title: ANTIBIOTIC-LOADED REGENOSS FOR THE TREATMENT OF SEPTIC BONE DEFECTS: IN VITRO STUDY AND PRELIMINARY CLINICAL EXPERIENCE.
abstract: Bone and joint infections are a difficult to treat condition, often associated with bone loss. Although the management of septic bone defects may currently be achieved through various treatment modalities, there is a continuous need for bone substitutes able at the same time to favour bone repair and to provide local antibacterial protection. RegenOss, a biomimetic and resorbable bone substitute, has been previously shown to be highly biocompatible and osteoconductive. Aims of the present study were to test the in vitro ability of RegenOss to act as a local carrier of antibiotics and to investigate its clinical safety and efficacy in a continuous series of patients, affected by bone loss in active or previous infection. In vitro study was performed by adding vancomycin, levofloxacin or meropenem and assessing elution properties of RegenOss at fixed time intervals by means of a microbiological assay. At 48 hours, 98.5% of meropenem, 94.1% of levofloxacin and 76.3% of vancomycin were recovered in the medium, while all antibiotics were completely eluted at seven days. Clinical safety and efficacy of vancomicyn- or vancomicyn and meropenem-loaded RegenOss had been tested in 13 consecutive patients. After the surgical procedure, each patient underwent clinical, laboratory and radiographic evaluation at 3, 6, 12, 18 and 24 months. No adverse events associated with the use of RegenOss were observed. Twelve patients showed no infection recurrence and ten satisfactory bone healing at follow-up. In conclusion, this study shows the ability of RegenOss to act as local carrier when loaded with three different antibiotics with a complete elution in one week. The clinical use of antibiotic-loaded RegenOss appears safe in this preliminary clinical series, while larger studies are needed to confirm the efficacy of the intra-operative combination of this biomimetic bone substitute with various antibacterials in the treatment of septic bone defects.
authors.affiliation: Department of Reconstructive Surgery of Osteo-articular Infections C.R.I.O. Unit, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
authors.forename: C L
authors.initials: CL
authors.lastname: Romano'
authors.affiliation: Department of Reconstructive Surgery of Osteo-articular Infections C.R.I.O. Unit, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Gallazzi
authors.affiliation: Department of Reconstructive Surgery of Osteo-articular Infections C.R.I.O. Unit, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Logoluso
authors.affiliation: Laboratory of Clinical Chemistry and Microbiology, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
authors.forename: E
authors.initials: E
authors.lastname: De Vecchi
authors.affiliation: Laboratory of Clinical Chemistry and Microbiology, I.R.C.C.S. Galeazzi Orthopaedic Institute, Milano, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Drago