"Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis

Osteoarthritis Clinical Trial

Official title:

Definition of a "Score Infectivity" During Reoperation on Total Hip or Knee Prosthesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02467764
• Other study ID #: 2015-20
• Status: Not yet recruiting
• Phase: N/A
• First received: May 14, 2015
• Last updated: June 7, 2015
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: June 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 hip or knee is a validated treatment of end-stage osteoarthritis, and these interventions commonly make a significant improvement in the quality of life of patients. Infection can occur in 1-5% of cases. Diagnosis is often difficult, but the knowledge of infected or not infected character directly influences the surgical conduct. It is therefore recommended that the positive or negative diagnosis is made in the most reliable way possible, but no single element only allows a low diagnosis. The concomitant use of several clinical, radiological and aggregated into a composite score history could help facilitate this preoperative approach during reoperation on prosthetic joint

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years

• Patients operated in the service in 2014 to care for end-stage hip or knee osteoarthritis by implantation of a total hip or knee prosthesis.

Exclusion Criteria:

• Patients under 18 years

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Retrospective 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	define a composite score on total Hip or Knee Prosthesis		patient's medical data will be collected by health professional for the duration hospital stay, up to 1 year]	No