Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis

Knee Infection Clinical Trial

Official title:

Does the Selection of Patients Helps Healing the Infection After Change in One Step of a Knee Replacement?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02405702
• Other study ID #: 007-14
• Status: Not yet recruiting
• Phase: N/A
• First received: January 25, 2015
• Last updated: April 2, 2015
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2015
• Source: University Hospital, Strasbourg, France
• Contact: Jean-Yves JENNY, MD
• Phone: 33.3.88.55.21.45
• Email: jean-yves.jenny[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The infection of a total knee replacement often imposes changing implants. The change in two step is currently considered the gold standard. The change in one step is a much debated attitude: strictly contra-indicated for some professionals, but others agree to reserve these for favorable suspected cases selected. Several criteria have been proposed in the literature: age, condition, duration of infection, known bacterium responsible, not virulent and sensitive to antibiotics, no fistula, no significant bone destruction. But these criteria are poorly validated, standing over an experience of surgical teams rather than high-level scientific studies. Some authors have proposed to achieve change in one step systematically. The results of these cohorts on healing the infection does not seem very different from the changes in two steps. But it is most often single-center series, uncontrolled, with small numbers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years

• Patient having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010.

Exclusion Criteria:

• Patients under 18 years

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infection
• Knee Infection

Intervention

Other:
• restrospective study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery from the infection measured visually	show that the selection process of patients used improve treatment outcomes of infection in total knee replacement	for the duration of hospital stay, up to 1 year	No