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The purpose of this pilot study is to determine the volume of irrigation required to achieve macroscopic clearance of contaminants during a debridement, antibiotics, and implant retention (DAIR) procedure for periprosthetic joint infection (PJI) of the knee. Given the lack of robust data guiding irrigation volume in this setting, the investigator proposes to use the application of methylene blue dye intraoperatively to simulate contaminant presence. Serial irrigation will be performed, with photographic documentation taken every 2,000mL until visible dye clearance is achieved. This study aims to identify the irrigation volumes that result in gross clearance of simulated contamination, thereby informing the design and stratification of a future randomized controlled trial (RCT) evaluating irrigation strategies in DAIR procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revision Arthroplasty with Documented PJI (DAIR) | Experimental | Participants undergoing revision total knee arthroplasty for periprosthetic joint infection will receive standard of care revision surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, documented intraoperatively. |
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| Primary Total Knee Arthroplasty | Active Comparator | Participants undergoing primary total knee arthroplasty will receive standard of care primary surgery. During the procedure, methylene blue dye will be applied intra-articularly via soaked gauze to simulate contaminant presence. Irrigation will be performed in 2,000 mL increments until macroscopic clearance is achieved, which will be documented intraoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylene Blue 10 MG/ML (intra-articular application) | Drug | 10 mL of 0.25% methylene blue dissolved in 20 mL normal saline, applied intra-articularly via sterile gauze to simulate contaminant presence. Irrigation performed in 2,000 mL increments until macroscopic dye clearance is achieved. Used solely as a surrogate marker; no therapeutic intent |
| Measure | Description | Time Frame |
|---|---|---|
| Irrigation Volume Required for Clearance of Methylene Blue Dye | To determine the volume of irrigation fluid (mL) required to achieve complete macroscopic clearance of methylene blue dye from the surgical site. The irrigation volume will be recorded intraoperatively at each increment and clearance assessed by direct visual confirmation | Within 15 minutes intraoperatively, immediately following methylene blue dye application and completion of irrigation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew R Moya, MD | Contact | 305-243-3000 | arm577@miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Colin A McNamara, MD, MBA | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHealth Tower | Recruiting | Miami | Florida | 33125 | United States |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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| Revision Arthroplasty for PJI (DAIR) | Procedure | Standard of care surgical procedure performed for documented periprosthetic joint infection |
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| Primary Total Knee Arthroplasty | Procedure | Standard of care surgical procedure performed for severe knee osteoarthritis |
|
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |