Clinical Trial Using A Silver-Coated Screw-Rod System and One-Year Follow-Up of The First 50 Patients

Abstract

Aim: The occurrence of implant-related infection in all surgical branches is one of the challenges for which a definitive solution has yet to be found. One way to reduce the incidence of implant-related infection is to use implants which are coated with antibacterial materials such as silver. The aim of this study is to investigate if the nanoparticle silver coated spinal implants reduce the implant related infection rates and safe for human use.

Method: In this clinical trial performed with 50 patients, we investigated whether or not silver-coated titanium implants alter renal and/or hepatic functions and increase serum silver levels at one year postoperatively. The required stabilization procedure was performed using the “nanoparticle silver coated transpedicular stabilisation system”. Blood and urine samples were taken from each patient at six different time points for detection of any alteration in silver concentration. Silver levels of all samples were investigated spectrophotometrically. Additional serum samples were taken for monitoring liver and kidney functions.

Results: All values measured were regarded as safe since they were lower than 5 μg/L. There was no alteration in renal and/or hepatic function, and the amount of silver in urine and serum was at undetectable levels using atomic absorption spectrophotometer. Neither complication was related to silver nor any implant infection was detected in one year follow- up period.

Conclusions: This study showed that, nanoparticular silver coated spinal implants are capable to reduce implant- related infection rates and these type of implants are safe for human use.