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Bone Infection clinical trials

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NCT ID: NCT06132347 Not yet recruiting - Joint Infection Clinical Trials

Performances of DendrisCHIP®OA in Bone and Joint Infections

DENDRIS
Start date: December 2023
Phase:
Study type: Observational

Bone and joint infections (BJI) with and without prosthetic material (knee, hip and shoulder) are complex to diagnose and treat, justifying the creation of expert centers by the French Ministry of Health (CRIOAc). In case of BJI with material, the diagnosis is based on a set of clinical, bacteriological, cytological and radiological criteria known as the EBJIS 2021 (European Bone & Joint Infections Society) criteria. For septic arthritis, diagnosis is based on bacteriology and cytology. Microbiology remains essential, and the delay of obtention of microbiological results is crucial to adapt the antibiotic treatment. Although, culture-based microbiology remains the most common diagnosis of BJI, its regular failure to identify the causative pathogen as well as its long-term modus operandi motivates the development of rapid and accurate molecular methods. The DendrisCHIP®OA platform has demonstrated its ability to offer routine molecular identification of the current micro-organisms involved in BJI, in less than 5 hours, with the detection of mecA resistance genes on series of 16 to 64 samples . The DendrisCHIP®OA is CE-marked and has already been the subject of an initial publication evaluating its performance in a single center. The main objective of this study is to evaluate the diagnostic performances of the DendrisCHIP®OA in detecting the pathogens recognized in its panel and the detection of the mecA gene compared with the routine microbiological techniques used in the inclusion centers participating to the study. The study aims to include 100 patients during 6 months in five inclusion centers in the Ile de France region.

NCT ID: NCT05927311 Recruiting - Joint Infection Clinical Trials

Side Effects of Antibiotics in Bone and Joint Infections

PROSEAB
Start date: August 11, 2023
Phase:
Study type: Observational

Treatment for bone and joint infection (BJI) is not standardized, which allows a wide range of antibiotic therapy to potentially be given, most often in high doses over long periods of time. Patients are regularly confronted with the adverse effects of these antibiotics, which can lead to loss of adherence and treatment failure. The frequency, severity and impact on quality of life of the adverse effects of long-term antibiotics will be studied in a cohort followed for one year.

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: NCT05883995 Recruiting - Bone Infection Clinical Trials

Avis-PHAGEinLYON Clinic

Start date: February 1, 2023
Phase:
Study type: Observational

Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.

NCT ID: NCT05753215 Recruiting - Clinical trials for Bone and Joint Infection

Controlled Trial of Omadacycline Randomized Treatment Given for Bone and Joint Infection

CORGI
Start date: May 9, 2023
Phase: Phase 2
Study type: Interventional

The study design is a randomized, open-label, clinical trial of omadacycline vs Standard of Care (SOC) antibiotics for bone and join infection (BJI) treatment. Study participants will have their BJI regimen chosen by their treating physicians, (typically Infectious Diseases for hardware and prosthetic joint infections, or multidisciplinary Limb Salvage team for diabetic foot infections) prior to enrollment. Then participants will be randomized to an omadacycline-containing regimen versus the a priori chosen SOC regimen. Participants must require between 4 and 12 weeks of therapy for their BJI. The exact duration of therapy will be decided by the participants' treating physician. At 12 weeks, if the treating physician wishes to extend therapy, participants receiving omadacycline will be transitioned to other SOC antibiotics. Once enrolled, participants will be followed via in-person clinic visits at the following intervals: weeks 0, 2, 4, 8, and 12. A final in-person visit will occur 2 weeks post-treatment completion. A phone survey will occur 3 months post-treatment completion. Participants in the SOC group will follow the same schedule. Oral once-daily dosing options for S. aureus and Coagulase negative Staphylococcus are essentially non-existent. Thus, omadacycline possesses a novel and advantageous option for BJI treatment. Its convenient dosing regimen will almost certainly be associated with improved adherence, and higher adherence may, in turn, improve clinical outcome. Investigators hypothesize that omadacycline will be a well-tolerated and efficacious oral antibiotic for BJIs and will be associated with improved adherence compared with standard of care oral antibiotics. Investigators believe omadacycline addresses the unmet need for an oral antibiotic that is well-tolerated and efficacious for use as a prolonged therapy for BJIs. To this aim, investigators will perform a randomized, open-label clinical trial of omadacycline to SOC antibiotics for BJIs.

NCT ID: NCT05732558 Completed - Bone Tumor 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: NCT04945434 Active, not recruiting - Osteomyelitis Clinical Trials

Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis

Start date: September 1, 2011
Phase: N/A
Study type: Interventional

This clinical trial studies the clinical effectiveness of S53P4 bioactive glass (BAG) as a bacterial growth inhibiting bone graft substitute in a one-stage or two-stage surgical procedure for treatment of chronic long bone osteomyelitis.

NCT ID: NCT04927637 Active, not recruiting - Trauma Injury Clinical Trials

ICG 24h Prior to Operative Treatment of Orthopaedic Infection

Start date: August 13, 2021
Phase:
Study type: Observational

The focus of this study is to (1) Explore variability in distribution of 24h ICG in bone and soft tissue infection (2) Evaluate the change in 24h ICG distribution from pre to post debridement (3) Preliminarily determine whether 24h ICG has the possibility predict infection / treatment failure. Patients will be administered a single, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. The patient will be prepared and transported to surgery as per routine at Dartmouth-Hitchcock. ICG fluorescence images will be acquired prior to surgical debridement.

NCT ID: NCT04746001 Enrolling by invitation - Clinical trials for Prosthetic Joint Infection

Artificial Intelligence in the Diagnosis of Orthopaedic Conditions, Particularly Bone Tumours and Infection

AIortho
Start date: June 28, 2021
Phase:
Study type: Observational

Translational research aimed at improving diagnostic accuracy of musculoskeletal infection and musculoskeletal tumours using machine learning applied to clinical data, histopathological sections and genomic sequencing.

NCT ID: NCT04563325 Active, not recruiting - Osteomyelitis Clinical Trials

Oral-only Antibiotics for Bone and Joint Infections in Children

CHILD@HOME_BJI
Start date: September 15, 2020
Phase: Phase 4
Study type: Interventional

A nationwide, multicenter, randomized, non-inferiority trial of children with bone and joint infections. The primary objective is to determine if oral-only antibiotics (experimental arm) is non-inferior to initial intravenous antibiotics followed by oral therapy (control arm). Children will be randomized 1:1. The total treatment duration is identical in both groups. The study is open label with blinding of the primary endpoint assessor.