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

NCT ID: NCT02594930

Last Updated: 2016-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Infection of Total Knee Joint Prosthesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

synovial biopsy of total knee arthroplasty

Intervention Type PROCEDURE

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

Interventions

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synovial biopsy of total knee arthroplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Harrasser

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruediger Eisenhart-Rothe, Prof.

Role: STUDY_CHAIR

Klinikum rechts der Isar, TU Munich

Locations

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Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Norbert Harrasser, Dr.

Role: CONTACT

00498941405229

Ingo Banke, Dr.

Role: CONTACT

00408941405284

Facility Contacts

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Norbert Harrasser, DR.

Role: primary

00498941405229

Ingo Banke, Dr.

Role: backup

00498941405284

References

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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.

Reference Type DERIVED
PMID: 31658475 (View on PubMed)

Other Identifiers

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AAA-11/145

Identifier Type: -

Identifier Source: org_study_id

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