JBJS | Article

The Journal of Bone & Joint Surgery, Volume 84, Issue 5

Scientific Article | May 01, 2002

Cefuroxime-Impregnated Cement in Primary Total Knee Arthroplasty : A Prospective, Randomized Study of Three Hundred and Forty Knees

Fang-Yao Chiu, MD; Chuan-Mu Chen, MD; Chien-Fu Jeff Lin, MD, PhD; Wai-Hee Lo, MD

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Investigation performed at the Department of Orthopedics and Traumatology, Veterans General Hospital-Taipei, and National Yang-Ming University, Taipei, Taiwan

Fang-Yao Chiu, MD
Chuan-Mu Chen, MD
Chien-Fu Jeff Lin, MD, PhD
Wai-Hee Lo, MD
Department of Orthopedics and Traumatology, Veterans General Hospital-Taipei, 201, Sec. 2, Shih-pai Road, Taipei 11217, Taiwan. E-mail address for F.-Y. Chiu: fychiu@ughtpe.gov.tw

The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

The Journal of Bone & Joint Surgery. 2002; 84:759-762

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Abstract

Background: A prospective, randomized study was conducted to evaluate the efficacy of cefuroxime-impregnated cement in the prevention of deep infection after primary total knee arthroplasties performed without so-called clean-air measures, such as laminar flow and body-exhaust suits.

Methods: Three hundred and forty primary total knee arthroplasties were performed with cementless fixation of the femoral component and cement fixation of the patellar and tibial components. The knees were randomly divided into two groups. In Group 1 (178 knees), cefuroxime-impregnated cement was used for fixation, whereas in Group 2 (162 knees), the cement did not contain cefuroxime. There was no significant difference between the two groups regarding demographic variables, the preoperative or postoperative knee score, the duration of the operation or of the use of the tourniquet, or the amount of blood transfused perioperatively. The average duration of follow-up was forty-nine months (range, twenty-six to eighty months).

Results: No deep infection developed in the 178 knees in Group 1, whereas a deep infection developed in five (3.1%) of the 162 knees in Group 2 (p = 0.0238). Two superficial wound infections developed in each group.

Conclusions: Cefuroxime-impregnated cement was shown to be effective in the prevention of early to intermediate deep infection after primary total knee arthroplasty performed with use of perioperative systemic antibiotic prophylaxis but no so-called clean-air measures.

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Introduction

Introduction | Materials and Methods | Results | Discussion | References

One of the most devastating and costly complications of total knee arthroplasty is deep infection. The rate of deep infection after total knee arthroplasty has ranged from <1% to 23% ^1-21 in series ranging in size from 112 to 12,118 knees. Perioperative antibiotics have been very effective in lowering the rate of deep infection, but there remains a persistent 1% to 2% prevalence of deep infection in most large series ^5-21 . The focus of this prospective study was to evaluate the efficacy of cefuroxime-impregnated cement in the prevention of infection after primary total knee arthroplasty performed in a setting where so-called clean-air measures such as laminar flow and body-exhaust suits were not available.

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TABLE I: Comparisons of Parameters Between Groups 1 and 2

*Mean and standard deviation. Student t test. Fisher exact test.

	Group 1 (N = 178)	Group 2 (N = 162)	P Value
Age*	70 ± 7.4 yr	68 ± 6.9 yr	0.157
Tourniquet time*	34 ± 5.8 min	32 ± 5.4 min	0.637
Operative time	62 ± 4.6 min	65 ± 3.6 min	0.745
Amount of blood transfusion*	4 ± 1.3 units	4 ± 1.2 units	0.824
The Hospital for Special Surgery knee score*
Preoperative	45 ± 7.6 points	48 ± 7.7 points	0.431
Postoperative	90 ± 3.8 points	88 ± 8.2 points	0.523
Sex (male/female)	70%/30%	69%/31%	1.00
Side (left/right)	55%/45%	51%/49%	0.638
Infection rate
Superficial	1.1%	1.2%	1.00
Deep	0	3.1%	0.0238

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TABLE I: Comparisons of Parameters Between Groups 1 and 2

*Mean and standard deviation. Student t test. Fisher exact test.

	Group 1 (N = 178)	Group 2 (N = 162)	P Value
Age*	70 ± 7.4 yr	68 ± 6.9 yr	0.157
Tourniquet time*	34 ± 5.8 min	32 ± 5.4 min	0.637
Operative time	62 ± 4.6 min	65 ± 3.6 min	0.745
Amount of blood transfusion*	4 ± 1.3 units	4 ± 1.2 units	0.824
The Hospital for Special Surgery knee score*
Preoperative	45 ± 7.6 points	48 ± 7.7 points	0.431
Postoperative	90 ± 3.8 points	88 ± 8.2 points	0.523
Sex (male/female)	70%/30%	69%/31%	1.00
Side (left/right)	55%/45%	51%/49%	0.638
Infection rate
Superficial	1.1%	1.2%	1.00
Deep	0	3.1%	0.0238

Materials and Methods

Introduction | Materials and Methods | Results | Discussion | References

The study included 340 consecutive primary total knee arthroplasties performed in 285 patients from 1994 to 1998. Patients with diabetes mellitus, peripheral arterial occlusive disease, psoriasis, prior knee surgery, any kind of lower-extremity infection, osteomyelitis, or a malignant tumor or who were being treated with immunosuppressive agents had been excluded from the study. The study was approved by our Institutional Review Board, and all patients provided written informed consent prior to the operation.

All of the operations were done in a standard operating room without ultraviolet light, laminar flow, or body-exhaust suits. All of the arthroplasties were performed with a midline incision and through a medial parapatellar approach. A Duracon prosthesis (Howmedica, Limerick, Ireland) was used with hybrid fixation in all knees. The femoral component was fixed without cement, and the patellar and tibial components were fixed with cement (Simplex P; Howmedica). All procedures were performed by the same surgeon (F.-Y.C.).

Cefuroxime-impregnated cement ¹⁶ (2 g of cefuroxime in 40 g of Simplex P cement) was used to fix the components in patients with an odd chart number (Group 1), and pure Simplex P cement without cefuroxime was used in patients with an even chart number (Group 2). The fifty-five patients undergoing bilateral total knee arthroplasty were treated with cefuroxime-impregnated cement on one side (Group 1) and not on the other (Group 2).

Group 1 comprised 178 knees, 124 of which were in men and fifty-four of which were in women. The average age of the patients was seventy years (range, thirty-four to ninety years). There were ninety-eight left knees and eighty right knees. The preoperative diagnosis was osteoarthritis in 154 Group-1 knees, rheumatoid arthritis in ten, posttraumatic arthritis in ten, gouty arthritis in one, and osteonecrosis in three. Group 2 consisted of 162 knees, 111 of which were in men and fifty-one of which were in women. The patients had an average age of sixty-eight years (range, thirty-eight to eighty-nine years). There were eighty-three left knees and seventy-nine right knees. The preoperative diagnosis was osteoarthritis in 146 knees, rheumatoid arthritis in six, posttraumatic arthritis in six, gouty arthritis in two, and osteonecrosis in two. With the numbers available, there were no significant differences between the two groups with regard to age, sex, side of the operation, preoperative diagnosis, preoperative or postoperative knee score, tourniquet time, operative time, or amount of blood transfused perioperatively ( Table I ).

Preoperatively, each patient received intravenous bolus injections of cefazolin (500 mg) and gentamicin (80 mg). Intravenous injections of cefazolin (500 mg/6 hr) and gentamicin (80 mg/12 hr) were given for thirty-six hours after the operation, and then oral cefazolin (500 mg/6 hr) was given for seven days. A drain was used routinely and was removed on the second postoperative day. Continuous passive motion was used from the first postoperative day to the day of discharge. Weight-bearing on the involved knee was allowed from the second postoperative day, and crutches were used as needed. The mean hospital stay was eight days (range, five to fifteen days). The type of anesthesia, operative time, tourniquet time, estimated blood loss, postoperative transfusion requirement, wound condition, and improvement of the range of motion were recorded for each patient.

The patients were examined postoperatively at three weeks, eight weeks, and six months and then every six months thereafter. The average duration of follow-up was forty-nine months (range, twenty-six to eighty months). Radiographic evaluation was performed at every follow-up visit, and a functional evaluation was performed, starting on the third postoperative visit, with use of The Hospital for Special Surgery score ²² . The infections were classified as superficial or deep ¹⁶ and as early (developing within two months after the operation), intermediate (developing two to twenty-four months after the operation), or late (developing more than twenty-four months after the operation) ¹⁹ . All deep infections were confirmed by laboratory parameters (the erythrocyte sedimentation rate and level C-reactive protein) and a positive culture of joint fluid.

Data were entered and analyzed with an SAS statistical program (SAS Institute, Cary, North Carolina). All response variables, including demographic variables and important outcomes, were measured for all patients. Data were represented as the mean and standard deviation for continuous response variables and as percentages for discrete variables. The Fisher exact test was used to compare differences between the two groups for each discrete variable, and a Student t test was used to compare the differences between the groups for each continuous variable. Before the analysis, the p value was set at 0.05 for each test.

Results

Introduction | Materials and Methods | Results | Discussion | References

There were two early superficial wound infections (1.1%) in Group 1 as well as two (1.2%) in Group 2. All were effectively treated with wound dï¿½bridement and intravenous antibiotics for one week and oral antibiotics for another week. The difference between the two groups with regard to the rate of superficial infection was not significant according to the Fisher exact test (p = 1).

No deep infection was noted in Group 1, whereas there were five early or intermediate deep infections (3.1%) in Group 2. None of the infections developed in a patient treated with a bilateral procedure. The difference between groups with regard to the rate of deep infection was significant (Fisher exact test, p = 0.0238).

One (0.6%) of the 178 knees in Group 1 had a loose femoral component at two years after the primary operation, and the femoral component was revised. No component was noted to be loose in the 162 Group-2 knees. With the numbers available, the difference in loosening rates between the two groups was not significant. One patellar fracture (0.6%) developed after a traumatic episode in Group 2, and it was treated with open reduction and internal fixation with tension band wiring. No other complications developed in this series.

Discussion

Introduction | Materials and Methods | Results | Discussion | References

The major focus of this prospective study was to evaluate the efficacy of antibiotic (cefuroxime) impregnated cement in the prevention of infection after primary total knee arthroplasty performed without so-called clean-air measures. The prevalence of superficial infection in this series was similar to those in other reports ^1-35 . The cefuroxime-impregnated cement did not appear to have an effect on the prevention of superficial infection.

Three early and two intermediate deep infections (3.1%) developed in patients in whom the arthroplasty had not been performed with cefuroxime-impregnated cement (Group 2). The prevalence of deep infection in this group was relatively higher than those reported in other series ^{1,15,16,23,27} . However, our perioperative environment, which did not include ultraviolet light for disinfection, laminar flow, or body-exhaust systems, is relatively poor compared with those in well-developed countries. No deep infection developed in any patient who had been treated with cefuroxime-impregnated cement (Group 1). The difference between the two groups was significant (p = 0.0238). We do not believe that cefuroxime-impregnated cement alone will prevent deep infection, but we think that when it is combined with other preventive measures such as intravenous antibiotics it can aid in the prevention of early or intermediate deep infection. This effectiveness might be more meaningful in a relatively poorer perioperative environment.

The main effect of antibiotic-impregnated cement is a stronger local resistance to infection in the postoperative period as a result of elution of antibiotics into the joint fluid. Mixing cement with antibiotics is a simple procedure that may enhance the resistance to deep infection after primary total knee arthroplasty, as shown in this series. Many antibiotics can be used to impregnate cement with only minor adverse effects on the cement's strength. Concentrations of up to 2 g of antibiotic powder per 40-g package of cement does not substantially change the static tensile and compressive strength of cement, although the fatigue strength may be lessened ^{4,16,23,24,29,35} . In the present study, use of cefuroxime-impregnated cement had no adverse clinical effect, such as loosening of the component, after intermediate-term follow-up. However, longer follow-up might alter this finding. The choice of cefuroxime in this series was based on its good thermal stability, its biological effectiveness in bone cement, good clinical results in earlier studies ^{1,7,15,23,29,33} , and its ready availability in our hospital.

In conclusion, this prospective, randomized study strongly supports the efficacy of antibiotic (cefuroxime) impregnated cement in the prevention of early and intermediate deep infection after primary total knee arthroplasty. On the basis of these data, we recommend the use of antibiotic-impregnated cement in primary total knee arthroplasty when the procedure is performed in an operative environment that does not include so-called clean-air measures.

Note: The authors thank Miss Pui-Ching Lee, BPH, for her help in the statistical analysis for this article.

References

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TABLE I: Comparisons of Parameters Between Groups 1 and 2

*Mean and standard deviation. Student t test. Fisher exact test.

	Group 1 (N = 178)	Group 2 (N = 162)	P Value
Age*	70 ± 7.4 yr	68 ± 6.9 yr	0.157
Tourniquet time*	34 ± 5.8 min	32 ± 5.4 min	0.637
Operative time	62 ± 4.6 min	65 ± 3.6 min	0.745
Amount of blood transfusion*	4 ± 1.3 units	4 ± 1.2 units	0.824
The Hospital for Special Surgery knee score*
Preoperative	45 ± 7.6 points	48 ± 7.7 points	0.431
Postoperative	90 ± 3.8 points	88 ± 8.2 points	0.523
Sex (male/female)	70%/30%	69%/31%	1.00
Side (left/right)	55%/45%	51%/49%	0.638
Infection rate
Superficial	1.1%	1.2%	1.00
Deep	0	3.1%	0.0238

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TABLE I: Comparisons of Parameters Between Groups 1 and 2

*Mean and standard deviation. Student t test. Fisher exact test.

	Group 1 (N = 178)	Group 2 (N = 162)	P Value
Age*	70 ± 7.4 yr	68 ± 6.9 yr	0.157
Tourniquet time*	34 ± 5.8 min	32 ± 5.4 min	0.637
Operative time	62 ± 4.6 min	65 ± 3.6 min	0.745
Amount of blood transfusion*	4 ± 1.3 units	4 ± 1.2 units	0.824
The Hospital for Special Surgery knee score*
Preoperative	45 ± 7.6 points	48 ± 7.7 points	0.431
Postoperative	90 ± 3.8 points	88 ± 8.2 points	0.523
Sex (male/female)	70%/30%	69%/31%	1.00
Side (left/right)	55%/45%	51%/49%	0.638
Infection rate
Superficial	1.1%	1.2%	1.00
Deep	0	3.1%	0.0238