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

Abstract

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.

First clinical experience with posterior lumbar interbody fusion using a thermal-sprayed silver-containing hydroxyapatite-coated cage

“…Ag-related adverse reactions, such as argyria and mental or neurological disorders [ 31 ], hepatic and renal dysfunction [ 32 ], cytotoxicity [ 33 ], and mutagenicity [ 34 ], can result from a total dose of 4 g of Ag or a blood Ag concentration of ≥ 300 ppb [ 23 , 32 ]. Regarding neurological damage, Seçinti et al reported that the implantation of 23 g of Ag does not cause neuropathy, based on the listed dental literature [ 35 ]. The maximum amount of Ag contained in the Ag-HA implant for THA and the double cage was reported to be 3 mg [ 15 ] and 1.6 mg, respectively.…”

Implant Surface Technologies to Prevent Surgical Site Infections in Spine Surgery

“…33 In addition, the authors of a 2017 clinical trial in Turkey using a titanium-silver nanoparticle-dipped screw-rod system reported no infections in 50 patients, and undetectable serum/urine silver levels over a 1-year study period. 34 Historically, the MUTARS (Modular Universal Tumor And Revision System; implantcast, Buxtehude, Germany) and other silver ion-coated titanium alloy endoprostheses have been used in Europe for tumor orthopedic reconstruction due to their inherently high risk of postoperative SSIs (up to 47%). 3 The MUTARS system was first introduced in 1992.…”

Development of Silver-Containing Hydroxyapatite-Coated Antimicrobial Implants for Orthopaedic and Spinal Surgery

“…Trovarelli [ First, most reports of orthopedic antimicrobial implants have been for surgical operations using antimicrobial implants for extremity fractures [119,156] or antimicrobial megaprosthesis for bone tumor reconstruction surgery in the extremities, which is associated with a relatively high infection rate [6,31,[136][137][138][139][140][141][142][143][144][145][146][147][148][149], with spinal application described in few cases [117,[151][152][153][154]. Moreover, as for the type or site of the spinal antimicrobial instrumentation, the pedicle screw is expected based on the frequency of use and the intervertebral cage from the viewpoint of host-site immunity; however, most cases of clinical use described the use of antimicrobial pedicle screws.…”