The pharmacokinetics of Simplex-tobramycin bone cement

Sterling, Greg J.; Crawford, Scott K.; Potter, Julia M.; Koerbin, Gus; Crawford, Ross

doi:10.1302/0301-620x.85b5.13746

Cited by 75 publications

(67 citation statements)

References 8 publications

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“…About the use and characteristics of the Simplex P with tobramycin cement, much research has already been performed and published, and its use is widely accepted in clinical practice. 1,5,8,28 The results of this type of cement in this study were comparable to the results previously reported by Nijhof et al, using the same experimental infection model. 1 Although two tobra rabbits did have a positive culture of a bone sample distal from the cement, it showed to be effective in the prevention of infection in the majority of the cases.…”

Section: Discussionsupporting

confidence: 91%

“…[1][2][3] Using cement as the carrier for antibiotics provides a way to deliver high levels of antibiotics locally, without increased risk of renal toxicity or ototoxicity due to high serum levels. [4][5][6][7][8] Therefore, many orthopedic surgeons currently use either commercially available or hand-mixed antibiotic-containing bone cement in primary and revision hip and knee arthroplasties.…”

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confidence: 99%

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No efficacy of silver bone cement in the prevention of methicillin‐sensitive Staphylococcal infections in a rabbit contaminated implant bed model

Moojen

Charles

Fleer

et al. 2009

Journal Orthopaedic Research

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Data from literature showed that a new type of metallic silver PMMA cement had good results in infection prophylaxis. This study investigated the in vivo efficacy of silver cement in the prevention of methicillin-sensitive Staphylococcal infections, compared to plain and tobramycin-containing cement. In 48 rabbits, 0.6% silver, 1% silver, plain, or tobramycin PMMA cement was injected into the femoral medullary canal after contamination with 10 5 , 10 6 , or 10 7 colony forming units (CFU) Staphylococcus aureus. After 14 days, bone was collected for bacteriology and histopathology. All plain and silver cement rabbits were infected, whereas only two tobra rabbits were infected (p < 0.001). The number of bacteria cultured ( 10 logCFU) from bone adjacent to the cement, was 6.4 AE 0.3 and 6.1 AE 0.3 for the 0.6% and 1% silver rabbits. For the rabbits with plain and tobra cement, this was 6.2 AE 0.2 (p > 0.95) and 0.0 AE 0.0 (p < 0.001), respectively. Two tobra rabbits had a positive culture of a distal bone sample. Histological sections of plain, 0.6%, and 1% silver rabbits all showed signs of infection; these signs were absent in the tobra rabbits. Silver and plain cement were not effective in preventing infection, whereas tobra cement was effective. As silver cement predominantly exhibits an antimicrobial effect at the direct cement surface, this cement seems less useful in situations where there are bacteria present in surrounding tissues, like revision surgery. Whether silver cement has relevance in the prevention of bacterial colonization of cement remains to be determined. ß

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Section: Discussionsupporting

confidence: 91%

mentioning

confidence: 99%

No efficacy of silver bone cement in the prevention of methicillin‐sensitive Staphylococcal infections in a rabbit contaminated implant bed model

Moojen

Charles

Fleer

et al. 2009

Journal Orthopaedic Research

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“…As chitosan is also used as a carrier for drug delivery, we hypothesized that chitosan added to bone cement could act as a drug-delivery carrier for gentamicin. Moreover, although the exact mechanism by which antibiotics are released from PMMA cement is unknown, it has been suggested that surface elution and diffu- sion are the main mechanisms of antibiotic release from the loaded material (Sterling et al 2003, Bertazzoni et al 2004. Thus, if the porosity of cement could be increased as a result of chitosan degradation giving a more efficacious route of antibiotic release, the degree of gentamicin release would be enhanced-thereby preventing bacterial colonization and biofilm formation on the surface of bone cement.…”

Section: Discussionmentioning

confidence: 99%

In vitro testing of chitosan in gentamicin-loaded bone cement No antimicrobial effect and reduced mechanical performance

Dunne¹,

Buchanan²,

Hill³

et al. 2008

Acta Orthopaedica

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Background and purpose Efforts to prevent infection of arthroplasties, including the use of antibiotic-loaded bone cement, are not always successful. We investigated whether the incorporation of chitosan in gentamicinloaded bone cement increases antibiotic release, and prevents bacterial adherence and biofilm formation by clinical isolates of Staphylococcus spp. In addition, we performed mechanical and degradation tests.Methods Different amounts of chitosan were added to the powder of the gentamicin-loaded bone cement. Gentamicin release was determined using high-performance liquid chromatography mass spectrometry. Bacterial adherence and bacterial biofilm formation were determined using clinical isolates cultured from implants retrieved at revision hip surgery. The mechanical properties were determined as a function of degradation in accordance with ISO and ASTM standards for PMMA bone cement.Results The addition of chitosan to bone cement loaded with gentamicin reduced gentamicin release and did not increase the efficacy of the bone cement in preventing bacterial colonization and biofilm formation. Moreover, the mechanical performance of cement containing chitosan was reduced after 28 days of degradation. The compressive and bending strengths were not in compliance with the minimum ISO and ASTM requirements.Interpretation Clinically, incorporation of chitosan into gentamicin-loaded bone cement for use in joint replacement surgery has no antimicrobial benefit and

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“…The pharmacokinetics of tobramycin cement in primary total hip replacements have been studied [21], however the pharmacokinetics of tobramycin cement in primary total knee replacements, to our knowledge, have not been reported, and thus provided the motivation for our study. This is in contrast to the standard use of systemic intravenous prophylactic antibiotics routinely used in joint replacement surgery [4].…”

Section: Introductionmentioning

confidence: 99%

What is the Intraarticular Concentration of Tobramycin Using Low-dose Tobramycin Bone Cement in TKA: An In Vivo Analysis?

Vrabec

Stevenson

Elguizaoui

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background Antibiotic-impregnated bone cement has increased in popularity as an effort to reduce the risk of infection in high-risk TKAs. However, limited data has been reported regarding antibiotic levels achieved when using tobramycin-impregnated bone cement after implanting total knee components. Questions/Purposes We asked: (1) What is the tobramycin serum and knee intraarticular levels in patients undergoing primary TKA using tobramycin cement? (2) What is the intraarticular tobramycin level for patients receiving only intravenous tobramycin? Methods All patients undergoing primary TKA by one of the two study surgeons (GV, JP) during a 6-month period were evaluated for inclusion and invited to participate. The study enrolled 15 patients undergoing primary TKA by one of two surgeons (GV, JP) who met inclusion criteria; treatment allocation was assigned randomly through blinded envelope. The study group consisted of 10 patients whose components were implanted using a commercially prepared low-dose tobramycin bone cement mixture (1 g/ 40 g). The control group consisted of five patients who received standard weight-based dose intravenous tobramycin. Samples of serum and Hemovac 1 drain-collected intraarticular hematoma were analyzed at 6, 24, and 48 hours postoperatively. Tobramycin levels were measured using an immunoassay technique with a low-end sensitivity of 0.28 lg/mL. Mann-Whitney U tests were performed to compare the serum and intraarticular tobramycin concentrations at each time in the independent variable of group (Control and Study). Results The median (interquartile range [IQR]) intraarticular tobramycin concentrations for the study group, with tobramycin-impregnated bone cement, was 31.8 (29.0) lg/ mL at 6 hours, 17.1 (13.1) lg/mL at 24 hours, and 6.8 (6.8) lg/mL at 48 hours. The intraarticular tobramycin concentrations of this study group were larger than those for the control group at 6 hours (median = 1.3; IQR = 0.7; p = 0.002), 24 hours (median = 1.3, IQR = 1.0; p = 0.002), and 48 hours (median = 1.4; IQR = 1.0; p = 0.02). The serum concentrations for the tobramycinimpregnated bone cement group were 0.3 lg/mL or less for all samples whereas serum concentrations and median (IQR) for the control group were 1.2 (2.6) lg/mL, 1.6 (4.4) lg/mL, and 2.0 (3.3) lg/mL at 6, 24, and 48 hours respectively. The serum levels for the tobramycin-impregnated cement group were less than those for the control group at 6 hours (p = 0.001), 24 (p = 0.001), and 48 hours (p \ 0.001).

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The pharmacokinetics of Simplex-tobramycin bone cement

Cited by 75 publications

References 8 publications

No efficacy of silver bone cement in the prevention of methicillin‐sensitive Staphylococcal infections in a rabbit contaminated implant bed model

No efficacy of silver bone cement in the prevention of methicillin‐sensitive Staphylococcal infections in a rabbit contaminated implant bed model

In vitro testing of chitosan in gentamicin-loaded bone cement No antimicrobial effect and reduced mechanical performance

What is the Intraarticular Concentration of Tobramycin Using Low-dose Tobramycin Bone Cement in TKA: An In Vivo Analysis?

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