Abstract
Chronic osteomyelitis is historically treated in a two stage fashion with antibiotic-loaded polymethylmethacrylate (PMMA) as local antibacterial therapy. However, two-stage surgeries are associated with high morbidity, long hospitalization and high treatment costs. In recent years new biomaterials were developed that allow to change this treatment algorithm. S53P4 bioactive glass is such a novel biodegradable antibacterial bone graft substitute that enables a one-stage surgery in local treatment of chronic osteomyelitis. This study aimed to explore the eradication of infection and bone healing capacities of S53P4 bioactive glass in clinical practice.
In this prospective longitudinal outcome study, clinical applicability of S53P4 bioactive glass in treatment of patients with chronic osteomyelitis was assessed. All patients with clinically, haematologically and radiologically evident chronic osteomyelitis were included. All patients were treated with an extensive debridement surgery, S53P4 bioactive glass implantation and systemic antibiotic administration. Primary endpoint of this study is eradication of infection. During follow-up eradication was analysed based on clinical outcomes, blood samples (inflammatory parameters) and radiological outcomes. The secondary endpoint, bone healing, is assessed using conventional radiographic images of the treated region.
Between 2011 and 2016, 25 patients were included in this study, with a mean follow-up of 23 months (range 4 – 57). Hospital stay was short with a mean of 18 days (range 4 – 40) and patients required an average of 1,4 surgeries (range 1 – 4). The inflammatory parameter C-reactive protein (CRP) showed a normalization after a mean duration of 46 days (range 0 – 211). At the end of follow-up haematological and clinical outcomes showed eradication of infection in 24 (96%) of all patients. Radiologically none of all patients showed persisting signs of infection and bone healing was observed in 22 (88%) patients based on changes on conventional radiographic images. One patient had a persistent infection without any bone healing, this patient had an infected non-union prior to surgery. There were two other patients with an initial infected non-union fracture which was not consolidated at last follow-up, although they had successful infection treatment. Another patient had a femoral fracture after surgery that needed additional surgery which did not interfere with eradication of infection. Four (16%) of all patients had initial wound healing problems related to compromised skin and/or soft tissue prior to surgery.
Based on the results of our clinical experience, S53P4 bioactive glass can successfully be used in a one-stage procedure for treatment of chronic osteomyelitis. Eradication of infection was successful in almost all patients and so far no patients required a second surgery due to infection recurrence. Bone healing (incorporation of the bioactive glass) was seen in all patients except for the patients with an initial infected non-union fracture. As a consequence of these results, we changed our institutional protocol for treatment of chronic osteomyelitis to a one-stage approach instead of a two-step approach.
