The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 89, Issue 6

Scientific Articles | June 01, 2007

Safety of Simultaneous Bilateral Total Knee Arthroplasty: A Meta-Analysis

Camilo Restrepo, MD¹; Javad Parvizi, MD, FRCS¹; Thomas Dietrich, MD, DMD, MPH²; Thomas A. Einhorn, MD³

¹ Rothman Institute, 925 Chestnut Street, 5th Floor, Philadelphia, PA 19107. E-mail address for J. Parvizi: parvj@aol.com
² Department of Biostatistics, Boston University Goldman School of Dental Medicine, 715 Albany Street, Boston, MA 02118
³ Department of Orthopaedic Surgery, Boston University Medical Center, Doctors Office Building, 720 Harrison Avenue, Boston, MA 02118

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Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. A commercial entity (Stryker Orthopaedics) paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.

Investigation performed at the Department of Orthopedic Surgery, Rothman Institute at Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, and the Departments of Biostatistics and Orthopaedic Surgery, Boston University Medical Center, Boston, Massachusetts

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2007 Jun 01;89(6):1220-1226. doi: 10.2106/JBJS.F.01353

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Abstract

Background: The safety of simultaneous bilateral total knee replacement remains controversial. Some studies have demonstrated a higher rate of serious complications, including death, following bilateral procedures, whereas others have suggested no increase in the complication rate. The objective of this meta-analysis was to compare the safety of simultaneous bilateral total knee replacement with that of staged bilateral and unilateral total knee replacements.

Methods: A computerized literature search was conducted to identify all citations, from 1966 to 2005, concerning bilateral total knee replacement. All of the English-language abstracts were obtained. A multistage assessment was then performed to identify articles fulfilling the inclusion criteria for the study. All randomized, prospective studies reporting the outcome of bilateral total knee replacement were included. The details of the reported data were extracted, and an extensive analysis of relevant variables was carried out.

Results: One hundred and fifty published articles were identified, and eighteen that included a total of 27,807 patients (44,684 knees) were included in the meta-analysis. There were 10,930 unilateral total knee replacements, 16,419 simultaneous bilateral total knee replacements, and 458 staged bilateral total knee replacements with at least three months between the operative procedures. The prevalences of pulmonary embolism (odds ratio = 1.8), cardiac complications (odds ratio = 2.49), and mortality (odds ratio = 2.2) were higher after simultaneous bilateral total knee replacement. The prevalence of deep venous thrombosis was lower after simultaneous bilateral total knee replacement, but this difference was not significant. The complication rates after the staged bilateral total knee replacements were similar to those in the patients who had undergone unilateral total knee replacement only.

Conclusions: Compared with staged bilateral or unilateral total knee replacement, simultaneous bilateral total knee replacement carries a higher risk of serious cardiac complications, pulmonary complications, and mortality. The period of time between staged procedures that would eliminate these increased risks could not be determined from this study.

Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

The choice of simultaneous or staged total knee arthroplasty for the operative treatment of bilateral knee arthritis remains controversial. An increased risk of serious complications or even death when the arthroplasties are done simultaneously has been reported in several studies^1-15. On the other hand, several investigators believe that simultaneous total knee arthroplasty is associated with a minimal or no increase in complications or risks^16-33.

Although simultaneous bilateral total knee arthroplasty has been compared with staged bilateral total knee arthroplasty in a few randomized and nonrandomized controlled trials^5,14,31,34, there have been conflicting results. Part of the problem is that it is difficult to carry out a truly controlled randomized trial of patients with bilateral knee arthritis because of ethical issues. In addition, many of the studies dealing with complications associated with bilateral total knee arthroplasty may have selection bias, as patients with more comorbidities are often deemed to be inappropriate candidates for simultaneous total knee arthroplasty and are usually excluded from studies of those procedures. Finally, and perhaps most importantly, because of the relative rarity of major complications following total knee arthroplasty, most of the studies had relatively small sample sizes and probably were underpowered to detect differences between the two treatment options.

Meta-analysis allows the accumulation of data to address pertinent questions such as the safety of bilateral total knee arthroplasty. Using strict criteria for selection, we amassed the available published data to determine if the prevalence of major complications and mortality differed between bilateral and staged total knee arthroplasties. All available randomized and nonrandomized trials that compared simultaneous bilateral total knee arthroplasty with staged bilateral total knee arthroplasty were included to evaluate the safety of simultaneous bilateral total knee replacement compared with that of staged bilateral and unilateral total knee replacements.

Materials and Methods

Materials and Methods | Results | Discussion | References

Study Selection

We searched MEDLINE, EMBASE, COCHRANE, and OVID for randomized and nonrandomized trials comparing simultaneous bilateral total knee arthroplasty with staged total knee arthroplasty; the last search was performed in September 2005. We set no language restrictions. References of retrieved articles were also screened. We noted frequently cited articles and conducted a Science Citation Index search (SCISEARCH) to locate potentially relevant studies in which these articles were cited. Additional strategies to identify relevant studies included a manual search of the tables of contents from the 1998 to 2005 volumes of four major orthopaedic journals, including The Journal of Bone and Joint Surgery (American and British volumes), Journal of Arthroplasty, and Clinical Orthopaedics and Related Research, and the bibliography reference sections of three major arthroplasty textbooks, including Joint Replacement Arthroplasty³⁵, The Adult Knee³⁶, and Campbell's Operative Orthopaedics³⁷. Two of us (C.R. and J.P.) reviewed the titles of the studies and the retrieved abstracts if there was a possibility for inclusion in the meta-analysis. Review of the complete articles that had been retrieved after the assessment of the abstracts included only the methods sections, with the reviewer blinded to the author, institution, journal, and results of the study.

We considered all studies comparing the safety of simultaneous bilateral total knee arthroplasty with that of staged bilateral total knee arthroplasty, regardless of the diagnosis, the surgical technique, or the specific type of prosthesis used. Whenever reports pertained to the same patient population at different follow-up periods, we retained the study with the longer duration of follow-up. Personal communication with the authors of published eligible reports was attempted whenever the published information was not adequate for the analysis. The relevant information regarding the population, intervention, and outcomes was abstracted from each article.

Variables that were not consistently reported included race, weight, body mass index, medical comorbidities, previous operations on the index knee, method of anesthesia, operative techniques, perioperative antibiotics, thromboembolic prophylaxis, and details of postoperative rehabilitation. Systemic complications were also reported with some inconsistency. Very few studies disclosed sources of funding.

Outcomes

The primary outcomes that were assessed included the prevalence of mortality and major complications such as deep venous thrombosis, pulmonary embolism, and cardiac complications.

Data Extraction

Two of us (C.R. and J.P.) independently reviewed the articles on five separate occasions to extract every reported pertinent detail including, but not limited to, demographics, previous operations, details of thromboembolic and infection prophylaxis, patient satisfaction, functional outcome, complication rate, prevalence of reoperations, and arthroplasty revision rate and then reached consensus on all extracted items. Information was gathered on the characteristics of the studied population in each report. The number of patients who underwent a simultaneous or staged procedure was recorded, as were the complications mentioned and the necessity for revision operations.

Statistical Analysis

Meta-analysis was performed with use of the random-effects models³⁸. This model is usually chosen when generalizations are being made about a population in which treatments are permitted to have different effects. The intuition underpinning random-effects models is that, because of the availability of various approaches for conducting a study, many different potential treatment effects could arise. This situation corresponds to an analysis-of-variance model where there is interstudy variation in the mean outcome in addition to within-study variation. We used estimates of relative risk to calculate the risk difference and the number needed to treat for risk reduction. Major differences in the apparent effect size were found across studies. In order to define heterogeneity, we examined the study populations, treatments, measures of outcome, and methodologies to determine the source of the heterogeneity. For each determinant of heterogeneity, we compared relative risks across categories and determined whether these relative risks were significantly different. Additional analyses included evaluation for relative risk ratios and tests of heterogeneity effect. This analysis calculates a weighted mean of the values in each study where the weights are the study sizes. Study size was taken to be the reported number of patients in each study.

Results

Materials and Methods | Results | Discussion | References

Eligible Studies

Eighteen articles were selected for inclusion in the meta-analysis (Table I)^{4-6,8,10,18,20,22-27,29,31,34,39,40}. The published reports provided data on 27,807 patients. The total number of knee arthroplasties was 44,684, of which 10,930 were unilateral total knee arthroplasties, 16,419 were simultaneous bilateral total knee arthroplasties, and 458 were staged bilateral total knee arthroplasties with at least three months between the operative procedures. Six reports provided data on the rates of deep venous thrombosis in the two groups (staged and simultaneous total knee arthroplasty)^{5,8,10,18,25,31}. Eleven articles provided information on the prevalence of pulmonary embolism in the population being studied^{5,8,10,18,20,22,25,26,29,31,39}. Eight trials were used to calculate the prevalence of cardiac complications^{5,8,10,18,29,31,34,39}. Information on the rate or prevalence of mortality in the sample was provided by eight articles^{5,6,8,10,14,25,29,39}. The prevalence of the four most serious complications—namely, deep venous thrombosis, pulmonary embolism, cardiac events, and mortality—was compared between the two groups of patients.

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TABLE I Details on All of the Studies That Were Included in Meta-Analysis

Authors	Year of Study	Number of Patients	Number of Knees	Findings
Leonard et al.⁸	2003	184	276	Higher deep venous thrombosis rate after unilateral total knee arthroplasty
Bullock et al.⁵	2003	769	1024	Higher deep venous thrombosis rate after unilateral total knee arthroplasty
Ritter et al.²⁹	2003	3998	6200	Higher mortality rate after bilateral total knee arthroplasty
Gill et al.⁶	2003	2848	3048	Higher mortality rate after bilateral total knee arthroplasty
Dorr et al.³⁴	2002	153	227	Higher cardiac complication rate after bilateral total knee arthroplasty
Reuben et al.⁴⁰	1998	116	128	No differences
Bould et al.⁴	1998	56	84	No differences
Lane et al.³⁹	1997	200	300	Higher cardiac complication rate after bilateral total knee arthroplasty
Ritter et al.¹⁴	1998	17446	30368	No differences
Lynch et al.¹⁰	1997	196	294	Higher cardiac complication rate after bilateral total knee arthroplasty
Cohen et al.¹⁸	1997	186	272	No difference in cardiac complication rate
Jankiewicz et al.²²	1994	155	254	No difference in pulmonary embolism rate
Kolettis et al.²³	1994	35	53	No differences
Ritter et al.²⁶	1987	209	341	No difference in pulmonary embolism rate
Morrey et al.²⁵	1987	877	1253	Higher deep venous thrombosis rate after bilateral total knee arthroplasty
McLaughlin et al.²⁴	1985	68	136	No differences
Soudry et al.³¹	1985	230	304	Higher deep venous thrombosis rate after bilateral total knee arthroplasty
Gradillas and Volz²⁰	1979	81	122	Higher pulmonary embolism rate after bilateral total knee arthroplasty
Total		27807	44684

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TABLE I Details on All of the Studies That Were Included in Meta-Analysis

Authors	Year of Study	Number of Patients	Number of Knees	Findings
Leonard et al.⁸	2003	184	276	Higher deep venous thrombosis rate after unilateral total knee arthroplasty
Bullock et al.⁵	2003	769	1024	Higher deep venous thrombosis rate after unilateral total knee arthroplasty
Ritter et al.²⁹	2003	3998	6200	Higher mortality rate after bilateral total knee arthroplasty
Gill et al.⁶	2003	2848	3048	Higher mortality rate after bilateral total knee arthroplasty
Dorr et al.³⁴	2002	153	227	Higher cardiac complication rate after bilateral total knee arthroplasty
Reuben et al.⁴⁰	1998	116	128	No differences
Bould et al.⁴	1998	56	84	No differences
Lane et al.³⁹	1997	200	300	Higher cardiac complication rate after bilateral total knee arthroplasty
Ritter et al.¹⁴	1998	17446	30368	No differences
Lynch et al.¹⁰	1997	196	294	Higher cardiac complication rate after bilateral total knee arthroplasty
Cohen et al.¹⁸	1997	186	272	No difference in cardiac complication rate
Jankiewicz et al.²²	1994	155	254	No difference in pulmonary embolism rate
Kolettis et al.²³	1994	35	53	No differences
Ritter et al.²⁶	1987	209	341	No difference in pulmonary embolism rate
Morrey et al.²⁵	1987	877	1253	Higher deep venous thrombosis rate after bilateral total knee arthroplasty
McLaughlin et al.²⁴	1985	68	136	No differences
Soudry et al.³¹	1985	230	304	Higher deep venous thrombosis rate after bilateral total knee arthroplasty
Gradillas and Volz²⁰	1979	81	122	Higher pulmonary embolism rate after bilateral total knee arthroplasty
Total		27807	44684

The analysis showed that, although a large number of studies on this topic have been published, the overall conclusions are inconsistent. There is also a marked variation in the reporting of the results, specifically the final odds ratio, among the different articles.

Deep Venous Thrombosis

The probability of a deep venous thrombosis event was lower after simultaneous total knee arthroplasty, but this finding was not significant (Fig. 1). The overall pooled odds ratio was 0.99. The lowest odds ratio for deep venous thrombosis occurring after simultaneous bilateral total knee arthroplasty was 0.37 for a sample size of 769 patients and 1024 knees⁵. The highest odds ratio was 3.53¹⁸, in a study that contributed only 4.7% weight to the overall calculation and did not substantially influence the overall result.

Pulmonary Embolism

In contrast to the findings regarding deep venous thrombosis, the probability of a pulmonary embolism in patients who had undergone simultaneous bilateral total knee arthroplasty was higher than that in patients who had undergone a unilateral total knee arthroplasty (Fig. 2). The overall odds ratio was 1.82, based on the data from eleven articles^{5,8,10,18,20,22,25,26,29,31,39}. The odds ratios ranged from 0.14 to 7.22. Two of the articles contributed most to the overall calculation^10,29. The first study, with a sample size of 196 patients and 294 knees, contributed 10.4% weight¹⁰. The second study, with a sample size of 3998 patients and 6200 knees, contributed 39.7% weight and demonstrated an odds ratio of 2.64 for pulmonary embolism after simultaneous bilateral total knee arthroplasty²⁹. The highest odds ratio for pulmonary embolism after bilateral total knee arthroplasty was 7.22³⁹. That article, however, had only 3.8% weight in the overall calculation.

Cardiac Complications

The probability of cardiac complications also showed little variation among the groups. Almost all of the articles analyzed showed an increase in the prevalence of cardiac events in patients who had undergone simultaneous total knee arthroplasty (Fig. 3). The overall odds ratio was 2.49, which was the highest for all of the complications analyzed. Only one study showed a negative odds ratio^5,31, and this study contributed little weight to the overall calculations. The highest odds ratio was 20.32³⁴. A study in which the odds ratio was 1.61 in an overall population of 3998 patients and 6200 knees contributed the most (27.7%) to the calculation of overall cardiac complications²⁹. Another study, on 200 patients (300 knees), in which the odds ratio was 2.11 contributed 17.4% to the overall calculation³⁹.

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Fig. 1: Forest plot showing the odds ratios for deep venous thrombosis occurring following simultaneous bilateral total knee arthroplasty (TKA) and the weights contributed by each study to the overall calculation.

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Fig. 2: Forest plot showing the odds ratios for pulmonary embolism occurring following simultaneous bilateral total knee arthroplasty (TKA) and the weights contributed by each study to the overall calculation.

Mortality

The prevalence of mortality was significantly higher in the population that had undergone simultaneous total knee arthroplasty (Fig. 4). There was little variation in the prevalence of this complication among the studies. A negative odds ratio for this complication was reported in only a single study²⁵. All other studies showed a significant increase in mortality following simultaneous bilateral total knee arthroplasty. The overall odds ratio across eight studies was 2.24. The range in odds ratios was from 0.99 to 10.15. Three studies contributed the most to these calculations. A study on 877 patients (1253 knees) in which an odds ratio was reported to be 0.99 contributed 28.1% weight to the overall calculation²⁵. Another study, on a much larger patient population of 17,446 patients (30,368 knees), demonstrated an odds ratio of 3.47 and contributed 28.5% to the overall calculations¹⁴. The third study revealed an odds ratio of 1.54 for mortality following simultaneous total knee arthroplasty and contributed an overall weight of 21.6% to the calculation²⁹.

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Fig. 3: Forest plot showing the odds ratios for cardiac complications occurring following simultaneous bilateral total knee arthroplasty (TKA) and the weights contributed by each study to the overall calculation.

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Fig. 4: Forest plot showing the odds ratios for mortality occurring following simultaneous bilateral total knee arthroplasty (TKA) and the weights contributed by each study to the overall calculation.

Discussion

Materials and Methods | Results | Discussion | References

Total knee arthroplasty continues to be one of the most effective orthopaedic operative procedures and is considered to be extremely safe^41,42. Although the majority of patients with arthritis of the knee undergo unilateral total knee arthroplasty, not infrequently patients present with symptomatic arthritis of both knees. The orthopaedic surgeon must then decide if bilateral simultaneous total knee arthroplasty is a safe operation to perform in this setting.

There are many advantages to performing bilateral arthroplasty during one anesthetic session. Patient convenience, a reduced length of stay in the hospital, and a potentially shortened period of rehabilitation and disability are some of the appeals of this approach^16-33. On the other hand, the fear of increased complications deters some surgeons from performing bilateral arthroplasty during one anesthetic session^1-15. An orthopaedic surgeon attempting to extract information from the literature regarding the safety of simultaneous bilateral total knee arthroplasty may be faced with conflicting findings. There may be several reasons for the apparent conflict noted in the literature. Because of the relative rarity of complications such as pulmonary embolism, the majority of studies have a type-II statistical error resulting from a patient population of inadequate size. In addition, the effect of probable, and important, selection bias cannot often be gleaned from these studies.

In a very recent study of the Medicare population, the investigators attempted to overcome the above limitations by including a very large patient sample⁴³. That study demonstrated a higher incidence of pulmonary embolism in patients who had undergone simultaneous bilateral total knee arthroplasty compared with the incidence following unilateral total knee arthroplasty. The incidence of pulmonary embolism in the first three months after arthroplasty was 0.81% in the patients who had undergone a single procedure compared with 1.44% in the patients who had been treated with a simultaneous bilateral total knee arthroplasty⁴³. Despite its strengths, this study suffered from the limitations that are inherent to analyses involving that Medicare database, as outlined previously⁴⁴. The Medicare database lacks important clinical information such as operative details. Hence, it was not possible for the investigators in that study to distinguish between sequential and simultaneous bilateral procedures.

Hence we set out, nearly two years ago, to conduct this meta-analysis to combine data from a number of qualified studies in an effort to determine the prevalence of serious complications, including death, following bilateral total knee arthroplasty. The meta-analysis amassed data from 44,684 procedures and revealed that the prevalence of major complications such as pulmonary embolus, cardiac events, and death was higher following simultaneous total knee arthroplasty. The prevalence of deep venous thrombosis seemed to be slightly lower after bilateral total knee arthroplasty than it was after unilateral and staged total knee arthroplasty, but was not significantly different. This complication was not consistently reported in the studies included in this meta-analysis.

The findings of our study are somewhat troubling. The higher rates of cardiopulmonary complications and mortality call for caution in the selection of patients for simultaneous bilateral total knee arthroplasty. Although it was not a direct finding of this study, one may deduce that patients with concomitant cardiopulmonary conditions may not be good candidates for simultaneous bilateral total knee arthroplasty even with the improvements in surgical and anesthesia techniques that have occurred over the last few years. This concern is reinforced by the fact that, in recent years, the prevalence of cardiopulmonary complications and mortality has been found to be higher in patients treated with simultaneous bilateral total knee arthroplasty than it was in the earlier era of arthroplasty.

The findings of this meta-analysis should be interpreted with a recognition of the limitations, primarily in relation to the variability in the reporting of data in the studies, that apply to meta-analysis. In addition, because of the difficulty in extracting the relevant information, this meta-analysis did not distinguish between simultaneous and sequential bilateral total knee arthroplasty. Some surgeons may argue that the safety of bilateral total knee arthroplasty is only a concern if the procedure on both knees is truly carried out simultaneously and that staging, even during the same anesthetic session, does not involve higher risks if the actual interventions occur sequentially²⁶. Another potential limitation of this meta-analysis is related to the strict criteria for inclusion of randomized and comparative studies, as some potentially relevant studies may have been excluded. This step was necessary in order to eliminate important confounding variables. Finally, the meta-analysis was intended to evaluate the prevalence of major and life-threatening complications. Hence, information on other complications such as periprosthetic infection or functional recovery was not sought. The majority of the studies did not provide information pertinent to these problems. ?

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Materials and Methods | Results | Discussion | References

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Topics

deep vein thrombosis ; pulmonary embolism ; safety ; knee replacement arthroplasty ; cardiac complication

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Camilo Restrepo, Javad Parvizi, Thomas Dietrich, Thomas A. Einhorn; Safety of Simultaneous Bilateral Total Knee ArthroplastyA Meta-Analysis. The Journal of Bone & Joint Surgery. 2007 Jun;89(6):1220-1226.

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