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

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, 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. Technology Bone 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. Purpose The 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. Methods A 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. Results Three systematic reviews, five RCTs, one arthroplasty record, one HTA, one EE and three clinical practice guidelines were included. Hip arthroplasty Two 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 arthroplasty One 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