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Completed

NCT Number: NCT03343288

Silver Doped Ceramic Coated Orthopedic Implants

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,

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University Hospital

Eskişehir, 26480, Turkey (Türkiye)

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver doped hydroxyapatite coated implants

Device

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 outcomes

  1. Number of pin site with positive culture resuls

    Time frame: 12 months

    incidence of pin tract infection

Secondary outcomes

  1. Number of patient with elevated level of serum ALT levels

    Time frame: 12 months

    liver dysfunction

  2. Number of patient with elevated BUN levels

    Time frame: 12 months

    Kidney dysfunction

  3. Number of patient with elevated blood silver

    Time frame: 12 months

    Silver exposure

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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