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

October 17, 2016 updated by: Harrasser, Technical University of Munich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: undirected and directed biopsy
Via an antero-lateral incision of the knee samples are taken without visual control; Afterwards an arthroscope is inserted and samples are taken from 5 defined regions of the knee (suprapatellar pouch, medial and lateral gutter, notch, Hoffa's fat pad)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of microbiological and histological results of undirected and directed synovial biopsies
Time Frame: within the first 14 days after surgery
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of microbiological results from synovial biopsy with intraoperative findings at revision
Time Frame: within the first 14 days after surgery
within the first 14 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Chair: Ruediger Eisenhart-Rothe, Prof., Klinikum rechts der Isar, TU Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

October 31, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAA-11/145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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