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
Sponsored by
About this trial
This is an interventional prevention trial for Implant Site Infection focused on measuring Silver Hydroxiapatite Coating, Antimicrobial, Medical Device
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Learn more about this trial
Silver Doped Ceramic Coated Orthopedic Implants
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