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RETR(Osteomyelitis)

RETR(Osteomyelitis)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04936958
Enrollment
50
Registered
2021-06-23
Start date
2023-05-01
Completion date
2025-05-01
Last updated
2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteomyelitis

Keywords

hematogenous, bone substitute

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.

Interventions

OTHERpatients having had an osteomyelitis since 2017

description of osteomyelitis and their management

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients who presented with osteomyelitis between 2017 and 2021

Exclusion criteria

* Patients who objected to participating in the study

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactTristan Ferry, Md,PhD
tristan.ferry@chu-lyon.fr04 26 73 29 38
Backup ContactJohanna Boulant, CRA
johanna.boulant@chu-lyon.fr04 26 73 29 38

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026