NCT03192124|CompletedFDA Device
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Sponsor study identifier
observational
40
1 country
5
Study Start
July 1, 2017
Actual (reported)Primary Completion
December 22, 2018
Actual (reported)Study Completion
March 22, 2019
Actual (reported)To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 22, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2017
Actual (reported)June 19, 2017
Actual (reported)July 1, 2017
Actual (reported)December 22, 2018
Actual (reported)March 22, 2019
Actual (reported)Reduction WBC
To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage
Intraoperative
Bacteria Identification
One Week
Level 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin. Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Potential Subjects (M and F, age 18 years or older) diagnosed with Prosthetic Joint Infection (PJI) following primary total knee (TKA) implantation, who are undergoing I \& D or reoperation (revision) surgery
LA Orthopedic Institute
Los Angeles, California, 90057, United States
University of Kentucky Orthopedic Spine & Total Joint Service
Lexington, Kentucky, 40508, United States
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, 40241, United States
The Cleveland Clinic
Cleveland, Ohio, 22644, United States
The Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Level 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin. Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present.
Kacy Arnold, MBA
Zimmer Biomet
40 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2017
First Posted
June 19, 2017
Study Start
July 1, 2017
Actual (reported)Phage Therapy in Prosthetic Joint Infection Due to Staphylococcus Aureus Treated With DAIR.
Contact the study team to confirm eligibility.
Primary Completion
December 22, 2018
Actual (reported)Study Completion
March 22, 2019
Actual (reported)Last Updated
January 27, 2020
Record last verified: 2020-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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