Abstract
Nearly 1.3 million total joint replacement procedures are performed in the United States annually, with numbers projected to rise exponentially in the coming decades. Although finite infection rates for these procedures remain consistently low, device-related infections represent a significant cause of implant failure, requiring secondary or revision procedures. Revision procedures manifest several-fold higher infection recurrence rates. Importantly, many revision surgeries, infected or not, require bone void fillers to support the host bone and provide a sufficient tissue bed for new hardware placement. Antibiotic-eluting bone void fillers (ABVF), providing both osteoconductive and antimicrobial properties, represent one approach for reducing rates of orthopedic device-related infections. Using a solvent-free, molten-cast process, a polymer-controlled antibiotic-eluting calcium carbonate hydroxyapatite (HAP) ceramic composite BVF (ABVF) was fabricated, characterized, and evaluated in vivo using a bacterial challenge in a rabbit radial defect window model. ABVF loaded with tobramycin eliminated the infectious burden in rabbits challenged with a clinically relevant strain of Staphylococcus aureus (inoculum as high as 107 CFU). Histological, microbiological, and radiographic methods were used to detail the effects of ABVF on microbial challenge to host bone after 8 weeks in vivo. In contrast to the HAP/BVF controls, which provided no antibiotic protection and required euthanasia 3 weeks post-operatively, tobramycin-releasing ABVF animals showed no signs of infection (clinical, microbiological, or radiographic) when euthanized at the 8-week study endpoint. ABVF sites did exhibit fibrous encapsulation around the implant at 8 weeks. Local antibiotic release from ABVF to orthopedic sites requiring bone void fillers eliminated the periprosthetic bacterial challenge in this 8-week in vivo study, confirming previous in vitro results.
Highlights
Global markets for orthopedic procedures and products are estimated to reach $41.8 billion by 2016 based on an anticipated annual growth rate of 7.4% from 2009–2016 [1,2]
Rising numbers of Total Joint Replacements (TJRs) combined with finite infection rates have yielded dramatic growth in numbers of patients worldwide suffering with these devastating infections [10,11,12]
Antibiotic-eluting polymer-controlled bone void filler (BVF)/HAP composite devices were fabricated in controlled dimensions, readily handled and compressed into the molds, shaped and carved for facile perioperative manipulation in diverse bone site dimensions and geometries
Summary
Global markets for orthopedic procedures and products are estimated to reach $41.8 billion by 2016 based on an anticipated annual growth rate of 7.4% from 2009–2016 [1,2]. This growth can be attributed to increased applications in aging global populations and in new patient groups from developing countries [1,3]. Major contributors to this growth are revision Total Joint Replacements (TJRs), including Total Hip Arthroplasty (THA) revisions projected to exceed 50,000 annually by 2030 and Total Knee Arthroplasty (TKA) revisions projected to number nearly 250,000 procedures by 2030 [4]. Infection prevention and treatment both continue to be ongoing foci of the orthopedic community
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