Treatment of infection in long bones (Intramedullary nails)

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Prophylaxis and treatment of infection in long bones using an antibiotic-loaded ceramic coating with interlocking intramedullary nails

 

Key points

    • ✔ 61 patient retrospective analysis comparing efficacy of antibiotic-loaded STIMULAN-coated interlocking intramedullary nails (IMN) to antibiotic-loaded PMMA-coated IMN.
    • ✔ Prophylactic use of STIMULAN-coated IMN prevented infection in 100% (24/24 patients) of high-risk patients treated and resulted in a 95.5% bony union or fusion rate (21/22 patients) and 100% (24/24 patients) limb salvage rate.
    • ✔ Early analysis suggests STIMULAN-coated IMN are non-inferior to PMMA-coated IMN in treating infection.
    • ✔ Use of STIMULAN-coated IMN was demonstrated to be safe in this small patient cohort.
    • ✔ Limitations of this study are the small sample size, its retrospective nature and the shorter follow-up in the STIMULAN-coated IMN group (28.3 months) versus the PMMA-coated IMN group (40 months).

 

Summary
A study by Downey et al. (2022), titled ” Prophylaxis and treatment of infection in long bones using an antibiotic-loaded ceramic coating with interlocking intramedullary nails”, compared the safety and efficacy of either antibiotic-loaded polymethylmethacrylate-coated intramedullary nails (PMMA-IMN, with vancomycin and tobramycin) or antibiotic-loaded calcium sulfate-coated interlocking intramedullary nails (CS-IMN, STIMULAN with vancomycin and tobramycin) to prevent infection in high-risk patients and to eradicate infection when infection is confirmed. In this study, a retrospective review of medical records was conducted for consecutive patients who underwent a limb salvage procedure for infection eradication or infection prophylaxis using either PMMA-IMN or CS-IMN. All patients had a minimum follow-up period of six months.

For infection prophylaxis the efficacy of CS-IMN was evaluated in 24 high risk patients, including those undergoing one-stage conversions from external fixation to internal fixation, patients with a history of recent infection in the planned operative site, who had a history of external fixation for limb lengthening, and patients with a history of an open fracture and resultant non-union. The results demonstrated a 100% (24/24 patients) prevention of infection rate, 95.5% union rate (21/22 patients), and 100% (24/24 patients) limb salvage rate.

For infection eradication the efficacy of CS-IMN (9 patients) was compared with PMMA-IMN (28 patients). In all cases of confirmed infection, the patients were also treated with culture specific intravenous antibiotic therapy for 6 weeks, followed by oral antibiotics. The infection was eradicated in 7/9 patients (77.8 %) in the CS-IMN group versus 21/26 patients (80 %) in the PMMA-IMN group (p = 0.44). Bone union/fusion was achieved in 8/9 patients (88.9 %) in the CS-IMN group versus 21/24 patients (87.5 %) in the PMMA-IMN group (p = 0.11). The limb salvage rate in the CS-IMN group was 100% (9/9 patients) versus 89% (25/28 patients) in the PMMA-IMN group.

Early analysis suggests that CS-IMN is non-inferior to PMMA-IMN for infection eradication. CS-IMN are safe and easy to use. Limitations of this study include a very small sample size, its retrospective nature, and shorter follow-up period in the CS-IMN group.

Publication
https://pmc.ncbi.nlm.nih.gov/articles/PMC9051659/

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 SIMULAN is available here. These Instructions for Use specify the approved/cleared intended use, indications, contraindications, warnings and precautions.