COSPI
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
Sponsor study identifier
interventional
30
1 country
1
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2015
Actual (reported)November 3, 2015
Actual (reported)September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Correlation of microbiological results from synovial biopsy with intraoperative findings at revision
within the first 14 days after surgery
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)
synovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results
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Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
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.
Ruediger Eisenhart-Rothe, Prof.
Klinikum rechts der Isar, TU Munich
First Submitted
October 31, 2015
First Posted
November 3, 2015
Study Start
September 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2017
Estimated (date passed)Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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