Implant Site InfectionNCT03343288
Silver Doped Ceramic Coated Orthopedic Implants
A study testing Silver doped hydroxyapatite coated implants in people with Implant Site Infection and Implant Infection, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Implant Site Infection, Implant Infection
- What is being tested?
- Silver doped hydroxyapatite coated implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 - -
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University Hospital
Eskişehir, 26480
About this study
Official title: The Use of Silver Doped Calcium Phosphate Based Ceramic Coated Orthopedic Implants for Preventing Implant Related Infection
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,
Read the 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..
- Conditions
- Implant Site Infection, Implant Infection
- Being tested
- Silver doped hydroxyapatite coated implants
- Keywords
- Silver Hydroxiapatite Coating, Antimicrobial, Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver doped hydroxyapatite coated implantsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Silver HA coated implants | Experimental | Silver doped hydroxyapatite coated implants Receives: Device: Silver doped hydroxyapatite coated implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pin site with positive culture resuls
incidence of pin tract infection
Measured: 12 months
Secondary outcomes (3)
Number of patient with elevated level of serum ALT levels
liver dysfunction
Measured: 12 months
Number of patient with elevated BUN levels
Kidney dysfunction
Measured: 12 months
Number of patient with elevated blood silver
Silver exposure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Mar 2017
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NUSRET KOSE, Eskisehir Osmangazi University
- Investigators
- Nusret kose, MD, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343288
- Sponsor's protocol ID
- 315S101
- Status last verified
- Jul 2020
- First submitted
- 22 Oct 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Silver Doped Calcium Phosphate Based Ceramic Coated Orthopedic Implants for Preventing Implant Related Infection
- ClinicalTrials.gov ID
- NCT03343288
- Acronym / sponsor ID
- 315S101
- Conditions
- Implant Site Infection, Implant Infection
- Keywords
- Silver Hydroxiapatite Coating, Antimicrobial, Medical Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Silver HA coated implants | Experimental | Device: Silver doped hydroxyapatite coated implantsSilver doped hydroxyapatite coated implants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silver doped hydroxyapatite coated implantsIn 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. | Device | Silver HA coated implants |
Primary outcome
Number of pin site with positive culture resuls
Time frame: 12 months
incidence of pin tract infection
3 secondary outcomes
Number of patient with elevated level of serum ALT levels
Time frame: 12 months
Number of patient with elevated BUN levels
Time frame: 12 months
Number of patient with elevated blood silver
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Related trials for Implant Site Infection
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
Recruiting
Impact of the Choice of Gastric Tube Placement Sites on the Incidence of Ventilator Associated Pneumonia
Intubated Patient Requiring a Gastric Tube
Enrolling by invitation
A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
Surgical Site Infection (SSI)
RecruitingPhase 4
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
Breast Cancer
Not yet recruitingPhase 4
Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study
Surgical Site Infection (SSI), Spine Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nusret kose, MD principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver doped hydroxyapatite coated implants in people with Implant Site Infection and Implant Infection, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pin site with positive culture resuls (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.