Implant Infection, Implant Site Infection
Conditions
Keywords
Silver Hydroxiapatite Coating, Antimicrobial, Medical Device
Brief summary
In this study, CE (European Conformity) marked, domestic manufactured standard orthopedic implants will be used after silver HA coating with electrospray method in 30 patients requiring hip joint prostheses, intramedullary nails or external fixator in 30 patients to antimicrobial effectiveness. These patients will be tasted for 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,
Detailed description
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..
Interventions
DEVICESilver doped hydroxyapatite coated implants
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.
Sponsors
Eskisehir Osmangazi University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
In this study, hip joint prostheses, intramedullary nails and external fixator implants to be used in 30 patients . CE marked, domestic manufactured standard orthopedic implants will be used in patients after silver doped HA coating . Antimicrobial effectiveness of the coating will be evaluated. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pin site with positive culture resuls | 12 months | incidence of pin tract infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed