View clinical trials related to Osteomyelitis.
Filter by:Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with risk of fracture and amputation. It is due to the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess. Chronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery. The bacteria involved have the ability to modify their metabolism and involve persistence mechanisms (such as biofilm) making them difficult to eradicate. The treatment of chronic osteomyelitis requires surgery, i.e. corticotomy, which means opening of the bone cortex to perform an endomedullary curettage to identify the bacteria, remove any sequestration (bone fragments to which the bacteria adhere as biofilm) and reduce the bacterial inoculum. At the same time, or at a second stage, a skin and soft tissue/muscle flap may be required, especially in patients with long-standing disease with embrittlement and adhesion of the skin and soft tissue to the underlying bone. Post-operatively, the patient receives a probabilistic systemic antibiotic therapy and then a systemic antibiotic therapy targeted on the identified germ, for a period of 3 months. The effectiveness of these antibiotics is based on their ability to penetrate bone tissue. Despite the progress made in both antibiotics and surgical treatments, the probability of failure (recurrence of infection) is around 20%, and has unfortunately remained stable for more than 20 years. Cerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin, fills the "dead space" formed during surgery, prevents infection of this blood-filled cavity, and promotes bone regeneration within this space (limiting the risk of fracture in the medium and long term). Cerament-G also delivers locally very high doses of gentamicin (concentration of 17.5 mg/mL in the device) for several weeks. Gentamicine is a broad-spectrum bactericidal antibiotic effective against the vast majority of bacteria involved in osteoarticular infections. It provides effective local antibiotic therapy through wide exposure and prolonged concentrations during several weeks. To date, there is no other bone substitute with antibiotics available in France. Two prospective studies have shown that Cerament-G reduces the number of infectious recurrences (about 5%). This innovation is available in France but at a high price (between 2,500 and 4,000 euros) and is not currently reimbursed. However, the use of this product would make it possible to improve the health and quality of life of patients while avoiding certain consumption of resources.
Infectious vertebral osteomyelitis are infectious diseases of the vertebral bone, intervertebral disc and/ or adjacent tissue. Most of cases are due to hematogenous dissemination of pathogen but direct inoculation is an aetiology after surgery. Majority of cases concern adults after 50 years and the annual incidence ranging between 0.5 and 2.4 cases per 100 000 habitants in Europe but seems to increase during last 20 years. The infectious spondylodiscitis is an important source of morbidity and mortality. The treatment is based on pathogen adapted antimicrobial therapy, which may be associated with bedrest. Surgical act is necessary when neurological complication occurs or when vertebral column instability is too important. The immobilization in bed is use to limit pain and neurological complications. However, the immobilization is based on few literature data and causes important complications especially in elderly. The of immobilization in Nancy universitity hospital changed in 2019 after institutional recommendations based on expert opinion which recommend an early verticalization of uncomplicated spondylodiscitis. The investigators aimed to evaluate the consequences of this practice change on the hospitalization duration and complication rates due to spondylodiscitis and immobilization.
The objective of the study is to establish a prospective disease registry for chronic recurrent multifocal osteomyelitis (CRMO)/chronic nonbacterial osteomyelitis (CNO) in order to investigate the natural history of the disease and the responses of patients to different clinical managements over 10 years.
This will be a prospective, open-label, two-center study to assess the safety of omadacycline use in the treatment of hospitalized subjects with moderate to severe DFI with or without Acute osteomyelitis (AOM) who are at a high risk for development of CDI, AKI, and/or resistant pathogens compared to retrospective controls. Prospective enrollment will be continued until the sample size is achieved up to one year from start date (October 2020). Secondary to slower than anticipated enrollment due to the COVID-19 pandemic and initial exclusion of AOM, following protocol amendment, patient enrollment will be continued until the sample size is achieved up to 18 months from amendment approval (anticipate April 2022 - October 2023). A historical matched case cohort (standard of care) at the two hospitals based on ICD10 codes associated with DFI [E11.(621, 622), E10.(621, 622); L97.(509, 521, 522, 523, 524, 529)], including subjects with AOM [M86.(08-09, 10, 16-19, 8X0, 8X7-8X9, 9) will be utilized for comparison.
Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications. The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.
This study is designed as a randomized, placebo-controlled, double-blinded, clinical trial with two parallel groups. This study investigates the association between a single dose of the drug, Clonidine, and the total amount of opioid administered under and 24 hours after surgery in children undergoing orthopedic limb surgery with the use of tourniquet. The investigators hypothesize that administration of clonidine to children undergoing limb surgery with the use of inflatable tourniquets would reduce post-procedural pain. This study is a pilot to obtain an effect size. Based on this the investigators will calculate a sample size for the main trial enabling us to reach a power of 0.8 with a significans level of 0.05.
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.
The incidence of bone and joint infections (BJI) in children (osteomyelitis, septic arthritis and spondylodiscitis) is 22 per 100,000 children in France. Every year, 3,000 children are hospitalized for BJI, 46% of whom are hospitalized for osteomyelitis. The clinical pictures of BJI are varied: some are severe from the outset; others are non-severe, such as BJIs in Kingella kingae, which are most common in children between the ages of 6 months and 5 years. Currently, the management of children's BJI, regardless of their severity, involves initial hospitalization to start intravenous antibiotic therapy. This non-inferiority trial evaluates, in children with acute osteomyelitis with no severity criteria, less invasive outpatient management with an oral antibiotic treatment given at the outset compared to standard management. Main objective : Demonstrate the non-inferiority of an ambulatory management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis in children aged 1-4 years without severity criteria. Primary endpoint: Complete cure without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, periosteal abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis related to the initial infection. This criterion will be assessed blindly by an adjudication committee. Randomized controlled trial of non inferiority, with active control, in open multi-center. The control or experimental arm allocation (1:1 ratio) will be open-label of the physician, patient and parents. This is a PROBE study: The evaluation of the main judgment criterion will be carried out blindly by an adjudication committee.
This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.
The optimal treatment of uncomplicated native vertebral osteomyelitis (NVO) is unknown. While some authors recommend surgical treatment (consisting of spinal debridement, decompression and instrumentation using hardware implantation of hardware), others recommend conservative treatment (with antimicrobial therapy alone). In the proposed randomized controlled multicentric trial, we plan to compare the outcome of conservative vs, surgical treatment of NVO regarding (i) infection outcome (i.e. infection-free proportion of subjects), (ii) functional outcome (pain intensity, spine scores, general mobility, quality of life evaluation), and (iii) socioeconomic impact (direct and indirect costs due to NVO). A total of 350 subjects will be screened, 300 subjects will be randomized 1:1 into 2 arms: experimental (surgical treatment) and control (conservative treatment). Subjects in both groups will receive pathogen-directed antimicrobial therapy for 6 weeks. Excluded will be patients with acute neurologic impairment, extensive bone destruction, epidural/intraspinal abscess and with spinal hardware. The clinical impact of this study is enormous since it will generate evidence for rational treatment guidelines. We hypothesize that the conservative treatment of uncomplicated NVO is non-inferior to surgical therapy regarding infection outcome. If the conservative treatment of NVO demonstrate non-inferiority, patients may benefit from avoiding unnecessary surgical intervention.