Silver Doped Ceramic Coated Orthopedic Implants

Not Applicable

Completed

• Conditions: Implant Infection; Implant Site Infection
• Interventions: Device: Silver doped hydroxyapatite coated implants

• Registration Number: NCT03343288
• Lead Sponsor: Eskisehir Osmangazi University

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..

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-17
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silver HA coated implants	Silver doped hydroxyapatite coated implants	Silver doped hydroxyapatite coated implants

Primary Outcome Measures

Name	Time	Method
Number of pin site with positive culture resuls	12 months	incidence of pin tract infection

Secondary Outcome Measures

Name	Time	Method
Number of patient with elevated BUN levels	12 months	Kidney dysfunction
Number of patient with elevated level of serum ALT levels	12 months	liver dysfunction
Number of patient with elevated blood silver	12 months	Silver exposure

Trial Locations

Locations (1)

Eskisehir Osmangazi University Hospital; 🇹🇷 Eskişehir, Turkey