CLINICAL TRIAL
JOURNAL ARTICLE
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The Use of Bioactive Glass S53P4 as Bone Graft Substitute in the Treatment of Chronic Osteomyelitis and Infected Non-Unions - a Retrospective Study of 50 Patients.

BACKGROUND: Treatment of chronic osteomyelitis (COM) remains challenging and often results in large bone defects. Dead space management and proper defect filling are essential for successful treatment. Bioactive glass S53P4 (BAG-S53P4) is an anorganic bone graft substitute with antibacterial, osteoconductive, osteostimulative and angiogenic properties. The aim of our study was to analyse the outcome of patients with COM and infected non-unions, whose bone defects were filled with BAG-S53P4.

MATERIAL AND METHODS: In this retrospective study (07/13 - 02/16), we analysed all patients with COM and infected non-unions, who obtained BAG-S53P4 after surgical debridement to fill their bone defects. Epidemiological data, pre-, peri- and postoperative characteristics were evaluated. The primary endpoint was the successful control of infection during the follow-up period. Secondary endpoints were the absence of BAG-S53P4-related complications, the time period to full weight bearing as well as to radiologically detectable incorporation of BAG. X-ray examinations were routinely performed 1 month, 3 - 4 months, 6 months and 12 months postoperatively.

RESULTS: 50 patients were analysed. Staphylococcus aureus was the most common pathogen involved. On average, 11.1 ± 6.7 cm3 BAG-S53P4 were implanted. Mean follow-up was at 12.3 months. After 6 months, 26/37 (70.3%) and after 12 months, 35/42 (83.3%) of the filled bone defects were healed. X-ray examinations showed a thickened neo-cortex. 40 patients (80%) have achieved full weight bearing after a mean of 4 months. There were no complications at all in 76% of patients. Seven patients suffered reinfection. BAG-associated complications were not seen.

CONCLUSIONS: The use of BAG-S53P4 in patients with COM and infected non-unions is promising. Adequate debridement and proper defect filling are necessary. BAG is well tolerated. X-ray examinations showed a thickened neo-cortex. The antibacterial effect is not mediated by antibiotics and is advantageous in times of evolving antibiotic resistance. High quality studies with a longer follow-up are required.

TRIAL REGISTRATION: TRN DRKS00011679.

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