Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 11:44 PM
Study NCT ID:
NCT04936958
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RETR(Osteomyelitis)
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
RETR(Osteomyelitis)
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: