The Economics of Antibiotic Cement in Total Knee Arthroplasty: Added Cost with No Reduction in Infection Rates

Yayac, Michael; Rondon, Alexander J.; Tan, Timothy L.; Levy, Hannah A; Parvızı, Javad; Courtney, P. Maxwell

doi:10.1016/j.arth.2019.04.043

Cited by 28 publications

(22 citation statements)

References 40 publications

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“…For example, certain combinations of antibioticeluting cement may decrease the risk of PJI in high-risk patient populations such as femoral neck fractures, veteran patients and paediatric spinal deformity surgery [148][149][150] . However, other studies have shown no benefit to infection prophylaxis and poor cost-effectiveness for commercially available antibiotic bone cement formulations when used across a broad population [151][152][153] . One strategy for infection prevention is active immunization.…”

Section: Synovial Fluidmentioning

confidence: 99%

Skeletal infections: microbial pathogenesis, immunity and clinical management

et al. 2022

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Osteomyelitis is an infection of bone that can result from contiguous spread from surrounding tissue, direct bone trauma due to surgery or injury, or haematogenous spread from systemic bacteraemia. It remains a significant health-care burden with a prevalence of ~22 cases per 100,000 person-years in the United States, and its incidence has been rising over time, especially in the elderly and individuals with diabetes 1 . Although it is a heterogeneous disease, subset classifications include implant-associated osteomyelitis (including peri-prosthetic joint infection (PJI) and instrumented spinal infections), fracture-related infection, acute haematogenous osteomyelitis, diabetic foot infection, septic arthritis and native spinal osteomyelitis.Crucial to expanding our understanding of osteomyelitis and advancing treatment algorithms has been the application of animal models, which illustrate the interaction between the pathogen and cells of both the immune and skeletal systems in a manner that in vitro models cannot yet replicate. Animal models are available to study virtually all aspects of skeletal infection, and typically involve inoculation of bacteria at the time of implant placement (Fig. 1). They can vary in complexity from simple models where metal implants are placed under the skin (for example, tissue cage 2 ) or into cortical bone (for example, metal wire 3 ) versus more complex models that mimic functional orthopaedic devices 4 . Additionally, approaches have been developed to induce non-implant infections by haematogenous inoculation into the tail vein 5 , direct inoculation into vertebral bodies or intervertebral discs 6 to induce vertebral osteomyelitis, or inoculation into the foot pad of diabetic obese rodents to induce diabetic foot infection 7 .As disease pathogenesis differs across different infection classes, so does microbial aetiology. Many different microorganisms have been implicated in skeletal infection, and the most common, along with their incidence and tropism, are shown in Table 1. In general, Staphylococcus aureus and coagulase-negative staphylococci (CoNS), such as Staphylococcus epidermidis and Staphylococcus lugdunensis, are responsible for up to two-thirds of all skeletal infections, with S. aureus being the most prevalent single pathogen. Additionally, antimicrobial resistance remains a challenge in osteomyelitis treatment with up to 50% of cases of S. aureus osteomyelitis caused by methicillin-resistant S. aureus (MRSA) strains 8 . Other less commonly identified pathogens include Enterococcus spp., Pseudomonas aeruginosa, Escherichia coli and Cutibacterium acnes (Table 1). Most cases of osteomyelitis are monomicrobial; however,

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Section: Synovial Fluidmentioning

confidence: 99%

Skeletal infections: microbial pathogenesis, immunity and clinical management

et al. 2022

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“…When surgeons do consider using ALBC for primary arthroplasty, they can choose to either utilize commercially prepared low‐dose ALBC or manually add antibiotic powder to nonantibiotic‐loaded cement. Proponents of commercially prepared ALBC point out that these products, in comparison to hand‐mixed ALBC, reduce operating time and claim that they provide ALBC with more consistent homogenously mixed antibiotics that improve the drug delivery and produce a cement mantle that has a better mechanical profile 42 . However, such advantages have not been consistently verified.…”

Section: Resultsmentioning

confidence: 99%

“…Proponents of commercially prepared ALBC point out that these products, in comparison to handmixed ALBC, reduce operating time and claim that they provide ALBC with more consistent homogenously mixed antibiotics that improve the drug delivery and produce a cement mantle that has a better mechanical profile. 42 greater. 19 Medical devices that release antibiotic as a secondary mode of action are considered "combination products" by the FDA, and must undergo rigorous testing to evaluate both safety and efficacy.…”

Section: Questionmentioning

confidence: 97%

Adjuvant antibiotic‐loaded bone cement: Concerns with current use and research to make it work

Schwarz

McLaren

Sculco

et al. 2020

Journal Orthopaedic Research

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106

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Antibiotic‐loaded bone cement (ALBC) is broadly used to treat orthopaedic infections based on the rationale that high‐dose local delivery is essential to eradicate biofilm‐associated bacteria. However, ALBC formulations are empirically based on drug susceptibility from routine laboratory testing, which is known to have limited clinical relevance for biofilms. There are also dosing concerns with nonstandardized, surgeon‐directed, hand‐mixed formulations, which have unknown release kinetics. On the basis of our knowledge of in vivo biofilms, pathogen virulence, safety issues with nonstandardized ALBC formulations, and questions about the cost‐effectiveness of ALBC, there is a need to evaluate the evidence for this clinical practice. To this end, thought leaders in the field of musculoskeletal infection (MSKI) met on 1 August 2019 to review and debate published and anecdotal information, which highlighted four major concerns about current ALBC use: (a) substantial lack of level 1 evidence to demonstrate efficacy; (b) ALBC formulations become subtherapeutic following early release, which risks induction of antibiotic resistance, and exacerbated infection from microbial colonization of the carrier; (c) the absence of standardized formulation protocols, and Food and Drug Administration‐approved high‐dose ALBC products to use following resection in MSKI treatment; and (d) absence of a validated assay to determine the minimum biofilm eradication concentration to predict ALBC efficacy against patient specific micro‐organisms. Here, we describe these concerns in detail, and propose areas in need of research.

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“…Local antimicrobial therapy in the form of bioresorbable delivery devices is a rapidly emerging technology in FRI 108 , with multiple studies demonstrating its efficacy in the prevention and treatment of infection 109 . While the current literature on its effectiveness in preventing PJI is still conflicting 110 , there is some evidence supporting its use in patients with a high risk of infection, although this decision should be balanced against the risk of adverse drug reactions and the development of drug-resistant organisms 111 . This further begets the question of whether safety and efficacy should be treated separately in the regulatory process for anti-infective technologies.…”

Section: Redefining Clinical Worthmentioning

confidence: 99%

Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market

Goh

Tornetta

Parvızı

2021

Journal of Bone and Joint Surgery

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:Orthopaedic device-related infection is one of the most devastating complications in orthopaedic and trauma surgery. With increasing life expectancies as well as the lifelong risk of bacterial seeding on an implant, the prevention and treatment of device-related infection remains an important area for research and development. To facilitate information exchange and enhance collaboration among various stakeholders in the orthopaedic community, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) organized an inaugural workshop on orthopaedic device-related infections, exploring the regulatory challenges that are faced when proceeding from the bench level to marketing and clinical implementation of new infection-control devices and products. This article summarizes the perspectives of scientists, clinicians, and industry partners on the current regulatory approval process for orthopaedic anti-infective technologies as well as the proposed strategies to overcome these regulatory challenges.

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The Economics of Antibiotic Cement in Total Knee Arthroplasty: Added Cost with No Reduction in Infection Rates

Cited by 28 publications

References 40 publications

Skeletal infections: microbial pathogenesis, immunity and clinical management

Skeletal infections: microbial pathogenesis, immunity and clinical management

Adjuvant antibiotic‐loaded bone cement: Concerns with current use and research to make it work

Facilitating the Approval Process of Anti-Infective Technologies and Advancing Them to the Market

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