RETR(Osteomyelitis)

NCT ID: NCT04936958

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteomyelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients having had an osteomyelitis since 2017

patients having had an osteomyelitis since 2017

Intervention Type OTHER

description of osteomyelitis and their management

Interventions

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patients having had an osteomyelitis since 2017

description of osteomyelitis and their management

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who presented with osteomyelitis between 2017 and 2021

Exclusion Criteria

* Patients who objected to participating in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Tristan Ferry, Md,PhD

Role: CONTACT

04 26 73 29 38

Johanna Boulant, CRA

Role: CONTACT

04 26 73 29 38

Facility Contacts

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Eugenie Mabrut, CRA

Role: primary

Related Links

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Other Identifiers

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405

Identifier Type: -

Identifier Source: org_study_id

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