An observational study in Osteomyelitis, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Hospices Civils de Lyon · Observational
This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.
Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with the risk of fracture and amputation. It is caused by 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.
Despite the progress made in both antibiotics and surgical treatment, the probability of failure of this treatment (infectious recurrence) is of the order of 20%, and has unfortunately remained stable for more than 20 years.
An innovative treatment, Cerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin (CE marking), fills the "dead space" which is formed during surgery, prevents this cavity filled with blood from becoming infected, and promotes the regeneration of the bone within this space, limiting the risk of fracture in the medium and long term. It also locally delivers very high doses of gentamicin for several weeks.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 50 is below the median of 86 across 41 observational studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who presented with osteomyelitis between 2017 and 2021 managed at the CRIOAc Lyon
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: patients having had an osteomyelitis since 2017
description of osteomyelitis and their management
rate of osteomyelitis in BJI
proportion of patients having had an osteomyelitis
Time frame: between 2017 and 2021
site of osteomyelitis
localisation
Time frame: between 2017 and 2021
bone defect size
dimension of the bone defect size
Time frame: between 2017 and 2021
type of osteomyelitis
hematogenous or after a trauma or after a surgery
Time frame: between 2017 and 2021
rate of bacteria involved in osteomyelitis
description of bacteria responsible for osteomyelitis
Time frame: between 2017 and 2021
Description of patients
comorbidities, age
Time frame: between 2017 and 2021
Description of the follow up of the patients
duration of the follow up of patients
Time frame: between 2017 and 2021
description of patients : medical treatment
description and duration of antibiotics
Time frame: between 2017 and 2021
Description of patients : surgical treatment
description of surgery performed
Time frame: between 2017 and 2021
rate of patient treated with CERAMENT
proportion of patients having had CERAMENT
Time frame: between 2017 and 2021
rate of treatment failure
treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Time frame: between 2017 and 2021
Plan to share: Undecided
Start is estimated for May 2023; primary completion for May 2024, 12 months later.
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