Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-03-15
2020-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Silver HA coated implants
Silver doped hydroxyapatite coated implants
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Eskisehir Osmangazi University
OTHER
Responsible Party
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NUSRET KOSE
Professor of Orhopedics and Traumatology
Principal Investigators
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Nusret kose, MD
Role: PRINCIPAL_INVESTIGATOR
Eskisehir Osmangazi University
Locations
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Eskisehir Osmangazi University Hospital
Eskişehir, , Turkey (Türkiye)
Countries
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Other Identifiers
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315S101
Identifier Type: -
Identifier Source: org_study_id
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