RETR(Osteomyelitis)

Recruiting

• Conditions: Osteomyelitis
• Interventions: Other: patients having had an osteomyelitis since 2017

• Registration Number: NCT04936958
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-23
• Status Verified: 2022-05
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Study Start: 2023-05-01
• Primary Completion: 2024-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients who presented with osteomyelitis between 2017 and 2021

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Exclusion Criteria

• Patients who objected to participating in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients having had an osteomyelitis since 2017	patients having had an osteomyelitis since 2017	-

Primary Outcome Measures

Name	Time	Method
rate of bacteria involved in osteomyelitis	between 2017 and 2021	description of bacteria responsible for osteomyelitis
site of osteomyelitis	between 2017 and 2021	localisation
rate of osteomyelitis in BJI	between 2017 and 2021	proportion of patients having had an osteomyelitis
type of osteomyelitis	between 2017 and 2021	hematogenous or after a trauma or after a surgery
Description of the follow up of the patients	between 2017 and 2021	duration of the follow up of patients
rate of patient treated with CERAMENT	between 2017 and 2021	proportion of patients having had CERAMENT
rate of treatment failure	between 2017 and 2021	treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
description of patients : medical treatment	between 2017 and 2021	description and duration of antibiotics
bone defect size	between 2017 and 2021	dimension of the bone defect size
Description of patients	between 2017 and 2021	comorbidities, age
Description of patients : surgical treatment	between 2017 and 2021	description of surgery performed

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Lyon, France