Decrease in acute periprosthetic joint infections

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Decrease in acute periprosthetic joint infections incidence with vancomycin-loaded calcium sulfate beads in patients with non-modifiable risk factors. A randomized clinical trial

 

Key points

    • ✔ Prospective, randomized trial including 83 patients with non-modifiable risk factors undergoing total hip or knee replacement.
    • ✔ Patient were randomized to receive either local antibiotic prophylaxis using calcium sulfate beads (STIMULAN) or standard IV antibiotic prophylaxis.
    • ✔ Prophylactic local antibiotic delivery prevented acute infection in 90.7% of patients compared to 32.5% of patients using IV antibiotic prophylaxis.
    • ✔ Use of local antibiotic delivery resulted in shorter mean hospital stay compared to IV prophylaxis (4.67 versus 15.25 days, respectively).
    • ✔ Study limitations include small sample size, short follow-up, and potential for patients to not have adequate control of their comorbid conditions.

 

Summary

de Lachica, et al. conducted a prospective, randomized, controlled trial in 83 patients over the age of 60 with one or more non-modifiable risk factors who underwent either total knee or hip replacement surgery. Results were published in 2022 in the paper entitled “Decrease in acute periprosthetic joint infections incidence with vancomycin-loaded calcium sulfate beads in patients with non-modifiable risk factors. A randomized clinical trial.” The aim of this study was to evaluate and compare the incidence of periprosthetic joint infection after either local or intravenous antibiotic prophylaxis. Those in the experimental group (n=43) received local prophylactic antibiotic therapy with calcium sulfate beads (STIMULAN) impregnated with vancomycin while those in the control group (n=40) were administered IV prophylaxis with cephalosporin 20 minutes before joint replacement surgery and then every 8 hours for 24 hours.

Acute periprosthetic joint infection, defined as occurring within 3 months post-operatively, was reported in 27 patients (67.5%) in the control group compared to 4 patients (9.3%) in the calcium sulfate group (p =0.0001). This represented a relative risk of 0.13 (CI; 0.05–0.33) for periprosthetic infection in patients with non-modifiable risk factors with the use of local prophylaxis compared to standard IV prophylaxis. The length of hospitalization was shorter in the calcium sulfate group (4.67 days, ± 4.62 days) compared to the control group (15.25 days, ± 10.06 days, p < 0.0001). Study limitations include small sample size, short follow-up, and potential for patients to not have adequate control of their comorbid conditions.

Authors conclude that local antibiotic prophylaxis in patients with non-modifiable risk factors undergoing arthroplasty procedures for hip or knee reduces the risk of acute periprosthetic joint infection compared to standard IV antibiotic prophylaxis.

Publication

https://www.jisakos.com/article/S2059-7754(22)00077-3/fulltext

Statements

Key Points and Summary prepared by Biocomposites Ltd. The new/unapproved uses of STIMULAN described in this scientific article have not been approved/cleared by the (US) FDA and the safety and effectiveness for the new/unapproved use has not been established.

The (US) FDA approved/cleared use of STIMULAN is available here. These Instructions for Use specify the approved/cleared intended use, indications, contraindications, warnings and precautions.