Silver Doped Ceramic Coated Orthopedic Implants

E

Eskisehir Osmangazi University

Status

Completed

Conditions

Implant Infection
Implant Site Infection

Treatments

Device: Silver doped hydroxyapatite coated implants

Study type

Interventional

Funder types

Other

Identifiers

NCT03343288
315S101

Details and patient eligibility

About

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,

Full 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..

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Silver HA coated implants
Experimental group
Description:
Silver doped hydroxyapatite coated implants
Treatment:
Device: Silver doped hydroxyapatite coated implants

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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