Abstract
Objective
The implications of the interval of staged bilateral total knee arthroplasty (TKA) procedures for postoperative complications and costs are not clear. We aimed to determine the optimal time interval between the two stages of bilateral TKA procedures under the enhanced recovery after surgery (ERAS) protocol.
Methods
This retrospective study of collected data included bilateral TKA cases under the ERAS protocol performed between 2018 and 2021 at the West China Hospital of Sichuan University. The staged time was subdivided into three groups according to the interval between the first TKA and second contralateral TKA: group 1: 2‐ to 6‐month, group 2: 6‐ to 12‐month, and group 3: >12 months. The primary outcome was the incidence of postoperative complications. The secondary outcomes were the length of hospital stay (LOS), hemoglobin (Hb) decrease, hematocrit (Hct) decrease, and albumin (Alb) decrease.
Results
We analyzed 281 patients who underwent staged bilateral TKAs between 2018 and 2021 at the West China Hospital of Sichuan University. Regarding postoperative complications, there were no statistically significant differences among the three groups (P = 0.21). For the mean LOS, the 6‐ to 12‐month group had a significantly shorter LOS compared with the 2‐ to 6‐month group (P < 0.01). There was also a significant decrease in Hct of the 2‐ to 6‐month group compared with the 6‐ to 12‐month group and the >12 months group (P = 0.02; P < 0.05, respectively).
Conclusion
Staging the second arthroplasty for more than a half year seems to offer a reduction in the rate of postoperative complications and LOS under ERAS protocol. ERAS shortens the interval of staged bilateral TKA by at least 6 months for patients who might receive their second surgery without the need to wait for an extended period.
Keywords: Blood loss, Complications, Enhanced recovery after surgery, Total knee arthroplasty
We collected data included bilateral TKA cases under the ERAS protocol performed between 2018 and 2021 at our hospital. The staged time was subdivided into three groups according to the interval between the first TKA and second contralateral TKA: group 1: 2‐ to 6‐month, group 2: 6‐ to 12‐month, and group 3: >12 months. The primary outcome was the incidence of postoperative complications. The secondary outcomes were the length of hospital stay (LOS), hemoglobin (Hb) decrease, hematocrit (Hct) decrease, and albumin (Alb) decrease. We aimed to determine the optimal time interval between the two stages of bilateral TKA procedures under the ERAS protocol.
Introduction
Total knee arthroplasty (TKA) has been confirmed to be one of the most cost‐effective and consistently successful surgeries concerning pain relief, functional restoration, and improved quality of life for patients with symptomatic knee osteoarthritis (OA). 1 Symptomatic knee OA is an increasingly common condition due to extended life span, increasing incidence of obesity, and demand for a high quality of life. 2 While OA affects millions of Americans, the annual incidence of knee OA is estimated at 240 per 100,000 patients in the United States. 3 Previous studies showed that one‐third of patients presented with OA in both knees. 4 , 5 If both knees are involved with OA, controversy remains regarding how to properly choose the timing of TKA, as surgery can be performed in a simultaneous or staged manner. Recent reports showed that approximately 7% of all TKA in America were simultaneous bilateral TKA, and 15% performed staged bilateral TKA. 6
Although simultaneous bilateral TKA offered the benefits of decreased costs and recovery time, they resulted in a greater physiological burden and a higher incidence of perioperative complications. 7 , 8 , 9 , 10 Abdelaal et al. demonstrated that simultaneous bilateral TKA was associated with more complications and revisions than staged bilateral TKAs. 11 Therefore, not all patients are candidates for simultaneous bilateral TKA, and orthopedic surgeons prefer to stage the two TKAs. The interval of staged bilateral TKA has been the most crucial challenge for surgeons. A growing body of evidence suggests that the timing of staged bilateral TKA is at least 90 days but not more than 365 days apart, involving a reduced risk of perioperative complications compared with simultaneous bilateral TKA. 12
Enhanced recovery after surgery (ERAS) protocols, first described by Henrik Kehlet in 1997, have made significant advancements in TKA success. 13 ERAS is of great significance for orthopedic patients and can effectively shorten the length of hospital stay (LOS), accelerate rehabilitation, prevent deep venous thrombosis (DVT) of the lower limbs and enhance the satisfaction rate of patients. 14 In ERAS, numerous perioperative intervention regimens have been advanced, including early ambulation and multimodal pain management. 15 For example, early ambulation within 24 hours and partial or full weight‐bearing activities within 24 hours after TKA associated with improved knee function and lower hospitalization costs in the Chinese population. 16 Additionally, one aspect of ERAS is multimodal pain management. This can reduce opioid consumption, which can potentially lessen the incidence of hospital adverse events such as nausea and vomiting and urinary retention. 17 , 18
However, the perioperative risks based on the timing of the second‐stage TKA under the ERAS protocol are not known. Our purpose was: (i) to determine whether the interval to the second stage influences the clinical outcomes; and (ii) to evaluate the optimal interval of staged bilateral TKA under the ERAS protocol.
Methods
Study Design
This study was approved by our institutional review board of the West China Hospital of Sichuan University (No. 201302007). We performed a retrospective analysis of all staged bilateral TKA procedures from January 2018 to December 2021 at the West China Hospital of Sichuan University. The starting time point of the interval of staged bilateral TKA was on the day of the first TKA surgery and the ending time point was on the day of the second contralateral TKA surgery.
The inclusion criteria included: (i) patients who were 18 years older and diagnosed with primary knee OA or rheumatoid arthritis (RA) who needed to undergo staged bilateral TKA at the West China Hospital of Sichuan University; (ii) the interval of staged bilateral TKA which was longer than 2 months; and (iii) the medical records of patients during the hospital were complete.
The exclusion criteria included: (i) patients who performed simultaneous TKA during this study period; (ii) patients were diagnosed fracture (posttraumatic OA) and hemophilic arthropathy; and (iii) patients who undergone total hip arthroplasty (THA).
The staged time was subdivided into three groups according to the interval between the first TKA and second contralateral TKA: group 1: 2 to 6 months, group 2: 6 to 12 months, and group 3: >12 months. Their procedures and medical records, which are linked to the unique identifier, were tracked using the Hospital Information System (HIS) at the West China Hospital of Sichuan University. We included patient characteristic information such as age, gender, ethnicity, type of work (sedentary, strenuous activity, or others), body mass index (BMI), comorbidity (hypertension, type 2 diabetes, or others), and history of medications. Surgical procedure‐related data, such as the American Society of Anesthesiologists (ASA) grade, estimated blood loss, and infusion fluid volume, were also included.
At our facility, patients who underwent staged bilateral TKA at intervals of less than 60 days were almost younger and more physically fit. To maintain the consistency of the baseline data and medical state of the included patients, we omitted patients who underwent staged bilateral TKA at intervals of less than 60 days. The detailed process of inclusion and exclusion is shown in Fig. 1.
Fig. 1.
The flowchart of the patient selection process and the patients were divided into different groups. TKA: total knee arthroplasty; THA: total knee arthroplasty
ERAS Protocol
All patients received the same ERAS protocol. In the preoperative period, patients were optimized for the following comorbidities before the surgery. For example, blood pressure was optimized to less than 140/90 mmHg if diagnosed with hypertension and postprandial sugars within normal limits with an HbA1c of less than 6.5 gm/dL if diagnosed with diabetes. Patients were advised to quit smoking and drinking before surgery. All patients received education from trained nursing staff and physiotherapists regarding perioperative pain management, preoperative physiotherapies such as knee range of motion and active quadriceps exercises, postoperative rehabilitation program, and the arrangements required at home postdischarge. All patients fasted for 6 h for solids and milk liquids and 2 h for clear liquids before surgery.
In the intraoperative period, all surgeries were performed under general anesthesia using the standard mid‐vast approach. Intravenous tranexamic acid and antibiotics were given during surgery. All patients received a single dose of dexamethasone to reduce postoperative nausea and vomiting (PONV) and ropivacaine for postoperative pain relief. We did not use negative suction drains at the wound site. Urinary catheters were not used in all patients. Intraoperative body temperature was controlled using warm saline infusions.
In the postoperative period, all knees were kept elevated over a pillow and covered with a cold pack immediately. All patients received low molecular weight heparin for deep venous thrombosis prophylaxis. Intravenous patient‐controlled analgesia (PCA) or oral opioids as needed was used to reduce the risk of PONV. All patients were encouraged to consume adequate high‐protein food and milk. From the evening following surgery, bedside sitting and straight leg raising were recommended. The following day, all patients were fully mobile with walking aids. Once these goals were met, patients were instructed to begin ascending steps. These were also regarded as the criteria for hospital discharge.
Outcome Evaluation
The primary outcome was the occurrence of all postoperative complications after the second TKA procedure including medical and surgical complications. We reviewed the medical records of all patients in HIS systems, allowing us to maximize the capture rate for these clinical outcomes. Medical complications include infection, anemia, hypotension, electrolyte imbalance, etc. Surgical complications include hematoma, seroma, wound dehiscence, etc. Multiple occurrences of the same complication are denoted as separate events. If one patient simultaneously experienced two more adverse events resulting from the same reason, such as nausea, oliguria, and hypotension due to postoperative anemia, the postoperative complication of this case was computed only once.
The secondary outcomes were LOS, hemoglobin (Hb) decrease, hematocrit (Hct) decrease, and albumin (Alb) decrease. The LOS was defined as the period from the operative day to discharge. Once admission, all patients were examined for preoperative Hb, Hct and Alb. After surgery, the lowest levels of Hb, Hct and Alb were determined for all patients as the postoperative Hb, Hct and Alb. The decrease in Hb, Hct and Alb were defined as the preoperative levels of Hb, Hct and Alb minus the postoperative levels of Hb, Hct and Alb, respectively.
Statistical Analysis
For the baseline characteristics of the included patients, the continuous variables were described by the median (interquartile range), and categorical variables were described by the frequency (percentage). The Kruskal–Wallis test was used for statistical analysis of demographic differences among the three groups, while the chi‐squared test and Fisher's exact test were used to compare categorical variables. We used the frequency (percentage) and chi‐square test for binary outcomes, or median (interquartile range) and Kruskal–Wallis test for continuous outcomes in the comparisons of three intervals groups and three pairwise comparisons. All statistical analyses were performed using R (version 4.1.0; Lucent Technologies, New Providence, NJ, USA). The significance level for all hypotheses was P < 0.05.
Results
Baseline Characteristics
We collected 355 staged bilateral TKA cases under the ERAS protocol performed between 2018 and 2021 at our hospital. Finally, we analyzed 281 patients who underwent staged bilateral TKA. The median age at the time of the second surgical procedure was 66 years old, and the median BMI was 26.6 kg/m2. Female patients accounted for a greater proportion (84.3%) of all patients than male patients. Most (90.7%) patients underwent bilateral TKA for knee OA. The three staged interval groups were comparable concerning demographic characteristics, comorbidities (hypertension, diabetes, and osteoporosis), and some major preoperative laboratory indicators (Hb, Hct, and Alb). Table 1 summarizes the detailed baseline information of the included patients and comparisons among the three groups of staged bilateral TKA.
TABLE 1.
The baseline characteristic of patients in different groups of staged bilateral primary total knee arthroplasty
| Overall | 2‐ to 6‐ months Group | 6‐ to 12‐ months Group | >12 months Group | P‐value | Statistic value | |
|---|---|---|---|---|---|---|
| Number of patients | 281 | 107 | 95 | 79 | ||
| Interval b , day | 231.0 [132.0, 383.0] | 116.0 [98.0, 145.0] | 265.0 [222.0, 308.0] | 561.0 [430.5, 737.5] | <0.01 | 245 |
| Age b , years | 66.0 [61.0, 72.0] | 65.0 [60.0, 70.5] | 68.0 [61.5, 73.0] | 67.0 [65.0, 71.0] | 0.23 | 2.9 |
| Gender a | 0.81 | 0.4 | ||||
| Female | 237 (84.3) | 89 (83.2) | 81 (85.3) | 67 (84.8) | ||
| Male | 44 (15.7) | 18 (16.8) | 14 (14.7) | 12 (15.2) | ||
| BMI b , kg/m2 | 26.6 [24.1, 28.9] | 26.7 [24.5, 28.9] | 25.9 [23.4, 28.5] | 26.71 [24.7, 29.2] | 0.04 | 6.5 |
| Diagnose a | 0.97 | 0.07 | ||||
| OA | 255 (90.7) | 96 (89.7) | 86 (90.5) | 73 (92.4) | ||
| RA | 26 (9.3) | 11 (10.3) | 9 (9.5) | 6 (7.6) | ||
| Ethnic a | 0.33 | 2.2 | ||||
| Han | 246 (87.5) | 98 (91.6) | 80 (84.2) | 68 (86.1) | ||
| Hui | 3 (1.1) | 2 (1.9) | 1 (1.1) | 0 (0.0) | ||
| Tibetan | 32 (11.4) | 7 (6.5) | 14 (14.7) | 11 (13.9) | ||
| Profession a | 0.53 | 1.3 | ||||
| Sedentary | 85 (30.5) | 23 (21.5) | 35 (37.6) | 27 (34.2) | ||
| Strenuous | 96 (34.4) | 45 (42.1) | 29 (31.2) | 22 (27.8) | ||
| Others | 98 (35.1) | 39 (36.4) | 29 (31.2) | 30 (38.0) | ||
| Hypertension a | 0.48 | 1.5 | ||||
| Yes | 137 (48.8) | 54 (50.5) | 46 (48.4) | 37 (46.8) | ||
| No | 144 (51.2) | 53 (49.5) | 49 (51.6) | 42 (53.2) | ||
| Diabetes a | 0.94 | 0.1 | ||||
| Yes | 44 (15.7) | 16 (15.0) | 15 (15.8) | 13 (16.5) | ||
| No | 237 (84.3) | 91 (85.0) | 80 (84.2) | 66 (83.5) | ||
| Osteoporosis a | 0.45 | 1.6 | ||||
| Yes | 106 (37.7) | 43 (40.2) | 33 (34.7) | 30 (38.0) | ||
| No | 175 (62.3) | 64 (59.8) | 62 (65.3) | 49 (62.0) | ||
| ASA grade a | 0.39 | 1.86 | ||||
| 1 | 6 (2.2) | 1 (0.9) | 4 (4.3) | 1 (1.3) | ||
| 2 | 66 (24.0) | 27 (25.5) | 20 (21.5) | 19 (25.0) | ||
| 3 | 202 (73.5) | 78 (73.6) | 69 (74.2) | 55 (72.4) | ||
| 4 | 1 (0.4) | 0 (0.0) | 0 (0.0) | 1 (1.3) | ||
| Preoperative Hb b , g/L | 133.0 [124.0, 141.0] | 131.0 [123.5, 137.5] | 133.0 [123.5, 142.5] | 136.0 [127.0, 141.5] | 0.47 | 1.5 |
| Preoperative Hct b , (%) | 41.0 [38.0, 43.0] | 40.0 [38.0, 42.0] | 41.0 [38.0, 43.5] | 41.0 [39.0, 43.0] | 0.76 | 0.5 |
| Preoperative Alb b , g/L | 44.9 [42.7, 46.7] | 45.3 [43.3, 47.5] | 44.5 [42.1, 46.4] | 44.7 [43.0, 46.2] | 0.16 | 3.7 |
Abbreviations: Alb: Albumin; ASA: American Society of Anesthesiologists; BMI: Body mass index; Hb: Hemoglobin; Hct: Hematocrit; OA: Osteoarthritis; RA: Rheumatoid arthritis.
N (%).
Median [Interquartile range].
Primary Outcomes
All outcomes for comparison are presented in Tables 2 and 3. Regarding postoperative complications, although the >12 months group showed a lowest incidence of postoperative complications, there were not statistically significant difference among three groups (P = 0.21). The incidence of all postoperative complications in each group is shown in Table 4.
TABLE 2.
Comparison of primary and secondary outcomes among three intervals groups of staged bilateral total knee arthroplasty
| 2‐ to 6‐months group N = 107 | 6‐ to 12‐months group N = 95 | >12 months group N = 79 | P‐value | Statistic value | |
|---|---|---|---|---|---|
| Postoperative‐complication | 30/107 (28.9%) | 20/95 (21.1%) | 11/79 (13.9%) | 0.21 | 3.1 |
| LOS a , day | 3.0 [3.0, 4.0] | 3.0 [2.0, 3.0] | 3.0 [3.0, 3.0] | 0.02 | 7.3 |
| Hb decrease a , g/L | 24.0 [15.5, 29.0] | 21.0 [13.0, 25.0] | 21.0 [14.0, 28.0] | 0.06 | 5.5 |
| Hct decrease a , % | 8.0 [5.5, 9.6] | 6.0 [5.0, 8.0] | 6.0 [5.0, 9.0] | 0.03 | 6.7 |
| Alb decrease a , g/L | 7.2 [4.9, 9.7] | 6.8 [4.5, 9.0] | 6.5 [4.5, 8.7] | 0.39 | 1.9 |
Abbreviations: Alb, albumin; Hb, hemoglobin; Hct, hematocrit; LOS, length of hospital stay.
Median [1st quartile; 3rd quartile].
TABLE 3.
Each pair group statistical comparison of primary and secondary outcomes of staged bilateral total knee arthroplasty
| Each pair group statistical comparison, p‐value | |||
|---|---|---|---|
| 2‐ to 6‐months group vs 6‐ to 12‐ months group | 2‐ to 6‐months group vs >12 months group | 6‐ to 12‐months group vs >12 months group | |
| Postoperative‐complication | 0.26 | 0.02 | 0.50 |
| LOS c , day | <0.01 a | 0.20 | 0.19 |
| Hb decrease c , g/L | 0.02 | 0.20 | 0.39 |
| Hct decrease c , % | 0.02 | <0.05 b | 0.85 |
| Alb decrease c , g/L | 0.35 | 0.19 | 0.68 |
Abbreviations: Alb, Albumin; Hb, Hemoglobin; Hct, Hematocrit; LOS, length of hospital stay.
p = 0.008.
p = 0.048.
Median [1st quartile; 3rd quartile].
TABLE 4.
The incidence of postoperative complications in different groups of staged bilateral primary total knee arthroplasty
| Postoperative complications | 2‐ to 6‐months group N = 107 | 6‐ to 12‐months group N = 95 | >12 months group N = 79 |
|---|---|---|---|
| Hypokalemia requires supplementation of chloride potassium | 2 | 2 | 0 |
| Hypotension | 1 | 2 | 1 |
| Hypothermia of lower limp | 1 | 0 | 0 |
| Nausea and vomiting | 6 | 5 | 4 |
| Acute circumscribed oedema | 0 | 1 | 0 |
| Intramuscular venous thrombosis | 2 | 0 | 0 |
| Blood glucose rise to critical values requiring an injection of regular insulin | 5 | 3 | 1 |
| Wound complications: hematoma, seroma, exudation, ecchymosis around the wound | 10 | 5 | 5 |
| Arrhythmia | 4 | 1 | 1 |
| Oliguria requiring fluid infusion | 1 | 0 | 1 |
| Urinary retention | 1 | 1 | 1 |
| Hoarseness | 1 | 1 | 2 |
| Blood transfusion | 1 | 0 | 0 |
| Infective shock | 1 | 0 | 0 |
Secondary Outcomes
For the mean LOS, there was statistically significant difference between the 2‐ to 6‐month group and the 6‐ to 12‐month group (P < 0.01). The 6‐ to 12‐month group had a shorter LOS than the 2‐ to 6‐month group under ERAS protocol. Regarding the major preoperative laboratory indicators, the decrease in Hb was not statistically significant among the three groups (p = 0.06). But there were significant in decrease in Hct among the three groups (P = 0.03). There was a significant decrease in Hct of the 2‐ to 6‐month group compared with the 6‐ to 12‐month group and the >12 months group (P = 0.02; P < 0.05, respectively). The Alb decrease of the 2‐ to 6‐month group was highest in the three groups but not statistically significant compared with the 6‐ to 12‐month group and the >12 months group (P = 0.35; P = 0.19, respectively).
Discussion
Summary of Results
The important finding of this study was that patients who have second TKA within 6 months had highest rates of postoperative complications and longest mean LOS. For postoperative complications, patients who performed secondary TKA more than a year apart from the first TKA had a lowest incidence under ERAS protocol. The LOS was significantly shorter when the second TKA was done at 6 months to 1 year apart from the first one.
The majority of orthopedic surgeons concurred that a second TKA should be scheduled for at least 3 months after the first one if a patient was not a good candidate for same‐day bilateral TKA. 8 Liu et al. suggested that only a restricted group of patients should undergo bilateral TKA on the same day; however, staging bilateral TKA 1–3 days or 4–7 days apart should be opposed. 19 Another study found that there is no increased risk of complications when the second TKA is performed 90 days or less after the first TKA. 11
Postoperative Complications
Villa et al. evaluated 192 patients who underwent staged bilateral TKA, and there were no statistically significant differences in hospital adverse events or transfusion rates between the two groups when using either the 180 or 365 thresholds. 20 Yeh et al. revealed no significant differences in complication rates and knee functional outcomes evaluated by the Oxford Knee Score and Short‐Form‐36 among intervals of 31–90, 91–180, 181–270, and 271–365 days. 21 Chen et al. found no difference between staged groups (21–90, 91–180, 181–270, and 271–360 days after the first TKA). 22 These results were consistent with our study. The 6‐ to 12‐month group and the >12 months group had a lower rate of postoperative complications than the 2‐ to 6‐month group, although the difference was not significant. The cause for the rising incidence of postoperative complications may be that patients with baseline comorbidities did not have enough time to build up an adequate physiologic reserve when they suffer from the trauma of surgery if second TKA performed closer to the first one.
LOS
The number of TKAs has increased annually because of the aging of the population, and the associated expense has become a challenging issue for patients. 23 Previous studies found that shorter LOS was typically related to reduced expenditures. 24 The LOS was considerably reduced using the ERAS protocol. For example, ambulating within 24 hours after TKA, as one part of the ERAS protocol, was associated with a significant reduction in LOS, lower hospitalization costs, and improved knee function. 16 , 25 Villa et al. found that patients who underwent staged bilateral TKA with the operations separated by 1 year had a shorter LOS than those who underwent the second TKA performed less than 1 year (staged within 1 year: 2.58 ± 0.86 days; staged more than 1 year:2.38 ± 1.18 days; P = 0.46). 20 In our study, the LOS in the 6 to 12 months group was significantly shorter than in the 2 to 6 months group (staged 2–6 months: 3 [3, 4] days; staged 6–12 months: 3 [2, 3] days; P < 0.01). As the interval between TKAs lengthened, the mean LOS slightly decreased.
Limitation and Strengths
This study has several limitations. First, this study was a retrospective analysis of a small sample of individuals, which involved inherent constraints. Second, we could not identify the precise elements that led surgeons and patients to choose the timing of second procedures in staged bilateral TKA. Patients who were younger and had fewer comorbidities selected the shorter interval of staged bilateral TKA, which is probably caused by the doctors' tendency to choose healthier patients to undergo multiple surgeries at once. Third, we only reported complications that occurred during the postoperative stay and our analysis focused on the medical records of our hospital. At that time, each patient received treatment from multiple doctors, nurses, and other health professionals, thus it is unlikely that we would be able to adequately capture the details of patients throughout the perioperative period. In addition, we did not evaluate all complications following hospital discharge. Some potential complications of patients may not have been recorded if they were admitted to other hospitals.
We have some strengths in our article. First, we conducted the ERAS protocol to compare the different intervals of staged bilateral TKA in our study. In previous studies, the ERAS protocol was not involved in the comparison of intervals of staged bilateral TKA. This study also provided a relatively proper time to perform the second contralateral TKA under the ERAS protocol when comparing clinical outcomes in different periods undergone staged bilateral TKA.
Conclusion
Staging the second arthroplasty for more than a half year seems to offer a reduction in the rate of postoperative complications and LOS under ERAS protocol. ERAS shortens the interval of staged bilateral TKA by at least 6 months for patients who might receive their second surgery without the need to wait for an extended period. However, the optimized interval considering staged bilateral TKA should be counseled on the health status of patients to make a comprehensive perioperative risk assessment.
Author Contributions
K.S. and J.P. conceived, designed and wrote the manuscript. Y.W., Y.Z., J.X., L.W. and M.L. contributed to the data acquisition. B.S. revised the manuscript. All authors read and approved the final manuscript.
Acknowledgments
This study was funded by National Natural Science Foundation of China (No. 81974347), China Postdoctoral Science Foundation (No.2021M702351), Medical Science and Technology Project of Health Commission of Sichuan Provincial (No.21PJ040) and Science and Technology Department of Sichuan Province (No.2023YFS0096).
Kaibo Sun and Jinkui Pi contributed equally to this paper as first authors.
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