Silver Doped Ceramic Coated Orthopedic Implants

Eskisehir Osmangazi University30 enrolled

Overview

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,

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..

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Implant Site Infection Implant Infection

Interventions

Silver doped hydroxyapatite coated implantsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Eskisehir Osmangazi University Hospital

Eskişehir, Turkey (Türkiye)

Outcomes

Primary Outcomes

Number of pin site with positive culture resuls

incidence of pin tract infection

Time frame: 12 months

Secondary Outcomes

Number of patient with elevated level of serum ALT levels

liver dysfunction

Time frame: 12 months

Number of patient with elevated BUN levels

Kidney dysfunction

Time frame: 12 months

Number of patient with elevated blood silver

Silver exposure

Time frame: 12 months

Data from ClinicalTrials.gov

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