Computer-assisted Versus Non-navigated Total Knee Arthroplasty a Review Martin

  • Journal List
  • Int Orthop
  • v.35(3); 2011 Mar
  • PMC3047658

Int Orthop. 2011 Mar; 35(3): 331–339.

Imageless computer assisted versus conventional total human knee replacement. A Bayesian meta-analysis of 23 comparative studies

Yaron S. Brin

aneSection of Orthopaedic Surgery, Jewish General Hospital, McGill University, Montreal, Quebec Canada

Vassilios S. Nikolaou

oneSection of Orthopaedic Surgery, Jewish Full general Infirmary, McGill University, Montreal, Quebec Canada

Lawrence Joseph

2Partitioning of Clinical Epidemiology, Biostatistics, and Occupational Health, McGill Academy, Montreal, Quebec Canada

David J. Zukor

iDepartment of Orthopaedic Surgery, Jewish Full general Hospital, McGill University, Montreal, Quebec Canada

John Antoniou

iDepartment of Orthopaedic Surgery, Jewish General Infirmary, McGill University, Montreal, Quebec Canada

Received 2010 Jan 16; Revised 2010 Mar 20; Accepted 2010 Mar 20.

Abstruse

Nosotros accept undertaken a meta-analysis of the English literature, to assess the component alignment outcomes after imageless calculator assisted (CAOS) total knee arthroplasty (TKA) versus conventional TKA. Nosotros reviewed 23 publications that met the inclusion criteria. Results were summarised via a Bayesian hierarchical random effects meta-assay model. Carve up analyses were conducted for prospective randomised trials lone, also equally for all randomised and observational studies. In 20 papers (4,199 TKAs) we found a reduction in outliers rate of approximately eighty% in limb mechanical axis when operated with the CAOS. For the coronal femoral and tibial implants positions, the analysis included 3,058 TKAs. The assay for the femoral implant showed a reduction in outliers rate of approximately 87% and for the tibial implant a reduction in outliers charge per unit of approximately lxxx%. Imageless navigation when performing TKA improves component orientation and postoperative limb alignment. The clinical significance of these findings though has to exist proven in the future.

Introduction

Human knee pain is a mutual complaint in older adults. Estimates of cocky-reported almanac prevalence range from 33% (hurting on most days for one month or longer) [1] to 47% (hurting in or effectually the articulatio genus in the last year) [2]. The definitive treatment for articulatio genus osteoarthrosis is total knee arthroplasty (TKA) [3]. The demand for this operation in the Us in 2005 was 450,000 procedures yearly and it is projected to grow to three.48 meg procedures annually by 2030 [4]. The success of TKA is dependent on multiple factors, including patient characteristics, implant selection, operative technique, component positioning, and limb alignment [5]. Information technology has been shown that in that location is a positive correlation between a good clinical event and a well positioned prosthesis [half-dozen, 7]. Proper coronal alignment has been correlated with adept clinical outcomes, whereas malalignment of more than 3° of varus or valgus results in a higher failure rate [eight–ten].

Estimator assisted orthopaedic surgery (CAOS) was first introduced in 1999 past Krackow et al. Its objective is to improve the accurateness of implant positioning and extremity alignment [11–thirteen]. CAOS for total knee arthroplasty (TKA) is gaining popularity amongst orthopaedic surgeons. Currently, there are three main categories of navigation systems: intra-operative, prototype-gratuitous (no CT or radiograph) navigation systems; pre-operative, image-based (CT-based) navigation systems; and intra-operative, image-based (radiograph no CT) systems [14]. Image-gratuitous navigation is gaining in popularity since information technology avoids the time, expense and radiations associated with pre-operative CT, and the extra OR time and personnel required for intra-operative radiographs.

Despite the initial enthusiasm there is still disagreement amongst orthopaedic surgeons regarding the effectiveness of imageless navigation systems to ameliorate the radiological and clinical consequence of TKA [15–19]. Considering the absence of prove consistently supporting the utilise of imageless CAOS to amend limb alignment and implant coronal position, we carried out a meta-analysis of trials comparing TKA outcomes with the employ of imageless CAOS to the conventional technique.

Methods

Data sources and trial pick

We identified reports of clinical trials that compared imageless navigated knee arthroplasty with conventional full knee arthroplasty, regardless of the underlying condition or disease. An electronic search was conducted covering all the major medical databases (Medline, EMBASE, SciSearch, Scopus and the Cochrane library) entering the following terms and Boolean operators: "total articulatio genus replacement", "alignment", "navigation", "imageless", "image-free", "outcome", "reckoner assisted" until October 2008.

2 authors (Y.S.B. and V.S.Due north.) identified abstracts which discussed any blazon of comparing between imageless CAOS and conventional TKRs. These abstracts and their accompanying manufactures were and then paired down to those that compared the mechanical axes and the coronal implant position with CAOS versus conventional TKA and those that compared the outliers in each of the mentioned angles. In a 3rd stride, authors D.Z. and J.A. checked the reference lists of the manufactures to place citations to articles missed by the search steps. Finally, some articles were rejected because they reported insufficient data, used non-standardised scoring systems, or lacked precise comparing methods.

The written report was limited to publications in English literature. We included randomised controlled trials, nonrandomised accomplice studies, retrospective studies and studies that used a historical accomplice. We included all types of TKR prostheses and all types of imageless navigation systems. This allowed usa to compare the overall effect of imageless CAOS and conventional TKR without being biased by the use of specific types of prostheses or types of equipment used.

Statistical analysis

Differences in trial methods, patients' characteristics and investigators' practice patterns hateful that the effect of CAOS within each of these trials is unlikely to exist identical, as would exist implied by the apply of a fixed-effects meta-analysis model. We therefore used a Bayesian hierarchical (random effects) model to summarise the data beyond trials, thereby bookkeeping for between-trial variations in odds ratios. In this model, the probability (p) of an event (outlier greater than ii or 3 degrees) inside each group of each trial is immune to vary both between the treatment and control groups within each written report and between each study included in the meta-analysis. To model the betwixt-study variability, the logarithms of the odds ratios of each outcome variable are causeless to follow a normal distribution. The mean of the normal distribution of log odds ratios across studies therefore represents the average effect in the studies, and the variance represents the variability among the studies. Depression-information prior distributions were used throughout, so that the data from the trials dominate the final inferences. Inferences were calculated using a Gibbs sampler algorithm programmed in WinBUGS software (version 1.4.one, MRC Biostatistics Unit of measurement, Cambridge, UK). Forest plots for all major outcomes, which display the odds ratios and 95% apparent intervals (Bayesian analogue of frequentist confidence intervals) for both the private trials based on the random furnishings meta-analytic model, and for the pooled results from our meta-assay.

For each outcome, we performed two meta-analyses, one incorporating information from randomised clinical trials alone, and a second analysis using data from all studies, including both randomised trials and observational studies.

Results

Out of 46 publications identified for screening, the electronic search yielded 23 publications that met the inclusion criteria and were considered eligible for the report. In ii studies the authors did not calculate the outliers rate of the mechanical limb axis [20, 21], but in one of them the outliers for the components were calculated [20], so it was included in our meta-analysis for the evaluation of the implant position only. In the remaining 21 studies, ane of the studies used a cut-off bending for the mechanical limb bending equally ±2° or more [22]. There were 4,063 patients with 4,163 TKRs. Ten trials were prospective and randomised [22–31]. Table1 is a descriptive table that summarises the various trial characteristics and participant demographics. First we analysed the prospective randomised studies alone. Then we analysed all the studies together and compared the results. The results were like for both analyses.

Table one

Trial characteristics

Writer Study type Navigation system Knees Males Females Historic period conventional Age navigation Mechanical axis > ±three° Femoral angle > ±3° Tibial angle > ±3° Operating time
Jenny and Boeri [32] Retrospective Aesculap C = 30
N = 30
21 39 C = 9
N = v
C = 5a
N=2a
C = 6a
N=iia
C = xc
N=110
Sparmann et al. [23] Prospective randomised Stryker C=120
N=120
C = 41
Northward = 32
C = 79
North = 88
66.ane 64.seven C=16
N = 0
C = 34
Due north=1
C=12
Northward=one
Bahtis et al. [24] Prospective randomised BrainLAB C = fourscore N
 = fourscore
C=27
N=21
C = 53
N = 59
lxx.9  ±  9.ane 68.7  ±  9.three C=eighteen
Northward = iii
C=11
N = half dozen
C = 5
N=2
C = 64 ± 11
N = 78 ± 12
Chauhan et al. [25] Prospective randomised Stryker C = 35
N = 35
C=10
North = 5
C = iii
Due north = 0
C = 3
N = 0
C = 67
Northward = lxxx
Matsumoto et al. [26] Retrospective matched pared control study Brain LAB C = xxx
N = 30
C = 5
N = 5
C=25
Due north=25
73.3 75.3 C=10
N=ii
C = 9a
N=2a
C = 7a
N=2a
Haaker et al. [33] Retrospective Aesculap C=100
Due north=100
C = 74
N = 66
C=26
Due north = 34
69 68 C = 72
 North=21
C=101 ± 21
Northward=111 ± 22
Daubresse et al. [34] Retrospective Aesculap. C = 50
N = fifty
C=15
N=19
C = 35
Due north = 31
61 63 C=16
 North = 0
C = 3 N = 0
C=thirteena N = 5a
C = 0 Due north = 0 C=10a Due north = 0a
Zorman et al. [35] Prospective report compared to a historical accomplice BrainLAB C = 62
N = 72
C=nineteen
Northward = 0
C=12
Northward = 0
C = 7
North = 0
Decking et al. [22] Prospective randomised Aesculap. C=25
N=27
C = 8
Northward = 9
C=17
N=18
67.3  ±  6.iii 64.7  ±  ix.4 C=xvia
N=13a
C = fivea
N = 5a
C = fivea
Due north=onea
C = 79 ± 8
Due north = 92 ± 9
Kim et al. [36] Prospective study compared to a historical cohort. Stryker C = 69
N = 78
C=26
North=23
C = 54
North = 44
68 70 C=19
Due north = iv
Bolognesi and Hofman [49] Retrospective Navitrack C = 50
N = fifty
C=21
N=24
C=27
Due north=26
C = 5 N=i C = 4 N = 0
Jenny et al. [37] Retrospective Aesculap C=235
North=235
107 363 C = 65
 North=18
C = 54
N=26
C = 41
North=26
C = 99 ± 22
Due north=108 ± 22
Beneyto et al. [38] Prospective randomised multicenter study Stryker C = 84
N=102
72.3 71.vi C = 59
N = 53
C = 76.ix
North = 93.6
Ensini et al. [27] Prospective randomised Stryker C = 60
N = 60
C=20
N = xxx
C = 40
N = 30
71.1 ± seven.eight 68.viii  ±  half-dozen.3 C=15
Due north = 7
C = ix
N = 0
C=ii
N=1
Matziolis et al. [28] Prospective randomised Pigalielo C=28
Due north = 32
twenty 40 70 ± 9 71 ± 7 C = 7
N=1
C = 3
N = 0
C = 5
N = 0
C = 94 ± 18
N=101 ± 17
Martin et al. [29] Prospective randomised BrainLAB C=100
Due north=100
C=27
N = 32
C = 73
N = 68
71.1 ± vii.5 lxx.three ± 8.2 C=24
N = eight
C=14
N = 5
C=xv
 Due north = iii
C = 68 ± xviii
Northward = 88 ± 16
Mullaji et al. [30] Prospective randomised Brain LAB C=185
N=282
C = 47
N = 67
C=143
N=215
65.nine 65.v C = forty
N=26
Kim et al. [15] Prospective- BrainLAB C=100
N=100
C=fifteen
Due north=15
C = 85
N = 85
C = 35
N=28
C = 9
N=13
C = seven
Due north=16
C = 82
N = 97
Tingart et al. [39] Prospective study Encephalon LAB C = 500
North = 500
C=137
Northward=156
C = 363
N = 344
70.8 ± 9.4 67.3 ± 8.ix C=128
N=26
C=159
N=20
C=105
North=23
C = 78 ± 23
N = 86 ± twenty
Oberst et l. [31] Prospective randomised Encephalon LAB C = 35
Due north = 34
C = seven
Due north=2
Rosenberger et al. [40] Retrospective Medtronic C = 50
Northward = fifty
C=14
N=15
C = 36
Due north = 35
66.92 ± 7.48 65.63 ± six.83 C=21
N = v
C = 6
N=i
C=ten
N=two
Yau et al. [16] Retrospective BrainLAB C = 52
N = 52
C = 5
N = 8
C=28
N=25
66.three ± vii.6 69 ± 9.two C=13
N=15
C = three
N = 3
C = 5
N = 7

Results of meta-analysis for prospective randomised studies solitary are presented in Table2 and Fig.1. Table3 presents the results of the meta-assay for all the studies combined. Figures2, 3 and 4 graphically present the results for the limb mechanical centrality, femoral angle, and tibial bending, respectively.

Table 2

Outliers reduction rate for the different angles, calculated merely for the prospective randomised studies

Angle OR 95% CI
HKA angle > ±3° 0.289 0.116–0.524
HKA angle > ±2° and ± 3° 0.313 0.149– 0.517
coronal femoral bending > ±3° 0.106 0.008–0.866
coronal femoral angle > ±two° and ± 3° 0.149 0.016–0.878
coronal tibial angle > ±3° 0.19 0.020–1.144
coronal tibial angle > ±ii° and ±3° 0.188 0.028–0.828

OR odds ratio, CI confidence interval, HKA hip-knee-ankle

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Mechanical centrality diagram for prospective randomised studies alone

Table iii

Outliers reduction charge per unit for the different angles, calculated for all studies (prospective randomised and retrospective)

Bending OR 95% CI
HKA bending > ±3° 0.201 0.111–0.324
HKA bending > ±2° and ± three° 0.211 0.123–0.333
coronal femoral angle > ±2° 0.345 0.057–1.87
coronal femoral bending > ±3° 0.thirteen 0.036–0.344
coronal femoral angle > ±2° and ± 3° 0.19 0.077–0.392
coronal tibial angle > ±ii° 0.112 0.005–1.395
coronal tibial angle > and ±iii° 0.206 0.057–0.521
coronal tibial angle > ±2° and ± 3° 0.19 0.068–0.411

OR odds ratio, CI conviction interval, HKA hip-knee-ankle

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Mechanical axis diagram for prospective randomised and retrospective studies

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Femoral angle diagram for prospective randomised and retrospective studies

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Tibial angle diagram for prospective randomized and retrospective studies

In 20 papers (4,199 TKAs) the outlier cutting-off angle for the mechanical axis was defined as ±3° from the neutral [xv, 16, 23–41]. For these trials, in two,039 cases the conventional technique was used and the other 2,160 cases were operated with imageless CAOS. There were 390 (18.6%) outliers for the mechanical axis in the conventional grouping compared to 92 (4.iii%) in the CAOS group. The meta-analysis estimated an odds ratio of OR = 0.201 (95% CI 0.111–0.324). This represents a strong event, with CAOS reducing outlier charge per unit by approximately 80%. The outcome was similar when we combined the data with the one report where the chosen cut-off value was 2° (OR = 0.211; 95% CI 0.123–0.333) (Tables2, three; Figs.ane and ii).

For the coronal femoral and coronal tibial implants position, 14 studies defined the outlier cut-off equally ±3° or more than. The analysis included 1,522 patients in the conventional group and 1,536 in the CAOS group. Analysing the femoral implant position revealed 280 (18.iv%) patients in the conventional group that had outliers in femoral implant position, compared to 48 (iii.1%) in the CAOS group. The meta-analysis estimated better results with the CAOS TKA. With a cut-off of 3° we found OR = 0.thirteen (95% CI 0.036–0.344), implying a strong effect with reducing the outliers rate past approximately 87% when using the CAOS (Tables2 and iii; Fig.3).

Four studies defined the outlier cutting-off for coronal femoral implants equally ±2° [22, 26, 32, 34]. They included 272 operated knees. One hundred thirty-v were operated upon using the conventional technique and 137 with CAOS. The results for the femoral implant showed 32 (23.7%) outliers in the conventional group compared to 14 (10.ii%) in the CAOS grouping. The meta-analysis resulted in a wide 95% CI (0.057–ane.87), that precludes definitive conclusion. When we combined studies with cut-off value of 3° or more with those whose cutting-off values were 2° or more, the result was OR = 0.19 (95% CI 0.077–0.392). This result shows a reduction in the outlier rate for the coronal femoral implant angle past approximately 81% (Tablestwo and iii; Fig.3).

The tibial implant analysis with cutting-off value of ±iii° or more exhibited outliers in 185 (12.ii%) conventional cases, compared to 53 (iii.5%) in the CAOS group. The results of the meta-assay were conclusive for the coronal tibial bending, showing meliorate results when CAOS was used. The reduction rate of outliers was approximately 80% (OR = 0.206; 95% CI 0.057–0.521) in favour of the CAOS. In the four studies with cut-off angle of ±2° or more than the result of the meta-analysis showed a wide 95% CI which precludes definitive conclusions. When the two values for cut-off were combined, the result showed a reduction rate of approximately 81% (OR = 0.nineteen; 95% CI 0.068–0.411) in outliers (Tables2 and 3; Fig.iv).

The study results reveal that 1,065 (51%) women were operated upon with CAOS and 1,021 by the conventional technique. Among men, 516 (52%) were operated upon with the assist of CAOS and 477 by the conventional technique. In four studies with another 459 operated knees, the authors did not mention the patients' gender (Tabular array1). These numbers bear witness that in the total population of patients that underwent TKA and that were included in the studies, no gender bias for CAOS or conventional technique occurred.

Finally, we observed increased mean operating time comparing CAOS TKA to conventional TKA, with an average difference of 24.seven minutes (95% CI −9.0, 58.6) when all studies were included, and a deviation of xiii.six minutes (95% CI −28.6, 56.5) when but randomised studies were included. Yet, the wide apparent intervals hateful that farther study is required to see if the upshot arose by chance or not.

Word

The virtually important conclusion of this meta-analysis is that the usage of imageless CAOS for TKA significantly reduces the number of outliers in the limb mechanical axis and coronal position of the implants past a rate of approximately lxxx%. This can be an important message for decision makers in health care systems, since ameliorate surgical results may, in the long run, mean less revision operations, hence considerable savings in human suffering and toll.

CAOS has drawbacks that are well described, including the increased operative fourth dimension (of 20 minutes on average) and the actress costs for hardware and software usage and dispensable parts that need to be purchased [fifteen, 22, 24, 25, 28, 29, 33, 37–39, 32, 42, 43]. With imageless CAOS for TKA surgeons avoid exposing patients to the extra radiation associated with pre-operative CT, and avoid the extra OR time and personnel required for intra-operative radiographs [14]. Because of these advantages imageless CAOS is continuously gaining in popularity and thus we wanted to perform a meta-assay of imageless CAOS studies only.

Ii previous meta-analyses investigated the effectiveness of the navigated TKA versus the conventional [44, 45]. These studies concluded meliorate results for navigated TKA and accept analysed prospective randomised studies, but also quasi-randomised controlled trials, nonrandomised accomplice studies, studies with historical cohorts, and studies investigating the issue of computed tomography or paradigm-gratuitous navigation systems for both unicompartmental and full knee arthroplasty. However, these meta-analyses included comparative studies of both imageless and CT-based navigation systems.

To the best of our knowledge, this is the offset meta-analysis in the literature analysing only prototype-costless navigation systems. We included both prospective randomised studies and others. We ran divide analyses for the prospective randomised studies simply and subsequently for all the studies combined. We found similar results whether the studies were prospectively randomised or non, so we concluded that there might not be a bias effect for the non prospective randomised studies, although it could serve as a signal for criticism to our study. Finally, our meta-analysis evaluated only English language written studies that were published until October 2008.

This meta-assay evaluates studies with different navigation systems (Tabular arrayi). All are image-gratis navigation systems and there might exist differences between them. We could not separate the meta-analysis for each manufacturer because of the small number of studies done with each separate organization. Since all share the same principles of image-costless CAOS, we decided it would exist reasonable to include them all in i meta-assay. In the future, with more studies, there will be a identify to consider a meta-analysis for one kind of navigation system only

The cut-off value for outliers in this meta-analysis was 3° or 2°. These are the values that are used in the studies that we evaluated. Indeed, these cut-off values have proven to be significantly correlated to the long-term survivorship of TKA [8–10]. Others have shown that coronal malalignment of greater than 3° can reduce TKA ten-year survival from 90% to 73% [8, 46]. Yet, despite this testify, the clinical significance of the use of CAOS TKA is however debated. Spenser et al. showed no difference in the following clinical scores: genu society score, WOMAC score, Oxford knee score and Bartlett patellar score, between navigated and conventional TKA patients in a prospective randomised written report with up to 2 years of follow-up [47]. Ensini et al. failed to evidence a meliorate clinical comeback up to 28 months subsequently the operation using the Oxford score, patellofemoral articulation score, and satisfaction score [27]. Anderson et al. did not observe any improvement in range of motion at six months follow-upwards [48]. Finally, Decking et al. showed the same clinical results at three months following the operation using the WOMAC score and the Articulatio genus Social club score [22]. These studies show that although there are meliorate outcomes in alignment and implant position in CAOS TKA, there is no issue on the clinical consequence in the short-term follow-up. We believe that the influence of a amend limb alignment and implant position volition be realised only after several years. Since CAOS TKA was get-go introduced in 1999 [11], at that place is non enough data available withal to show a reduction in implant failure charge per unit when CAOS is used. Further studies and longer survey of patients and outcomes will exist necessary to prove that.

Limitations of this study warrant farther discussion. First, we included studies with different levels of prove and not randomised studies only. Using non-randomised studies might introduce a bias. In this written report, we showtime performed a meta-assay for randomised studies and but then a second meta-analysis for randomised and non-randomised studies. We constitute the same results, so nosotros concluded that in that location is probably no bias in the non-randomised studies, hence nosotros could utilize both studies in the meta-analysis. Second, we concentrated only on the limb mechanical axis and the coronal angle of the femoral and tibial components, but did not evaluate the sagittal airplane of the implants. Third, our data did not evaluate clinical differences between the ii modalities. This data could be evaluated merely in the time to come. Fourth, we included information that was collected from different navigation systems of different manufacturers. All the same, all of them followed the same principle, i.eastward. image-free navigation systems.

Conclusions

Results of this meta-assay showed that the use of imageless CAOS for TKA significantly reduces the number of outliers in the limb mechanical axis and coronal position of the implants by a rate of approximately 80%. It should be taken into business relationship that there are some drawbacks with CAOS including the price, length of surgery, learning curve, etc. Withal, CAOS TKA seems to improve authentic component positioning; the clinical significance of this remains to be proven.

Source of funding

The authors declare that there was no external funding source for this report.

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