Impact of Irrigation Volumes in Revision Total Knee Arthroplasty (TKA) Surgical Washout: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Irrigation Volume Required for Clearance of Methylene Blue Dye
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Total Knee Arthroplasty (TKA) or Primary Total Knee Arthroplasty (TKA) with Prosthetic Joint Infection (PJI)
- •Able to provide informed consent
排除标准
- •Incomplete irrigation documentation
- •Patients with severe immunosuppression (example: chemotherapy, neutropenia, Human Immunodeficiency Virus [HIV], steroid use)
- •Positive fungal, parasitic, or mycobacterial cultures
- •Methylene Blue allergy
- •Patients on Monoamine Oxidase (MAO) inhibitors, Selective Serotonin Reuptake Inhibitors (SSRI), Selective Norepinephrine Reuptake Inhibitors (SNRI), and/or Tricyclic Antidepressants (TCA)
- •History of methemoglobinemia
- •Glucose-6-Phosphate (G6P) Enzyme Deficiency
- •Chronic Kidney disease or Glomerular Filtration Rate (GFR) less than 30mL/min
- •Prisoners
- •Pregnant Woman
研究组 & 干预措施
Revision Arthroplasty with Documented PJI (DAIR)
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.
干预措施: Methylene Blue 10 MG/ML (intra-articular application) (Drug)
Revision Arthroplasty with Documented PJI (DAIR)
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.
干预措施: Revision Arthroplasty for PJI (DAIR) (Procedure)
Primary Total Knee Arthroplasty
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.
干预措施: Methylene Blue 10 MG/ML (intra-articular application) (Drug)
Primary Total Knee Arthroplasty
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.
干预措施: Primary Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Irrigation Volume Required for Clearance of Methylene Blue Dye
时间窗: Within 15 minutes intraoperatively, immediately following methylene blue dye application and completion of irrigation procedure
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
次要结局
未报告次要终点
研究者
Colin A. McNamara
Assistant Professor of Orthopaedic Surgery
University of Miami