Abstract
Open fractures carry a high risk of infection. Our objective was to evaluate the effect of a resorbable bone substitute (BS) (calcium sulphate and hydroxyapatite) eluting Gentamicin (Cerament™| G) in the prevention of bone infection and nonunion after open fracture and/or skin lesion.
The data of patients undergoing osteosynthesis augmented with BS and Gentamicin between December 2012 and April 2015 were retrospectively analyzed from a prospectively established database. Patients were treated for open fractures grade 1 Gustilo or skin lesion with high risk of contamination. Surgical technique included initial debridement, open reduction and internal fixation (ORIF), implantation of BS and Gentamicin, soft tissue closure, and systemic antibiotic therapy for 2 weeks in all cases. Clinical outcome and radiographic bone defect filling were assessed by blinded observers.
From 12/2013 to 4/2015 nine male and six female with mean age 53yrs (24–77) were treated with ORIF and BS and Gentamicin for open fractures. Fracture locations were tibial plateau (two), tibia (two), proximal humerus (one), calcaneus (four), talus (one), forearm (three), and elbow (one) distal femur (one). at final follow-up (mean 11.1 months; range 7–13).
One patient developed a sterile seroma, which was treated conservatively. No post-operative infection occurred during the follow-up period. The calcium sulphate phase of BGS dissolved within 4–6 weeks in all cases.
Bone ingrowth was assessed at 1, 2, 3, 6 and 12 months and new bone formation was observed at 6 months. One patient with an exposed comminuted fracture and large bone defect showed poor bone regeneration and was treated with a revision surgery (exchange of plate, autologous cancellous bone graft combined with BGS and Gentamicin. No complications were reported.
The use of this bone substitute is well documented in the literature. The new product containing 175 mg gentamicin in 10 ml shows a high release of gentamicin in in-vitro testing, comparable to the elution profile of PMMA beads that some authors suggested to use to reduce the risk of infection.
However, the use of this antibiotic carrier in order to prevent bone infection after open fracture has not been studied yet. In this case series 15 patients have been treated and good early clinical outcomes were observed in almost all cases. This material is highly osteoconductive and has a potential for the prophylaxis of infection in the treatment of open fractures. Further investigations and larger series are necessary to show the prophylactic effect in detail.
