Is Self-transfusion Safe After Total Knee Arthroplasty in Terms of Nephrotoxicity of Gentamicin From Bone Cement?

Study Overview
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Brief Summary
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Considering that the high local concentration of antibiotic from bone cement is delivered intravenously through the self-transfusion process, systematic toxicity has never been evaluated. In addition, the effectiveness of self-transfusion with the routine concomitant use of other modern blood-salvage strategies, like tranexamic acid, should be also assessed. Therefore we performed a randomized study to assess: 1) the safety of self-transfusion in TKA by comparing the gentamicin concentrations resulting from the use or not of autologous blood transfusion. 2) the efficacy of self-transfusion in TKA, with the concomitant administration of tranexamic acid. The serum concentration of aminoglycosides has been measured in two groups of 20 patients each, after TKA, according to the use of self-transfusion. Hemoglobin, renal function and calculated blood loss were compared at several time points between groups.

Official Title
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Is Serum Gentamicin Concentration Modified With Autologous Cell-saved Blood Transfusion After Total Knee Arthroplasty Using Tranexamic Acid: A Randomized Control Trial

Conditions
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Arthroplasty Complications, Total Knee Arthroplasty

Intervention / Treatment
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* Device: Self-transfusion device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: end-stage of knee osteoarthritis, who scheduled for unilateral primary TKA in our department Exclusion Criteria: patients who had been treated with gentamicin within the past 10 days known allergies against the bone cement estimated glomerular filtration rate (eGFR) <30ml/minute previous nephrectomy and history of renal transplant contraindications against tranexamic acid
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-transfusion group<br>Patients to whom a self-transfusion device has been used after total knee arthroplasty. | Device: Self-transfusion device<br>* The Transfusion filter set for salvaged blood (Summit Medical Ltd, Gloucestershire, UK) has been randomly used in 20 patients postoperatively. Patients, who received autologous blood, transfused with the collected amount of blood, only once, 6h postoperatively<br>|
| No Intervention: Control group<br>Patients to whom conventional drains have been used after total knee arthroplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gentamicin serum concentration | using a quantitative fluorescent polarizing immunoassay (FPIA) in the Biochemical analyzer | Postoperatively at: 1 hour, 6 hours, 7 hours, 24 hours and 48 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gentamicin, self-transfusion, blood loss, toxicity, total knee arthoplasty