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Silver Doped Ceramic Coated Orthopedic Implants

Primary Purpose

Implant Site Infection, Implant Infection

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Silver doped hydroxyapatite coated implants

About this trial

This is an interventional prevention trial for Implant Site Infection focused on measuring Silver Hydroxiapatite Coating, Antimicrobial, Medical Device

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Eskisehir Osmangazi University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Silver HA coated implants

Arm Description

Silver doped hydroxyapatite coated implants

Outcomes

Primary Outcome Measures

Number of pin site with positive culture resuls

incidence of pin tract infection

Secondary Outcome Measures

Number of patient with elevated level of serum ALT levels

liver dysfunction

Number of patient with elevated BUN levels

Kidney dysfunction

Number of patient with elevated blood silver

Silver exposure

Full Information

NCT ID

NCT03343288

First Posted

October 22, 2017

Last Updated

July 21, 2020

Sponsor

Eskisehir Osmangazi University

1. Study Identification

Unique Protocol Identification Number

NCT03343288

Brief Title

Silver Doped Ceramic Coated Orthopedic Implants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Implant Site Infection, Implant Infection

Keywords

Silver Hydroxiapatite Coating, Antimicrobial, Medical Device

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Silver HA coated implants

Arm Type

Experimental

Arm Description

Silver doped hydroxyapatite coated implants

Intervention Type

Device

Intervention Name(s)

Silver doped hydroxyapatite coated implants

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of pin site with positive culture resuls

Description

incidence of pin tract infection

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of patient with elevated level of serum ALT levels

Description

liver dysfunction

Time Frame

12 months

Title

Number of patient with elevated BUN levels

Description

Kidney dysfunction

Time Frame

12 months

Title

Number of patient with elevated blood silver

Description

Silver exposure

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nusret kose, MD

Organizational Affiliation

Eskisehir Osmangazi University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eskisehir Osmangazi University Hospital

City

Eskişehir

ZIP/Postal Code

26480

Country

Turkey

12. IPD Sharing Statement

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Silver Doped Ceramic Coated Orthopedic Implants

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