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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02594930

Acronym

COSPI

Enrollment

Registered

2015-11-03

Start date

2015-09-30

Completion date

2017-11-30

Last updated

2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of Total Knee Joint Prosthesis

Keywords

synovial biopsy, knee arthroplasty, infection

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.

Interventions

PROCEDUREsynovial biopsy of total knee arthroplasty

synovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation of microbiological and histological results of undirected and directed synovial biopsies	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.

Secondary

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

Countries

Germany

Contacts

Primary ContactNorbert Harrasser, Dr.

norbert.harrasser@gmx.net00498941405229

Backup ContactIngo Banke, Dr.

ingo@banke.eu00408941405284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026