NCT04936958

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 13, 2023

Status Verified

May 1, 2022

Enrollment Period

1 year

First QC Date

June 15, 2021

Last Update Submit

April 12, 2023

Conditions

Keywords

hematogenousbone substitute

Outcome Measures

Primary Outcomes (11)

  • rate of osteomyelitis in BJI

    proportion of patients having had an osteomyelitis

    between 2017 and 2021

  • site of osteomyelitis

    localisation

    between 2017 and 2021

  • bone defect size

    dimension of the bone defect size

    between 2017 and 2021

  • type of osteomyelitis

    hematogenous or after a trauma or after a surgery

    between 2017 and 2021

  • rate of bacteria involved in osteomyelitis

    description of bacteria responsible for osteomyelitis

    between 2017 and 2021

  • Description of patients

    comorbidities, age

    between 2017 and 2021

  • Description of the follow up of the patients

    duration of the follow up of patients

    between 2017 and 2021

  • description of patients : medical treatment

    description and duration of antibiotics

    between 2017 and 2021

  • Description of patients : surgical treatment

    description of surgery performed

    between 2017 and 2021

  • rate of patient treated with CERAMENT

    proportion of patients having had CERAMENT

    between 2017 and 2021

  • 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

Study Arms (1)

patients having had an osteomyelitis since 2017

Other: patients having had an osteomyelitis since 2017

Interventions

description of osteomyelitis and their management

patients having had an osteomyelitis since 2017

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who presented with osteomyelitis between 2017 and 2021 managed at the CRIOAc Lyon

You may qualify if:

  • Patients who presented with osteomyelitis between 2017 and 2021

You may not qualify if:

  • Patients who objected to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

Related Links

MeSH Terms

Conditions

Osteomyelitis

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Tristan Ferry, Md,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 23, 2021

Study Start

May 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2025

Last Updated

April 13, 2023

Record last verified: 2022-05

Locations