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

Not Applicable

• Conditions: Infection of Total Knee Joint Prosthesis
• Interventions: Procedure: synovial biopsy of total knee arthroplasty

• Registration Number: NCT02594930
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-31
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-19
• Primary Completion: 2017-09
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
undirected and directed biopsy	synovial biopsy of total knee arthroplasty	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany