rates, and reduce economic and societal burdens.
Proponents of computer-aided navigation for TKA promise more exact component alignment and thus improved functional and clinical outcomes. Previous reports have demonstrated better component positioning with relationship to the mechanical axis with navigated (NAV) TKA.2,7,21,22,28–49 Previous meta-analyses have shown that NAV versus conventional (CONV) TKA have shown that NAV TKA produced tighter control of component positioning and fewer alignment outliers than CONV TKA, particularly in the coronal and sagittal planes.50–53 This meta-analysis hopes to further
received February 23, 2013 accepted after revision September 23, 2013 published online November 14, 2013
Copyright © 2014 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0033-1360659. ISSN 1538-8506.
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J Knee Surg 2014;27:235–248.
Navigated versus Conventional Total Knee Arthroplasty illuminate the influence of imageless navigation on the clinical outcomes, alignment outcomes, adverse events, and thus clinical relevance of NAV TKA through the published data from comparative studies. All of these studies evaluated neutral alignment with relationship to the mechanical axis as the optimal surgical goal and they did not consider “patient-specific functional alignment” as an endpoint.
Materials and Methods The literature searches using PubMed and leading orthopedic scientific journals looked for published studies that directly compared NAV and CONV TKA. The search terms were “computer-aided total knee arthroplasty,” “computer-aided total knee arthroplasty,” “computer-assisted total knee arthroplasty,” and “navigated total knee arthroplasty.” Publication dates were confined from 1990 to 2011. One patient population was covered in two studies; when data were repeated, it was considered once in the outcomes analysis and considered twice in the analysis of study characteristics and demographics.35,54 Multiple inclusion criteria were applied, and any study that failed to meet all inclusion criteria was excluded. Studies must have a prospective or retrospective comparative design (Level of evidence I, II, or III),55 compare NAV with CONV TKA, consist of adult-only populations, clearly report outcomes, and contain a minimum of 15 patients per treatment. All investigators (J.T.M., S.G.C., J.W.M., and J.A.S.) performed data extraction, and consensus was required for all extracted items. Outcome measures were included in analysis if at least four studies and eight treatment groups contained a particular measure. The frequency with which specific outcome measures were reported varied greatly; knee scores, component alignments, and adverse events were analyzed. Statistical analysis was conducted with the use of JMP version 9.02 (SAS Institute Inc., Cary, NC) and Comprehensive MetaAnalysis version 2 (Biostat, Englewood, NJ). Significance was defined by p < 0.05. Random effects meta-analysis using Comprehensive Meta-Analysis software was employed to reflect variation among studies. According to Borenstein et al, random effects meta-analysis should be employed when data are accumulated from a series of studies performed by a series of researchers functioning independently, and that this form of meta-analysis allows for the inclusion of studies regardless of population sizes without assigning too little or too much weight to data.56 All meta-analyses with significant findings were tested for publication bias; none were found to have severe bias. Total knee component alignments were compared by mathematically determining the “deviation from neutral.”57,58 Mechanical axis alignment and anatomic axis alignment measurements were treated as deviations from 180 degrees. Other measurements, such as component alignments in the coronal plane and in the sagittal plane (aka slope), were treated as deviations from 90 degrees.
Results Forty-seven prospective and retrospective controlled trials published from 2004 to 2011 were identified and found to be The Journal of Knee Surgery
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Moskal et al. eligible for inclusion.2,7,29,30,35,37,38,40,45,48,54,59–94 Therefore, a cumulative sample comprising 7,151 TKA – 3,555 CONV and 3,596 NAV – were included in the current analysis (►Table 1). Most of the studies occurred in Europe (45%, 21 of 47 studies), at single centers (96%, 45 of 47 studies), and at teaching institutions (87%, 41 of 47 studies). Nonrandomized studies slightly outnumbered randomized studies (25 vs. 22) and industry sponsorship was not commonly reported. Patient and surgical characteristics were not frequently reported (►Table 2). There were only slight differences when comparing NAV and CONV patient characteristics weighted means, thus providing groups suited for comparison. Comparison of the weighted mean age revealed that NAV was significantly younger than the CONV (68.17 vs. 70.34 years, p ¼ 0.0022); meta-analysis did not find this difference to be statistically significant. Three surgical characteristics, length of surgery, tourniquet time, and blood loss, were reported with enough frequency to be analyzed. Comparison of weighted means did not reveal any significant difference between NAV and CONV for any of these characteristics. Meta-analysis demonstrated that there may not have been a difference in length of surgery or blood loss, but that CONV had significantly lower tourniquet times (►Fig. 1). Clinical outcomes were reported with limited frequency and none were significantly different when comparing NAV and CONV weighted means (►Table 3). Knee society scores (Function score, Knee score, and Total score) were slightly larger for NAV, demonstrating some improvement compared with CONV. WOMAC scores (pain score, Stiffness score, and Physical Function score) were slightly lower for NAV, again showing some improvement compared with CONV. Range of motion was slightly higher in NAV than in CONV, also indicative of better functional outcomes. Meta-analyses of the clinical outcome scores were performed. Knee Society scores favor NAV (Function, p < 0.0005; Knee, p ¼ 0.003; and Total, p < 0.0005) (►Figs. 2–4). WOMAC scores also favor NAV (Pain, p ¼ 0.009; Stiffness, p ¼ 0.042; and Physical Function, p ¼ 0.001) (►Figs. 5–7). Meta-analysis of range of motion, while favoring NAV, was not significant (p ¼ 0.105). Alignment outcomes were recorded in two formats: “deviation from neutral” and “outliers” (►Tables 4 and 5). “Patientspecific functional alignment” was not included in the extracted data because it was not reported. Half of these measures were statistically significant (7 of 13 measures) when examining weighted means. For alignment outcomes, mechanical axis deviation from neutral was significantly lower for NAV (p ¼ 0.0293) and tibial component alignment deviation from neutral was significantly lower for the NAV (p ¼ 0.0263). For alignment outliers, the rates were significantly lower for the NAV (p < 0.0001): including anatomic axis outliers, coronal plane outliers for tibial and femoral components, and slope outliers for tibial and femoral components. Our meta-analyses of alignment outcomes are in agreement with previous meta-analyses.50–53 Four of the deviations from neutral meta-analyses demonstrated that NAV was significantly favored: tibial component coronal plane alignment deviation from neutral (p < 0.0005) (►Fig. 8),
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Table 1 Study characteristics ka
CONVb
NAV
Total
47
3,555 (49.71%)
3,596 (50.29%)
7,151
Asia
18
1,150 (16.08%)
1,242 (17.37%)
2,392 (33.45%)
Australia
2
86 (1.20%)
84 (1.17%)
170 (2.38%)
Europe
21
1,957 (27.37%)
1,845 (25.80%)
3,802 (53.17%)
N America
6
362 (5.06%)
425 (5.94%)
787 (11.01%)
Multicenter
2
265 (3.71%)
265 (3.71%)
530 (7.41%)
Single center
45
3,290 (46.01%)
3,331 (46.58%)
6,621 (92.59%)
Community
2
150 (2.10%)
150 (2.10%)
300 (4.20%)
Teaching
41
2,893 (40.46%)
2,843 (39.76%)
5,736 (80.21%)
Urban
1
56 (0.78%)
52 (0.73%)
108 (1.51%)
N/R
3
456 (6.38%)
551 (7.71%)
1,007 (14.08%)
RCT (Level I or II)
22
1,719 (24.04%)
1,808 (25.28%)
3,527 (49.32%)
nRCT (Level III)
25
1,836 (25.67%)
1,788 (25.00%)
3,624 (50.68%)
Level I
7
325 (4.54%)
322 (4.50%)
647 (9.05%)
Level II
15
1,394 (19.49%)
1,486 (20.78%)
2,880 (40.27%)
Level III
25
1,836 (25.67%)
1,788 (25.00%)
3,624 (50.68%)
No
16
1,316 (18.40%)
1,405 (19.65%)
2,721 (38.05%)
Yes
6
339 (4.74%)
406 (5.68%)
745 (10.42%)
N/R
25
1,900 (26.57%)
1,785 (24.96%)
3,685 (51.53%)
Total Geographic location
Setting
Study design
Level of evidence
Industry sponsorship
Abbreviations: CONV, conventional; NAV, navigated; N/R, not reported; nRCT, nonrandomized controlled trial; RCT, randomized controlled trial. a The number of studies reporting each characteristic. b The values are given as the incidence and percentage of total number of total knee arthroplasty.
Table 2 Patient and surgical characteristics
Age (y)
ka
nb
CONVc
n
NAV
ANOVA, p valued
16
1,242
70.34 14.52
1,172
68.17 17.12
0.0022
Weight (kg)
4
184
69.35 41.09
205
70.64 55.12
0.8021
Height (cm)
4
184
157.36 30.14
205
157.52 38.65
0.9665
BMI (kg/m2)
9
462
28.85 13.52
373
27.90 8.42
0.2431
Length of surgery (min)
10
978
83.09 174.01
920
95.13 217.70
0.2002
Tourniquet time (min)
6
270
86.55 111.91
270
102.14 96.39
0.1135
Blood loss (mL)
4
170
542.26 2,237.44
172
502.19 2,329.27
0.9317
k
e
N/n (%)
N/n (%)
Male
38
848/2,987 (28.39%)
903/3,044 (29.66%)
0.2811
Osteoarthritis
22
1,493/1,527 (97.77%)
1,526/1,571 (97.14%)
0.3050
Abbreviations: ANOVA, analysis of variance; CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The number of TKAs. c The values are given as the weighted mean and the standard deviation. d The level of significance was p < 0.05. e The number of incidents divided by the number of TKAs. The Journal of Knee Surgery
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Fig. 1 Meta-analysis of tourniquet times.
slope deviation from neutral tibial (p < 0.0005) (►Fig. 9) and femoral (p < 0.0005) (►Fig. 10), and femoral component flexion angle deviation from neutral (p < 0.0005) (►Fig. 11). The remaining two deviations from neutral meta-analyses, femoral component coronal plane alignment deviation from neutral and femoral component rotation, while also favoring NAV, were not statistically significant. All alignment outlier meta-analyses demonstrated that NAV was significantly favored: anatomic
axis, mechanical axis, tibial alignment, tibial slope, femoral alignment, and femoral slope (p 0.002) (►Figs. 12–17). Four adverse event measures were analyzed: total adverse events, deep vein thrombosis, infection/deep infection, and wound difficulty/superficial infection ( ►Table 6). Only total adverse events were significant when examining weighted means; NAV experienced fewer adverse events than CONV (p < 0.0001). Further meta-analyses did not
Table 3 Clinical outcomes
Knee Society Function and Knee scores
ka
nb
5
283
CONVc
n
NAV
ANOVA, p valued
Meta-analysis, p valuee
200
Follow-up (mo)
12.04 44.90
13.25 53.95
0.7989
Knee Society Function score, 0–100
72.18 77.71
74.61 68.59
0.7286
< 0.0001
Knee Society Knee score, 0–100
81.13 56.71
85.57 55.03
0.4143
0.003
Knee Society Total score
4
222
147
Follow-up (mo)
12.34 35.59
14.09 50.32
0.7186
Knee Society Total score, 0–200
148.30 197.75
170.72 40.87
0.1902
WOMAC scores
4
214
< 0.0001
139
Follow-up (mo)
10.95 24.42
10.24 24.24
0.8014
WOMAC Pain score, 20–0
4.06 15.66
2.69 15.43
0.4528
0.009
WOMAC Stiffness score, 8–0
2.27 3.39
1.99 4.91
0.5653
0.042
9.81 60.86
0.5657
0.001
13.95 63.99
WOMAC Physical Function score, 68–0 Range of motion
7
368
295
Follow-up (mo)
16.82 124.96
18.18 123.85
0.8904
Range of motion (degree)
115.86 61.17
117.52 63.35
0.7381
Abbreviations: ANOVA, analysis of variance; CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The number of TKAs. c The values are given as the weighted mean and the standard deviation. d The level of significance was p < 0.05. e The level of significance was p < 0.05. The Journal of Knee Surgery
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0.105
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Fig. 2 Meta-analysis of Knee Society Function scores.
Fig. 3 Meta-analysis of Knee Society Knee scores.
Fig. 4 Meta-analysis of Knee Society Total scores.
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Fig. 5 Meta-analysis of WOMAC Pain scores.
Fig. 6 Meta-analysis of WOMAC Stiffness scores.
Fig. 7 Meta-analysis of WOMAC Physical Function scores.
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Table 4 Alignment outcomes as deviations from neutral Alignment variable
ka
nb
CONVc
n
NAV
ANOVA, p valued
Mechanical axis (degree)
22
1,376
1.16 5.97
1,494
0.66 5.99
0.0293
0.085
Tibial component, coronal plane (degree)
19
1,144
0.83 4.37
1,159
0.45 3.50
0.0263
< 0.0001
Tibial slope (degree)
15
1,440
3.06 18.63
1,463
2.14 16.04
0.1674
0.002
Femoral component, coronal plane (degree)
18
1,040
1.42 12.44
1,053
1.19 15.39
0.7111
0.230
Femoral slope (degree)
11
1,382
5.30 45.39
1,403
2.93 27.04
0.1090
< 0.0001
Femoral component rotation (degree)
4
223
0.76 2.39
227
0.99 3.51
0.4341
0.239
Femoral component flexion angle (degree)f
4
189
3.37 6.38
193
1.61 9.40
0.0755
< 0.0001
Abbreviations: ANOVA, analysis of variance; CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The number of TKAs. c The values are given as the weighted mean and the standard deviation. d The level of significance was p < 0.05. e The level of significance was p < 0.05. f Early femoral component flexion angle deviation, postoperative to 6 months.
Table 5 Alignment outliers ka
CONVb
NAV
Contingency p valuec
Meta-analysis p valued
Anatomic axis
6
258/1,000 (25.80%)
69/996 (6.93%)
< 0.0001
0.002
Mechanical axis
30
643/2,405 (26.74%)
440/1,558 (28.24%)
0.3070
< 0.0001
Tibial component, coronal plane
27
331/2,036 (16.26%)
125/2,100 (5.95%)
< 0.0001
< 0.0001
Tibial slope
14
286/940 (30.43%)
175/959 (18.25%)
< 0.0001
0.001
Femoral component, coronal plane
27
424/2,061 (20.57%)
159/2,149 (7.40%)
< 0.0001
< 0.0001
Femoral slope
11
289/901 (32.08%)
203/983 (20.65%)
< 0.0001
< 0.0001
Abbreviations: CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The values are given as in incidence divided by the number of TKA and the resulting percentage. c The level of significance was p < 0.05. d The level of significance was p < 0.05.
discover any significant differences favoring one group over the other.
Discussion As demonstrated in previous meta-analyses,50–53 neutral component alignment is improved with navigation in TKA. We examined various component alignment measures (mechanical axis deviation from neutral, coronal plane alignment, component slope, and femoral component rotation; and outliers of anatomic axis, mechanical axis, coronal plane alignment, and component slope) and verified that navigation is superior to CONV methods. Analysis of surgical characteristics showed that weighted mean length of surgery and tourniquet time were lower for CONV, but not significantly so. Meta-analysis found that tourniquet times favored CONV, but there was not a strong relationship for length of surgery. Logically, significantly shorter tourniquet times should correlate to significantly shorter surgery times, however, because these two data
components were not consistently reported in single article sources that relationship cannot be proven. At the outset of this study, we had anticipated that sufficient data would exist to determine any correlations between clinical outcomes and component alignment; the existing published data are insufficient to perform those analyses. Meta-analysis of clinical outcomes, as measured by Knee Society scores and WOMAC scores, favored NAV TKA. The most severe limitations of this meta-analysis are weaknesses in the source data; by this we mean that the articles do not report the same variables all the time. For example, some report Knee Society Scores, some report WOMAC scores, and some report no clinical scores at all. This limitation is common to most orthopedic meta-analyses; it is the nature of orthopedic data. In conclusion, NAV TKA offers advantages, although they are not always statistically significant. We recommend continued study with a focus on the interactions between component alignment, surgical characteristics, and clinical The Journal of Knee Surgery
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Fig. 8 Meta-analysis of tibial component alignment deviation from neutral.
Fig. 9 Meta-analysis of tibial slope deviation from neutral.
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Fig. 10 Meta-analysis of femoral slope deviation from neutral.
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Fig. 11 Meta-analysis of femoral flexion angle deviation from neutral.
Fig. 12 Meta-analysis of anatomic axis outliers.
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Fig. 13 Meta-analysis of mechanical axis outliers.
Fig. 14 Meta-analysis of tibial component alignment outliers.
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Fig. 15 Meta-analysis of tibial slope outliers.
Fig. 16 Meta-analysis of femoral component alignment outliers.
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Fig. 17 Meta-analysis of femoral slope outliers.
Table 6 Adverse events ka
CONVb
NAV
Contingency p valuec
Meta-analysis p valued
Total adverse events
16
112/1,208 (9.27%)
50/1,308 (3.82%)
< 0.0001
0.171
Deep vein thrombosis
7
10/392 (2.55%)
4/334 (1.20%)
0.2790
0.794
Infection/deep infection
9
5/841 (0.59%)
3/878 (0.34%)
0.4982
0.681
Wound difficulties/superficial infection
7
13/668 (1.95%)
5/589 (0.85%)
0.1519
0.376
Abbreviations: CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. The number of studies reporting each characteristic. b The values are given as in incidence divided by the number of TKA and the resulting percentage. c The level of significance was p < 0.05. d The level of significance was p < 0.05. a
outcomes. It will be possible to determine statistically if there is a correlation between these factors, given more complete future studies.
8 9
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and clinical results in conventional and navigated total knee arthroplasty. Clin Orthop Relat Res 2007;457:156–162 Haaker RG, Stockheim M, Kamp M, Proff G, Breitenfelder J, Ottersbach A. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res 2005;433(433):152–159 Hart R, Janecek M, Chaker A, Bucek P. Total knee arthroplasty implanted with and without kinematic navigation. Int Orthop 2003;27(6):366–369 Jenny JY, Boeri C. Computer-assisted implantation of total knee prostheses: a case-control comparative study with classical instrumentation. Comput Aided Surg 2001;6(4):217–220 Kalairajah Y, Simpson D, Cossey AJ, Verrall GM, Spriggins AJ. Blood loss after total knee replacement: effects of computer-assisted surgery. J Bone Joint Surg Br 2005;87(11):1480–1482 Kalairajah Y, Cossey AJ, Verrall GM, Ludbrook G, Spriggins AJ. Are systemic emboli reduced in computer-assisted knee surgery? A prospective, randomised, clinical trial. J Bone Joint Surg Br 2006; 88(2):198–202 Kim SJ, MacDonald M, Hernandez J, Wixson RL. Computer assisted navigation in total knee arthroplasty: improved coronal alignment. J Arthroplasty 2005;20(7, Suppl 3):123–131 Nabeyama R, Matsuda S, Miura H, Mawatari T, Kawano T, Iwamoto Y. The accuracy of image-guided knee replacement based on computed tomography. J Bone Joint Surg Br 2004;86(3):366–371 Seon JK, Song EK. Navigation-assisted less invasive total knee arthroplasty compared with conventional total knee arthroplasty: a randomized prospective trial. J Arthroplasty 2006;21(6): 777–782 Sikorski JM, Blythe MC. Learning the vagaries of computer-assisted total knee replacement. J Bone Joint Surg Br 2005;87(7):903–910 Sparmann M, Wolke B, Czupalla H, Banzer D, Zink A. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br 2003;85(6): 830–835 Stöckl B, Nogler M, Rosiek R, Fischer M, Krismer M, Kessler O. Navigation improves accuracy of rotational alignment in total knee arthroplasty. Clin Orthop Relat Res 2004;(426):180–186 Victor J, Hoste D. Image-based computer-assisted total knee arthroplasty leads to lower variability in coronal alignment. Clin Orthop Relat Res 2004;(428):131–139 Bauwens K, Matthes G, Wich M, et al. Navigated total knee replacement. A meta-analysis. J Bone Joint Surg Am 2007;89(2): 261–269 Brin YS, Nikolaou VS, Joseph L, Zukor DJ, Antoniou J. Imageless computer assisted versus conventional total knee replacement. A Bayesian meta-analysis of 23 comparative studies. Int Orthop 2011;35(3):331–339 Cheng T, Zhang G, Zhang X. Imageless navigation system does not improve component rotational alignment in total knee arthroplasty. J Surg Res 2011;171(2):590–600 Mason JB, Fehring TK, Estok R, Banel D, Fahrbach K. Meta-analysis of alignment outcomes in computer-assisted total knee arthroplasty surgery. J Arthroplasty 2007;22(8):1097–1106 Decking R, Markmann Y, Mattes T, Puhl W, Scharf HP. On the outcome of computer-assisted total knee replacement. Acta Chir Orthop Traumatol Cech 2007;74(3):171–174 Wright JG, Swiontkowski MF, Heckman JD. Introducing levels of evidence to the journal. J Bone Joint Surg Am 2003;85-A(1):1–3 Borenstein M. Introduction to Meta-Analysis. Chichester, UK: John Wiley & Sons; 2009 Benjamin J. Component alignment in total knee arthroplasty. Instr Course Lect 2006;55:405–412 Cooke TD, Sled EA, Scudamore RA. Frontal plane knee alignment: a call for standardized measurement. J Rheumatol 2007;34(9): 1796–1801
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Kuroda R. Clinical values in computer-assisted total knee arthroplasty. Orthopedics 2006;29(12):1115–1120 Matziolis G, Krocker D, Weiss U, Tohtz S, Perka C. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am 2007;89(2): 236–243 Molfetta L, Caldo D. Computer navigation versus conventional implantation for varus knee total arthroplasty: a case-control study at 5 years follow-up. Knee 2008;15(2):75–79 Mombert M, Van Den Daelen L, Gunst P, Missinne L. Navigated total knee arthroplasty: a radiological analysis of 42 randomised cases. Acta Orthop Belg 2007;73(1):49–54 Mullaji A, Kanna R, Marawar S, Kohli A, Sharma A. Comparison of limb and component alignment using computer-assisted navigation versus image intensifier-guided conventional total knee arthroplasty: a prospective, randomized, single-surgeon study of 467 knees. J Arthroplasty 2007;22(7):953–959 Pang CH, Chan WL, Yen CH, et al. Comparison of total knee arthroplasty using computer-assisted navigation versus conventional guiding systems: a prospective study. J Orthop Surg (Hong Kong) 2009;17(2):170–173 Rosenberger RE, Hoser C, Quirbach S, Attal R, Hennerbichler A, Fink C. Improved accuracy of component alignment with the implementation of image-free navigation in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 2008;16(3): 249–257 Seon JK, Song EK. Functional impact of navigation-assisted minimally invasive total knee arthroplasty. Orthopedics 2005;28(10, Suppl):s1251–s1254 Seon JK, Song EK, Yoon TR, Park SJ, Bae BH, Cho SG. Comparison of functional results with navigation-assisted minimally invasive and conventional techniques in bilateral total knee arthroplasty. Comput Aided Surg 2007;12(3):189–193 Seon JK, Park SJ, Lee KB, Li G, Kozanek M, Song EK. Functional comparison of total knee arthroplasty performed with and without a navigation system. Int Orthop 2009;33(4): 987–990 Song EK, Seon JK, Yoon TR, Park SJ, Cho SG, Yim JH. Comparative study of stability after total knee arthroplasties between navigation system and conventional techniques. J Arthroplasty 2007; 22(8):1107–1111 Stulberg SD, Yaffe MA, Koo SS. Computer-assisted surgery versus manual total knee arthroplasty: a case-controlled study. J Bone Joint Surg Am 2006;88(Suppl 4):47–54 Tingart M, Lüring C, Bäthis H, Beckmann J, Grifka J, Perlick L. Computer-assisted total knee arthroplasty versus the conventional technique: how precise is navigation in clinical routine? Knee Surg Sports Traumatol Arthrosc 2008;16(1):44–50 Tyagi V, Kim TH, Hwang JH, Oh KJ. Imageless navigation assisted total knee arthroplasty with comprehensive gap balancing in medial osteoarthritic varus knees with anatomic variations. Comput Aided Surg 2010;15(4–6):90–97 van Strien T, van der Linden-van der Zwaag E, Kaptein B, van Erkel A, Valstar E, Nelissen R. Computer assisted versus conventional cemented total knee prostheses alignment accuracy and micromotion of the tibial component. Int Orthop 2009;33(5):1255–1261 Weng YJ, Hsu RW, Hsu WH. Comparison of computer-assisted navigation and conventional instrumentation for bilateral total knee arthroplasty. J Arthroplasty 2009;24(5):668–673 Zhang GQ, Chen JY, Chai W, Liu M, Wang Y. Comparison between computer-assisted-navigation and conventional total knee arthroplasties in patients undergoing simultaneous bilateral procedures: a randomized clinical trial. J Bone Joint Surg Am 2011;93(13): 1190–1196
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Navigated versus Conventional Total Knee Arthroplasty Joseph T. Moskal, MD1
Susan G. Capps, PhD2
John W. Mann, MD3
1 Department of Orthopaedic Surgery, Virginia Tech Carilion School of
Medicine, Roanoke, Virginia 2 BENSOL, Warsaw, Indiana 3 Department of Orthopaedic Surgery, Carilion Clinic Orthopaedics, Roanoke, Virginia 4 Department of Orthopaedic Surgery, University of Virginia, Charlottesville, Virginia
John A. Scanelli, MD4
Address for correspondence Susan G. Capps, PhD, BENSOL, 488 East Bell Drive, Warsaw, IN 46582 (e-mail: [email protected]).
Abstract
Keywords
► ► ► ► ►
arthroplasty reconstruction navigation survivorship clinical outcomes
Computer-aided navigation in total knee arthroplasty (TKA) promises improved alignment, performance, and survivorship. Previous meta-analyses demonstrated that navigation yields better component alignment; however, they did not discuss other indicators of performance. This meta-analysis compares navigated (NAV) and conventional (CONV) TKAs and includes clinical outcomes and adverse events. Forty-seven studies (22 randomized trials) of varying methodological quality involving 7,151 TKAs created the sample population. Statistical analyses included analysis of variance of weighted means and random effects modeling. As seen in previous meta-analyses, NAV is favored over CONV TKA. Analysis of surgical characteristics found that length of surgery and tourniquet times were lower for CONV, but not significant. Meta-analysis found that tourniquet times favored CONV but not a strong relationship for length of surgery. Analysis of individual adverse events did not reveal any significant differences. However, when examining adverse events in their totality, the NAV experienced significantly fewer complications. TKA performed with imageless navigation improves component alignment, provides for lower blood loss, improves clinical outcomes as measured by Knee Society and WOMAC scores, and has fewer total adverse events. Published data are insufficient to determine any correlations between component alignment and outcomes.
It is generally accepted that poor positioning and component orientation contribute to poor survivorship and performance in total knee arthroplasty (TKA).1–26 The number of patients receiving primary and revision TKA is expected to increase due to the aging population and the demands for functional, pain-free knees.27 If there are ways to improve TKA by improving component implantation, then there may be ways to improve quality of life, reduce failure rates, and reduce economic and societal burdens.
Proponents of computer-aided navigation for TKA promise more exact component alignment and thus improved functional and clinical outcomes. Previous reports have demonstrated better component positioning with relationship to the mechanical axis with navigated (NAV) TKA.2,7,21,22,28–49 Previous meta-analyses have shown that NAV versus conventional (CONV) TKA have shown that NAV TKA produced tighter control of component positioning and fewer alignment outliers than CONV TKA, particularly in the coronal and sagittal planes.50–53 This meta-analysis hopes to further
received February 23, 2013 accepted after revision September 23, 2013 published online November 14, 2013
Copyright © 2014 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel: +1(212) 584-4662.
DOI http://dx.doi.org/ 10.1055/s-0033-1360659. ISSN 1538-8506.
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J Knee Surg 2014;27:235–248.
Navigated versus Conventional Total Knee Arthroplasty illuminate the influence of imageless navigation on the clinical outcomes, alignment outcomes, adverse events, and thus clinical relevance of NAV TKA through the published data from comparative studies. All of these studies evaluated neutral alignment with relationship to the mechanical axis as the optimal surgical goal and they did not consider “patient-specific functional alignment” as an endpoint.
Materials and Methods The literature searches using PubMed and leading orthopedic scientific journals looked for published studies that directly compared NAV and CONV TKA. The search terms were “computer-aided total knee arthroplasty,” “computer-aided total knee arthroplasty,” “computer-assisted total knee arthroplasty,” and “navigated total knee arthroplasty.” Publication dates were confined from 1990 to 2011. One patient population was covered in two studies; when data were repeated, it was considered once in the outcomes analysis and considered twice in the analysis of study characteristics and demographics.35,54 Multiple inclusion criteria were applied, and any study that failed to meet all inclusion criteria was excluded. Studies must have a prospective or retrospective comparative design (Level of evidence I, II, or III),55 compare NAV with CONV TKA, consist of adult-only populations, clearly report outcomes, and contain a minimum of 15 patients per treatment. All investigators (J.T.M., S.G.C., J.W.M., and J.A.S.) performed data extraction, and consensus was required for all extracted items. Outcome measures were included in analysis if at least four studies and eight treatment groups contained a particular measure. The frequency with which specific outcome measures were reported varied greatly; knee scores, component alignments, and adverse events were analyzed. Statistical analysis was conducted with the use of JMP version 9.02 (SAS Institute Inc., Cary, NC) and Comprehensive MetaAnalysis version 2 (Biostat, Englewood, NJ). Significance was defined by p < 0.05. Random effects meta-analysis using Comprehensive Meta-Analysis software was employed to reflect variation among studies. According to Borenstein et al, random effects meta-analysis should be employed when data are accumulated from a series of studies performed by a series of researchers functioning independently, and that this form of meta-analysis allows for the inclusion of studies regardless of population sizes without assigning too little or too much weight to data.56 All meta-analyses with significant findings were tested for publication bias; none were found to have severe bias. Total knee component alignments were compared by mathematically determining the “deviation from neutral.”57,58 Mechanical axis alignment and anatomic axis alignment measurements were treated as deviations from 180 degrees. Other measurements, such as component alignments in the coronal plane and in the sagittal plane (aka slope), were treated as deviations from 90 degrees.
Results Forty-seven prospective and retrospective controlled trials published from 2004 to 2011 were identified and found to be The Journal of Knee Surgery
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Moskal et al. eligible for inclusion.2,7,29,30,35,37,38,40,45,48,54,59–94 Therefore, a cumulative sample comprising 7,151 TKA – 3,555 CONV and 3,596 NAV – were included in the current analysis (►Table 1). Most of the studies occurred in Europe (45%, 21 of 47 studies), at single centers (96%, 45 of 47 studies), and at teaching institutions (87%, 41 of 47 studies). Nonrandomized studies slightly outnumbered randomized studies (25 vs. 22) and industry sponsorship was not commonly reported. Patient and surgical characteristics were not frequently reported (►Table 2). There were only slight differences when comparing NAV and CONV patient characteristics weighted means, thus providing groups suited for comparison. Comparison of the weighted mean age revealed that NAV was significantly younger than the CONV (68.17 vs. 70.34 years, p ¼ 0.0022); meta-analysis did not find this difference to be statistically significant. Three surgical characteristics, length of surgery, tourniquet time, and blood loss, were reported with enough frequency to be analyzed. Comparison of weighted means did not reveal any significant difference between NAV and CONV for any of these characteristics. Meta-analysis demonstrated that there may not have been a difference in length of surgery or blood loss, but that CONV had significantly lower tourniquet times (►Fig. 1). Clinical outcomes were reported with limited frequency and none were significantly different when comparing NAV and CONV weighted means (►Table 3). Knee society scores (Function score, Knee score, and Total score) were slightly larger for NAV, demonstrating some improvement compared with CONV. WOMAC scores (pain score, Stiffness score, and Physical Function score) were slightly lower for NAV, again showing some improvement compared with CONV. Range of motion was slightly higher in NAV than in CONV, also indicative of better functional outcomes. Meta-analyses of the clinical outcome scores were performed. Knee Society scores favor NAV (Function, p < 0.0005; Knee, p ¼ 0.003; and Total, p < 0.0005) (►Figs. 2–4). WOMAC scores also favor NAV (Pain, p ¼ 0.009; Stiffness, p ¼ 0.042; and Physical Function, p ¼ 0.001) (►Figs. 5–7). Meta-analysis of range of motion, while favoring NAV, was not significant (p ¼ 0.105). Alignment outcomes were recorded in two formats: “deviation from neutral” and “outliers” (►Tables 4 and 5). “Patientspecific functional alignment” was not included in the extracted data because it was not reported. Half of these measures were statistically significant (7 of 13 measures) when examining weighted means. For alignment outcomes, mechanical axis deviation from neutral was significantly lower for NAV (p ¼ 0.0293) and tibial component alignment deviation from neutral was significantly lower for the NAV (p ¼ 0.0263). For alignment outliers, the rates were significantly lower for the NAV (p < 0.0001): including anatomic axis outliers, coronal plane outliers for tibial and femoral components, and slope outliers for tibial and femoral components. Our meta-analyses of alignment outcomes are in agreement with previous meta-analyses.50–53 Four of the deviations from neutral meta-analyses demonstrated that NAV was significantly favored: tibial component coronal plane alignment deviation from neutral (p < 0.0005) (►Fig. 8),
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Table 1 Study characteristics ka
CONVb
NAV
Total
47
3,555 (49.71%)
3,596 (50.29%)
7,151
Asia
18
1,150 (16.08%)
1,242 (17.37%)
2,392 (33.45%)
Australia
2
86 (1.20%)
84 (1.17%)
170 (2.38%)
Europe
21
1,957 (27.37%)
1,845 (25.80%)
3,802 (53.17%)
N America
6
362 (5.06%)
425 (5.94%)
787 (11.01%)
Multicenter
2
265 (3.71%)
265 (3.71%)
530 (7.41%)
Single center
45
3,290 (46.01%)
3,331 (46.58%)
6,621 (92.59%)
Community
2
150 (2.10%)
150 (2.10%)
300 (4.20%)
Teaching
41
2,893 (40.46%)
2,843 (39.76%)
5,736 (80.21%)
Urban
1
56 (0.78%)
52 (0.73%)
108 (1.51%)
N/R
3
456 (6.38%)
551 (7.71%)
1,007 (14.08%)
RCT (Level I or II)
22
1,719 (24.04%)
1,808 (25.28%)
3,527 (49.32%)
nRCT (Level III)
25
1,836 (25.67%)
1,788 (25.00%)
3,624 (50.68%)
Level I
7
325 (4.54%)
322 (4.50%)
647 (9.05%)
Level II
15
1,394 (19.49%)
1,486 (20.78%)
2,880 (40.27%)
Level III
25
1,836 (25.67%)
1,788 (25.00%)
3,624 (50.68%)
No
16
1,316 (18.40%)
1,405 (19.65%)
2,721 (38.05%)
Yes
6
339 (4.74%)
406 (5.68%)
745 (10.42%)
N/R
25
1,900 (26.57%)
1,785 (24.96%)
3,685 (51.53%)
Total Geographic location
Setting
Study design
Level of evidence
Industry sponsorship
Abbreviations: CONV, conventional; NAV, navigated; N/R, not reported; nRCT, nonrandomized controlled trial; RCT, randomized controlled trial. a The number of studies reporting each characteristic. b The values are given as the incidence and percentage of total number of total knee arthroplasty.
Table 2 Patient and surgical characteristics
Age (y)
ka
nb
CONVc
n
NAV
ANOVA, p valued
16
1,242
70.34 14.52
1,172
68.17 17.12
0.0022
Weight (kg)
4
184
69.35 41.09
205
70.64 55.12
0.8021
Height (cm)
4
184
157.36 30.14
205
157.52 38.65
0.9665
BMI (kg/m2)
9
462
28.85 13.52
373
27.90 8.42
0.2431
Length of surgery (min)
10
978
83.09 174.01
920
95.13 217.70
0.2002
Tourniquet time (min)
6
270
86.55 111.91
270
102.14 96.39
0.1135
Blood loss (mL)
4
170
542.26 2,237.44
172
502.19 2,329.27
0.9317
k
e
N/n (%)
N/n (%)
Male
38
848/2,987 (28.39%)
903/3,044 (29.66%)
0.2811
Osteoarthritis
22
1,493/1,527 (97.77%)
1,526/1,571 (97.14%)
0.3050
Abbreviations: ANOVA, analysis of variance; CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The number of TKAs. c The values are given as the weighted mean and the standard deviation. d The level of significance was p < 0.05. e The number of incidents divided by the number of TKAs. The Journal of Knee Surgery
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Fig. 1 Meta-analysis of tourniquet times.
slope deviation from neutral tibial (p < 0.0005) (►Fig. 9) and femoral (p < 0.0005) (►Fig. 10), and femoral component flexion angle deviation from neutral (p < 0.0005) (►Fig. 11). The remaining two deviations from neutral meta-analyses, femoral component coronal plane alignment deviation from neutral and femoral component rotation, while also favoring NAV, were not statistically significant. All alignment outlier meta-analyses demonstrated that NAV was significantly favored: anatomic
axis, mechanical axis, tibial alignment, tibial slope, femoral alignment, and femoral slope (p 0.002) (►Figs. 12–17). Four adverse event measures were analyzed: total adverse events, deep vein thrombosis, infection/deep infection, and wound difficulty/superficial infection ( ►Table 6). Only total adverse events were significant when examining weighted means; NAV experienced fewer adverse events than CONV (p < 0.0001). Further meta-analyses did not
Table 3 Clinical outcomes
Knee Society Function and Knee scores
ka
nb
5
283
CONVc
n
NAV
ANOVA, p valued
Meta-analysis, p valuee
200
Follow-up (mo)
12.04 44.90
13.25 53.95
0.7989
Knee Society Function score, 0–100
72.18 77.71
74.61 68.59
0.7286
< 0.0001
Knee Society Knee score, 0–100
81.13 56.71
85.57 55.03
0.4143
0.003
Knee Society Total score
4
222
147
Follow-up (mo)
12.34 35.59
14.09 50.32
0.7186
Knee Society Total score, 0–200
148.30 197.75
170.72 40.87
0.1902
WOMAC scores
4
214
< 0.0001
139
Follow-up (mo)
10.95 24.42
10.24 24.24
0.8014
WOMAC Pain score, 20–0
4.06 15.66
2.69 15.43
0.4528
0.009
WOMAC Stiffness score, 8–0
2.27 3.39
1.99 4.91
0.5653
0.042
9.81 60.86
0.5657
0.001
13.95 63.99
WOMAC Physical Function score, 68–0 Range of motion
7
368
295
Follow-up (mo)
16.82 124.96
18.18 123.85
0.8904
Range of motion (degree)
115.86 61.17
117.52 63.35
0.7381
Abbreviations: ANOVA, analysis of variance; CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The number of TKAs. c The values are given as the weighted mean and the standard deviation. d The level of significance was p < 0.05. e The level of significance was p < 0.05. The Journal of Knee Surgery
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Fig. 2 Meta-analysis of Knee Society Function scores.
Fig. 3 Meta-analysis of Knee Society Knee scores.
Fig. 4 Meta-analysis of Knee Society Total scores.
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Fig. 5 Meta-analysis of WOMAC Pain scores.
Fig. 6 Meta-analysis of WOMAC Stiffness scores.
Fig. 7 Meta-analysis of WOMAC Physical Function scores.
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Table 4 Alignment outcomes as deviations from neutral Alignment variable
ka
nb
CONVc
n
NAV
ANOVA, p valued
Mechanical axis (degree)
22
1,376
1.16 5.97
1,494
0.66 5.99
0.0293
0.085
Tibial component, coronal plane (degree)
19
1,144
0.83 4.37
1,159
0.45 3.50
0.0263
< 0.0001
Tibial slope (degree)
15
1,440
3.06 18.63
1,463
2.14 16.04
0.1674
0.002
Femoral component, coronal plane (degree)
18
1,040
1.42 12.44
1,053
1.19 15.39
0.7111
0.230
Femoral slope (degree)
11
1,382
5.30 45.39
1,403
2.93 27.04
0.1090
< 0.0001
Femoral component rotation (degree)
4
223
0.76 2.39
227
0.99 3.51
0.4341
0.239
Femoral component flexion angle (degree)f
4
189
3.37 6.38
193
1.61 9.40
0.0755
< 0.0001
Abbreviations: ANOVA, analysis of variance; CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The number of TKAs. c The values are given as the weighted mean and the standard deviation. d The level of significance was p < 0.05. e The level of significance was p < 0.05. f Early femoral component flexion angle deviation, postoperative to 6 months.
Table 5 Alignment outliers ka
CONVb
NAV
Contingency p valuec
Meta-analysis p valued
Anatomic axis
6
258/1,000 (25.80%)
69/996 (6.93%)
< 0.0001
0.002
Mechanical axis
30
643/2,405 (26.74%)
440/1,558 (28.24%)
0.3070
< 0.0001
Tibial component, coronal plane
27
331/2,036 (16.26%)
125/2,100 (5.95%)
< 0.0001
< 0.0001
Tibial slope
14
286/940 (30.43%)
175/959 (18.25%)
< 0.0001
0.001
Femoral component, coronal plane
27
424/2,061 (20.57%)
159/2,149 (7.40%)
< 0.0001
< 0.0001
Femoral slope
11
289/901 (32.08%)
203/983 (20.65%)
< 0.0001
< 0.0001
Abbreviations: CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. a The number of studies reporting each characteristic. b The values are given as in incidence divided by the number of TKA and the resulting percentage. c The level of significance was p < 0.05. d The level of significance was p < 0.05.
discover any significant differences favoring one group over the other.
Discussion As demonstrated in previous meta-analyses,50–53 neutral component alignment is improved with navigation in TKA. We examined various component alignment measures (mechanical axis deviation from neutral, coronal plane alignment, component slope, and femoral component rotation; and outliers of anatomic axis, mechanical axis, coronal plane alignment, and component slope) and verified that navigation is superior to CONV methods. Analysis of surgical characteristics showed that weighted mean length of surgery and tourniquet time were lower for CONV, but not significantly so. Meta-analysis found that tourniquet times favored CONV, but there was not a strong relationship for length of surgery. Logically, significantly shorter tourniquet times should correlate to significantly shorter surgery times, however, because these two data
components were not consistently reported in single article sources that relationship cannot be proven. At the outset of this study, we had anticipated that sufficient data would exist to determine any correlations between clinical outcomes and component alignment; the existing published data are insufficient to perform those analyses. Meta-analysis of clinical outcomes, as measured by Knee Society scores and WOMAC scores, favored NAV TKA. The most severe limitations of this meta-analysis are weaknesses in the source data; by this we mean that the articles do not report the same variables all the time. For example, some report Knee Society Scores, some report WOMAC scores, and some report no clinical scores at all. This limitation is common to most orthopedic meta-analyses; it is the nature of orthopedic data. In conclusion, NAV TKA offers advantages, although they are not always statistically significant. We recommend continued study with a focus on the interactions between component alignment, surgical characteristics, and clinical The Journal of Knee Surgery
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Fig. 8 Meta-analysis of tibial component alignment deviation from neutral.
Fig. 9 Meta-analysis of tibial slope deviation from neutral.
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Fig. 10 Meta-analysis of femoral slope deviation from neutral.
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Fig. 11 Meta-analysis of femoral flexion angle deviation from neutral.
Fig. 12 Meta-analysis of anatomic axis outliers.
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Fig. 13 Meta-analysis of mechanical axis outliers.
Fig. 14 Meta-analysis of tibial component alignment outliers.
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Fig. 15 Meta-analysis of tibial slope outliers.
Fig. 16 Meta-analysis of femoral component alignment outliers.
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Fig. 17 Meta-analysis of femoral slope outliers.
Table 6 Adverse events ka
CONVb
NAV
Contingency p valuec
Meta-analysis p valued
Total adverse events
16
112/1,208 (9.27%)
50/1,308 (3.82%)
< 0.0001
0.171
Deep vein thrombosis
7
10/392 (2.55%)
4/334 (1.20%)
0.2790
0.794
Infection/deep infection
9
5/841 (0.59%)
3/878 (0.34%)
0.4982
0.681
Wound difficulties/superficial infection
7
13/668 (1.95%)
5/589 (0.85%)
0.1519
0.376
Abbreviations: CONV, conventional; NAV, navigated; TKA, total knee arthroplasty. The number of studies reporting each characteristic. b The values are given as in incidence divided by the number of TKA and the resulting percentage. c The level of significance was p < 0.05. d The level of significance was p < 0.05. a
outcomes. It will be possible to determine statistically if there is a correlation between these factors, given more complete future studies.
8 9
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