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

T

Technical University of Munich

Status

Unknown

Conditions

Infection of Total Knee Joint Prosthesis

Treatments

Procedure: synovial biopsy of total knee arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT02594930
AAA-11/145

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

undirected and directed biopsy
Experimental group
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)
Treatment:
Procedure: synovial biopsy of total knee arthroplasty

Trial contacts and locations

1

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Central trial contact

Ingo Banke, Dr.; Norbert Harrasser, Dr.

Data sourced from clinicaltrials.gov

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