Silver Doped Ceramic Coated Orthopedic Implants

In this study, considering the differences in bone contact surface area and interactions; hip joint prostheses, intramedullary nails and external fixator implants to be used in 30 patients . CE (European Conformity) marked, domestic manufactured standard orthopedic implants will be used in patients after silver HA coating with electrospray method. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months. The performance of coating to be applied and any unwanted side effects in normal conditions of use will be evaluated..

• Silver doped hydroxyapatite coated implants (Device): In this study, CE marked, domestic manufactured standard orthopedic implants will be used in 30 patients after silver ceramic coating with electrospray method. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months.

Primary outcomes

• Number of pin site with positive culture resuls [12 months]: incidence of pin tract infection

Secondary outcomes

• Number of patient with elevated level of serum ALT levels [12 months]: liver dysfunction
• Number of patient with elevated BUN levels [12 months]: Kidney dysfunction
• Number of patient with elevated blood silver [12 months]: Silver exposure

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

1. Men and women between the ages of 18-65
2. Patients without heart, lung, renal or hepatic insufficiency
3. Patients without epilepsy, cerebrovascular attack or ischaemia
4. Patients without antibiotic allergy
5. Patients who have low immune defense mechanisms such as malignancy, diabetes mellitus, polytrauma, and open fracture
6. Patients using oral or parenteral corticosteroids, methotrexate, cyclosporine or other immunosuppressive drugs - -

Exclusion Criteria:

1. Pregnant women
2. Patients with another silver implant in their body, such as a silver-coated stent
3. Patients with known allergy or hypersensitivity to silver
4. Patients with too many antibiotics due to recurrent infections

• Nusret kose, MD, Principal investigator, Eskisehir Osmangazi University