Pseudoarthrosis of BoneNCT03620305
Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center
An observational study of Pseudoarthrosis of Bone, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pseudoarthrosis of Bone
- What is being tested?
- Description of treatment of septic pseudarthrosis
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 30 Dec 2018
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: : patients having septic pseudarthrosis managed with 2 steps chirurgical treatment
Who may be able to join
- patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)
- Conditions
- Pseudoarthrosis of Bone
- Being tested
- Description of treatment of septic pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of treatment of septic pseudarthrosisOther
description of chirurgical 2 steps management of septic pseudarthrosis
| Study group | Role | What they receive |
|---|---|---|
| Description of treatment of septic pseudarthrosis | chirurgical and medical treatment Receives: Other: Description of treatment of septic pseudarthrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis
Description of treatment of septic pseudarthrosis : chirurgical treatment
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes (2)
Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis
Description of treatment of septic pseudarthrosis : medical treatment
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Treatment failure : rate of failure with this 2 times chirurgical treatment
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Measured: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Apr 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoarthrosis of BoneStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugénie MABRUT, Hospices Civils de Lyon
- Investigators
- Tristan Ferry, Principal investigator, Hospices Civils de Lyon - Hôpital Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620305
- Sponsor's protocol ID
- 18-078
- Status last verified
- Feb 2019
- First submitted
- 27 Jul 2018
- Last updated
- 18 Feb 2019
- 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 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center
- ClinicalTrials.gov ID
- NCT03620305
- Acronym / sponsor ID
- 18-078
- Conditions
- Pseudoarthrosis of Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 8 Aug 2018 (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.
Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Description of treatment of septic pseudarthrosis | – | Other: Description of treatment of septic pseudarthrosischirurgical and medical treatment |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- : patients having septic pseudarthrosis managed with 2 steps chirurgical treatment
Key inclusion criteria (1 listed)
- patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Description of treatment of septic pseudarthrosisdescription of chirurgical 2 steps management of septic pseudarthrosis | Other | Description of treatment of septic pseudarthrosis |
Primary outcome
Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Description of treatment of septic pseudarthrosis : chirurgical treatment
2 secondary outcomes
Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Treatment failure : rate of failure with this 2 times chirurgical treatment
Time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- 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.
Tristan Ferry principal investigator
Hospices Civils de Lyon - Hôpital Croix-Rousse
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 Pseudoarthrosis of Bone, 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: finished, as of the sponsor's last update on 18 Feb 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis (time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)). 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 18 Feb 2019.