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Clinical Trial Summary

To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.


Clinical Trial Description

This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage.

This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I & D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects. ;


Study Design


Related Conditions & MeSH terms

  • Infection
  • Infection of Total Knee Joint Prosthesis

NCT number NCT03192124
Study type Observational
Source Zimmer Biomet
Contact
Status Completed
Phase
Start date July 1, 2017
Completion date March 22, 2019

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