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出境医 / 临床实验 / Antimicrobial Synthetic Bone Grafts

Antimicrobial Synthetic Bone Grafts

Study Description
Brief 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 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.


Condition or disease Intervention/treatment Phase
Bone Infection Bone Graft Infection Device: antimicrobial synthetic bone graft Device: parentaral antimicrobials and pure bone grafts Phase 1 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: experimental group will be compared with parental antibiotics group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Antimicrobial Synthetic Bone Grafts in the Treatment of Bone Infection
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: antimicrobial synthetic bone graft
This group will have parenteral antibiotics and antimicrobial (silver ions) synthetic bone graft
Device: antimicrobial synthetic bone graft
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

Active Comparator: parenteral antibiotics with pure synthetic bone graft
This group will have parenteral antibiotics and pure synthetic bone graft
Device: parentaral antimicrobials and pure bone grafts
Historical data of the department will be used for comparison of the results

Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Locations
Layout table for location information
Turkey
Eskisehir Osmangazi University Hospital
Eskişehir, Turkey, 26480
Sponsors and Collaborators
Eskisehir Osmangazi University
Tracking Information
First Submitted Date  ICMJE March 31, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antimicrobial Synthetic Bone Grafts
Official Title  ICMJE The Use of Antimicrobial Synthetic Bone Grafts in the Treatment of Bone Infection
Brief 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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
experimental group will be compared with parental antibiotics group
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bone Infection
  • Bone Graft Infection
Intervention  ICMJE
  • Device: antimicrobial synthetic bone graft
    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
  • Device: parentaral antimicrobials and pure bone grafts
    Historical data of the department will be used for comparison of the results
Study Arms  ICMJE
  • Experimental: antimicrobial synthetic bone graft
    This group will have parenteral antibiotics and antimicrobial (silver ions) synthetic bone graft
    Intervention: Device: antimicrobial synthetic bone graft
  • Active Comparator: parenteral antibiotics with pure synthetic bone graft
    This group will have parenteral antibiotics and pure synthetic bone graft
    Intervention: Device: parentaral antimicrobials and pure bone grafts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 9, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945864
Other Study ID Numbers  ICMJE 2019-2491
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: After the publication of the study nidividual participant data (IPD) will be available to other researchers.
Responsible Party NUSRET KOSE, Eskisehir Osmangazi University
Study Sponsor  ICMJE Eskisehir Osmangazi University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eskisehir Osmangazi University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP