SOLARIO study meets its primary endpoints - Bone substitute with local antibiotics enables reduced systemic antibiotic treatment
BONESUPPORT™, a leading company in orthobiologics for the management of bone injuries, today announces that the top-line results from the SOLARIO study show that patients with orthopedic infections, who were surgically treated with antibiotic-eluting bone substitute materials such as CERAMENT® G and CERAMENT® V, achieved equally good infection prevention with a short systemic antibiotic course of no more than seven days, compared to the previous standard treatment that extends over at least four weeks. The group that received the shorter antibiotic treatment exhibited significantly reduced side effects compared to standard treatment.
"The new results from the SOLARIO study underscore the importance of integrating antibiotic-eluting bone substitute materials, such as CERAMENT G and CERAMENT V, into treatment guidelines for orthopedic infections. This approach not only promotes patient well-being by reducing the risk of side effects, but it also helps reduce the overall use of systemic antibiotics, which is crucial in the fight against antibiotic resistance (AMR)", states Professor Martin McNally, Nuffield Orthopaedic Centre, Oxford University Hospital.
The full results from the SOLARIO study, conducted with funding from the European Bone & Joint Infection Society (EBJIS) and the National Institute for Health and Care Research (NIHR UK), are expected after publication.
The SOLARIO* study is a randomized controlled multicenter trial involving 500 adult patients with orthopaedic infections. These patients were surgically treated with antibiotic-eluting bone substitute materials and received additional intravenous and/or oral systemic antibiotics for either at least four weeks (standard treatment) or a maximum of seven days (intervention treatment). The aim of the study is to demonstrate that antibiotic-eluting bone substitute materials enable a shortened duration of systemic antibiotic therapy, which could offer significant benefits for both patients and society. These benefits include shorter treatment times, reduced antibiotic costs, fewer side effects, better patient adherence, improved antibiotic stewardship, and a reduced risk of antibiotic resistance.
*Dudareva M, Kumin M, Vach W, Kaier K, Ferguson J, McNally M, Scarborough M. Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomized controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy. Trials 2019; 20: 693.