Evidence map›Paper›PMID 27488378›Full record

Trial reportClinical orthopaedics and related research2016

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

Gregory Vrabec, Willis Stevenson, Sameh Elguizaoui, Matthew Kirsch, John Pinkowski

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical orthopaedics and related research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Gregory VrabecDepartment of Orthopaedic Surgery, Akron General Medical Center, 224 W. Exchange Street, Suite 430, Akron, OH, 44302, USA. Gregory.vrabec@akrongeneral.org.
Willis StevensonDepartment of Orthopaedic Surgery, Akron General Medical Center, 224 W. Exchange Street, Suite 430, Akron, OH, 44302, USA.
Sameh ElguizaouiDepartment of Orthopaedic Surgery, Akron General Medical Center, 224 W. Exchange Street, Suite 430, Akron, OH, 44302, USA.
Matthew KirschDepartment of Orthopaedic Surgery, Akron General Medical Center, 224 W. Exchange Street, Suite 430, Akron, OH, 44302, USA.
John PinkowskiDepartment of Orthopaedic Surgery, Akron General Medical Center, 224 W. Exchange Street, Suite 430, Akron, OH, 44302, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntibiotic-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?

methodsAll 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

resultsThe median (interquartile range [IQR]) intraarticular tobramycin concentrations for the study group, with tobramycin-impregnated bone cement, was 31.8 (29.0) μg/mL at 6 hours, 17.1 (13.1) μg/mL at 24 hours, and 6.8 (6.8) μg/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 tobramycin-impregnated bone cement group were 0.3 μg/mL or less for all samples whereas serum concentrations and median (IQR) for the control group were 1.2 (2.6) μg/mL, 1.6 (4.4) μg/mL, and 2.0 (3.3) μg/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).

conclusionsTobramycin-impregnated bone cement provides a way to deliver antibiotics in patients undergoing TKA. This supratherapeutic short-term prophylactic perioperative antibiotic local delivery can be achieved with limited systemic absorption, whereas joint tobramycin levels were less than therapeutic levels when given intravenously alone. In the control group, with only intravenous tobramycin, a subtherapeutic (< 2.0 μg/mL) level of tobramycin was found in all the intraarticular samples at 6, 24, and 48 hours. Based on the evidence obtained in this study, commercially prepared low-dose tobramycin bone cement can be used to obtain short-term supratherapeutic local concentrations in the knee while maintaining serum tobramycin levels at a minimum. LEVEL OF EVIDENCE: Level II, therapeutic study.

Indexed as

Administration, IntravenousAgedAnti-Bacterial AgentsArthroplasty, Replacement, KneeBone CementsDrug MonitoringFemaleHumansKnee JointKnee ProsthesisMaleMiddle AgedOhioProsthesis-Related InfectionsTissue DistributionTobramycinAnti-Bacterial AgentsBone CementsTobramycin

Identifiers

PMID27488378
PMCPMC5052204

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.