NCT04936958

RETR(Osteomyelitis)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Osteomyelitis

Interventions

Type	Name	Description
OTHER	patients having had an osteomyelitis since 2017	description of osteomyelitis and their management

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2021-06-23
• Last updated: 2023-04-13

Locations

1 site across 1 country: France