Silver Doped Ceramic Coated Orthopedic Implants

Study Overview
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Brief Summary
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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
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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..

Official Title
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The Use of Silver Doped Calcium Phosphate Based Ceramic Coated Orthopedic Implants for Preventing Implant Related Infection

Conditions
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Implant Site Infection, Implant Infection

Intervention / Treatment
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* Device: Silver doped hydroxyapatite coated implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the ages of 18-65 Patients without heart, lung, renal or hepatic insufficiency Patients without epilepsy, cerebrovascular attack or ischaemia Patients without antibiotic allergy Patients who have low immune defense mechanisms such as malignancy, diabetes mellitus, polytrauma, and open fracture Patients using oral or parenteral corticosteroids, methotrexate, cyclosporine or other immunosuppressive drugs - - Exclusion Criteria: Pregnant women Patients with another silver implant in their body, such as a silver-coated stent Patients with known allergy or hypersensitivity to silver Patients with too many antibiotics due to recurrent infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver HA coated implants<br>Silver doped hydroxyapatite coated implants | Device: Silver doped hydroxyapatite coated implants<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pin site with positive culture resuls | incidence of pin tract infection | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with elevated level of serum ALT levels | liver dysfunction | 12 months | 
| Number of patient with elevated BUN levels | Kidney dysfunction | 12 months | 
| Number of patient with elevated blood silver | Silver exposure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silver Hydroxiapatite Coating, Antimicrobial, Medical Device