Use of Antibiotic-Loaded Bone Cement in Primary Hip and Knee Arthroplasty

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; ALCARAZ, A.; GLUJOVSKY, D.; LOPEZ, A.; REY-ARES, L.; BARDACH, A.; CIAPPONI, A; URTASUN, M

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Total primary hip arthroplasty (THA) and total primary knee arthroplasty (TKA) involve replacing the diseased joint surfaces with synthetic materials to relieve pain, improve motion, joint function and quality of life. One of the most common and severe complications of THA and TKA is infection, not exceeding 1%, but it even may involve new surgical interventions or prosthesis removal. To prevent infections, preoperative systemic antibiotic prophylaxis is used as standard of care for all patients undergoing primary THA and TKA. The use of antibiotic-loaded bone cement in combination with systemic antibiotic prophylaxis has been postulated since it might decrease the rate of infection and revision surgery.TechnologyBone cement is an acrylic resin used to fix the prosthesis to the host bone tissue. It allows antibiotic release (gentamicin, erythromycin, colistin, tobramycin, vancomycin, clindamycin or fusidic acid) directly in the surgical area where the infection might develop.PurposeThe purpose of this report is to assess the evidence available on the efficacy, safety and coverage policy related issues on the use of antibiotic-loaded bone cement in primary hip and knee arthroplasty.MethodsA bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled randomized clinical trials (RCTs); health technology assessments (HTAs) and economic evaluations (EEs); clinical practice guidelines and coverage policies of other health systems.ResultsThree systematic reviews, five RCTs, one arthroplasty record, one HTA, one EE and three clinical practice guidelines were included.Hip arthroplastyTwo RCTs from 2006 and 2012 included 60 and 23 patients, respectively. No statistically significant differences were found in any of the results measured between primary THA treated with antibiotic-loaded bone cement vs. cement without antibiotics (ATB).A retrospective analysis from the Arthroplasty Norwegian Registry published in 2003 included 15,740 THAs, where systemic prophylaxis combined with ATB-loaded bone cement was used and 5,986 cases where only systemic ATB was used. It showed a higher risk of revision surgery in patients treated with systemic prophylaxis alone. A HR for all cause revision surgery of 1.4 (95%CI 1.1 - 1.7) was reported; a 1.8 HR when the cause was infection (95%CI 1.1 ? 3) and a 1.3 HR for revision surgery due to aseptic loosening (95%CI 1.0 - 1.7), for those who received systemic prophylaxis alone.Knee arthroplastyOne RCT from 2001 conducted on diabetic patients (78 THAs) and another RCT from 2002 (320 TKAs) randomized patients to systemic antibiotic prophylaxis plus cefuroxime-loaded cement or cement without ATB. The mean follow-up was 50 months. For diabetic patients the rate of deep infections reported was 0% in patients treated with ATB-loaded cement vs. 13.5% in patients treated with cement without ATB (p<0.05). In the study conducted in 2002, the reported rate of deep infections was 0% in the patients treated with cefuroxime-loaded cement vs. 3.1% in the patients treated with cement without ATB (p<0.05).Another RCT from 2013, randomized 2,948 TKA patients to systemic prophylaxis plus ATB-loaded cement (erythromycin and colistin) or plus cement without ATB. No statistically significant differences were found in the rate of deep infections or in the rate of superficial infections between both groups. No other related adverse effects were reported with the use of ATB-loaded cement.Clinical practice guidelines recommend preventing infections, to combine systemic antibiotics plus ATB-loaded cement as a more effective strategy; except one which recommends adding ATB-loaded cement only for high risk patients.One German HTA from 2010 evaluated the effectiveness and cost-effectiveness of using ATB-loaded cement for primary THA. It concluded that in surgical rooms with no air purifying measures, the ATB-loaded cement should be used only in addition to intravenous prophylaxis. It recommends performing new studies of better methodological quality.ConclusionsThe evidence found for primary THA was of moderate quality and it showed that ATB-loaded cement might add some clinical benefit to systemic prophylaxis, although there are no RCTs of adequate quality supporting this indication.The evidence found for TKAs was of good quality although contradictory regarding results. Some studies showed the benefits of adding ATB-loaded cement to the systemic antibiotic prophylaxis, however the most recent RCT, with the largest number of patients enrolled, found no clinical benefits associated to the use of antibiotic-loaded cement.In spite of the fact that evidence is not conclusive for THA and TKA, the clinical practice guidelines usually support its use, although in some cases they restrict it to patients considered at high risk.