InfectionNCT02825381
One-Stage Exchange for Chronically Infected Total Hip Arthroplasty
An observational study of Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Infection
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Jun 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cases operated on at the investigators institution between January 1, 2007 and November 30, 2010
Who may be able to join
- Chronically infected total hip Arthroplasty
- One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010
Who cannot join
- Patient refused to participate
Trial locations and contacts
1 site in 1 country.
France1 site
CCOM, Hôpitaux Universitaires de Strasbourg
Illkirch-Graffenstaden, Bas Rhin, 67400
Jean-Yves JENNY, MD
About this study
Official title: Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty
The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure.
The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure
- Conditions
- Infection
- Keywords
- Arthroplasty, Hip
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
infection of the prosthesis
Rate of diagnosis infection of the prosthesis
Measured: For the duration of hospital stay, up to 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825381
- Sponsor's protocol ID
- 2013-46
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2014
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02825381
- Acronym / sponsor ID
- 2013-46
- Conditions
- Infection
- Keywords
- Arthroplasty, Hip
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- 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.
The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure.
The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases operated on at the investigators institution between January 1, 2007 and November 30, 2010
Key inclusion criteria (2 listed)
- Chronically infected total hip Arthroplasty
- One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010
Key exclusion criteria (1 listed)
- Patient refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
infection of the prosthesis
Time frame: For the duration of hospital stay, up to 1 year]
Rate of diagnosis infection of the prosthesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
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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 Infection, run by University Hospital, Strasbourg, France 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 2 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 7 Jul 2016. 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 Jean-Yves JENNY, MD (0388552145, jean-yves.jenny@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection of the prosthesis (time frame: For the duration of hospital stay, up to 1 year]). 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 7 Jul 2016.