RETR(Osteomyelitis)

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04936958
Collaborator
(none)
50
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: patients having had an osteomyelitis since 2017

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
RETR(Osteomyelitis)
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
patients having had an osteomyelitis since 2017

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

Outcome Measures

Primary Outcome Measures

  1. rate of osteomyelitis in BJI [between 2017 and 2021]

    proportion of patients having had an osteomyelitis

  2. site of osteomyelitis [between 2017 and 2021]

    localisation

  3. bone defect size [between 2017 and 2021]

    dimension of the bone defect size

  4. type of osteomyelitis [between 2017 and 2021]

    hematogenous or after a trauma or after a surgery

  5. rate of bacteria involved in osteomyelitis [between 2017 and 2021]

    description of bacteria responsible for osteomyelitis

  6. Description of patients [between 2017 and 2021]

    comorbidities, age

  7. Description of the follow up of the patients [between 2017 and 2021]

    duration of the follow up of patients

  8. description of patients : medical treatment [between 2017 and 2021]

    description and duration of antibiotics

  9. Description of patients : surgical treatment [between 2017 and 2021]

    description of surgery performed

  10. rate of patient treated with CERAMENT [between 2017 and 2021]

    proportion of patients having had CERAMENT

  11. rate of treatment failure [between 2017 and 2021]

    treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients who presented with osteomyelitis between 2017 and 2021
Exclusion Criteria:
  • Patients who objected to participating in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Lyon France 69004

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04936958
Other Study ID Numbers:
  • 405
First Posted:
Jun 23, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022