Abstract
Background
To compare the outcomes of the culture positive and the culture negative infected TKA.
Methods
We determined the infection control rate in the 242 patients (140 patients with culture-positive and 102 patients with culture-negative diagnoses) with infected TKAs.
Results
The overall infection control rate was 90% in the culture positive group and 95% in the culture negative group.
Interpretation
The infection control rates and clinical outcomes of infected TKAs was not different between culture-positive and culture-negative groups.
Keywords: Infection control rate, Culture-positive, Culutre-negative, TKA
1. Introduction
Periprosthetic joint infection is one of the most challenging complications after total-knee arthroplasty (TKA) with an incidence of 1%–4% after primary TKA.1, 2, 3, 4 Accurate diagnosis of periprosthetic joint infection is essential and often involves withholding antibiotic therapy in hopes of isolating an organism from a preoperative joint aspiration or intraoperative tissue cultures. Determining the causative organism then allows tailored local and systemic antibiotic therapy. Despite extensive efforts, the cultures often have a high false-negative rate despite adequate clinical, radiographic, and surgical suspicion for periprosthetic joint infection. Incidence of negative cultures in most infection series ranged from 0% to 25%.5, 6, 7, 8, 9
The reported control rates of treating deep infection of TKA have ranged from 20% to 68% for surgical debridement with retention of the prosthesis, 50%–87% for one-stage exchange, and 56%–100% for two-stage exchange.10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 However, the clinical characteristics of culture negativity have not been well studied. In a culture-negative periprosthetic joint infection, choosing the appropriate antibiotic therapy is difficult. Therefore, it is important to understand the rates of infection control and antibiotic choices in the culture-negative periprosthetic joint infections. In many previous reports,1, 3, 4, 5, 6, 7, 8, 10, 16, 24 the results of culture positive and culture negative infected TKAs were not compared. Therefore, the current study analyzed the larger cohort of the patients with culture negative infected TKAs to determine their clinical characteristics and treatment results. Furthermore, their clinical characteristics and treatment results were compared with the patients with culture positive infected TKAs.
To confirm previous reports, we (1) compared each type of infected TKA that did not yield positive cultures at the time of treatment with those that had positive cultures to determine the control rates of infection, and (2) determined whether repeated dèbridement and rèpeated two-stage exchange TKA would improve further the control rate of infection after failed first treatment in culture-positive and culture-negative infected TKA.
2. Materials and methods
We retrospectively reviewed data for 260 prospectively followed patients with 260 infected TKAs from January 2001 to March 2008. All operations were performed by a senior author (YHK). Of the 260 patients, 11 were lost to follow-up before 2 years, and 7 died, leaving 242 patients (242 knees) for review. The records of the 242 patients had been entered into an ongoing computerized database that was updated continuously. The study was approved by the institutional review board, and patients provided written informed consent. There were 58 men and 184 women with a mean age of 66.3 ± 8.65 years (range, 40–90 years). Their mean body mass index was 28.29 ± 4.31 kg/m2 (range, 20.1–41.3 kg/m2). In all knees, the primary diagnosis was osteoarthritis. In the current series, no patient was immunocompromised due to a co-morbid disease such as rheumatoid arthritis, or long term steroid treatment, or past chemotherapy treatment, or positive HIV. The minimum duration of follow-up was 6 years (mean, 10 ± 0.92 years; range, 6–13 years) (Table 1).
Table 1.
Comparison of demographics and variables between culture-positive and culture-negative patients.
| Variable | Culture-positive (N = 140) |
Culture-negative (N = 102) |
P-value (Chi-square test) |
|---|---|---|---|
| Age (years) | 65.2 ± 8.4 (range, 57–79) | 67.4 ± 8.9 (range, 40–90) | 0.36 |
| Gender | 0.41 | ||
| Male | 30 | 28 | |
| Female | 110 | 74 | |
| Host condition | 0.59 | ||
| Uncompromised | 98 (70%) | 67 (66%) | |
| Compromised | 42 (30%) | 35 (34%) | |
| Implant | |||
| Primary | 140 (100%) | 102 (100%) | |
| Type of infection | 0.63 | ||
| Early deep | 75 (54%) | 52 (51%) | |
| Late chronic | 59 (42%) | 46 (45%) | |
| Acute hematogenous | 6 (4%) | 4 (4%) | |
| Draining Sinus | 0.16 | ||
| Yes | 10 (7%) | 0 (0%) | |
| No | 130 (93%) | 102 (100%) | |
| Preoperative antibiotic treatment | 0.003 | ||
| Yes | 97 (69%) | 42 (41%) | |
| No | 43 (31%) | 60 (59%) | |
| IV antibiotics | 0.001 | ||
| Vancomycin | 91 (65%) | 87 (85%) | |
| Others | 49 (35%) | 15 (15%) | |
| Oral antibiotics | 0.001 | ||
| Yes | 28 (20%) | 61 (60%) | |
| No | 112 (80%) | 41 (40%) | |
| Laboratory data | |||
| WBC (/ml) | 9287 ± 3895 | 8081 ± 2809 | 0.049 |
| ESR (mm/h) | 98.1 ± 38.7 | 79.8 ± 29.1 | 0.003 |
| CRP (mg/L) | 25.1 (10.1–58.8) | 15.5 (9–48.9) | 0.003 |
| Aspirates WBC (/mm3) | 46,750 (20,500–98,500) | 36,501 (19,500–72,762) | 0.004 |
| Aspirate Neutrophil (%) | 93 (78–96) | 91 (85–93) | 0.131 |
| Follow-up (years) | 9.3 (6–13) | 10.6 (6–13) | 0.323 |
As per the new definition for periprosthetic joint infection by the work group of the Musculoskeletal Infection Society (MSIS),25, 26 diagnosis of infection was made by presence of sinus tract communicating with the prosthesis; or growth of the microorganism from at least 2 separate tissue or joint fluid specimens from the affected prosthetic joint; or when 4 of the following six criteria: elevated erythrocyte sedimentation rate (ESR, ≥30 mm/h) and C-reactive protein (CRP, ≥10 mg/L), elevated synovial white blood cell (WBC) count (≥2000/UL), elevated synovial neutrophil percentage (PMN%, ≥65%), presence of purulence in the affected joint, isolation of a microorganism in one culture of tissue or fluid, more than 5 neutrophils per high-power field on histologic examination.27, 28, 29, 30, 31 Each infection was classified as early postoperative deep, late chronic, and acute hematogenous infection according to Tsukayama et al.32 Clinical host condition was classified as uncompromised, compromised, and significantly compromised based on the classification of McPherson et al.33 In the culture positive group, 119 of 140 patients (85%) were considered to be uncompromised (systemic host A), 14 patients (10%) were considered to be compromised (systemic host B), and 7 patients (5%) were considered to be significantly compromised (systemic host C). In the culture negative group, 85 of 102 patients (83%) were considered to be uncompromised (systemic host A), 12 patients (12%) were considered to be compromised (systemic host B), and 5 patients (5%) were considered to be significantly compromised (systemic host C).
Study patients were divided into 2 groups based on culture results from both preoperative joint aspirate and intraoperative periprosthetic tissues from the affected joint at the time of initial surgical treatment at our institution, which totaled 140 patients with positive culture results (culture-positive group), and 102 patients with negative culture results (culture-negative group). Gram-positive cocci were isolated from 84 knees, and gram-negative bacilli were cultured from 38 knees. The fungal (Candida albicans) and Mycobacterium (Mycobacterium tuberculosis) isolates came from late chronic infections (Table 2). Twenty-one of 140 patients who had negative culture initially turned culture positive later. MRSA was cultured in 10 knees, C. albicans in 5 knees, Enterococcus in three knees and Streptococcus in 3 knees. Patients' demographics, clinical characteristics, and treatment results were compared between the 2 study groups. The history of previous antibiotic treatment for infected TKA of the same joints and follow-up cultures of the same joints after failure of our initial surgical treatment were also documented to outline the pattern of 102 patients with negative culture results (Table 1). We used PCR analysis was performed in the culture negative TKAs in our institute. 16SrRNA gene PCR combined with sequencing (16SPCR) has proven to be useful for diagnosing various infections.34 However, it does not provide any additional information to select susceptible antibiotics. Even if the positive results of PCR in the culture negative group, selection of antibiotics are still made empirically.
Table 2.
Bacterial isolates in 140 infections in positive culture results.
| Pathogen | Group |
||
|---|---|---|---|
| Early deep (75) | Late chronic (59) | Acute hematogenous (6) | |
| Gram-positive cocci (84) | |||
| Coagulase-positive Staphylococci (n = 30) | 10 | 16 | 4 |
| Methicillin-susceptible | 8 | 10 | 2 |
| Methicillin-resistant | 2 | 6 | 2 |
| Coagulase-negative Staphylococci (n = 26) | |||
| Methicillin-susceptible | 6 | 10 | 0 |
| Methicillin-resistant | 2 | 4 | 4 |
| Streptococcus (n = 14) | 6 | 8 | – |
| Enterococcus (n = 14) | 8 | 6 | – |
| Gram-negative bacilli (n = 38) | |||
| Enterobacter (n = 22) | 10 | 10 | 2 |
| Acinobacter baumanii complex (n = 16) | 8 | 8 | – |
| Fungus (Candida ablicans) (n = 8) | – | 8 | – |
| Mycobacterium tuberculosis (n = 10) | – | 10 | – |
Treatment of infection was performed as the same protocol as in the previous report.24 Early deep postoperative infections were treated with debridement, replacement of the polyethylene insert of the tibial component, retention of the prosthesis, and intravenous administration of antibiotics for 6 weeks (Table 2). Parenteral antibiotic therapy was determined with consultation with an infectious disease specialist. Broad spectrum antibiotic was given empirically, and then therapy was adjusted subsequently based on the sensitivities. When the culture study showed negative results, empirical antibiotic treatment was maintained as patients with culture positive. If the infection recurred, repeated debridement and replacement of the polyethylene insert of the tibial component, retention of the prosthesis, and intravenous antibiotics for 6 weeks. If the infection recurred again, 2-stage exchange TKA was performed. First, we performed débridement, removal of all of the prosthetic components and bone cement, and placement of a vancomycin and gentamycin-impregrated (2.0 g, 800 mg per 40-g batch, respectively of bone cement) mobile cement spacer. Antibiotics were administered intravenously for 6 weeks (Table 3). After completion of antibiotic therapy, ESR, CRP levels, and total WBC count and differential in the joint aspirates were obtained, and the patient was observed for 2 more weeks. If results of these tests showed no evidence of infection, we performed TKA. Multiple cultures of specimens obtained during revision operations were performed to confirm infection eradication. If the infection recurred once again, repeated two-stage exchange arthroplasty was performed. Arthrodesis was performed if the infection recurred again. In very selective patients, who had mild atrophy of quadriceps and hamstring muscles with good muscle power, fusion-taken-down and TKA was performed. Late chronic infection was treated as for the recurrent early deep postoperative infection. Acute hematogenous infections were treated as for the early deep postoperative infections (Fig. 1).
Table 3.
Treatment of infection with antibiotics.
| Microorganism | Antimicrobial agent | Dosage | Route |
|---|---|---|---|
| Staphylococcus aureus coagulate-positive or -negative | |||
| Methicillin-susceptible | Nafcillin or floxacillin plus | 2 g every 6 h | IV |
| Rifampin for 2 weeks followed by | 450 mg every 12 h | PO | |
| Rifampin plus | 450 mg every 12 h | PO | |
| Ciprofloxacin or | 750 mg every 12 h | PO | |
| Levofloxacin | 750 mg every 24 h | PO | |
| Methicillin-resistant | Vancomycin plus | 1 g every 12 h | IV |
| Rifampin for 2 weeks | 450 mg every 12 h | PO | |
| Rifampin plus | 450 mg every 12 h | PO | |
| Ciprofloxacin or | 750 mg every 12 h | PO | |
| Levofloxacin or | 750 mg every 24 h | PO | |
| Teicoplanin or | 400 mg every 24 h | IV | |
| Fusidic acid | 500 mg every 8 h | PO | |
| Streptococcus and Enterococcus | Penicilln G or | 5 million units every 6 h | IV |
| Ampicillin or amoxicillin | 2 g every 4–6 h | IV | |
| Enterobacter and Actinobacter | Ceftazidime or cefepime plus | 2 g every 8 h | IV |
| Aminoglycoside for 2 weeks followed by ciprofloxacin | 750 mg every 12 h | PO | |
| Culture negative | Vancomycin plus | 1 g every 12 h | IV |
| Ciprofloxacin or | 750 mg every 12 h | PO | |
| Levofloxacin or | 750 mg every 24 h | PO | |
| Teicoplanin or | 400 mg every 24 h | IV | |
| Fusidic acid | 500 mg every 8 h | PO | |
| Candida albicans | Flucorazole | 400 mg OD (first day) | IV |
| 200 mg OD (from 2nd day) | IV | ||
| Caspofungin | 70 mg OD (first day) | IV | |
| 50 mg OD (from 2nd day) | IV | ||
| Mycobacterium tuberculosis | Isoniazid | 200–400 mg O.D | PO |
| Ethambutol | 12 mg/kg O.D | PO | |
| Rifampicin | 450–600 mg O.D | PO | |
| Pyrazinamide | 1.5–2.0 g OD or BiD, or TiD | PO | |
Fig. 1.
Diagram of the treatment pathway for an infected total-knee arthroplasty.
On the second day after surgery, a continuous passive motion machine was used for passive range-of-motion exercise twice daily for 30 min each time. The machine settings were advanced incrementally under the supervision of a physical therapist. On the second postoperative day, patients began standing at the bedside or walking with crutches or a walker twice daily for 30 min, each time under the supervision of a physical therapist. Patients used crutches or a walker with full weight bearing for 6 weeks and then a cane as needed thereafter. No patient received physiotherapy after discharge from the hospital.
Routine follow-up evaluation was scheduled at postoperative intervals of 3 months, 1 year, and yearly thereafter. At these intervals, we evaluated the patients and obtained radiographs. Preoperative and postoperative review data were recorded according to the system of the Knee Society.35 All of the knees were evaluated by one observer who was not connected with the original surgery, and the data were entered into a computerized record. The criteria for infection control were: no pain or swelling; no wound drainage; normal serology (ESR < 20 mm/h, CRP level <0.5 mg/dL); a synovial fluid leukocyte differential of less than 65% neutrophils (or a leukocyte count <1.7 × 103/uL); and a normal radiographic finding for at least 2 years after the end of antibiotic therapy.31 For a knee to be considered functional, there had to be no or only slight pain upon walking (with or without the use of a cane) and no radiographic findings, such as progressive osteolysis or loosening of the prosthetic components that indicated a need for immediate or impending surgical intervention. If the initial treatment failed, we recorded the number and type of subsequent courses of treatment that were attempted. In some instances, infection eradication was achieved only after multiple courses of treatment.
One of the study's authors evaluated the final radiographs. We defined radiographic loosening as a complete radiolucent line of ≥2 mm in width at the bone-cement or the prosthesis–cement interface or shift in position of a component or components on serial radiographic examination.36
2.1. Statistical analysis
We performed a sample size calculation based on detecting difference in the postoperative Knee Society Knee scores of 5 points between the 2 study groups, assuming a type-2 error (2-sided) of 5% with a statistical power of 80% (type-2 error = 0.20). With these assumptions, approximately 91 cases were needed in each group. Chi-square, descriptive, and Student's t-test analyses were used to compare demographics and comorbidities between the patients with culture-negative and culture-positive. The differences among the four types of infection in culture-positive and culture-negative groups for discrete variables (including age, period of follow-up, CRP, ESR, leukocyte count, and leukocyte differential) were compared using Fisher's exact probability two-tailed t-test. Logistic regression was used to assess the rate of failure associated with the different types of infection in both groups. One-way analysis of variance was used to confirm differences among the different types of infection with respect to the final clinical score. The level of significance was set at P < 0.05. All analyses were performed with use of SPSS software (version 18; SPSS, Chicago, Illinois).
3. Results
Overall rates of infection control, successful first treatment, and functional knee were not statistically different between the culture-positive and culture-negative groups (P < 0.05). Moreover, overall rates of infection control, successful first treatment and functional knee were not statically different between the gram-positive and gram-negative groups (P < 0.05). Overall infection control rate was 100% in both groups at means of 9.3 years and 10.6 years follow-up, respectively. If the patients with arthrodesis or amputation were defined as a failure of infection control, infection control rate was 90% in the culture-positive group and 95% in the culture-negative group. A functional knee was obtained in 90% in the culture-positive group and 95% in the culture-negative group. In the culture-positive group, the initial course of treatment was successful for 41 of 75 knees (55%) with early deep postoperative infection, 47 of 59 knees (80%) with late chronic infection, and 2 of 6 knees with acute hematogenous infection. In the culture-negative group, the initial course of treatment was successful for 31 of 52 knees (60%) with early deep postoperative infection, 38 of 46 knees (83%) with late chronic infection (Table 2), and 1 of 4 knees with acute hematogenous infection.
Infection control and maintenance of functional TKA after first treatment were further improved by repeated débridement and repeated 2-stage exchange TKA (Table 4). The mean Knee Society knee and function scores in the culture-positive group were 87 and 77 points, respectively, and they were 89 and 75 points, respectively, in the culture-negative group. In the culture-positive group, 7 knees (5%) were revised for aseptic loosening of femoral and/or tibial components, and 2 knees were required above-knee amputation for persistent infection after 2 revisions. These 2 patients who underwent above-knee amputation were immunocompromised by prolonged antibiotic therapy and superimposed MRSA with C. albicans infection. In the culture-negative group, 8 knees (8%) were revised for aseptic loosening of the femoral and/or tibial components. Survivorship of TKA at 9.3 years as the end point of revision, or arthrodesis, or amputation was 94% (95% confidence interval, 0.91–0.97) in the culture-positive group, and it was 92% (95% confidence interval, 0.89–0.98) in the culture-negative group.
Table 4.
Summary of overall results for each group.
| Results | Culture-positive (N = 140) |
Culture-negative (N = 102) |
||||
|---|---|---|---|---|---|---|
| Early deep infection (75 knees) |
Late chronic infection (59 knees) |
Acute hematogenous infection (6 knees) |
Early deep infection (52 knees) |
Late chronic infection (46 knees) |
Acute hematogenous infection (4 knees) |
|
| Successful first treatment | 41 knees (55%) |
47 knees (80%) |
2 knees (33%) |
31 knees (60%) |
38 knees (83%) |
1 knee (25%) |
| Infection eradicated | 75 knees (100%) |
59 knees (100%) |
6 knees (100%) |
52 knees (100%) |
46 knees (100%) |
4 knees (100%) |
| Functional knee | 70 knees (93%) |
56 knees (95%) |
5 knees (83%) |
48 knees (92%) |
44 knees (96%) |
4 knees (100%) |
4. Discussion
Although identification of a causative microorganisms from operative tissue samples or joint aspiration is the standard for diagnosis of periprosthetic joint infection, negative cultures are frequent in treatment of periprosthetic joint infections. In the present study, incidence of negative culture result was 42% (102 of 242 knees), which was substantially higher compared to other published series in the literature.6, 7, 37, 38 We suggest that this finding may be explained by higher incidence of previous intravenous and oral antibiotic treatment, which was consistent with the previous reports.6, 39 This suggests that a higher incidence of previous antibiotic treatment has led to the lower ESR and CRP values seen in the culture-negative group (p = 0.03).
Malekzadeh et al39 reported the largest series of culture-negative periprosthetic joint infection, which includes 135 cases (10.6% incidence) within 16 years. They found no differences in treatment failure between the culture-negative and culture-positive cases. Huang et al37 also found no differences in treatment failure between culture-negative and culture-positive cases. On the contrary, Choi et al38 reported that the culture-negative group showed significantly higher treatment success rates compared to the culture-positive group. They suggested that high usage of vancomycin and additional surgical treatment (reimplantation or arthrodesis) in culture-negative patients might have contributed to more favorable outcomes in their study. The findings of the current study showed no significant differences in the treatment failure between culture-negative and culture-positive groups. We believe that initial surgical treatment and subsequent aggressive additional treatments (repeated débridement, repeated two-stage exchange arthroplasty, arthrodesis or amputation), led to improved eradication of infection in both culture-negative and culture-positive groups.
In various series ranging in size from 5 to 116 infections, the overall infection control rate associated with the use of irrigation and débridement for the treatment of early deep postoperative infection ranged from 0 to 100%.10, 18, 19, 24, 40 Mont et al18 reported that a protocol of multiple debridement was successful for the treatment of 10 of 10 early deep postoperative infections (defined as those that occurred less than 4 weeks after index arthroplasty). In our study, the success rate of initial treatment in early postoperative infection was 55% in the culture-positive group and 60% in the culture-negative group, which is similar to the 50% reported for other series.20 The infection control rate was improved to 100% in both culture-positive and culture-negative groups after repeated debridement, repeated 2-stage revision, arthrodesis, or amputation. The infection control rate of initial treatment in the late chronic infection in our series was 80% in the culture-positive group and 83% in the culture-negative group. These figures are similar to the 83% reported for other series.20 After repeated debridement and repeated 2-stage revision, the infection control rate was improved to 100% in both groups. The infection control rate of the first course of treatment (retention of the prosthesis, debridement, and intravenous antibiotics for 6 weeks) for acute hematogenous infection was lower (33% versus 25%) than the rates reported by others.18, 20 We do not know why this was the case.
Segawa et al20 reported that 5 of 10 patients with early deep postoperative infection, and 24 of 29 with late chronic postoperative infection were able to walk with no or only slight pain (some with the assistance of a cane). None of their patients had radiographic findings (such as evidence of implant migration or progressive osteolysis) that would have indicated a need for immediate or impending surgical intervention. In the current series, 7 knees (5%) in the culture-positive group and 8 knees (8%) in the culture-negative group were revised for aseptic loosening of femoral and/or tibial components. 2 patients in the culture-positive group required above-knee amputation for persistent infection after 2 revisions. These two patients had persistent MRSA superimposed with C. albicans infection.
There are a few limitations in our study. First, although all patients in this study were prospectively followed, the design of the study was to test retrospectively our classification-based treatment algorithm for infected TKA. Second, owing to limited patient numbers, we were unable to analyze data for patients stratified according to infecting organism. It is possible that the infection control after infected TKA was influenced by the virulence of the infecting organism. Third, 11 of 260 patients (4%) were lost to follow-up, and 7 (3%) died. Nevertheless, the percentage of patients who died or were lost to follow up was small and likely did not influence the findings of our study, unless the majority of these lost and died cases had become reinfected.
The results of present study demonstrate that no significant differences exist in the infection control rate and clinical outcomes between culture-positive and culture-negative groups. The data suggest that treatment according to the types of infection in both culture-positive and culture-negative groups after TKA controlled infection and maintained functional TKA with a firm level of fixation for most patients. Repeated débridement and repeated 2-stage exchange TKA further improved infection control rates after the initial treatment and increased the likelihood of maintaining a functional TKA.
Conflicts of interest
All authors have none to declare.
References
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