RETR(Osteomyelitis)

Osteomyelitis Clinical Trial

Official title:

RETR(Osteomyelitis)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04936958
• Other study ID #: 405
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2022
• Source: Hospices Civils de Lyon
• Contact: Tristan Ferry, Md,PhD
• Phone: 04 26 73 29 38
• Email: tristan.ferry[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who presented with osteomyelitis between 2017 and 2021

Exclusion Criteria:

• Patients who objected to participating in the study

Related Conditions & MeSH terms

• Osteomyelitis

Intervention

Other:
• patients having had an osteomyelitis since 2017
description of osteomyelitis and their management

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of osteomyelitis in BJI	proportion of patients having had an osteomyelitis	between 2017 and 2021
Primary	site of osteomyelitis	localisation	between 2017 and 2021
Primary	bone defect size	dimension of the bone defect size	between 2017 and 2021
Primary	type of osteomyelitis	hematogenous or after a trauma or after a surgery	between 2017 and 2021
Primary	rate of bacteria involved in osteomyelitis	description of bacteria responsible for osteomyelitis	between 2017 and 2021
Primary	Description of patients	comorbidities, age	between 2017 and 2021
Primary	Description of the follow up of the patients	duration of the follow up of patients	between 2017 and 2021
Primary	description of patients : medical treatment	description and duration of antibiotics	between 2017 and 2021
Primary	Description of patients : surgical treatment	description of surgery performed	between 2017 and 2021
Primary	rate of patient treated with CERAMENT	proportion of patients having had CERAMENT	between 2017 and 2021
Primary	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	between 2017 and 2021

External Links

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