RETR(Osteomyelitis)

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

Study Overview

• Status: Recruiting
• Conditions: Osteomyelitis
• Intervention / Treatment: Other: patients having had an osteomyelitis since 2017

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Johanna Boulant, CRA; Phone Number: 04 26 73 29 38; Email: johanna.boulant@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Eugenie Mabrut, CRA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who presented with osteomyelitis between 2017 and 2021 managed at the CRIOAc Lyon

Description

Inclusion Criteria:

• Patients who presented with osteomyelitis between 2017 and 2021

Exclusion Criteria:

• Patients who objected to participating in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients having had an osteomyelitis since 2017	Other: patients having had an osteomyelitis since 2017; description of osteomyelitis and their management

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: bone substitute; hematogenous
• Additional Relevant MeSH Terms: Infections; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Osteomyelitis
• Other Study ID Numbers: 405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No