Total Hip ReplacementNCT02272205
Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time
An observational study of Total Hip Replacement, run by University Hospital, Strasbourg, France.
Trial summary
Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Retrospective analysis of records
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2014to 31 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.
Who may be able to join
- patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.
Who cannot join
- patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.
About this study
Official title: Evaluation of the Effect of a Conventional Antibiotic Prophylaxis on the Positivity of Intraoperative Bacteriological Samples During a Change of Hip or Knee Infected at a Time
Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time.
Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. It must be conventionally administered before the surgical incision. In response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. This attitude, however, is not formally validated by the scientific literature. In contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. Our multidisciplinary team opted for a few months for this new strategy. We wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.
- Conditions
- Total Hip Replacement
- Being tested
- Retrospective analysis of records
- Keywords
- Hip replacement, Knee replacement, Knee infection, Hip infection, Antibiotic prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of recordsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance of pre-and intraoperative bacteriological documentation
concordance of pre-and intraoperative bacteriological documentation (division into 3 classes: complete, partial, no - Chi-square test
Measured: preoperative; intraoperative
Secondary outcomes (1)
rates to relapse of the initial infection or a new infection
rates to relapse of the initial infection or a new infection (survival curves according to Kaplan-Meier with log-rank test)
Measured: preoperative; intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study start1 Nov 2014
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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
- 80 participants (actual)
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
- NCT02272205
- Sponsor's protocol ID
- 004-14
- Status last verified
- Sep 2025
- First submitted
- 20 Oct 2014
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Conventional Antibiotic Prophylaxis on the Positivity of Intraoperative Bacteriological Samples During a Change of Hip or Knee Infected at a Time
- ClinicalTrials.gov ID
- NCT02272205
- Acronym / sponsor ID
- 004-14
- Conditions
- Total Hip Replacement
- Keywords
- Hip replacement, Knee replacement, Knee infection, Hip infection, Antibiotic prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 22 Oct 2014 (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.
Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time.
Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. It must be conventionally administered before the surgical incision. In response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. This attitude, however, is not formally validated by the scientific literature. In contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. Our multidisciplinary team opted for a few months for this new strategy. We wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.
Key inclusion criteria (1 listed)
- patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.
Key exclusion criteria (1 listed)
- patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.
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 |
|---|---|---|
| Retrospective analysis of records | Other | – |
Primary outcome
concordance of pre-and intraoperative bacteriological documentation
Time frame: preoperative; intraoperative
concordance of pre-and intraoperative bacteriological documentation (division into 3 classes: complete, partial, no - Chi-square test
1 secondary outcome
rates to relapse of the initial infection or a new infection
Time frame: preoperative; intraoperative
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 5 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Replacement, run by University Hospital, Strasbourg, 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
concordance of pre-and intraoperative bacteriological documentation (time frame: preoperative; intraoperative). 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 5 Sep 2025.