Comparison of Two Different Techniques of Synovial Biopsy and Resistances of Cutaneous Smears in Suspected PPI

Infection of Total Knee Joint Prosthesis Clinical Trial

— COSPI  

Official title:

Comparison of Directed Versus Undirected Synovial Biopsy in Culture-negative Periprosthetic Joint Infections (With Preoperative Smears From the Skin) of the Knee and Evaluation of Outcome After Revision Joint Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02594930
• Other study ID #: AAA-11/145
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2015
• Last updated: October 17, 2016
• Start date: September 2015
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: Technische Universität München
• Contact: Norbert Harrasser, Dr.
• Phone: 00498941405229
• Email: norbert.harrasser[@]gmx.net
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.

Description:

Successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. The value of a preoperative biopsy remains controversial. We compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic painful knee prosthesis planned for synovial biopsy to detect infection

• Culture-negative joint aspiration

Exclusion Criteria:

• Co-morbidities: Tumour disease, immune suppression

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infection
• Infection of Total Knee Joint Prosthesis

Intervention

Procedure:
• synovial biopsy of total knee arthroplasty
synovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of microbiological and histological results of undirected and directed synovial biopsies	5 microbiological samples and 1 histological sample are taken form the knee undirected via an antero-lateral approach. Afterwards the same sample numbers are taken under arthroscopic view. Correlation of results between those two methods are investigated. If infection is detected two-stage exchange of prosthesis is performed. At this surgery samples from synovia and the implant-bone interface are again taken and again investigated for correlation.	within the first 14 days after surgery	No
Secondary	Correlation of microbiological results from synovial biopsy with intraoperative findings at revision		within the first 14 days after surgery	No