Clinical Trials Logo
  1. Home
  2. Osteomyelitis
  3. NCT04936958
  4. Details
NCT04936958 Clinical Trial

RETR(Osteomyelitis)

Osteomyelitis Clinical Trial

Official title:
RETR(Osteomyelitis)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04936958
Other study ID # 405
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date May 1, 2025

Study information
Verified date May 2022
Source Hospices Civils de Lyon
Contact Tristan Ferry, Md,PhD
Phone 04 26 73 29 38
Email tristan.ferry@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date May 1, 2025
Est. primary completion date May 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who presented with osteomyelitis between 2017 and 2021 Exclusion Criteria: - Patients who objected to participating in the study

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• patients having had an osteomyelitis since 2017
description of osteomyelitis and their management

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of osteomyelitis in BJI proportion of patients having had an osteomyelitis between 2017 and 2021
Primary site of osteomyelitis localisation between 2017 and 2021
Primary bone defect size dimension of the bone defect size between 2017 and 2021
Primary type of osteomyelitis hematogenous or after a trauma or after a surgery between 2017 and 2021
Primary rate of bacteria involved in osteomyelitis description of bacteria responsible for osteomyelitis between 2017 and 2021
Primary Description of patients comorbidities, age between 2017 and 2021
Primary Description of the follow up of the patients duration of the follow up of patients between 2017 and 2021
Primary description of patients : medical treatment description and duration of antibiotics between 2017 and 2021
Primary Description of patients : surgical treatment description of surgery performed between 2017 and 2021
Primary rate of patient treated with CERAMENT proportion of patients having had CERAMENT between 2017 and 2021
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04563325 - Oral-only Antibiotics for Bone and Joint Infections in Children Phase 4
Completed NCT03846804 - Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections N/A
Active, not recruiting NCT04945434 - Clinical Effectiveness of S53P4 Bioactive Glass in Treatment of Long-bone Chronic Osteomyelitis N/A
Recruiting NCT06084754 - Effect of Pulsed Electromagnetic Field Stimulation on Localized Pediatric Osteomyelitis N/A
Recruiting NCT05177107 - Bacteriophage Therapy in Patients With Diabetic Foot Osteomyelitis Phase 2
Recruiting NCT04554108 - Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses. N/A
Recruiting NCT02128256 - CERAMENT™|G - Bone Healing and Re-infection Prophylaxis Phase 4
Terminated NCT01612962 - Diagnostic Tests to Help Determine Osteomyelitis N/A
Terminated NCT03091439 - Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis Phase 2
Completed NCT03802552 - Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections Phase 1
Completed NCT03559530 - Acinetobacter Baumannii-related Osteomyelitis: Clinical and Epidemiological Characterization
Completed NCT00324922 - Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis Phase 3
Completed NCT02084147 - PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases N/A
Terminated NCT02099240 - Patients Response to Early Switch To Oral:Osteomyelitis Study Early Phase 1
Withdrawn NCT02344511 - Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Phase 3
Completed NCT00402064 - The Influence of Bisphosphonates in the Oral Cavity in Children N/A
Terminated NCT02168816 - Efficacy of Oral Antibiotic Therapy Compared to Intravenous Antibiotic Therapy for Osteomyelitis Phase 2
Completed NCT02685033 - Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis Phase 2
Completed NCT02335905 - Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children Phase 1/Phase 2
Completed NCT00428844 - Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci Phase 2

External Links