A Randomized Clinical Trial of Static Versus Articulating Antibiotic Spacer for Treatment of Periprosthetic Joint Infection in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Subjects With Repeat Infections
研究概览
简要总结
The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 to 100 years of age.
- •Preoperative diagnosis of bacterial infection by culture which would include a preoperative aspiration and at least three intraoperative cultures. The preoperative aspiration would also be sent for a cell count with differential. All patients would have an erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) drawn in the preoperative phase. Patients with a negative preoperative aspiration, but an actively draining wound or draining sinus tract, would be considered as infected. Intraoperative histopathology would also be obtained in all cases of infected total knee replacement at the time of the resection.
- •Intact extensor mechanism.
- •Adequate soft tissue envelope (no requirement for soft tissue coverage such as a muscle flap or skin graft)
- •Adequate bone stock for knee reconstruction
- •Medical fitness for staged knee reconstruction
排除标准
- •Known Atypical infection (mycobacterial or fungal)
- •Extensor mechanism disruption
- •Inadequate soft tissue envelope requiring muscle flap or skin grafting
- •Inadequate bone stock (T3 or F3 by the Anderson Orthopaedic Research Institute (AORI) classification)
- •Medical status precluding staged knee reconstruction
- •Requirement for hinged knee reconstruction at the time of reimplantation
- •Pregnant women - for women of child bearing age, a negative pregnancy test will be needed prior to enrollment to the study.
研究组 & 干预措施
Static Antibiotic Spacer
Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Static Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
干预措施: Static Antibiotic Spacer Surgical Implant (Device)
Articulating Antibiotic Spacer
Patient with prosthetic joint infection of their knee will have a two stage joint replacement surgery with the Articulating Antibiotic Spacer Surgical Implant being used to treat the joint infection until the second stage of surgery which will replace the joint after the infection is treated.
干预措施: Articulating Antibiotic Spacer Surgical Implant (Device)
结局指标
主要结局
Number of Subjects With Repeat Infections
时间窗: 1 year post-operatively
The rate of repeat infections after re-implantation Total Knee Arthroplasty.
Change in Total Knee Replacement Functional Scores
时间窗: baseline, 1 year post-operatively
Functional scores were measured using the Knee Society Score, a clinical standard for rating the outcome of total knee replacements. Scores range from 0 -100, where a higher score reflects a more positive outcome for the subject.
次要结局
- Pre-operative Range of Motion (ROM)(baseline)
- Post-operative Range of Motion (ROM)(1 year post-operatively)
研究者
Michael J. Taunton, M.D.
Assistant Professor of Orthopedics, College of Medicine
Mayo Clinic