Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 490
- 试验地点
- 2
- 主要终点
- Subjects free from failure
研究概览
简要总结
The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients who speak English and are willing to sign the consent form
- •Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms < 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as:
- •A sinus communicating with the prosthesis OR
- •Two positive cultures obtained from the prosthesis OR
- •4 of 5 criteria: Elevated ESR (> 30mm/hr) and CRP (> 10mg/L); Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on; leukocyte esterase strip; Elevated synovial neutrophil percentage (> 80%); One positive culture; Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high; Power field in 5 high power fields x 400).
- •OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR
排除标准
- •Patients with a chronic PJI, defined as: presentation of symptoms > 4 weeks in duration.
- •Revision surgery or previous two-stage reimplantation.
研究组 & 干预措施
Single DAIR Surgery Arm
Subjects will undergo a single Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.
干预措施: Single Debridement, Antibiotics and Implant Retention (Procedure)
Double DAIR Surgery Arm
Subjects will undergo planned double Debridement Antibiotics and Implant Retention (DAIR) surgical procedure, along with IV antibiotics and followed by oral suppressive antibiotics. This method is currently used and considered to be standard of care.
干预措施: Planned Double Debridement, Antibiotics and Implant Retention (Procedure)
结局指标
主要结局
Subjects free from failure
时间窗: 1 year following DAIR.
Total number of subjects considered failure free at one year from surgical DAIR procedure. Failure is defined as reoperation for infection within one year from surgical procedure.
次要结局
- Adverse events(10 years following DAIR procedure)
- 1-year surgical reoperation rate(1 year following DAIR procedure)
- Clinical Outcome Scores(1, 5, and 10 years following DAIR procedure)
- 10-year surgical revision rate(10 years following DAIR procedure)
- Hospital length of stay(Approximately 2 weeks following DAIR procedure)
- Resource analysis(Approximately 2 weeks following DAIR procedure)
- Readmission within 90 days of the surgical DAIR procedure(90 days following DAIR procedure)
- 5-year surgical reoperation rate(5 years following DAIR procedure)
- Survivorship(10 years following DAIR procedure)
研究者
Matthew P. Abdel, M.D.
Principal Investigator
Mayo Clinic