Bone InfectionPhase 1/2NCT03945864
Antimicrobial Synthetic Bone Grafts
A Phase 1/2 study testing antimicrobial synthetic bone graft and parentaral antimicrobials and pure bone grafts in people with Bone Infection and Bone Graft Infection, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This project aims to produce synthetic bone tissue graft that supports bone regeneration and combats infection simultaneously, according to industry standards and regulations. This original and high value added biomaterial "silver doped calcium phosphate based synthetic bone tissue " will be used in clinical trials in… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bone Infection, Bone Graft Infection
- What is being tested?
- antimicrobial synthetic bone graft and parentaral antimicrobials and pure bone grafts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 15 Aug 2021
- Phase
- Phase 1/2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic osteomyelitis, infected non-union or implant-associated infection with an indication for artificial bone grafting who read and accept the Informed consent.
- Male and female patients older than 18 years
- Patients without heart, lung, renal or hepatic failure, epilepsy, cerebrovascular attack or ischemia
- Patients who are not allergic to antibiotics
- Patients with additional immunosuppression such as malignancy, diabetes mellitus, poly travma and open fractures
- Patients using oral or parenteral corticosteroids, methotrexate, cyclosporine or other immunosuppressive drugs
Who cannot join
- Patients who have not accepted the method.
- Patients outside the working age range
- Pregnant women
- Patients with heart, lung, renal, hepatic failure, epilepsy, cerebrovascular attack or ischemia
- Patients with allergy to antibiotics
- Patients with another silvery implant in the body like a silver-coated implant
- Patients with a history of known allergies or hypersensitivity to silver
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 Antimicrobial Synthetic Bone Grafts in the Treatment of Bone Infection
This project aims to produce synthetic bone tissue graft that supports bone regeneration and combats infection simultaneously, according to industry standards and regulations. This original and high value added biomaterial "silver doped calcium phosphate based synthetic bone tissue " will be used in clinical trials in patients with osteomyelitis and implant-related infections for the treatment.
Chronic bone infections are one of the most important problems in orthopedic surgery and are not just a problem of developed societies. When open fracture cases, which may get infected in 1-50%, implant-related infections and diabetic foot ulcer cases are taken into consideration, osteomyelitis will be seen as a very common problem all over the world. Multiple surgeries, long-term use of antibiotics and the high costs affects all societies. The use of synthetic bone grafts is growing faster than the natural bone grafts in the world. USA has spent 246 million US dollars for the use of synthetic bone graft in 2010. For the treatment of bone infections antibiotic impregnated synthetic bone grafts with different characteristics are used. Although these antibiotic impregnated synthetic bone grafts are superior compared to antibiotic bone cement with the implementation of different antibiotics and to be absorbable but they cannot show optimum benefit because the release of antibiotics is not due to host matrix degradation but diffusion control. The other issue to be considered as this regard that the development of microbial resistance to these antibiotics which is also a serious problem. Innovative synthetic bone graft with better contribution of the needs of mechanical properties, depending on the applied bone region, optimized antimicrobial activity and bone tissue regeneration are needed.
Read more
In this study, it will be determined whether this silver ion -doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids that may occur in chronic bone infection during disease process or after surgical debridement, also has the capacity to treat the infection in the bone will be used in 12 patients who had been diagnosed as chronic osteomyelitis to see if it cause any unwanted side effect in normal usage conditions and generates unacceptable risks. Clinical, laboratory and radiological investigations will be used to demonstrate the healing of the infections and the cavities in the bone. Blood and urine levels of silver will be detected from patients.
Antimicrobial activity of silver is well-known. The effectiveness of the silver and potential toxicity is related to the dose of silver and application form. In orthopedics, the use of silver is mostly limited to elemental silver coating of metal implants. There is no biotechnologic approach manufactured silver ion -doped calcium phosphate -based synthetic bone graft in the health sector yet. Ionic silver has advantages such as low toxicity, no tolerance of silver against bacteria, and strong antibacterial activity. The trapping of silver ions in the calcium phosphate based ceramic structure overcomes the other systems with its controlled release and its ability to be effective at minimum doses. The project is an original work since it will contribute to bone regeneration while at the same time removing the infection.
- Conditions
- Bone Infection, Bone Graft Infection
- Being tested
- antimicrobial synthetic bone graft, parentaral antimicrobials and pure bone grafts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimicrobial synthetic bone graftDevice
It will be determined whether the silver ion-doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids also has the capacity to treat the infection in the bone in 12 patients with chronic osteomyelitis
parentaral antimicrobials and pure bone graftsDevice
Historical data of the department will be used for comparison of the results
| Study group | Role | What they receive |
|---|---|---|
| antimicrobial synthetic bone graft | Experimental | This group will have parenteral antibiotics and antimicrobial (silver ions) synthetic bone graft Receives: Device: antimicrobial synthetic bone graft |
| parenteral antibiotics with pure synthetic bone graft | Active comparator | This group will have parenteral antibiotics and pure synthetic bone graft Receives: Device: parentaral antimicrobials and pure bone grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
bony healing of the cavities in the bone
Number of Participants with bony healing of the cavities in the bone by x-ray
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 posted10 May 2019
- Study start1 Jun 2019
- Primary completion1 Sep 2020
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- experimental group will be compared with parental antibiotics group
- Masking
- None (open label)
- Enrolment
- 12 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945864
- Sponsor's protocol ID
- 2019-2491
- Status last verified
- Jul 2022
- First submitted
- 31 Mar 2019
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the publication of the study nidividual participant data (IPD) will be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Antimicrobial Synthetic Bone Grafts in the Treatment of Bone Infection
- ClinicalTrials.gov ID
- NCT03945864
- Acronym / sponsor ID
- 2019-2491
- Conditions
- Bone Infection, Bone Graft Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 10 May 2019 (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.
This project aims to produce synthetic bone tissue graft that supports bone regeneration and combats infection simultaneously, according to industry standards and regulations. This original and high value added biomaterial "silver doped calcium phosphate based synthetic bone tissue " will be used in clinical trials in patients with osteomyelitis and implant-related infections for the treatment.
Chronic bone infections are one of the most important problems in orthopedic surgery and are not just a problem of developed societies. When open fracture cases, which may get infected in 1-50%, implant-related infections and diabetic foot ulcer cases are taken into consideration, osteomyelitis will be seen as a very common problem all over the world. Multiple surgeries, long-term use of antibiotics and the high costs affects all societies. The use of synthetic bone grafts is growing faster than the natural bone grafts in the world. USA has spent 246 million US dollars for the use of synthetic bone graft in 2010. For the treatment of bone infections antibiotic impregnated synthetic bone grafts with different characteristics are used. Although these antibiotic impregnated synthetic bone grafts are superior compared to antibiotic bone cement with the implementation of different antibiotics and to be absorbable but they cannot show optimum benefit because the release of antibiotics is not due to host matrix degradation but diffusion control. The other issue to be considered as this regard that the development of microbial resistance to these antibiotics which is also a serious problem. Innovative synthetic bone graft with better contribution of the needs of mechanical properties, depending on the applied bone region, optimized antimicrobial activity and bone tissue regeneration are needed.
In this study, it will be determined whether this silver ion -doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids that may occur in chronic bone infection during disease process or after surgical debridement, also has the capacity to treat the infection in the bone will be used in 12 patients who had been diagnosed as chronic osteomyelitis to see if it cause any unwanted side effect in normal usage conditions and generates unacceptable risks. Clinical, laboratory and radiological investigations will be used to demonstrate the healing of the infections and the cavities in the bone. Blood and urine levels of silver will be detected from patients.
Antimicrobial activity of silver is well-known. The effectiveness of the silver and potential toxicity is related to the dose of silver and application form. In orthopedics, the use of silver is mostly limited to elemental silver coating of metal implants. There is no biotechnologic approach manufactured silver ion -doped calcium phosphate -based synthetic bone graft in the health sector yet. Ionic silver has advantages such as low toxicity, no tolerance of silver against bacteria, and strong antibacterial activity. The trapping of silver ions in the calcium phosphate based ceramic structure overcomes the other systems with its controlled release and its ability to be effective at minimum doses. The project is an original work since it will contribute to bone regeneration while at the same time removing the infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- experimental group will be compared with parental antibiotics group
| Arm | Type | Receives |
|---|---|---|
| antimicrobial synthetic bone graft | Experimental | Device: antimicrobial synthetic bone graftThis group will have parenteral antibiotics and antimicrobial (silver ions) synthetic bone graft |
| parenteral antibiotics with pure synthetic bone graft | Active comparator | Device: parentaral antimicrobials and pure bone graftsThis group will have parenteral antibiotics and pure synthetic bone graft |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with chronic osteomyelitis, infected non-union or implant-associated infection with an indication for artificial bone grafting who read and accept the Informed consent.
- Male and female patients older than 18 years
- Patients without heart, lung, renal or hepatic failure, epilepsy, cerebrovascular attack or ischemia
- Patients who are not allergic to antibiotics
- Patients with additional immunosuppression such as malignancy, diabetes mellitus, poly travma and open fractures
Key exclusion criteria (7 listed)
- Patients who have not accepted the method.
- Patients outside the working age range
- Pregnant women
- Patients with heart, lung, renal, hepatic failure, epilepsy, cerebrovascular attack or ischemia
- Patients with allergy to antibiotics
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 |
|---|---|---|
| antimicrobial synthetic bone graftIt will be determined whether the silver ion-doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids also has the capacity to treat the infection in the bone in 12 patients with chronic osteomyelitis | Device | antimicrobial synthetic bone graft |
| parentaral antimicrobials and pure bone graftsHistorical data of the department will be used for comparison of the results | Device | parenteral antibiotics with pure synthetic bone graft |
Primary outcome
bony healing of the cavities in the bone
Time frame: 12 months
Number of Participants with bony healing of the cavities in the bone by x-ray
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 29 Jul 2022.
- Individual participant dataSharing planned: No. After the publication of the study nidividual participant data (IPD) will be available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing antimicrobial synthetic bone graft and parentaral antimicrobials and pure bone grafts in people with Bone Infection and Bone Graft 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 7 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 29 Jul 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
bony healing of the cavities in the bone (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 29 Jul 2022.