Fracture-associated Infection (FAI)Re_FRINCT04455217
Long--term Outcome Analysis of Fracture--related Infections
An observational study of Fracture-associated Infection (FAI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fracture-associated Infection (FAI)
- What is being tested?
- data collection from patients with FAI (occuring January 2000 until December 2019)
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Feb 2020to 28 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with FAI attending the University Hospital Basel from January 2000 until December 2019
Who may be able to join
- Patients with FAI
Who cannot join
- documented denial of consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie
Basel, 4031
About this study
Official title: Long--term Outcome Analysis of Fracture--related Infections (Re_FRI)
This retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel.
- Conditions
- Fracture-associated Infection (FAI)
- Being tested
- data collection from patients with FAI (occuring January 2000 until December 2019)
- Keywords
- prosthesis infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection from patients with FAI (occuring January 2000 until December 2019)Other
data collection from patient files (data regarding surgery, adverse events, infections, demographic data)
What is being measured
The primary outcome is the main question the study is designed to answer.
number of flap failures at discharge from hospital
number of flap failures at discharge from hospital
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start13 Feb 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture-associated Infection (FAI)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Johannes Schaefer, Prof. Dr. med., Principal investigator, Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie; University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455217
- Sponsor's protocol ID
- 2020-00214; ch20Schaefer
- Acronym
- Re_FRI
- Status last verified
- Aug 2021
- First submitted
- 2 Jun 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morgenstern M, Erichsen C, Militz M, Xie Z, Peng J, Stannard J, Metsemakers WJ, Schaefer D, Alt V, Soballe K, Nerlich M, Buckley RE, Blauth M, Suk M, Leung F, Barla JD, Yukata K, Qing B, Kates SL. The AO trauma CPP bone infection registry: Epidemiology and outcomes of Staphylococcus aureus bone infection. J Orthop Res. 2021 Jan;39(1):136-146. doi: 10.1002/jor.24804. Epub 2020 Jul 27.
PubMed 32720352
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long--term Outcome Analysis of Fracture--related Infections (Re_FRI)
- ClinicalTrials.gov ID
- NCT04455217
- Acronym / sponsor ID
- Re_FRI / 2020-00214; ch20Schaefer
- Conditions
- Fracture-associated Infection (FAI)
- Keywords
- prosthesis infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 2 Jul 2020 (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 retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with FAI attending the University Hospital Basel from January 2000 until December 2019
Key inclusion criteria (1 listed)
- Patients with FAI
Key exclusion criteria (1 listed)
- documented denial of consent
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 |
|---|---|---|
| data collection from patients with FAI (occuring January 2000 until December 2019)data collection from patient files (data regarding surgery, adverse events, infections, demographic data) | Other | – |
Primary outcome
number of flap failures at discharge from hospital
Time frame: at baseline
number of flap failures at discharge from hospital
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 25 Aug 2021.
- Results publication: PubMed 32720352Morgenstern M, Erichsen C, Militz M, Xie Z, Peng J, Stannard J, Metsemakers WJ, Schaefer D, Alt V, Soballe K, Nerlich M, Buckley RE, Blauth M, Suk M, Leung F, Barla JD, Yukata K, Qing B, Kates SL. The AO trauma CPP bone infection registry: Epidemiology and outcomes of Staphylococcus aureus bone infection. J Orthop Res. 2021 Jan;39(1):136-146. doi: 10.1002/jor.24804. Epub 2020 Jul 27.
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.
Dirk Johannes Schaefer, Prof. Dr. med. principal investigator
Klinik für Plastische, Rekonstruktive, Ästhetische und Handchirurgie; University Hospital Basel
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 Fracture-associated Infection (FAI), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 25 Aug 2021. 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 Switzerland. 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?
number of flap failures at discharge from hospital (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04455217, which also lists 1 linked publication.
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 25 Aug 2021.