Knee Hinge Prosthesis Following TKA Infection

TKA Infection Clinical Trial

Official title:

Rotating Hinge Knee Arthroplasty for Septic Revision After Total Knee Arthroplasty: a Retrospective Cohort About 50 Patients With 2 Years Follow up

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02856971
• Other study ID #: 69HCL16_0522
• Status: Active, not recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: October 17, 2016
• Start date: December 2015
• Est. completion date: May 2018

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: May 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 91 Years

Eligibility

Inclusion Criteria:

• All the patients who had a rotating hinge knee arthroplasty for septic revision after total knee arthroplasty, proved by bacteriological samples or purulent drainage at involved site or other obvious clinical signs or radiological signs of infection

Exclusion Criteria:

• Patients who benefited of a hinge prosthesis following a unicompartmental prosthesis, following a mechanical issue on a total prosthesis

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• TKA Infection

Locations

Country	Name	City	State
France	Centre de reference des infections ostéo-articulaires de Lyon,Groupement Hospitalier Nord - Hôpital de la Croix-Rousse - Bât. B, niveau 3 103 Grande-Rue de la Croix-Rousse	Lyon cedex 04

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional results	Objective functional results : joint motions (Physician assessment)	at two years follow up	No
Primary	functional results	Subjective functional results : satisfaction, patient expectations, functional activities. These items are based on the new IKS score	at two years follow up	No
Secondary	infection control	presence or absence of clinical and/or biological signs of infection, recurrence of the infection or new secondary infection	after 2 years follow up	No

External Links

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