NCT02272205

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

October 20, 2014

Last Update Submit

September 4, 2025

Conditions

Keywords

Hip replacementKnee replacementKnee infectionHip infectionAntibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

  • concordance of pre-and intraoperative bacteriological documentation

    concordance of pre-and intraoperative bacteriological documentation (division into 3 classes: complete, partial, no - Chi-square test

    preoperative; intraoperative

Secondary Outcomes (1)

  • rates to relapse of the initial infection or a new infection

    preoperative; intraoperative

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

80 patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.

You may qualify if:

  • patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.

You may not qualify if:

  • patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2014

First Posted

October 22, 2014

Study Start

November 1, 2014

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

September 5, 2025

Record last verified: 2025-09