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Bone Infection clinical trials

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NCT ID: NCT05895903 Completed - Clinical trials for Dental Implant Failed

Alveolar Ridges Expansion Using Osseodensification Versus Screw Expansion Technique

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Alveolar ridge expansion is suggested for alveolar crest thicknesses of 3-5 mm. Osseodensification (OD) and screw expansion (SE) techniques have been utilized to expand narrow alveolar ridges (NAR). This study aims to compare the implant stability quotient (ISQ) values of endosteal dental implants (DIs) inserted into NAR via osseodensification versus manual screw expansion.

NCT ID: NCT05732558 Completed - Bone Infection Clinical Trials

Augmented Reality Navigation System (Endosight) for the Guidance of Bone Biopsy

Start date: December 16, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical study is to evaluate the duration of the procedure, the precision (distance between the needle tip and the centre of the target), and the safety of endosight system in the guidance for bone biopsies.

NCT ID: NCT04440631 Completed - Fractures, Bone Clinical Trials

Gut Microbiome of Patients Undergoing Antibiotic Therapy for Orthopedic Device-related Infection

IMPAT-ODRI
Start date: November 1, 2019
Phase:
Study type: Observational

The microbiome of 80 orthopedic-device related infection (ODRI) patients treated with antibiotics and 10 healthy controls will be investigated. Samples (blood, stool, saliva, skin-swab) are collected 4x within 6 months. Composition and diversity of the microbiome will be assessed by 16sRNA sequencing, skins swabs are screened for rifampicin-resistant staphylococci onto Mannitol-salt-agar plates supplemented with rifampicin, inflammation markers and antibodies in blood and saliva are monitored to track changes in the immune response. For further analysis patients are assigned to one of two groups: 1) antibiotic therapy including rifampicin and 2) non-rifampicin antibiotic therapy.

NCT ID: NCT03945864 Completed - Bone Infection Clinical Trials

Antimicrobial Synthetic Bone Grafts

Start date: June 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

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.

NCT ID: NCT03426761 Completed - Osteomyelitis Clinical Trials

Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections

Start date: January 25, 2018
Phase: Phase 4
Study type: Interventional

Because of its prolonged terminal half-life, dalbavancin is an extremely attractive option in treating Gram-positive infections caused by S. aureus including MRSA, and streptococcal species. Systemic bacterial infections due to Staphylococci such as osteomyelitis and septic arthritis, are conditions which require prolonged IV therapy, typically for at least 3-6 weeks, though sometimes more. Due to dalbavancin's prolonged terminal half-life, it may offer the opportunity to substantially reduce costs and morbidity in native joint and prosthetic joint infections with one infusion every fourteen days until completion of therapy.

NCT ID: NCT03403608 Completed - Joint Infection Clinical Trials

Subcutaneous Suppressive Antibiotic Therapy for Bone and Joint Infections

Start date: March 1, 2017
Phase: N/A
Study type: Observational

For patients having a bone or joint infections, with or without device, optimal surgical therapy could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Subcutaneous (SC) administration of injectable intravenous antibiotics as prolonged suppressive antibiotic therapy could be a convenient way when oral treatment is not available to facilitate ambulatory care, this practice being considered as routine care. The aim of this study is to evaluate tolerance and efficacy of subcutaneous administration of antibiotics for prolonged suppressive antibiotic therapy in patients having this treatment as part of their routine care.

NCT ID: NCT03082066 Completed - Emergencies Clinical Trials

Soft Tissue and Bone Diameter in Children and Adults for Intraosseus Access

Start date: March 15, 2017
Phase:
Study type: Observational

Retrospective observational study: Soft tissue and bone diameters are assessed in MRI and CT scans of patients. Data is compared with recommendations of intraosseus needle producers to assess whether the information provided by the producers can be optimised. Study sites are head of humerus bone, distal femur, proximal and distal tibia in accordance with recommended intraosseus access sites. Primary and secondary outcome parameters will be assessed at one time only, i.e. when the patient has received MRI or CT scan for the diagnostic work up of their primary disease. Data collection for a given patient in this study can be completed within one session, e.g. 5-10 minutes. No additional investigation is required for this retrospective study.

NCT ID: NCT02335905 Completed - Osteomyelitis Clinical Trials

Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Start date: June 3, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline), which fights infections like the one the subject has. Ceftaroline is effective against S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus (MRSA.) Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in adults and children with Community-Acquired Bacterial Pneumonia [a type of lung infection] and Acute Bacterial Skin and Skin Structure Infections. Ceftaroline is not yet approved for treatment in subjects with hematogenous osteomyelitis, therefore, the use of Ceftaroline in this research study is considered "investigational". The goal of this research study is to find out what side effects there may be when children are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections due to Staphylococcus aureus in children. The investigators are also studying what the body does to the study drug, Ceftaroline, and if the doses the investigators use result in blood levels that the investigators think are going to be effective against bone infections in children. This is called pharmacokinetics (PK).

NCT ID: NCT01677000 Completed - Clinical trials for Staphylococcus Aureus

Clinical Priority Program-Bone Infection Registry

CPPInfection
Start date: June 2012
Phase:
Study type: Observational

Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include: 1. baseline patient attributes; 2. surgical approach, implants and technology; 3. hospital course; 4. surgeon and institutional characteristics; 5. longitudinal patient outcome, 6. post-procedure complications and revisions, 7. serum/tissue/drainage samples.

NCT ID: NCT00974493 Completed - Joint Infection Clinical Trials

Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)

OVIVA
Start date: June 2010
Phase: Phase 4
Study type: Interventional

The study will compare the outcomes of treating bone and joint infections with 6 weeks of intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic "strategy" rather than of individual antibiotics. The study will be open label, but the primary outcome will be proven failure of infection treatment, determined by pre-established objective criteria for treatment failure. The null hypothesis tested is that there will be no difference in treatment failure rates.