Silver Doped Ceramic Coated Orthopedic Implants

NCT03343288 | Completed

• 1 other identifier: 315S101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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,

Conditions

Implant Site Infection; Implant Infection

Keywords

Silver Hydroxiapatite Coating; Antimicrobial; Medical Device

Outcome Measures

Primary Outcomes (1)

• Number of pin site with positive culture resuls

  incidence of pin tract infection

  12 months

Secondary Outcomes (3)

• Number of patient with elevated level of serum ALT levels

  12 months

• Number of patient with elevated BUN levels

  12 months

• Number of patient with elevated blood silver

  12 months

Study Arms (1)

Silver HA coated implants

EXPERIMENTAL

Silver doped hydroxyapatite coated implants

Device: Silver doped hydroxyapatite coated implants

Interventions

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.

Silver HA coated implants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 - -

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University Hospital

Eskişehir, 26480, Turkey (Türkiye)

Location

Study Officials

• Nusret kose, MD

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orhopedics and Traumatology

Model Details: 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.

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: November 17, 2017
• Study Start: March 15, 2017
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

TU (1)