OsteomyelitisNCT04936958
RETR(Osteomyelitis)
An observational study of Osteomyelitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis
- What is being tested?
- patients having had an osteomyelitis since 2017
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who presented with osteomyelitis between 2017 and 2021 managed at the CRIOAc Lyon
Who may be able to join
- Patients who presented with osteomyelitis between 2017 and 2021
Who cannot join
- Patients who objected to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69004
Eugenie Mabrut, CRA
About this study
This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.
Read the 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
- Being tested
- patients having had an osteomyelitis since 2017
- Keywords
- hematogenous, bone substitute
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients having had an osteomyelitis since 2017Other
description of osteomyelitis and their management
| Study group | Role | What they receive |
|---|---|---|
| patients having had an osteomyelitis since 2017 | Not described Receives: Other: patients having had an osteomyelitis since 2017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of osteomyelitis in BJI
proportion of patients having had an osteomyelitis
Measured: between 2017 and 2021
site of osteomyelitis
localisation
Measured: between 2017 and 2021
bone defect size
dimension of the bone defect size
Measured: between 2017 and 2021
type of osteomyelitis
hematogenous or after a trauma or after a surgery
Measured: between 2017 and 2021
rate of bacteria involved in osteomyelitis
description of bacteria responsible for osteomyelitis
Measured: between 2017 and 2021
Description of patients
comorbidities, age
Measured: between 2017 and 2021
Description of the follow up of the patients
duration of the follow up of patients
Measured: between 2017 and 2021
description of patients : medical treatment
description and duration of antibiotics
Measured: between 2017 and 2021
Description of patients : surgical treatment
description of surgery performed
Measured: between 2017 and 2021
rate of patient treated with CERAMENT
proportion of patients having had CERAMENT
Measured: 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
Measured: between 2017 and 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936958
- Sponsor's protocol ID
- 405
- Status last verified
- May 2022
- First submitted
- 15 Jun 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RETR(Osteomyelitis)
- ClinicalTrials.gov ID
- NCT04936958
- Acronym / sponsor ID
- 405
- Conditions
- Osteomyelitis
- Keywords
- hematogenous, bone substitute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients having had an osteomyelitis since 2017 | – | Other: patients having had an osteomyelitis since 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who presented with osteomyelitis between 2017 and 2021 managed at the CRIOAc Lyon
Key inclusion criteria (1 listed)
- Patients who presented with osteomyelitis between 2017 and 2021
Key exclusion criteria (1 listed)
- Patients who objected to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients having had an osteomyelitis since 2017description of osteomyelitis and their management | Other | patients having had an osteomyelitis since 2017 |
Primary outcome
rate of osteomyelitis in BJI
Time frame: between 2017 and 2021
proportion of patients having had an osteomyelitis
site of osteomyelitis
Time frame: between 2017 and 2021
localisation
bone defect size
Time frame: between 2017 and 2021
dimension of the bone defect size
type of osteomyelitis
Time frame: between 2017 and 2021
hematogenous or after a trauma or after a surgery
rate of bacteria involved in osteomyelitis
Time frame: between 2017 and 2021
description of bacteria responsible for osteomyelitis
Description of patients
Time frame: between 2017 and 2021
comorbidities, age
Description of the follow up of the patients
Time frame: between 2017 and 2021
duration of the follow up of patients
description of patients : medical treatment
Time frame: between 2017 and 2021
description and duration of antibiotics
Description of patients : surgical treatment
Time frame: between 2017 and 2021
description of surgery performed
rate of patient treated with CERAMENT
Time frame: between 2017 and 2021
proportion of patients having had CERAMENT
rate of treatment failure
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tristan Ferry, Md,PhD (04 26 73 29 38, tristan.ferry@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of osteomyelitis in BJI (time frame: between 2017 and 2021). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.