Antibiotic Elution Profile and Outcomes in the Treatment of Prosthetic Joint Infections of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Intra-articular Antibiotic Elution Profile
研究概览
简要总结
Patients presenting with prosthetic joint infections of a total knee replacement who are treated with an antibiotic spacer will be observed prospectively for their response to treatment and antibiotic elution profiles will be measured post-operatively utilizing mass spectrometry from synovial fluid acquired as part of standard of care in the management of prosthetic joint infection. Secondary outcomes including post-operative complications, re-operation rates, and re-admission rates will also be compared.
详细描述
The current study aims to assess the surgical and patient-reported outcomes and in vivo antibiotic elution profile of the management of total knee arthroplasty (TKA) prosthetic joint infection (PJI). Within the standard of care, TKA PJI is treated via a resection arthroplasty and antibiotic cement spacer placement. Patients will be enrolled if they are undergoing surgical management for a chronic TKA PJI and will receive surgical treatment according to the standard of care. In the post-operative period, patients will be monitored for surgical and patient-reported outcomes including re-operation rate, pain scores, complication rates, and re-infection rates. Synovial fluid obtained from intra-articular postoperative drains and at postoperative knee aspirations during reimplantation evaluations will also be utilized for antibiotic concentration quantification via mass spectrometry, if sufficient specimen is available. Patient who undergo surgical management for their chronic TKA PJI will then have their measured antibiotic elution concentrations compared. The study hypothesizes that patients undergoing treatment of a PJI with antibiotic spacer + antibiotic cement spacer will have better surgical and patient-related outcomes with higher antibiotic elution concentrations. These improved outcomes would include lower re-operation rates, lower pain scores, lower wound healing complications, and higher rates of second stage re-implantation observed in patients with higher antibiotic elution concentrations.
Specific aims:
- To evaluate the antibiotic elution profile and post-operative intra-synovial concentrations in the treatment of chronic PJI after TKA.
- To evaluate surgical and patient-related outcomes in chronic TKA PJI patients following implant resection and knee spacer placement, including amount of post-operative drain output, wound healing complications, 30- and 90-day risk of re-operation, pain scores, and rate of second stage re-implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients planned for treatment of a total knee arthroplasty prosthetic joint infection
- •Patients greater than 18 years of age
- •Patients able to provide informed consent
排除标准
- •Prior history of ipsilateral or contralateral prosthetic joint infection warranting operative management
- •Patients less than 18 years of age
- •Patients unable to provide informed consent.
研究组 & 干预措施
Chronic TKA PJI Group
Patients presenting for surgical management of a chronic total knee arthroplasty (TKA) prosthetic joint infection (PJI). Patients will be excluded if they are less than 18 years of age, have a prior history of ipsilateral or contralateral PJI warranting operative management, or are unable to provide informed consent.
干预措施: Treatment of Chronic TKA PJI (Procedure)
结局指标
主要结局
Intra-articular Antibiotic Elution Profile
时间窗: Post-operative day 2 and during 2nd stage re-implantation evaluation (around 10 weeks according to standard of care)
Antibiotic concentration will be quantified utilizing mass spectrometry from intra-articular synovial fluid obtained from post-operative drain and knee aspirations performed for re-implantation evaluation.
次要结局
- Drain Output(Each 12 hours period until removal of the drain up to 5 days postoperatively based on drain output less than 30cc in 12 hours.)
- Wound Healing Complications(up to 6 months following surgery)
- Re-admission Rates(30 days and 90 days post-operatively.)
- Re-operation Rates(30 days and 90 days post-operatively.)
- ESR assessment(baseline, 10 weeks to 6 months posteroperatively)
- Second Stage Re-implantation Rates(Through study completion up to 1 year)
- C-reactive protein assessment(baseline, 10 weeks to 6 months posteroperatively)
- Pain Scores(Daily on postop day 0 until postop day 5, 3 weeks, 6 weeks and 10 weeks, 6 months postoperatively.)
- Knee aspiration cell count(3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.)
- Knee aspiration culture(3 weeks, 6 weeks and 10 weeks - 6 months postoperatively.)
研究者
F. Johannes Plate
Associate Professor
University of Pittsburgh