Silver Doped Ceramic Coated Orthopedic Implants

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

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,

Study Overview

• Status: Completed
• Conditions: Implant Site Infection; Implant Infection
• Intervention / Treatment: Device: Silver doped hydroxyapatite coated implants

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eskişehir, Turkey, 26480
    • Eskişehir Osmangazi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Silver HA coated implants; Silver doped hydroxyapatite coated implants

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Nusret kose, MD, Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: October 22, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Medical Device; Antimicrobial; Silver Hydroxiapatite Coating
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 315S101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No