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To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bactisure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bacteria Identification | To quantitatively and qualitatively assess the synovial fluid for the presence of bacteria prior to and after lavage. This testing will compare the microbial population (species) of the surgical wounds by serial culture dilution, and bacterial identification by PCR before and after irrigation. | One Week |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded from this study if:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold, MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA Orthopedic Institute | Los Angeles | California | 90057 | United States | ||
| University of Kentucky Orthopedic Spine & Total Joint Service |
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| ID | Term |
|---|---|
| D007239 | Infections |
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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.
| 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 |