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

Primary Purpose

Infection of Total Knee Joint Prosthesis

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
synovial biopsy of total knee arthroplasty
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infection of Total Knee Joint Prosthesis focused on measuring synovial biopsy, knee arthroplasty, infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum rechts der IsarRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

undirected and directed biopsy

Arm Description

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Correlation of microbiological results from synovial biopsy with intraoperative findings at revision

Full Information

First Posted
October 31, 2015
Last Updated
October 17, 2016
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02594930
Brief Title
Comparison of Two Different Techniques of Synovial Biopsy and Resistances of Cutaneous Smears in Suspected PPI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection of Total Knee Joint Prosthesis
Keywords
synovial biopsy, knee arthroplasty, infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
undirected and directed biopsy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
synovial biopsy of total knee arthroplasty
Intervention Description
synovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results
Primary Outcome Measure Information:
Title
Correlation of microbiological and histological results of undirected and directed synovial biopsies
Description
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.
Time Frame
within the first 14 days after surgery
Secondary Outcome Measure Information:
Title
Correlation of microbiological results from synovial biopsy with intraoperative findings at revision
Time Frame
within the first 14 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Norbert Harrasser, Dr.
Phone
00498941405229
Email
norbert.harrasser@gmx.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ingo Banke, Dr.
Phone
00408941405284
Email
ingo@banke.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruediger Eisenhart-Rothe, Prof.
Organizational Affiliation
Klinikum rechts der Isar, TU Munich
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum rechts der Isar
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Harrasser, DR.
Phone
00498941405229
Email
norbert.harrasser@gmx.net
First Name & Middle Initial & Last Name & Degree
Ingo Banke, Dr.
Phone
00498941405284
Email
ingo@banke.eu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31658475
Citation
Scheele C, Krauel I, Pohlig F, Muehlhofer H, Gerdesmeyer L, Lasic I, Prodinger PM, Banke I, von Eisenhart-Rothe R, Harrasser N. Guided and Unguided Biopsy in the Diagnostic of Periprosthetic Infections of the Knee - Evaluation of an Evidence-based Algorithm. Z Orthop Unfall. 2019 Dec;157(6):684-694. doi: 10.1055/a-1034-0923. Epub 2019 Oct 28. English, German.
Results Reference
derived

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

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