- Email: [email protected]
Comparison of Clinical Outcome Between Simultaneous-Bilateral and Staged-Bilateral Total Knee Arthroplasty: A Systematic Review of Retrospective Studies
The Journal of Arthroplasty 28 (2013) 1141–1147
Contents lists available at SciVerse ScienceDirect
The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Comparison of Clinical Outcome Between Simultaneous-Bilateral and Staged-Bilateral Total Knee Arthroplasty: A Systematic Review of Retrospective Studies Dong Fu MD 1, Guodong Li MD 1, Kai Chen MD, Hui Zeng MD, Xiaolong Zhang MD, Zhengdong Cai MD The tenth People's Hospital affiliated with Tong Ji University, Shanghai, People's Republic of China
a r t i c l e
i n f o
Article history: Received 21 July 2012 Accepted 29 September 2012 Keywords: total knee arthroplasty simultaneous staged
a b s t r a c t The purpose of this study is to conduct a systematic review assessing the clinical outcome associated with Simultaneous bilateral and staged bilateral total knee arthroplasty (TKA). A literature search for eligible studies was conducted. Eighteen retrospective comparative studies were included. Pooled results showed that the prevalence of mortality at 30 days postoperatively, pulmonary embolism, blood transfusion rate were significantly higher in simultaneous TKA group. A significantly lower rate of deep infection and revision were found in simultaneous TKA. No significant difference was seen in regard to neurological complications, deepvein thrombosis, cardiac complications, superficial infection. Compared with staged bilateral TKA, simultaneous bilateral TKA is associated with higher rates of mortality, pulmonary embolism and blood transfusion, while decreasing the risk of deep infection and revision rate. © 2013 Elsevier Inc. All rights reserved.
Total knee arthroplasty (TKA) is a successful procedure for relieving pain and restoring function in cases with severe rheumatoid arthritis and osteoarthritis. The prevalence of bilateral knee osteoarthritis has been shown to be as high as 5% [1]. Patients requiring bilateral total knee arthroplasties may have both joints replaced simultaneously or during two separate hospitalizations (two-stage). A staged procedure involves 2 unilateral arthroplasties, performed during separate anesthesias, frequently over 2 separate inpatient stays. In contrast, simultaneous arthroplasties are performed by 1 or 2 surgical team with the patient under 1 anesthetic. Although a patient with symptomatic bilateral knee diseases can be treated by replacing both knees during a single operative session, the rates of perioperative morbidity and mortality with simultaneous bilateral total knee arthroplasty remain a concern [2]. There are reports of increased perioperative complications, including pulmonary embolism, deep vein thrombosis, cardiac, neurologic and wound complications, and intensive care unit admissions in the simultaneous group [3–11]. And
Authors’ disclosures of potential conflicts of interest: The author(s) indicated no potential conflicts of interest. Author contributions: Conception and design: Dong Fu, Guodong Li. Financial support: Zhengdong Cai. Provision of study materials or patients: Guodong Li, Zhengdong Cai. Collection and assembly of data: Dong Fu, Kai Chen, Hui Zeng. Data analysis and interpretation: Dong Fu, Hui Zeng, Xiaolong Zhang. Manuscript writing: All authors. The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2012.09.023. Reprint requests: Zhengdong Cai MD, Department of Orthopedics, The Tenth People's Hospital affiliated with Tong Ji University, 301 Yanchang Rd, Shanghai 200072, People's Republic of China. 1 Dong Fu and Guodong Li are co-first authors. 0883-5403/2807-0019$36.00/0 – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.arth.2012.09.023
some other studies suggested that the overall incidence of complications might be lower after simultaneous-bilateral TKA than after staged bilateral arthroplasty [12–14]. Several clinical trials have evaluated the effect of simultaneous and staged TKA, but most of them involved relatively small cohorts of patients and thus their results lacked statistical power. The aim of this meta-analysis was to evaluate the prevalence of mortality, various complications and cost effectiveness between these two procedures. Materials and Methods Identification and Selection of Studies We carried out a literature search using Medline, Embase, Ovid and Cochrane databases to identify all articles published between 1965 and 2012 that evaluated the outcome of patients undertaking either simultaneous bilateral TKA or staged bilateral TKA. No other restrictions were placed except that the language of the publications was limited in English. Reports relating to both simultaneous TKA and staged TKA were included regardless of whether unilateral TKA was involved in the comparison. The following Medical Subject Headings (MeSH) and terms were used in searching: “bilateral total knee arthroplasty”, “staged total knee arthroplasty”, and “total knee arthroplasty”. The reference list of each comparative study and previous reviews were manually examined to find additional relevant studies. We also contacted each author of the included studies to identify some more details of the clinical outcome and further studies on the same topic by e-mail.
1142
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
To minimize any possible selection bias, the following criteria were established. Strict inclusion criteria included clinically significant osteoarthritis or rheumatoid arthritis in both knees and severe pain unrelieved by conventional therapy. Patients who had a primary trauma, knee infection, total knee arthroplasty or revision were excluded. Two reviewers (D. F and Gd. L) independently assessed each of the studies for eligibility for inclusion. Firstly the title or the abstract was judged by either reviewer and then if it was potentially eligible, the full article would be examined. All disagreements were resolved by consensus. Data Extraction Data were extracted independently by two authors subsequently after all the eligible studies were recruited. All pertinent information regarding participant and clinical outcome were recorded. Participant data included the number of patients, age, gender (the rate of males in all participants). The principal outcomes of interest included details of the incidence of complications (pulmonary embolism, deep-vein thrombosis, cardiac complications, neurological complications, deep infection and superficial infection) and mortality (within 30 days after surgery) as well as blood loss and transfusion, length of hospital stay, and the rate of revision arthroplasty. Study Quality Based on the Cochrane Bone, Joint and Muscle Trauma Group [15], assessment of the methodological quality of each included study was made by the 2 reviewers (D.F and Gd. L) who were blinded with respect to the journal, the authors and the source institution. Any controversy was cross-checked and resolved by a third author (K.C) to reach a final consensus.
Statistical Analysis Study-specific OR (Odds risks) and associated 95 % CI (confidence intervals) accounting for discontinuous variables within the study were pooled using a random-effects model, which considered both within-study and between-study variation. Standardized mean difference (SMD) or weighted mean difference (WMD) were used for continuous variables for which a fixed effect model was used initially, and if the P value of heterogeneity test was b0.1 or I 2 N 50% [16], the random effect model replaced the previous modality. Sensitivity analysis was performed to evaluate the stability of the results. Subgroup analysis was conducted if the data was present. Forest plots were used to graphically present the results of individual studies and the respective pooled estimate of effect size. All statistical analysis were performed with Review Manager (version 5.0.0 for Windows, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, 2008). Results Study characteristics A flow chart of the studies recruited in our review was shown in Fig. 1. Eighteen retrospective cohort studies [10,13,17–32] with 107,318 patients of which 28,760 were simultaneous bilateral TKA and 78,558 were staged bilateral TKA were selected for inclusion in the meta analysis. Details on all of the studies were shown in Table 1(A, B). Preoperative patient characteristics did not show any significant differences between groups with the exception of a greater percentage of female in the staged group. The result of each comparison was shown in Table 2.
Fig. 1. Flow chart of the studies recruited in this meta-analysis.
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
1143
Table 1A Details On All of The Studies Included In The Meta-Analysis.
Patients Study (year) Meehan 2011 Yoon 2010 Qian 2008 Stefansdottir 2008 Forster 2006 Hutchinson2006 Stubbs 2005 Sliva 2005 Ritter 2003 Mangaleshkar2001 Liu 1998 Ritter 1997 Jankiewicz 1994 Stanley 1990 Morrey 1987 Soudry 1985 Mclaughlin 1985 Willian 1978
Age (Years)
Sex
Sim Complications
Sim/Sta
Sim(M/F)
Sta(M/F)
Sim
Sta
Mor
PE
11,445/23,715 119/119 48/48 1,139/3,432 28/74 438/125 61/38 26/306 2,050/152 54/34 64/24 12,922/50,108 99/56 32/18 145/231 56/18 22/46 12/14
5,280/6,165 7/112 9/39 465/674 15/13 245/193 NC 14/12 906/1,144 21/33 3/61 4,988/7,934 34/65 8/24 56/89 17/39 7/15 8/4
9,171/14,544 7/112 9/39 1,287,2,145 34/49 46/79 NC 106/200 35/117 13/21 0/24 16,595/33,513 14/42 4/14 71/160 5/13 12/34 6/8
67.2 70 61 70.4 66 67 64 59.3 69.9 73 66.7 73.4 69 62 63.2 68.8 70 61
67.7 70 61 71.2 68 65 67 65.6 69.2 71.7 68.6 72.9 71 58 62.4 69 69 62
43 0 0 11 0 1 0 0 NC 4 0 128 0 NC 4 NC NC NC
110 0 1 NC 1 15 NC 0 18 NC 0 NC 3 NC 3 2 NC NC
Sta Complications
DVT Car Neu
DI
SI
Others Mor
96 0 1 NC NC 77 NC NC NC NC NC NC NC NC 2 NC 0 NC
96 0 1 NC NC 4 0 NC 31 NC 1 NC 0 NC NC 1 0 NC
27 6 0 NC NC NC 0 NC 14 NC 1 NC 0 1 NC NC NC NC
627 3 NC NC NC 7 17 9 44 NC 9 NC NC NC NC 4 NC 3
81 0 3 NC 0 10 15 0 NC NC 0 NC NC NC NC 0 0 NC
29 2 4 NC 1 0 9 0 6 NC NC NC 12 NC NC NC 1 NC
76 0 0 14 0 1 0 1 NC 0 0 160 0 NC 5 NC NC NC
PE
DVT
Car
Neu
DI
SI
Others
161 0 0 NC 3 4 NC 1 1 NC 0 NC 2 NC 1 0 NC NC
190 0 0 NC NC 21 NC NC NC NC NC NC NC NC 1 NC 7 NC
176 1 1 NC 1 5 22 4 NC NC 2 NC NC NC NC 2 2 NC
62 0 1 NC 2 0 9 1 0 NC NC NC 7 NC NC NC 0 NC
391 0 0 NC NC 3 0 NC 3 NC 0 NC 0 NC NC 0 1 NC
59 5 O NC NC NC 0 NC 2 NC 1 NC 0 0 NC NC NC NC
1195 1 NC NC NC 2 16 45 2 NC 1 NC NC NC NC 0 NC 5
Abbreviations: Sim, simultaneous bilateral total knee arthroplasty; Sta, staged bilateral total knee arthroplasty; Mor, mortality; PE, pulmonary embolism; DVT, deep-vein thrombosis; Car, cardiac complications; Neu, neurological complications (stroke, cerebrovascular accidents); DI, deep infection; SI, superficial infection; others, other minor complications (respiratory, digestive, urinary complications and so on); M/F, male/female; NC, not clear.
group than that happened in staged group with a significant difference (Fig. 4).
Mortality A total of 7 studies [17,20,22,23,25,27,29] including 104,120 patients were included for analysis of mortality. The prevalence of mortality was significantly higher in patients that had undergone simultaneous TKA when compared with those who had undergone staged TKA 30 days after surgery Fig. 1 (Fig. 2). During analysis, an obvious heterogeneity (p = 0.009) of the combined data was found. Each of the 7 studies was excluded respectively to do a sensitivity analysis. The result showed that the heterogeneity disappeared only when the study by Ritter [27] was deleted and the higher risk of mortality in simultaneous group still existed while without significant difference (Fig. 3).
Blood Transfusion Based on the available data, only 3 studies [23,24,28] with 586 patients were involved. Patients in simultaneous group did have a significant higher rate of blood transfusion [OR = 11.52, 95% CI (2.59, 51.28)] intra- and post-operatively. Because of the limited data, we had not done a sensitivity analysis despite the high Heterogeneity (p = 0.009). Information about the units of blood transfusion only give in one article [26] as mean plus minus standard error and whether the amount of transfusion was significantly different remained unclear.
Pulmonary Embolism Deep Infection Nine studies [10,17,19,21,22,24,28–30] with 39,135 patients were involved when comparing the prevalence of pulmonary embolism (PE). The odds ratios ranged from 0.20 to 4.86 and the total value of odds ratios was 1.39. The rate of PE was higher in simultaneous TKA
A deep infection was considered any infection that occurred inside the knee joint and required liner removal, arthrotomy, debridement, synovectomy, or even revision knee arthroplasty. Seven studies
Table 1B Sim Group Study (Year) Meehan 2011 Yoon 2010 Qian 2008 Stefansdottir 2008 Forster 2006 Hutchinson2006 Stubbs 2005 Sliva 2005 Ritter 2003 Mangaleshkar2001 Liu 1998 Ritter 1997 Jankiewicz 1994 Stanley 1990 Morrey 1987 Soudry 1985 Mclaughlin 1985 Willian 1978
BL(ml) NC 1,299 973 ± 38 NC 3,312 NC 1,701 NC NC NC 2,744 ± 727 NC 1,521 NC NC NC NC NC
Sta Group
BT(N)
BT(Units)
R
NC NC NC NC NC NC 58 14 NC NC NC NC 60 NC NC NC NC NC
NC NC NC NC 6 NC 3.59 2 NC NC 4.8 ± 1.4 NC 2.9 NC NC NC NC NC
61 NC NC NC NC 1 1 NC NC NC NC NC NC NC 7 NC NC 0
LOHS(days) NC 7.5 NC NC 11 NC 11 NC NC NC 16.5 ± 4.5 12 NC 22 NC NC NC 24 ± 3
BL(ml) NC 1,302 1,020 ± 40 NC 2,578 NC 896 NC NC NC 2,030 ± 551 NC 1,072 NC NC NC NC NC
P
BT(N)
BT(Units)
R
NC NC NC NC NC NC 21 11 NC NC NC NC 17 NC NC NC NC NC
NC NC NC NC 5.8 NC 2.0 1 NC NC 4.94 ± 1.58 NC 2.25 NC NC NC NC NC
254 NC NC NC NC 1 0 NC NC NC NC NC NC NC 31 NC NC 0
LOHS(Days) NC 11.7 NC NC 15 NC 16 NC NC NC 20.9 ± 3.5 20 NC 44 NC NC NC 33 ± 2
BL
BT(N)
BT(Unit)
R
LOHS
b0.05 N0.05 N0.05
b0.01
NC NC
b0.01 b0.01
b0.05 b0.01
b0.05
NC NC NC
N0.05 N0.05
N0.05 b0.01
NC
b0.01 b0.01
NC b0.01 b0.01
b0.01
Abbreviations: Sim, simultaneous bilateral total knee arthroplasty; Sta, staged bilateral total knee arthroplasty; BL, blood loss; BT, blood transfusion; R, revision; LOHS, length of hospital stay.
1144
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
Table 2 Outcome Measures In The Meta-Analysis of Comparisons Between Simultaneous And Staged Bilateral TKA. Outcome
Odds Ratio (95% CI)
Mortality⁎ Pulmonary embolism⁎ Deep-vein thrombosis Cardiac complications Neurological complications Deep infection⁎ Superficial infection Other minor complications Revision Rate⁎ Blood transfusion rate⁎
2.25 1.39 1.07 0.52 1.01 0.52 0.92 1.65 0.48 11.52
(1.87–2.72) (1.11–1.76) (0.86–1.33) (0.27, 1.03) (0.71–1.44) (0.42–0.64) (0.62–1.38) (0.92–2.96) (0.37–0.62) (2.59–51.28)
P b0.0001⁎ 0.005⁎ 0.57 0.06 0.96 b0.00001⁎ 0.69 0.10 b0.0001⁎ 0.001⁎
Heterogeneity
I2 %
Number of Patients
Number of Studies
0.009 0.9 0.86 0.05 0.65 0.9 0.85 0.01 0.64 0.009
73 0 0 46 0 0 0 59 0 86
104,120 39,135 36,507 36,820 39,015 38,743 38,085 38,321 36,198 586
7 9 5 10 9 7 5 9 4 3
⁎ Significantly different between simultaneous and staged bilateral TKA.
[10,17,19,22,26,30,31] with 38,743 patients were involved and the pooled data showed a much lower incidence in patients who had received simultaneous TKA than those in staged group with significant difference without heterogeneity [OR = 0.52, 95% CI = (0.42–0.64)].
studies have shown the procedure of simultaneous bilateral TKA to be safe in selected patient populations. The sum of the risks associated with the two operations of a staged procedure may equal or exceed the risk of simultaneous total knee replacement.
Revision Rate
Mortality
Four studies [11,22,27,29] with 36,198 were involved in this analysis. The rate of revision was statistically significantly different between the 2 groups; a trend toward higher rates existed in the staged TKA group without heterogeneity [OR = 0.48, 95% CI =(0.37–0.62)].
Mortality within 30 days after surgery is chosen as a primary end point, because death occurring during that time is likely to be causally associated with the operation. The predominant cause of death (77.8%) was a disease of the circulatory system [21]. In this analysis, the incidence of mortality with 30 days postoperatively was significant higher in simultaneous group which might be influenced by the higher rate of pulmonary embolism. Another possible reason was the fact that the rate of mortality in staged group was calculated in the patients who had to survive the first operation to have the second one, which indicated a selection bias of healthier patients for the second operation. The study by Ritter et al. [27] was deleted because of high heterogeneity. We explored potential sources of this study and tried to explain this difference. It was observed that the gap between the procedures in case of two-stage TKA were divided into 4 subgroups [within six weeks (4354 knees), three months (4524 knees), six months (9829 knees), and one year (31,401 knees)] while the mean interval averaged 1 year in almost all the other included studies. 30 days after surgery, compared with staged group, a larger proportion of patients survived in simultaneous group and the rate of mortality increased with the increasing of interval between two unilateral procedures without significant difference. Yoon et al. [18] have suggested the time of the second operation would be decided through discussion with the patient as the patient wished as long as the patient did not have a medication problem.
Neurological Complications, Deep Vein Thrombosis, Cardiac Complications, Superficial Infection, Other Minor Complications Even though most previous studies have shown a difference between simultaneous bilateral and staged TKA, no significant difference was seen in regards to neurological complications [OR = 1.01, 95% CI = (0.71–1.44)], deep vein thrombosis [OR = 1.07, 95% CI = (0.86–1.33)], cardiac complications [OR = 0.52, 95% CI (0.27– 1.03)], superficial infection [OR = 0.92, 95% CI = (0.62–1.38)] or other minor complications [OR = 1.65, 95% CI = (0.92–2.96)] in this meta analysis which involved considerable participants. Discussion Approximately 20% of patients with OA have severe symptoms from the other knee at the time of primary TKA and10% of patients have the other knee operated on within 1 year [32]. In patients with symmetrically severe disease in both knees, a decision must be made whether to operate at 2 different settings or a single setting. Multiple
Fig. 2. Forest plot showing the odds ratio and 95% CI for a mortality 30 days after surgery.
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
1145
Fig. 3. Forest plot showing the odds ratio and 95% CI for a mortality 30 days after surgery without the study by Ritter during a sensitivity analysis.
Pulmonary Embolism Thromboprophylaxis was routinely used during the entire study period, but we have no information concerning which thromboprophylaxis was given to each patient or for how long. The patients with simultaneous bilateral TKA had a higher proportion of patients with pulmonary embolism than the patients who had surgery on both knees at separated time. The use of a pneumatic tourniquet, intramedullary guides, and cement are factors that probably are of importance [33–35]. The most common reason for PE was fat embolism. TKA, particularly when performed as a simultaneous bilateral procedure, theoretically increased the risk for entry of fat globules into the blood stream as a result of increased operative time of both knees under one anesthesia compared with two unilateral surgery [36]. Blood Loss and Transfusion Because of the differences in the standard of reporting blood transfusion rates and blood loss, as well as the varying methods used to manage operative blood loss. A significant variation in reported blood transfusion rates for simultaneous bilateral TKA existed; rates reported had ranged from 17% to 91% [3,6,7,37–39]. The rate of blood transfusion in our study was significant higher in simultaneous group. There was the possibility that in the staged group, a mean interval of 12 months would be enough for hemopoiesis to replenish the blood loss after the first surgery. Recently, blood transfusion have decreased over time in both groups as policy was changed and patients were
treated symptomatically rather than automatically receiving a transfusion if hemoglobin levels dropped below particular levels (approximately 8 g/dL) [40]. Wound Infection and Revision Rate All the patients in each of the two operative groups were given antibiotics preoperatively, during surgery and postoperatively. A deep infection was considered any infection that occurred inside the knee joint and sometimes required removal of the prosthesis. A superficial infection was any infection of the skin that responded well to antibiotics with no residual problems [10]. The rate of wound infection associated with simultaneous bilateral TKA is the same as staged TKA of superficial infection and lower than staged TKA of deep infection which might contribute to the fact that the revision rate in simultaneous group was significant lower than that in the staged group. Cardiac Complications Prior studies have reported a significantly higher incidence of cardiac complications in patients who underwent simultaneousbilateral total knee arthroplasty compared with unilateral total knee arthroplasty or with sequential staged bilateral total knee arthroplasty [27,38]. In a recent meta-analysis on safety of a simultaneous bilateral group, Restrepo et al. [41] reported that the prevalence of cardiac complications (odds ratio = 2.49) was higher after simultaneous
Fig. 4. Forest plot showing the odds ratio and 95% CI for a pulmonary embolism (PE).
1146
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
bilateral TKA. In our study, there was no increase in cardiovascular complications in either group during our analysis. Preoperative cardiovascular comorbidities had been found to be potential risks for occurring of cardiac complications intra- and postoperatively [42]. Siler et al. [24] reported that hypertension was the most common medical comorbidity in both groups and was present in 50% of all patients. Consequently, the higher rates of cardiac morbidity following previous comorbidity calls for caution in the selection of patients for simultaneous bilateral total knee arthroplasty. Neurological Complications We were particularly interested in postoperative confusion which could be life threatening potentially. They have been consistently reported to be higher in simultaneous bilateral TKA than unilateral or staged procedures, as there was the possibility that patients who had bilateral surgery were more likely to have fat embolism from the displacement of intramedullary fat intraoperatively [43]. Nevertheless, in this analysis we found that a simultaneous procedure had no increased risk of neurological change over a staged procedure. This conflict might be explained by lacking exact definition of neurological complications and the relative small population, rarity of neurological complications following total knee arthroplasty in each previous study. Length of Hospital Stay The mean length of hospital stay in the staged bilateral group was calculated as the sum of two hospital stays. A comparison between simultaneous and staged was unavailable because of the limited data. However, 6 included studies [13,18,21,26,27,32] have made a comparison and gave the consentaneous consequence that the difference in the length of hospital stay was highly significant (P b 0.05). This result is not hard to acknowledge because of two separated procedures in staged group. Other studies have also noted that sequential procedures often reduce the number of inpatient hospital days after the procedure [6,27,31]. Reuben et al. [44] have found there was a significant correlation between hospital length of stay and total costs. Cost-Effectiveness Using a microcosting approach, Macario et al. [45] found that the average in-hospital costs for one-stage total knee arthroplasty (27,468 US dollars) were significantly lower (by 24%) than for two-stage total knee arthroplasty. Considering the repeated laboratory tests and medical consultations as well as double fees for operating room, anesthesia, recovery room, antibiotics, and physical therapy, the patients in the staged group incurred 58 per cent additional costs on average when compared with the group of patients undergoing simultaneous replacement [32]. Reuben et al. [44] also reported that bilateral simultaneous total knee arthroplasty was 36% less costly than 2 unilateral total knee arthroplasties. However, the financial savings have been questioned as more sequential rehabilitation costs are needed in simultaneous group. In general, simultaneous bilateral TKA offers the potential benefits of decreased overall recovery time, decreased overall cost, decreased number of anesthetic administrations, and simultaneous pain release and function recovery of both knees. Limitations Some limitations must be recognized in this meta-analysis. First, it is difficult to carry out a truly controlled randomized trial of patients with bilateral total knee replacement as patients with more comorbidities are often suggested to be inappropriate candidates for
simultaneous total knee arthroplasty knee arthritis because of ethical issues. It would have been expected that the sequential group would have fewer overall complications. All included studies were retrospectively reviewed with a poor methodological quality. In addition, because of the inability in extracting the related information about whether the patients in simultaneous group were operated by single or two team surgeons. Some experts have argued that only when the procedure on both knees is truly carried out simultaneously, the safety of bilateral total knee arthroplasty should be a concern [11]. Third, the information was not consistently reported in all studies included in this meta-analysis. Some comparisons between simultaneous and staged bilateral TKA were limited with the present data. Although this current Meta analysis is the one with the most studies and largest population, further well-designed and large-scale clinical trials and Systemic review are required to confirm these findings. Conclusion The results of this analysis have shown that the rate of mortality within 30 days after surgery, PE and blood transfusion associated with simultaneous TKA are higher compared with staged TKA. Mortality mainly resulting from PE may be well controlled through perioperative management of anticoagulation. New policies have decreased the use of blood transfusion. Simultaneous bilateral TKA is associated with potential benefit of lower rate of infection and revision, reduced costs, shorter anesthetic time and decreased total recovery time without increasing the incidence of neurological complications, DVP, cardiac complications. When active prevention measurements of perioperative complications are strictly applied, it remains an appropriate option in selected patients. References 1. Davis MA, Ettinger WH, Neuhaus JM, et al. The association of knee injury and obesity with unilateral and bilateral osteoarthritis of the knee. Am J Epidemiol 1989;130(2):278. 2. Taylor BC, Dimitris C, Mowbray JG, et al. Perioperative safety of two-team simultaneous bilateral total knee arthroplasty in the obese patient. J Orthop Surg Res 2010;17(5):38. 3. Adili A, Bhandari M, Petruccelli D, et al. Sequential bilateral total knee arthroplasty under 1 anesthetic in patients 75 years old: complications and functional outcomes. J Arthroplasty 2001;16(3):271. 4. Bederman SS, Betsy M, Winiarsky R, et al. Postoperative ileus in the lower extremity arthroplasty patient. J Arthroplasty 2001;16(8):1066. 5. Dorr LD, Merkel C, Mellman MF, et al. Fat emboli in bilateral total knee arthroplasty. Predictive factors for neurologic manifestations. Clin Orthop 1989;248:112. 6. Jankiewicz JJ, Sculco TP, Ranawat CS, et al. One-stage versus 2-stage bilateral total knee arthroplasty. Clin Orthop 1994;309:94. 7. Lombardi AV, Mallory TH, Fada RA, et al. Simultaneous bilateral total knee arthroplasties: who decides? Clin Orthop 2001;392:319. 8. Lynch NM, Trousdale RT, Ilstrup DM. Complications after concomitant bilateral total knee arthroplasty in elderly patients. Mayo Clin Proc 1997;72(9):799. 9. Mantilla CB, Horlocker TT, Schroeder DR, et al. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology 2002;96(5):1140. 10. Mantilla CB, Horlocker TT, Schroeder DR, et al. Risk factors for clinically relevant pulmonary embolism and deep venous thrombosis in patients undergoing primary hip or knee arthroplasty. Anesthesiology 2003;99(3):552. 11. Ritter MA, Meding JB. Bilateral simultaneous total knee arthroplasty. J Arthroplasty 1987;2(3):185. 12. Memtsoudis SG, Gonz´ alez Della Valle A, Besculides MC, et al. Inhospital complications and mortality of unilateral, bilateral, and revision TKA: based on an estimate of 4,159,661 discharges. Clin Orthop Relat Res 2008;466:2617. 13. Stanley D, Stockley I, Getty CJM. Simultaneous or staged bilateral total knee replacements in rheumatoid arthritis. J Bone Joint Surg Br 1990;72-B:772. 14. Gradillas E, Volz RG. Bilateral total knee replacement under one anaesthetic. Clin Orthop 1979;140:153. 15. Handoll HH, Gillespie WJ, Gillespie LD, et al. Moving towards evidence-based healthcare for musculoskeletal injuries: featuring the work of the Cochrane Bone, joint and Muscle Trauma Group. J R Soc Promot Health 2007;127:168. 16. Cochran WG. The combination of estimates from different experiments. Biometrics 1954;10:101. 17. Meehan JP, Danielsen B, Daniel J, et al. A population-based comparison of the incidence of adverse outcomes after simultaneous-bilateral and staged-bilateral total knee arthroplasty. J Bone Joint Surg Am 2011;93:2203.
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147 18. Yoon HS, Han CD, Yang IH. Comparison of simultaneous bilateral and staged bilateral total knee arthroplasty in terms of perioperative complications HangSeob. J Arthroplasty 2010;25(2):179. 19. Qian WW, Qiu GX, Weng XS. Comparison of perioperative complications between simultaneous and staged bilateral total knee arthroplasty. CMJ 2008;46(12):929. 20. Stefansdottir A, Lidgren L, Robertsson O. Higher early mortality with simultaneous rather than staged bilateral TKAs results from the Swedish Knee Arthroplasty register. Clin Orthop Relat Res 2008;466:3066. 21. Forster MC, Bauze AJ, Bailie AG. A retrospective comparative study of bilateral total knee replacement staged at a one-week interval. J Bone Joint Surg Br 2006;88-B: 1006. 22. Hutchinson JRM, Parish EN, Cross MJ. A comparison of bilateral uncemented total knee arthroplasty: simultaneous or staged? J Bone Joint Surg Br 2006;88B:40. 23. Stubbs E, Pryke ERP, Tewari T. Safety and cost benefits of bilateral total knee replacement in an acute hospital. J Surg 2005;75:739. 24. Silva CD, Callaghan JJ, Goetz DD, et al. Staggered bilateral total knee arthroplasty performed four to seven days apart during a single hospitalization. J Bone Joint Surg Am 2005;87(3):508. 25. Mangaleshkar SR, Prasad PSV, Chugh S, et al. Staged bilateral total knee replacement – a safer approach in older patients. Knee 2001;8:207. 26. Liu TK, Chen SH. Simultaneous bilateral total knee arthroplasty in a single procedure. Int Orthop 1998;22:390. 27. Ritter M, Mamlin L, Melfi CA, et al. Outcome implications for the timing of bilateral total knee arthroplasties. Clin Orthop Relat Res 1997;345:99. 28. Jankiewicz JJ, Sculco TP, Ranawat CS, et al. One-stage vs two-stage bilateral total knee arthroplasty. Clin Orthop Relat Res 1994;309:94. 29. Morrey BF, Adams BA, Dm Ilstrup. Complications and mortality associated with bilateral and unilateral total knee arthroplasty. J Bone Joint Surg Am 1987:484. 30. Soudry M, Binazzi R, Insall JN, et al. Successive bilateral total knee replacement. J Bone Joint Surg Am 1985;67:573. 31. Mclaughlin TP, Fisher RL. Bilateral total knee arthroplasties. Comparison of simultaneous (two-team), sequential, and staged knee replacements. Clin Orthop Relat Res 1985:220.
1147
32. Walmsley P, Murray A, Brenkel IJ. The practice of bilateral, simultaneous total knee replacement in Scotland over the last decade: data from the Scottish Arthroplasty Project. Knee 2006;13:102. 33. Berman AT, Parmet JL, Harding SP, et al. Emboli observed with use of transesophageal echocardiography immediately after tourniquet release during total knee arthroplasty with cement. J Bone Joint Surg Am 1998;80:389. 34. Parmet JL, Horrow JC, Berman AT, et al. The incidence of large venous emboli during total knee arthroplasty without pneumatic tourniquet use. Anesth Analg 1998;87: 439. 35. Parvizi J, Sullivan TA, Trousdale RT, et al. Thirty-day mortality after total knee arthroplasty. J Bone Joint Surg Am 2001;83:1157. 36. Yoon JY, Nam CH, Kim TK, et al. Cerebral fat embolism syndrome after simultaneous bilateral total knee arthroplasty: a case series. J Arthroplasty 2012;27(3):409. 37. Lane GJ, Hozack WJ, Shah S, et al. Simultaneous bilateral versus unilateral total knee arthroplasty: outcomes analysis. Clin Orthop Relat Res 1997;345:106. 38. Bullock DP, Sporer SM, Shirreffs TG. Comparison of simultaneous bilateral with unilateral total knee arthroplasty in terms of perioperative complications. J Bone Joint Surg Am 2003;85(10):1981. 39. Pavone V, Johnson T, Saulog PS, et al. Perioperative morbidity in bilateral one-stage total knee replacements. Clin Orthop Relat Res 2004;421:155. 40. Taylor BC, Dimitris C, Mowbray JG, et al. Research article Perioperative safety of two-team simultaneous bilateral total knee arthroplasty in the obese patient. Clin Orthop Relat Res 2010;17(5):38. 41. Restrepo C, Parvizi J, Dietrich T, et al. Safety of simultaneous bilateral total knee arthroplasty. A meta-analysis. J Bone Joint Surg Am 2007;89:1220. 42. Camilo R, Javad P, Thomas D, et al. Safety of simultaneous bilateral total knee arthroplasty. A meta-analysis. J Bone Joint Surg Am 2007;89:1220. 43. Lane GJ, Hozack WJ, Shah S, et al. Simultaneous bilateral versus unilateral total knee arthroplasty: outcomes analysis. Clin Orthop Relat Res 1997:106. 44. Reuben JD, Meyers SJ, Cox DD, et al. Cost comparison between bilateral simultaneous, staged, and unilateral total joint arthroplasty. J Arthroplasty 1998;13(2):172. 45. Macario A, Schilling P, Rubio R, et al. Economics of one-stage versus two-stage bilateral total knee arthroplasties. Clin Orthop Relat Res 2003;414:149.
Contents lists available at SciVerse ScienceDirect
The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org
Comparison of Clinical Outcome Between Simultaneous-Bilateral and Staged-Bilateral Total Knee Arthroplasty: A Systematic Review of Retrospective Studies Dong Fu MD 1, Guodong Li MD 1, Kai Chen MD, Hui Zeng MD, Xiaolong Zhang MD, Zhengdong Cai MD The tenth People's Hospital affiliated with Tong Ji University, Shanghai, People's Republic of China
a r t i c l e
i n f o
Article history: Received 21 July 2012 Accepted 29 September 2012 Keywords: total knee arthroplasty simultaneous staged
a b s t r a c t The purpose of this study is to conduct a systematic review assessing the clinical outcome associated with Simultaneous bilateral and staged bilateral total knee arthroplasty (TKA). A literature search for eligible studies was conducted. Eighteen retrospective comparative studies were included. Pooled results showed that the prevalence of mortality at 30 days postoperatively, pulmonary embolism, blood transfusion rate were significantly higher in simultaneous TKA group. A significantly lower rate of deep infection and revision were found in simultaneous TKA. No significant difference was seen in regard to neurological complications, deepvein thrombosis, cardiac complications, superficial infection. Compared with staged bilateral TKA, simultaneous bilateral TKA is associated with higher rates of mortality, pulmonary embolism and blood transfusion, while decreasing the risk of deep infection and revision rate. © 2013 Elsevier Inc. All rights reserved.
Total knee arthroplasty (TKA) is a successful procedure for relieving pain and restoring function in cases with severe rheumatoid arthritis and osteoarthritis. The prevalence of bilateral knee osteoarthritis has been shown to be as high as 5% [1]. Patients requiring bilateral total knee arthroplasties may have both joints replaced simultaneously or during two separate hospitalizations (two-stage). A staged procedure involves 2 unilateral arthroplasties, performed during separate anesthesias, frequently over 2 separate inpatient stays. In contrast, simultaneous arthroplasties are performed by 1 or 2 surgical team with the patient under 1 anesthetic. Although a patient with symptomatic bilateral knee diseases can be treated by replacing both knees during a single operative session, the rates of perioperative morbidity and mortality with simultaneous bilateral total knee arthroplasty remain a concern [2]. There are reports of increased perioperative complications, including pulmonary embolism, deep vein thrombosis, cardiac, neurologic and wound complications, and intensive care unit admissions in the simultaneous group [3–11]. And
Authors’ disclosures of potential conflicts of interest: The author(s) indicated no potential conflicts of interest. Author contributions: Conception and design: Dong Fu, Guodong Li. Financial support: Zhengdong Cai. Provision of study materials or patients: Guodong Li, Zhengdong Cai. Collection and assembly of data: Dong Fu, Kai Chen, Hui Zeng. Data analysis and interpretation: Dong Fu, Hui Zeng, Xiaolong Zhang. Manuscript writing: All authors. The Conflict of Interest statement associated with this article can be found at http:// dx.doi.org/10.1016/j.arth.2012.09.023. Reprint requests: Zhengdong Cai MD, Department of Orthopedics, The Tenth People's Hospital affiliated with Tong Ji University, 301 Yanchang Rd, Shanghai 200072, People's Republic of China. 1 Dong Fu and Guodong Li are co-first authors. 0883-5403/2807-0019$36.00/0 – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.arth.2012.09.023
some other studies suggested that the overall incidence of complications might be lower after simultaneous-bilateral TKA than after staged bilateral arthroplasty [12–14]. Several clinical trials have evaluated the effect of simultaneous and staged TKA, but most of them involved relatively small cohorts of patients and thus their results lacked statistical power. The aim of this meta-analysis was to evaluate the prevalence of mortality, various complications and cost effectiveness between these two procedures. Materials and Methods Identification and Selection of Studies We carried out a literature search using Medline, Embase, Ovid and Cochrane databases to identify all articles published between 1965 and 2012 that evaluated the outcome of patients undertaking either simultaneous bilateral TKA or staged bilateral TKA. No other restrictions were placed except that the language of the publications was limited in English. Reports relating to both simultaneous TKA and staged TKA were included regardless of whether unilateral TKA was involved in the comparison. The following Medical Subject Headings (MeSH) and terms were used in searching: “bilateral total knee arthroplasty”, “staged total knee arthroplasty”, and “total knee arthroplasty”. The reference list of each comparative study and previous reviews were manually examined to find additional relevant studies. We also contacted each author of the included studies to identify some more details of the clinical outcome and further studies on the same topic by e-mail.
1142
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
To minimize any possible selection bias, the following criteria were established. Strict inclusion criteria included clinically significant osteoarthritis or rheumatoid arthritis in both knees and severe pain unrelieved by conventional therapy. Patients who had a primary trauma, knee infection, total knee arthroplasty or revision were excluded. Two reviewers (D. F and Gd. L) independently assessed each of the studies for eligibility for inclusion. Firstly the title or the abstract was judged by either reviewer and then if it was potentially eligible, the full article would be examined. All disagreements were resolved by consensus. Data Extraction Data were extracted independently by two authors subsequently after all the eligible studies were recruited. All pertinent information regarding participant and clinical outcome were recorded. Participant data included the number of patients, age, gender (the rate of males in all participants). The principal outcomes of interest included details of the incidence of complications (pulmonary embolism, deep-vein thrombosis, cardiac complications, neurological complications, deep infection and superficial infection) and mortality (within 30 days after surgery) as well as blood loss and transfusion, length of hospital stay, and the rate of revision arthroplasty. Study Quality Based on the Cochrane Bone, Joint and Muscle Trauma Group [15], assessment of the methodological quality of each included study was made by the 2 reviewers (D.F and Gd. L) who were blinded with respect to the journal, the authors and the source institution. Any controversy was cross-checked and resolved by a third author (K.C) to reach a final consensus.
Statistical Analysis Study-specific OR (Odds risks) and associated 95 % CI (confidence intervals) accounting for discontinuous variables within the study were pooled using a random-effects model, which considered both within-study and between-study variation. Standardized mean difference (SMD) or weighted mean difference (WMD) were used for continuous variables for which a fixed effect model was used initially, and if the P value of heterogeneity test was b0.1 or I 2 N 50% [16], the random effect model replaced the previous modality. Sensitivity analysis was performed to evaluate the stability of the results. Subgroup analysis was conducted if the data was present. Forest plots were used to graphically present the results of individual studies and the respective pooled estimate of effect size. All statistical analysis were performed with Review Manager (version 5.0.0 for Windows, The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, 2008). Results Study characteristics A flow chart of the studies recruited in our review was shown in Fig. 1. Eighteen retrospective cohort studies [10,13,17–32] with 107,318 patients of which 28,760 were simultaneous bilateral TKA and 78,558 were staged bilateral TKA were selected for inclusion in the meta analysis. Details on all of the studies were shown in Table 1(A, B). Preoperative patient characteristics did not show any significant differences between groups with the exception of a greater percentage of female in the staged group. The result of each comparison was shown in Table 2.
Fig. 1. Flow chart of the studies recruited in this meta-analysis.
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
1143
Table 1A Details On All of The Studies Included In The Meta-Analysis.
Patients Study (year) Meehan 2011 Yoon 2010 Qian 2008 Stefansdottir 2008 Forster 2006 Hutchinson2006 Stubbs 2005 Sliva 2005 Ritter 2003 Mangaleshkar2001 Liu 1998 Ritter 1997 Jankiewicz 1994 Stanley 1990 Morrey 1987 Soudry 1985 Mclaughlin 1985 Willian 1978
Age (Years)
Sex
Sim Complications
Sim/Sta
Sim(M/F)
Sta(M/F)
Sim
Sta
Mor
PE
11,445/23,715 119/119 48/48 1,139/3,432 28/74 438/125 61/38 26/306 2,050/152 54/34 64/24 12,922/50,108 99/56 32/18 145/231 56/18 22/46 12/14
5,280/6,165 7/112 9/39 465/674 15/13 245/193 NC 14/12 906/1,144 21/33 3/61 4,988/7,934 34/65 8/24 56/89 17/39 7/15 8/4
9,171/14,544 7/112 9/39 1,287,2,145 34/49 46/79 NC 106/200 35/117 13/21 0/24 16,595/33,513 14/42 4/14 71/160 5/13 12/34 6/8
67.2 70 61 70.4 66 67 64 59.3 69.9 73 66.7 73.4 69 62 63.2 68.8 70 61
67.7 70 61 71.2 68 65 67 65.6 69.2 71.7 68.6 72.9 71 58 62.4 69 69 62
43 0 0 11 0 1 0 0 NC 4 0 128 0 NC 4 NC NC NC
110 0 1 NC 1 15 NC 0 18 NC 0 NC 3 NC 3 2 NC NC
Sta Complications
DVT Car Neu
DI
SI
Others Mor
96 0 1 NC NC 77 NC NC NC NC NC NC NC NC 2 NC 0 NC
96 0 1 NC NC 4 0 NC 31 NC 1 NC 0 NC NC 1 0 NC
27 6 0 NC NC NC 0 NC 14 NC 1 NC 0 1 NC NC NC NC
627 3 NC NC NC 7 17 9 44 NC 9 NC NC NC NC 4 NC 3
81 0 3 NC 0 10 15 0 NC NC 0 NC NC NC NC 0 0 NC
29 2 4 NC 1 0 9 0 6 NC NC NC 12 NC NC NC 1 NC
76 0 0 14 0 1 0 1 NC 0 0 160 0 NC 5 NC NC NC
PE
DVT
Car
Neu
DI
SI
Others
161 0 0 NC 3 4 NC 1 1 NC 0 NC 2 NC 1 0 NC NC
190 0 0 NC NC 21 NC NC NC NC NC NC NC NC 1 NC 7 NC
176 1 1 NC 1 5 22 4 NC NC 2 NC NC NC NC 2 2 NC
62 0 1 NC 2 0 9 1 0 NC NC NC 7 NC NC NC 0 NC
391 0 0 NC NC 3 0 NC 3 NC 0 NC 0 NC NC 0 1 NC
59 5 O NC NC NC 0 NC 2 NC 1 NC 0 0 NC NC NC NC
1195 1 NC NC NC 2 16 45 2 NC 1 NC NC NC NC 0 NC 5
Abbreviations: Sim, simultaneous bilateral total knee arthroplasty; Sta, staged bilateral total knee arthroplasty; Mor, mortality; PE, pulmonary embolism; DVT, deep-vein thrombosis; Car, cardiac complications; Neu, neurological complications (stroke, cerebrovascular accidents); DI, deep infection; SI, superficial infection; others, other minor complications (respiratory, digestive, urinary complications and so on); M/F, male/female; NC, not clear.
group than that happened in staged group with a significant difference (Fig. 4).
Mortality A total of 7 studies [17,20,22,23,25,27,29] including 104,120 patients were included for analysis of mortality. The prevalence of mortality was significantly higher in patients that had undergone simultaneous TKA when compared with those who had undergone staged TKA 30 days after surgery Fig. 1 (Fig. 2). During analysis, an obvious heterogeneity (p = 0.009) of the combined data was found. Each of the 7 studies was excluded respectively to do a sensitivity analysis. The result showed that the heterogeneity disappeared only when the study by Ritter [27] was deleted and the higher risk of mortality in simultaneous group still existed while without significant difference (Fig. 3).
Blood Transfusion Based on the available data, only 3 studies [23,24,28] with 586 patients were involved. Patients in simultaneous group did have a significant higher rate of blood transfusion [OR = 11.52, 95% CI (2.59, 51.28)] intra- and post-operatively. Because of the limited data, we had not done a sensitivity analysis despite the high Heterogeneity (p = 0.009). Information about the units of blood transfusion only give in one article [26] as mean plus minus standard error and whether the amount of transfusion was significantly different remained unclear.
Pulmonary Embolism Deep Infection Nine studies [10,17,19,21,22,24,28–30] with 39,135 patients were involved when comparing the prevalence of pulmonary embolism (PE). The odds ratios ranged from 0.20 to 4.86 and the total value of odds ratios was 1.39. The rate of PE was higher in simultaneous TKA
A deep infection was considered any infection that occurred inside the knee joint and required liner removal, arthrotomy, debridement, synovectomy, or even revision knee arthroplasty. Seven studies
Table 1B Sim Group Study (Year) Meehan 2011 Yoon 2010 Qian 2008 Stefansdottir 2008 Forster 2006 Hutchinson2006 Stubbs 2005 Sliva 2005 Ritter 2003 Mangaleshkar2001 Liu 1998 Ritter 1997 Jankiewicz 1994 Stanley 1990 Morrey 1987 Soudry 1985 Mclaughlin 1985 Willian 1978
BL(ml) NC 1,299 973 ± 38 NC 3,312 NC 1,701 NC NC NC 2,744 ± 727 NC 1,521 NC NC NC NC NC
Sta Group
BT(N)
BT(Units)
R
NC NC NC NC NC NC 58 14 NC NC NC NC 60 NC NC NC NC NC
NC NC NC NC 6 NC 3.59 2 NC NC 4.8 ± 1.4 NC 2.9 NC NC NC NC NC
61 NC NC NC NC 1 1 NC NC NC NC NC NC NC 7 NC NC 0
LOHS(days) NC 7.5 NC NC 11 NC 11 NC NC NC 16.5 ± 4.5 12 NC 22 NC NC NC 24 ± 3
BL(ml) NC 1,302 1,020 ± 40 NC 2,578 NC 896 NC NC NC 2,030 ± 551 NC 1,072 NC NC NC NC NC
P
BT(N)
BT(Units)
R
NC NC NC NC NC NC 21 11 NC NC NC NC 17 NC NC NC NC NC
NC NC NC NC 5.8 NC 2.0 1 NC NC 4.94 ± 1.58 NC 2.25 NC NC NC NC NC
254 NC NC NC NC 1 0 NC NC NC NC NC NC NC 31 NC NC 0
LOHS(Days) NC 11.7 NC NC 15 NC 16 NC NC NC 20.9 ± 3.5 20 NC 44 NC NC NC 33 ± 2
BL
BT(N)
BT(Unit)
R
LOHS
b0.05 N0.05 N0.05
b0.01
NC NC
b0.01 b0.01
b0.05 b0.01
b0.05
NC NC NC
N0.05 N0.05
N0.05 b0.01
NC
b0.01 b0.01
NC b0.01 b0.01
b0.01
Abbreviations: Sim, simultaneous bilateral total knee arthroplasty; Sta, staged bilateral total knee arthroplasty; BL, blood loss; BT, blood transfusion; R, revision; LOHS, length of hospital stay.
1144
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
Table 2 Outcome Measures In The Meta-Analysis of Comparisons Between Simultaneous And Staged Bilateral TKA. Outcome
Odds Ratio (95% CI)
Mortality⁎ Pulmonary embolism⁎ Deep-vein thrombosis Cardiac complications Neurological complications Deep infection⁎ Superficial infection Other minor complications Revision Rate⁎ Blood transfusion rate⁎
2.25 1.39 1.07 0.52 1.01 0.52 0.92 1.65 0.48 11.52
(1.87–2.72) (1.11–1.76) (0.86–1.33) (0.27, 1.03) (0.71–1.44) (0.42–0.64) (0.62–1.38) (0.92–2.96) (0.37–0.62) (2.59–51.28)
P b0.0001⁎ 0.005⁎ 0.57 0.06 0.96 b0.00001⁎ 0.69 0.10 b0.0001⁎ 0.001⁎
Heterogeneity
I2 %
Number of Patients
Number of Studies
0.009 0.9 0.86 0.05 0.65 0.9 0.85 0.01 0.64 0.009
73 0 0 46 0 0 0 59 0 86
104,120 39,135 36,507 36,820 39,015 38,743 38,085 38,321 36,198 586
7 9 5 10 9 7 5 9 4 3
⁎ Significantly different between simultaneous and staged bilateral TKA.
[10,17,19,22,26,30,31] with 38,743 patients were involved and the pooled data showed a much lower incidence in patients who had received simultaneous TKA than those in staged group with significant difference without heterogeneity [OR = 0.52, 95% CI = (0.42–0.64)].
studies have shown the procedure of simultaneous bilateral TKA to be safe in selected patient populations. The sum of the risks associated with the two operations of a staged procedure may equal or exceed the risk of simultaneous total knee replacement.
Revision Rate
Mortality
Four studies [11,22,27,29] with 36,198 were involved in this analysis. The rate of revision was statistically significantly different between the 2 groups; a trend toward higher rates existed in the staged TKA group without heterogeneity [OR = 0.48, 95% CI =(0.37–0.62)].
Mortality within 30 days after surgery is chosen as a primary end point, because death occurring during that time is likely to be causally associated with the operation. The predominant cause of death (77.8%) was a disease of the circulatory system [21]. In this analysis, the incidence of mortality with 30 days postoperatively was significant higher in simultaneous group which might be influenced by the higher rate of pulmonary embolism. Another possible reason was the fact that the rate of mortality in staged group was calculated in the patients who had to survive the first operation to have the second one, which indicated a selection bias of healthier patients for the second operation. The study by Ritter et al. [27] was deleted because of high heterogeneity. We explored potential sources of this study and tried to explain this difference. It was observed that the gap between the procedures in case of two-stage TKA were divided into 4 subgroups [within six weeks (4354 knees), three months (4524 knees), six months (9829 knees), and one year (31,401 knees)] while the mean interval averaged 1 year in almost all the other included studies. 30 days after surgery, compared with staged group, a larger proportion of patients survived in simultaneous group and the rate of mortality increased with the increasing of interval between two unilateral procedures without significant difference. Yoon et al. [18] have suggested the time of the second operation would be decided through discussion with the patient as the patient wished as long as the patient did not have a medication problem.
Neurological Complications, Deep Vein Thrombosis, Cardiac Complications, Superficial Infection, Other Minor Complications Even though most previous studies have shown a difference between simultaneous bilateral and staged TKA, no significant difference was seen in regards to neurological complications [OR = 1.01, 95% CI = (0.71–1.44)], deep vein thrombosis [OR = 1.07, 95% CI = (0.86–1.33)], cardiac complications [OR = 0.52, 95% CI (0.27– 1.03)], superficial infection [OR = 0.92, 95% CI = (0.62–1.38)] or other minor complications [OR = 1.65, 95% CI = (0.92–2.96)] in this meta analysis which involved considerable participants. Discussion Approximately 20% of patients with OA have severe symptoms from the other knee at the time of primary TKA and10% of patients have the other knee operated on within 1 year [32]. In patients with symmetrically severe disease in both knees, a decision must be made whether to operate at 2 different settings or a single setting. Multiple
Fig. 2. Forest plot showing the odds ratio and 95% CI for a mortality 30 days after surgery.
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
1145
Fig. 3. Forest plot showing the odds ratio and 95% CI for a mortality 30 days after surgery without the study by Ritter during a sensitivity analysis.
Pulmonary Embolism Thromboprophylaxis was routinely used during the entire study period, but we have no information concerning which thromboprophylaxis was given to each patient or for how long. The patients with simultaneous bilateral TKA had a higher proportion of patients with pulmonary embolism than the patients who had surgery on both knees at separated time. The use of a pneumatic tourniquet, intramedullary guides, and cement are factors that probably are of importance [33–35]. The most common reason for PE was fat embolism. TKA, particularly when performed as a simultaneous bilateral procedure, theoretically increased the risk for entry of fat globules into the blood stream as a result of increased operative time of both knees under one anesthesia compared with two unilateral surgery [36]. Blood Loss and Transfusion Because of the differences in the standard of reporting blood transfusion rates and blood loss, as well as the varying methods used to manage operative blood loss. A significant variation in reported blood transfusion rates for simultaneous bilateral TKA existed; rates reported had ranged from 17% to 91% [3,6,7,37–39]. The rate of blood transfusion in our study was significant higher in simultaneous group. There was the possibility that in the staged group, a mean interval of 12 months would be enough for hemopoiesis to replenish the blood loss after the first surgery. Recently, blood transfusion have decreased over time in both groups as policy was changed and patients were
treated symptomatically rather than automatically receiving a transfusion if hemoglobin levels dropped below particular levels (approximately 8 g/dL) [40]. Wound Infection and Revision Rate All the patients in each of the two operative groups were given antibiotics preoperatively, during surgery and postoperatively. A deep infection was considered any infection that occurred inside the knee joint and sometimes required removal of the prosthesis. A superficial infection was any infection of the skin that responded well to antibiotics with no residual problems [10]. The rate of wound infection associated with simultaneous bilateral TKA is the same as staged TKA of superficial infection and lower than staged TKA of deep infection which might contribute to the fact that the revision rate in simultaneous group was significant lower than that in the staged group. Cardiac Complications Prior studies have reported a significantly higher incidence of cardiac complications in patients who underwent simultaneousbilateral total knee arthroplasty compared with unilateral total knee arthroplasty or with sequential staged bilateral total knee arthroplasty [27,38]. In a recent meta-analysis on safety of a simultaneous bilateral group, Restrepo et al. [41] reported that the prevalence of cardiac complications (odds ratio = 2.49) was higher after simultaneous
Fig. 4. Forest plot showing the odds ratio and 95% CI for a pulmonary embolism (PE).
1146
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147
bilateral TKA. In our study, there was no increase in cardiovascular complications in either group during our analysis. Preoperative cardiovascular comorbidities had been found to be potential risks for occurring of cardiac complications intra- and postoperatively [42]. Siler et al. [24] reported that hypertension was the most common medical comorbidity in both groups and was present in 50% of all patients. Consequently, the higher rates of cardiac morbidity following previous comorbidity calls for caution in the selection of patients for simultaneous bilateral total knee arthroplasty. Neurological Complications We were particularly interested in postoperative confusion which could be life threatening potentially. They have been consistently reported to be higher in simultaneous bilateral TKA than unilateral or staged procedures, as there was the possibility that patients who had bilateral surgery were more likely to have fat embolism from the displacement of intramedullary fat intraoperatively [43]. Nevertheless, in this analysis we found that a simultaneous procedure had no increased risk of neurological change over a staged procedure. This conflict might be explained by lacking exact definition of neurological complications and the relative small population, rarity of neurological complications following total knee arthroplasty in each previous study. Length of Hospital Stay The mean length of hospital stay in the staged bilateral group was calculated as the sum of two hospital stays. A comparison between simultaneous and staged was unavailable because of the limited data. However, 6 included studies [13,18,21,26,27,32] have made a comparison and gave the consentaneous consequence that the difference in the length of hospital stay was highly significant (P b 0.05). This result is not hard to acknowledge because of two separated procedures in staged group. Other studies have also noted that sequential procedures often reduce the number of inpatient hospital days after the procedure [6,27,31]. Reuben et al. [44] have found there was a significant correlation between hospital length of stay and total costs. Cost-Effectiveness Using a microcosting approach, Macario et al. [45] found that the average in-hospital costs for one-stage total knee arthroplasty (27,468 US dollars) were significantly lower (by 24%) than for two-stage total knee arthroplasty. Considering the repeated laboratory tests and medical consultations as well as double fees for operating room, anesthesia, recovery room, antibiotics, and physical therapy, the patients in the staged group incurred 58 per cent additional costs on average when compared with the group of patients undergoing simultaneous replacement [32]. Reuben et al. [44] also reported that bilateral simultaneous total knee arthroplasty was 36% less costly than 2 unilateral total knee arthroplasties. However, the financial savings have been questioned as more sequential rehabilitation costs are needed in simultaneous group. In general, simultaneous bilateral TKA offers the potential benefits of decreased overall recovery time, decreased overall cost, decreased number of anesthetic administrations, and simultaneous pain release and function recovery of both knees. Limitations Some limitations must be recognized in this meta-analysis. First, it is difficult to carry out a truly controlled randomized trial of patients with bilateral total knee replacement as patients with more comorbidities are often suggested to be inappropriate candidates for
simultaneous total knee arthroplasty knee arthritis because of ethical issues. It would have been expected that the sequential group would have fewer overall complications. All included studies were retrospectively reviewed with a poor methodological quality. In addition, because of the inability in extracting the related information about whether the patients in simultaneous group were operated by single or two team surgeons. Some experts have argued that only when the procedure on both knees is truly carried out simultaneously, the safety of bilateral total knee arthroplasty should be a concern [11]. Third, the information was not consistently reported in all studies included in this meta-analysis. Some comparisons between simultaneous and staged bilateral TKA were limited with the present data. Although this current Meta analysis is the one with the most studies and largest population, further well-designed and large-scale clinical trials and Systemic review are required to confirm these findings. Conclusion The results of this analysis have shown that the rate of mortality within 30 days after surgery, PE and blood transfusion associated with simultaneous TKA are higher compared with staged TKA. Mortality mainly resulting from PE may be well controlled through perioperative management of anticoagulation. New policies have decreased the use of blood transfusion. Simultaneous bilateral TKA is associated with potential benefit of lower rate of infection and revision, reduced costs, shorter anesthetic time and decreased total recovery time without increasing the incidence of neurological complications, DVP, cardiac complications. When active prevention measurements of perioperative complications are strictly applied, it remains an appropriate option in selected patients. References 1. Davis MA, Ettinger WH, Neuhaus JM, et al. The association of knee injury and obesity with unilateral and bilateral osteoarthritis of the knee. Am J Epidemiol 1989;130(2):278. 2. Taylor BC, Dimitris C, Mowbray JG, et al. Perioperative safety of two-team simultaneous bilateral total knee arthroplasty in the obese patient. J Orthop Surg Res 2010;17(5):38. 3. Adili A, Bhandari M, Petruccelli D, et al. Sequential bilateral total knee arthroplasty under 1 anesthetic in patients 75 years old: complications and functional outcomes. J Arthroplasty 2001;16(3):271. 4. Bederman SS, Betsy M, Winiarsky R, et al. Postoperative ileus in the lower extremity arthroplasty patient. J Arthroplasty 2001;16(8):1066. 5. Dorr LD, Merkel C, Mellman MF, et al. Fat emboli in bilateral total knee arthroplasty. Predictive factors for neurologic manifestations. Clin Orthop 1989;248:112. 6. Jankiewicz JJ, Sculco TP, Ranawat CS, et al. One-stage versus 2-stage bilateral total knee arthroplasty. Clin Orthop 1994;309:94. 7. Lombardi AV, Mallory TH, Fada RA, et al. Simultaneous bilateral total knee arthroplasties: who decides? Clin Orthop 2001;392:319. 8. Lynch NM, Trousdale RT, Ilstrup DM. Complications after concomitant bilateral total knee arthroplasty in elderly patients. Mayo Clin Proc 1997;72(9):799. 9. Mantilla CB, Horlocker TT, Schroeder DR, et al. Frequency of myocardial infarction, pulmonary embolism, deep venous thrombosis, and death following primary hip or knee arthroplasty. Anesthesiology 2002;96(5):1140. 10. Mantilla CB, Horlocker TT, Schroeder DR, et al. Risk factors for clinically relevant pulmonary embolism and deep venous thrombosis in patients undergoing primary hip or knee arthroplasty. Anesthesiology 2003;99(3):552. 11. Ritter MA, Meding JB. Bilateral simultaneous total knee arthroplasty. J Arthroplasty 1987;2(3):185. 12. Memtsoudis SG, Gonz´ alez Della Valle A, Besculides MC, et al. Inhospital complications and mortality of unilateral, bilateral, and revision TKA: based on an estimate of 4,159,661 discharges. Clin Orthop Relat Res 2008;466:2617. 13. Stanley D, Stockley I, Getty CJM. Simultaneous or staged bilateral total knee replacements in rheumatoid arthritis. J Bone Joint Surg Br 1990;72-B:772. 14. Gradillas E, Volz RG. Bilateral total knee replacement under one anaesthetic. Clin Orthop 1979;140:153. 15. Handoll HH, Gillespie WJ, Gillespie LD, et al. Moving towards evidence-based healthcare for musculoskeletal injuries: featuring the work of the Cochrane Bone, joint and Muscle Trauma Group. J R Soc Promot Health 2007;127:168. 16. Cochran WG. The combination of estimates from different experiments. Biometrics 1954;10:101. 17. Meehan JP, Danielsen B, Daniel J, et al. A population-based comparison of the incidence of adverse outcomes after simultaneous-bilateral and staged-bilateral total knee arthroplasty. J Bone Joint Surg Am 2011;93:2203.
D. Fu et al. / The Journal of Arthroplasty 28 (2013) 1141–1147 18. Yoon HS, Han CD, Yang IH. Comparison of simultaneous bilateral and staged bilateral total knee arthroplasty in terms of perioperative complications HangSeob. J Arthroplasty 2010;25(2):179. 19. Qian WW, Qiu GX, Weng XS. Comparison of perioperative complications between simultaneous and staged bilateral total knee arthroplasty. CMJ 2008;46(12):929. 20. Stefansdottir A, Lidgren L, Robertsson O. Higher early mortality with simultaneous rather than staged bilateral TKAs results from the Swedish Knee Arthroplasty register. Clin Orthop Relat Res 2008;466:3066. 21. Forster MC, Bauze AJ, Bailie AG. A retrospective comparative study of bilateral total knee replacement staged at a one-week interval. J Bone Joint Surg Br 2006;88-B: 1006. 22. Hutchinson JRM, Parish EN, Cross MJ. A comparison of bilateral uncemented total knee arthroplasty: simultaneous or staged? J Bone Joint Surg Br 2006;88B:40. 23. Stubbs E, Pryke ERP, Tewari T. Safety and cost benefits of bilateral total knee replacement in an acute hospital. J Surg 2005;75:739. 24. Silva CD, Callaghan JJ, Goetz DD, et al. Staggered bilateral total knee arthroplasty performed four to seven days apart during a single hospitalization. J Bone Joint Surg Am 2005;87(3):508. 25. Mangaleshkar SR, Prasad PSV, Chugh S, et al. Staged bilateral total knee replacement – a safer approach in older patients. Knee 2001;8:207. 26. Liu TK, Chen SH. Simultaneous bilateral total knee arthroplasty in a single procedure. Int Orthop 1998;22:390. 27. Ritter M, Mamlin L, Melfi CA, et al. Outcome implications for the timing of bilateral total knee arthroplasties. Clin Orthop Relat Res 1997;345:99. 28. Jankiewicz JJ, Sculco TP, Ranawat CS, et al. One-stage vs two-stage bilateral total knee arthroplasty. Clin Orthop Relat Res 1994;309:94. 29. Morrey BF, Adams BA, Dm Ilstrup. Complications and mortality associated with bilateral and unilateral total knee arthroplasty. J Bone Joint Surg Am 1987:484. 30. Soudry M, Binazzi R, Insall JN, et al. Successive bilateral total knee replacement. J Bone Joint Surg Am 1985;67:573. 31. Mclaughlin TP, Fisher RL. Bilateral total knee arthroplasties. Comparison of simultaneous (two-team), sequential, and staged knee replacements. Clin Orthop Relat Res 1985:220.
1147
32. Walmsley P, Murray A, Brenkel IJ. The practice of bilateral, simultaneous total knee replacement in Scotland over the last decade: data from the Scottish Arthroplasty Project. Knee 2006;13:102. 33. Berman AT, Parmet JL, Harding SP, et al. Emboli observed with use of transesophageal echocardiography immediately after tourniquet release during total knee arthroplasty with cement. J Bone Joint Surg Am 1998;80:389. 34. Parmet JL, Horrow JC, Berman AT, et al. The incidence of large venous emboli during total knee arthroplasty without pneumatic tourniquet use. Anesth Analg 1998;87: 439. 35. Parvizi J, Sullivan TA, Trousdale RT, et al. Thirty-day mortality after total knee arthroplasty. J Bone Joint Surg Am 2001;83:1157. 36. Yoon JY, Nam CH, Kim TK, et al. Cerebral fat embolism syndrome after simultaneous bilateral total knee arthroplasty: a case series. J Arthroplasty 2012;27(3):409. 37. Lane GJ, Hozack WJ, Shah S, et al. Simultaneous bilateral versus unilateral total knee arthroplasty: outcomes analysis. Clin Orthop Relat Res 1997;345:106. 38. Bullock DP, Sporer SM, Shirreffs TG. Comparison of simultaneous bilateral with unilateral total knee arthroplasty in terms of perioperative complications. J Bone Joint Surg Am 2003;85(10):1981. 39. Pavone V, Johnson T, Saulog PS, et al. Perioperative morbidity in bilateral one-stage total knee replacements. Clin Orthop Relat Res 2004;421:155. 40. Taylor BC, Dimitris C, Mowbray JG, et al. Research article Perioperative safety of two-team simultaneous bilateral total knee arthroplasty in the obese patient. Clin Orthop Relat Res 2010;17(5):38. 41. Restrepo C, Parvizi J, Dietrich T, et al. Safety of simultaneous bilateral total knee arthroplasty. A meta-analysis. J Bone Joint Surg Am 2007;89:1220. 42. Camilo R, Javad P, Thomas D, et al. Safety of simultaneous bilateral total knee arthroplasty. A meta-analysis. J Bone Joint Surg Am 2007;89:1220. 43. Lane GJ, Hozack WJ, Shah S, et al. Simultaneous bilateral versus unilateral total knee arthroplasty: outcomes analysis. Clin Orthop Relat Res 1997:106. 44. Reuben JD, Meyers SJ, Cox DD, et al. Cost comparison between bilateral simultaneous, staged, and unilateral total joint arthroplasty. J Arthroplasty 1998;13(2):172. 45. Macario A, Schilling P, Rubio R, et al. Economics of one-stage versus two-stage bilateral total knee arthroplasties. Clin Orthop Relat Res 2003;414:149.