NCT02594930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

October 31, 2015

Last Update Submit

October 17, 2016

Conditions

Infection of Total Knee Joint Prosthesis

Keywords

synovial biopsyknee arthroplastyinfection

Outcome Measures

Primary Outcomes (1)

  • 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.

    within the first 14 days after surgery

Secondary Outcomes (1)

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

    within the first 14 days after surgery

Study Arms (1)

undirected and directed biopsy

EXPERIMENTAL

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

Interventions

synovial biopsy of total knee arthroplastyPROCEDURE

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

undirected and directed biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic painful knee prosthesis planned for synovial biopsy to detect infection
  • Culture-negative joint aspiration

You may not qualify if:

  • Co-morbidities: Tumour disease, immune suppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31658475DERIVED

MeSH Terms

Conditions

Infections

Study Officials

  • Ruediger Eisenhart-Rothe, Prof.

    Klinikum rechts der Isar, TU Munich

    STUDY CHAIR

Central Study Contacts

Norbert Harrasser, Dr.

CONTACT

00498941405229norbert.harrasser@gmx.net

Ingo Banke, Dr.

CONTACT

00408941405284ingo@banke.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 31, 2015

First Posted

November 3, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

October 19, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)