Silver Doped Ceramic Coated Orthopedic Implants | NCT03343288

Studies
Silver Doped Ceramic Coated Orthopedic Implants

NCT03343288

Sponsor

Eskisehir Osmangazi University

Status

Completed

Last Update Posted

Jul 22, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Implant Site Infection
Implant Infection

Interventions

Silver doped hydroxyapatite coated implants

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2017Actual

Primary Completion Date

Mar 15, 2020Actual

Completion Date

Mar 15, 2020Actual

First Submitted Date

Oct 22, 2017

First Submission Date that Met QC Criteria

Nov 9, 2017

First Posted Date

Nov 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2020

Last Update Posted Date

Jul 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

NUSRET KOSE, Professor of Orhopedics and Traumatology, Eskisehir Osmangazi UniversityPrincipal Investigator

Lead Sponsor

Eskisehir Osmangazi UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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..

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silver HA coated implants	Experimental	Silver doped hydroxyapatite coated implants	Device: Silver doped hydroxyapatite coated implants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of pin site with positive culture resuls	incidence of pin tract infection	12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of patient with elevated level of serum ALT levels	liver dysfunction	12 months
Number of patient with elevated BUN levels	Kidney dysfunction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nusret kose, MD	Eskisehir Osmangazi University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eskisehir Osmangazi University Hospital		Eskişehir		26480	Turkey (Türkiye)

Intervention 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.