Silver Doped Ceramic Coated Orthopedic Implants

Implant Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343288
• Other study ID #: 315S101
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: July 2020
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Implant Infection
• Implant Site Infection
• Infection

Intervention

Device:
• Silver 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.

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University Hospital	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of pin site with positive culture resuls	incidence of pin tract infection	12 months
Secondary	Number of patient with elevated level of serum ALT levels	liver dysfunction	12 months
Secondary	Number of patient with elevated BUN levels	Kidney dysfunction	12 months
Secondary	Number of patient with elevated blood silver	Silver exposure	12 months